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Nexplanon

Nexplanon(etonogestrel) – Merck

THERAPEUTIC CLASS

Progestin contraceptive

INDICATIONS

Prevention of pregnancy.

ADULT DOSAGE

Adults: ≥18 yrs: Insert subdermally in the inner side of the nondominant upper arm about 8-10 cm (3-4 inches) above the medial epicondyle of the humerus. Refer to PI for initiation; depends on recent contraceptive history. Remove by the end of the 3rd yr and may be replaced by a new implant at the time of removal using the same incision of the previous implant.

HOW SUPPLIED

Implant: 68mg

CONTRAINDICATIONS

Known or suspected pregnancy, current/history of thrombosis or thromboembolic disorders, benign or malignant liver tumors, active liver disease, undiagnosed abnormal genital bleeding, known or suspected breast cancer, personal history of breast cancer, current/history of other progestin-sensitive cancer.

WARNINGS/PRECAUTIONS

Confirm by palpation immediately after insertion; failure to insert implant properly may lead to an unintended pregnancy. Complications related to insertion or removal procedures (eg, pain, paresthesias, bleeding, hematoma, scarring, infection) may occur. Neural or vascular injury may occur if inserted too deeply. Implant removal may be difficult/impossible if inserted incorrectly, inserted too deeply, not palpable, encased in a fibrous tissue, or has migrated. Failure to remove may result in compromised fertility, ectopic pregnancy, or persistence or occurrence of drug-related adverse event. May cause ectopic pregnancy, thrombotic/vascular events, ovarian cysts, breast cancer, cervical cancer or intraepithelial neoplasia, hepatic adenoma, gallbladder disease, or fluid retention. In case of undiagnosed, persistent, or recurrent abnormal vaginal bleeding, perform appropriate measures to rule out malignancy. Do not use prior to 21 days postpartum. Consider removal of implant if significant depression develops or in case of long-term immobilization due to surgery or illness. Remove implant if thrombosis or jaundice develops. May cause HTN; discourage use in patients with history of HTN related diseases or renal disease; remove if significant increase in BP unresponsive to antihypertensive therapy or sustained HTN occurs. May induce mild insulin resistance and small changes in glucose concentrations; monitor prediabetic and diabetic women. May elevate LDL levels; caution in patients with hyperlipidemia. Restart contraception immediately after removal for continued contraceptive protection. Contact lens wearers may develop visual changes/changes in lens tolerance and should be assessed by an ophthalmologist if occurs. May decrease sex hormone-binding globulin (SHBG) and thyroxine concentrations initially followed by gradual recovery. Not indicated for use before menarche and in patients >65 yrs.

ADVERSE REACTIONS

Change in menstrual bleeding pattern, headache, vaginitis, weight increase, acne, breast pain, abdominal pain, pharyngitis, leukorrhea, influenza-like symptoms, dizziness, dysmenorrhea, back pain, emotional lability, nausea.

DRUG INTERACTIONS

Drugs or herbal products that induce enzymes, including CYP3A4 (eg, barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's wort, topiramate), may decrease levels and effectiveness; consider removal of implant if on long-term treatment with hepatic enzyme inducing drugs. Significant changes (increase or decrease) in plasma levels with HIV protease inhibitors or non-nucleoside reverse transcriptase inhibitors reported. CYP3A4 inhibitors (eg, itraconazole, ketoconazole) may increase levels. Plasma concentrations of coadministered drugs may either increase (eg, cyclosporine) or decrease (eg, lamotrigine).

PREGNANCY

Contraindicated in pregnancy, safe in nursing (after the 4th postpartum week).

MECHANISM OF ACTION

Progestin contraceptive; suppresses ovulation, increases viscosity of cervical mucus, and alters the endometrium.

PHARMACOKINETICS

Absorption: Bioavailability (100%); Cmax=1200pg/mL; Tmax=2 weeks. Distribution: Vd=201L; plasma protein binding [albumin (66%), SHBG (32%)]; found in breast milk. Metabolism: Liver via CYP3A4. Elimination: Urine, feces; T1/2=25 hrs.

ASSESSMENT

Assess for current or past history of thrombosis or thromboembolic disorders, benign or malignant liver tumors, active liver disease, undiagnosed abnormal genital bleeding, known or suspected breast cancer, personal history of breast cancer, current or past history of other progestin-sensitive cancer, history of HTN-related diseases or renal disease, history of depressed mood, diabetes, other conditions where the drug is cautioned or contraindicated, pregnancy/nursing status, and possible drug interactions.

MONITORING

Monitor for complications of insertion/removal of implant, changes in menstrual bleeding pattern, ectopic pregnancy, thrombotic/other vascular events, ovarian cysts, breast/cervical cancer, intraepithelial neoplasia, weight gain, gallbladder disease, fluid retention, and other adverse events. Monitor for visual changes or changes in lens tolerance in patients who wear contact lens and refer to an ophthalmologist if they occur. Monitor for insulin resistance and glucose level changes in diabetic and prediabetic patients, BP with history of HTN, lipid levels with a history of hyperlipidemia. Monitor for signs of liver dysfunction (eg, jaundice). Have yearly visit for BP check and other indicated health care.

PATIENT COUNSELING

Inform of the risks and benefits of the drug. Counsel women about insertion and removal procedure of the implant. Provide a copy of the Patient Labeling and ensure information is understood before insertion and removal. Inform that user card and consent form are included in the package and advise to complete consent form. Give the filled out user card to the patient after insertion so that she will have a record of the location of the implant and when the implant should be removed. Inform that the medication does not protect against HIV infection (AIDS) or other sexually transmitted diseases. Advise that medication may be associated with changes in their normal menstrual bleeding patterns so that they know what to expect.

ADMINISTRATION/STORAGE

Administration: Subdermal route. Refer to PI for insertion, removal, or replacing procedures. Storage: 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Avoid storing at temperatures >30°C (86°F).


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    Nexplanon

    Nexplanon

    Generic Name: etonogestrel (Intradermal route)

    e-toe-noe-JES-trel

    OverviewSide EffectsInteractionsFor ProfessionalsMore…

    Commonly used brand name(s)

    In the U.S.

    • Implanon
    • Nexplanon

    Available Dosage Forms:

    • Implant

    Therapeutic Class: Contraceptive, Progestin

    Pharmacologic Class: Progestin

    Uses For Nexplanon

    Etonogestrel implant is a medicine that is used in women to prevent pregnancy. It is a form of birth control. This medicine contains a hormone in a flexible plastic rod about the size of a matchstick. It is effective for three years when inserted just beneath the skin of your upper arm.

    Etonogestrel implant will not protect a woman from sexually transmitted diseases (STDs), including human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS). The use of latex (rubber) condoms or abstinence (not having sex) is recommended for protection from these diseases.

    This medicine is available only with your doctor’s prescription.

    Before Using Nexplanon

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies on the relationship of age to the effects of etonogestrel implant have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected. This medicine may be used for birth control in teenage females but should not be used before the start of menstruation.

    Geriatric

    Appropriate studies on the relationship of age to the effects of etonogestrel implant have not been performed in the geriatric population. This medicine should not be used in elderly women.

    Breast Feeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Interactions with Medicines

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Isotretinoin
    • Theophylline
    • Tizanidine
    • Tranexamic Acid

    Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Alprazolam
    • Amprenavir
    • Aprepitant
    • Atazanavir
    • Bacampicillin
    • Betamethasone
    • Bexarotene
    • Bosentan
    • Carbamazepine
    • Colesevelam
    • Cyclosporine
    • Darunavir
    • Delavirdine
    • Efavirenz
    • Etravirine
    • Fosamprenavir
    • Fosaprepitant
    • Fosphenytoin
    • Griseofulvin
    • Lamotrigine
    • Licorice
    • Modafinil
    • Mycophenolate Mofetil
    • Mycophenolic Acid
    • Nelfinavir
    • Nevirapine
    • Oxcarbazepine
    • Phenobarbital
    • Phenytoin
    • Pioglitazone
    • Prednisolone
    • Primidone
    • Rifabutin
    • Rifampin
    • Rifapentine
    • Ritonavir
    • Rosuvastatin
    • Rufinamide
    • Selegiline
    • St John’s Wort
    • Telaprevir
    • Topiramate
    • Troglitazone
    • Troleandomycin
    • Voriconazole
    • Warfarin

    Interactions with Food/Tobacco/Alcohol

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

    • Caffeine

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Abnormal or unusual vaginal bleeding (non-menstrual) or
    • Breast cancer, now or in the past or if suspected or
    • Cancer (progestin-sensitive), now or in the past or
    • Liver disease, active or
    • Liver tumors, benign or malignant—Should not be used in patients with these conditions.
    • Blood clots, now or in the past—Should not be used in patients with blood clots in the brain, legs, lungs, eyes, or heart.
    • Depression, or history of or
    • Diabetes or
    • Fluid retention (body swelling) or
    • Gallbladder disease or
    • Heart disease or
    • Hypertension (high blood pressure) or
    • Hyperlipidemia (high cholesterol or fats in the blood)—Use with caution. May make these conditions worse.
    • Obesity—This condition may cause the medicine to not work as well.

    Proper Use of etonogestrel

    This section provides information on the proper use of a number of products that contain etonogestrel. It may not be specific to Nexplanon. Please read with care.

    It is very important that you tell your doctor if you think you might be pregnant or if you missed a period before you receive this medicine. Tests will be done to make sure you are not pregnant before this medicine is inserted.

    This medicine comes with patient instructions. After reading the instructions, you will be asked to sign a USER CARD and a Patient Consent Form before you receive this medicine. The Consent Form tells you about some possible risks when using this medicine, and when it must be removed. Make sure you understand what is in the patient instructions and the Consent Form before you sign it. Keep the USER CARD in a safe place at home with your health records. If you have any questions, ask your doctor to answer them.

    After this medicine is inserted, you should check that it is in place. Gently press your fingertips over the skin in your arm where this medicine was inserted. You should be able to feel the small rod.

    You may have to use another form of birth control (e.g., condoms, diaphragms, or spermicides) until the implant has been in place for 7 days. Talk with your doctor about this.

    Your doctor must remove this medicine after 3 years. If you would like to stop using this medicine, your doctor can remove it at any time.

    If you still want to prevent pregnancy after this medicine is removed, you should start using another form of birth control (e.g., condoms, diaphragms, or spermicides) right away. If you still want to continue using this medicine, your doctor can insert a new implant under your skin after taking the old one out.

    Precautions While Using Nexplanon

    If you will be using the etonogestrel implant for a long time, it is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by this medicine.

    If you become pregnant while using this medicine, you have a slightly higher chance of having an ectopic pregnancy (occurs outside the womb). Ectopic pregnancies can cause serious internal bleeding. Contact your doctor immediately to have the implant removed.

    Tell your doctor if you are breastfeeding or planning to breastfeed. You may start using this medicine if you had a baby more than 4 weeks ago.

    Etonogestrel implant will not protect you against HIV/AIDS or other sexually transmitted diseases. The use of latex (rubber) condoms or abstinence (not having sex) is recommended for protection from these diseases.

    Tell your doctor if you have had an allergic reaction to numbing medicines (anesthetics) or skin cleansers (antiseptics). These medicines will be used when etonogestrel implant is inserted into your arm.

    This medicine may cause several problems related to insertion and removal, such as pain, irritation, swelling, bruising, scarring, or other complications. Talk to your doctor about these possible risks.

    Using this medicine may increase your risk of blood clots in the legs (deep vein thrombosis), lungs (pulmonary embolism), brain (stroke), heart (heart attack), or eyes (blindness). Make sure your doctor knows at least 4 weeks before if you are going to have a surgery or will need to be on bed rest. Your risk of these serious medical problems is greater during surgery or bed rest, or if you smoke cigarettes.

    This medicine may also increase your risk of having irregular monthly periods, ovarian cysts, high blood pressure, gallbladder problems, or liver tumors.

    Call your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

    If you wear contact lenses and you have blurred vision, difficulty in reading, or any other change in vision while using this medicine, check with your doctor right away. Your doctor may want you to get your eyes checked by an eye doctor (ophthalmologist).

    This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests, or if you have any questions, check with your doctor.

    Before you have any medical tests, tell the medical doctor in charge that you are using etonogestrel implant. The results of some tests may be affected by this medicine.

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (St. John’s wort) or vitamin supplements.

    Nexplanon Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor or nurse immediately if any of the following side effects occur:

    More common

    • Breast pain
    • chills
    • cough
    • diarrhea
    • fever
    • general feeling of discomfort or illness
    • headache
    • joint pain
    • loss of appetite
    • muscle aches and pain
    • nausea
    • runny nose
    • shivering
    • sore throat
    • sweating
    • trouble sleeping
    • unusual tiredness or weakness
    • vomiting

    Less common

    • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
    • bloating
    • blurred vision or other changes in vision
    • breast discharge
    • breast enlargement
    • burning while urinating
    • difficult or painful urination
    • difficulty with breathing
    • difficulty with swallowing
    • dizziness
    • fast heartbeat
    • headache, severe and throbbing
    • hives
    • itching
    • lumps in the breasts
    • nervousness
    • noisy breathing
    • painful or tender cysts in the breasts
    • pounding in the ears
    • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    • shortness of breath
    • skin rash
    • slow or fast heartbeat
    • stomach or pelvic discomfort, aching, or heaviness
    • swelling of the hands, ankles, feet, or lower legs
    • tightness in the chest
    • wheezing

    Rare

    • Collection of blood under the skin at the injection site
    • deep, dark purple bruise at the injection site

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    More common

    • Back pain
    • blemishes on the skin, pimples
    • body aches or pain
    • crying
    • depersonalization
    • discouragement
    • dysphoria
    • ear congestion
    • euphoria
    • feeling sad or empty
    • hoarseness
    • increased clear or white vaginal discharge
    • increased weight
    • irregular bleeding cycle
    • irritability
    • itching of the vagina or genital area
    • light vaginal bleeding between regular menstrual periods
    • loss of interest or pleasure
    • loss of voice
    • mental depression
    • nasal congestion
    • pain, cramps, or heavy menstrual bleeding
    • pain during sexual intercourse
    • pain or tenderness around the eyes and cheekbones
    • paranoia
    • quick to react or overreact emotionally
    • rapidly changing moods
    • stomach pain
    • tender, swollen glands in the neck
    • thick, white vaginal discharge with no odor or with a mild odor
    • trouble concentrating
    • voice changes

    Less common

    • Abdominal or stomach bloating and cramping
    • abnormal ejaculation
    • abnormal or decreased touch sensation
    • acid or sour stomach
    • belching
    • bone pain
    • burning feeling in the chest or stomach
    • decreased interest in sexual intercourse
    • difficulty having a bowel movement (stool)
    • difficulty with moving
    • dull ache or feeling of pressure or heaviness in the legs
    • earache, redness, or swelling in the ear
    • excess air or gas in the stomach or intestines
    • feeling of vaginal pressure
    • feeling of warmth
    • hair loss or thinning of the hair
    • heartburn
    • inability to have or keep an erection
    • increased appetite
    • increased hair growth on the forehead, back, arms, and legs
    • indigestion
    • itching skin near damaged veins
    • lack or loss of strength
    • loss in sexual ability, desire, drive, or performance
    • muscle cramping or stiffness
    • passing gas
    • pelvic pain
    • redness of the face, neck, arms, and occasionally upper chest
    • sleepiness or unusual drowsiness
    • sleeplessness
    • sneezing
    • stomach upset or pain
    • stuffy nose
    • swollen joints
    • tenderness in the stomach area
    • unable to sleep
    • vaginal burning or pain
    • weight loss

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

    See also: Nexplanon side effects (in more detail)

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    Nexplanon

    Nexplanon

    Generic Name: etonogestrel (implant) (e toe noe JES trel)

    Brand Name: Implanon, Nexplanon

    OverviewSide EffectsInteractionsFor ProfessionalsMore…

    What is Nexplanon (etonogestrel (implant))?

    Etonogestrel implant contains a hormone that prevents ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

    Etonogestrel implant is used as contraception to prevent pregnancy. The medicine is contained in a small plastic rod that is implanted into the skin of your upper arm. The medicine is released slowly into the body. The rod can remain in place and provide continuous contraception for up to 3 years.

    Etonogestrel implant may also be used for purposes not listed in this medication guide.

    What is the most important information I should know about Nexplanon (etonogestrel (implant))?

    Do not use an etonogestrel implant if you are pregnant. If you have recently had a baby, wait at least 3 weeks (4 weeks if breast-feeding) before receiving an etonogestrel implant.

    You should not use this implant if you are allergic to etonogestrel, or if you have any of the following conditions: unusual vaginal bleeding, liver disease or liver cancer, or if you have ever had breast or uterine cancer, a heart attack, a stroke, or a blood clot.

    Before receiving the etonogestrel implant, tell your doctor if you have diabetes, high blood pressure, high cholesterol, gallbladder disease, kidney disease, an ovarian cyst, headaches, a history of depression, if you are overweight, or if you are allergic to numbing medicines.

    Etonogestrel implant is inserted through a needle into the skin of your upper arm. The medicine is released slowly into the body from the implant. The implant can remain in place to provide continuous contraception for up to 3 years.

    You will most likely have irregular and unpredictable periods while using the etonogestrel implant. Tell your doctor if your periods are very heavy or long-lasting, or if you miss a period (you may be pregnant).

    If you need surgery or medical tests or if you will be on bed rest, you may need to have your etonogestrel implant removed for a short time. Any doctor or surgeon who treats you should know that you have an etonogestrel implant.

    The etonogestrel implant must be removed by the end of the third year after it was inserted and may be replaced at that time with a new implant. If you choose not to replace the implant, your ability to get pregnant will return quickly. Start using another form of birth control right away if you wish to avoid an unintended pregnancy.

    What should I discuss with my healthcare provider before receiving the Nexplanon (etonogestrel (implant))?

    Do not use an etonogestrel implant if you are pregnant. If you have recently had a baby, wait at least 3 weeks (4 weeks if breast-feeding) before receiving an etonogestrel implant.

    You should not use this implant if you are allergic to etonogestrel, or if you have:

    • a history of heart attack, stroke, or blood clot;

    • a history of hormone-related cancer such as breast or uterine cancer;
    • unusual vaginal bleeding that has not been checked by a doctor; or
    • liver disease or liver cancer.

    To make sure you can safely use the etonogestrel implant, tell your doctor if you have any of these other conditions:

    • diabetes;

    • high cholesterol or triglycerides, or if you are overweight;
    • high blood pressure;
    • headaches;
    • gallbladder disease;
    • kidney disease;
    • an ovarian cyst;
    • a history of depression; or
    • if you are allergic to numbing medicines.

    The etonogestrel implant should not be used in girls younger than 18 years old.

    Do not use the implant if you are breast-feeding a baby younger than 4 weeks old.

    How is the etonogestrel implant used?

    Etonogestrel implant is inserted through a needle into the skin of your upper arm, just inside and above the elbow. The implant will be placed in your arm under local anesthetic in your doctor’s office or other clinic setting.

    Before receiving this implant, you may need a pregnancy test to make sure you are not pregnant.

    The timing of when you will receive this implant depends on whether or not you were using birth control before, and what type it was. Follow your doctor’s instructions.

    This implant must be inserted only by a physician or other healthcare provider who has been specially trained in the insertion of the etonogestrel implant. Incorrect placement of the rod too deeply can make it difficult or impossible to remove later on. If the rod is incorrectly inserted and falls out, you will not be protected from unintended pregnancy.

    Once the implant is inserted, you should be able to feel it under your skin. Tell your doctor if you cannot feel the implant under the skin at any time while it is in place.

    Etonogestrel is released slowly into the body from the implant. The implant can remain in place to provide continuous contraception for up to 3 years. If the implant is placed correctly, you will not need to use back-up birth control. Follow your doctor’s instructions.

    After the implant is inserted, your doctor will cover your arm with two bandages. You may remove the top bandage after 24 hours, but leave the smaller bandage on your arm for 3 to 5 days. Keep the area clean and dry while wearing the bandage.

    You will most likely have irregular and unpredictable periods while using the etonogestrel implant. Tell your doctor if your periods are very heavy or long-lasting, or if you miss a period (you may be pregnant).

    Your doctor will need to see you on a regular basis while you are using this medication. You may also need to have routine mammograms. Do not miss any appointments.

    If you need surgery or medical tests or if you will be on bed rest, you may need to have your etonogestrel implant removed for a short time. Any doctor or surgeon who treats you should know that you have an etonogestrel implant.

    The etonogestrel implant must be removed by the end of the third year after it was inserted and may be replaced at that time with a new implant. If you choose not to replace the implant, your ability to get pregnant will return quickly. Some women have become pregnant within the first week after removal of an etonogestrel implant. Start using another form of birth control right away if you wish to avoid an unintended pregnancy.

    Do not use etonogestrel implants for longer than recommended by your doctor.

    What happens if I miss a dose?

    Since etonogestrel is given as an implant by a healthcare professional, you will not be on a frequent dosing schedule. Be sure to see your doctor for removal of the implant by the end of the third year.

    What happens if I overdose?

    If the implant is correctly inserted, an overdose of etonogestrel is highly unlikely. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

    What should I avoid while taking Nexplanon (etonogestrel (implant))?

    Do not smoke while using etonogestrel implant, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by etonogestrel implant.

    Etonogestrel implant will not protect you from sexually transmitted diseases–including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

    Nexplanon (etonogestrel (implant)) side effects

    Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

    Call your doctor at once if you have any of these serious side effects:

    • warmth, redness, swelling, or oozing where the implant was inserted;

    • sudden numbness or weakness, especially on one side of the body;
    • severe pain or cramping in your pelvic area (may be only on one side);
    • sudden severe headache, confusion, pain behind the eyes, problems with vision, speech, or balance;
    • sudden cough, wheezing, rapid breathing, coughing up blood;
    • pain, swelling, warmth, or redness in one or both legs;
    • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
    • a breast lump;
    • swelling in your hands, ankles, or feet;
    • jaundice (yellowing of the skin or eyes);
    • symptoms of depression (sleep problems, weakness, tired feeling, mood changes); or
    • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

    Less serious side effects may include:

    • pain, numbness, or tingling where the implant was inserted;

    • minor bleeding or scarring where the implant was inserted;
    • menstrual cramps, changes in your menstrual periods;
    • mild headache, dizziness, mood changes;
    • vaginal itching or discharge;
    • breast pain;
    • acne;
    • problems with contact lenses;
    • nausea, mild stomach pain;
    • back pain;
    • feeling nervous or depressed;
    • sore throat, flu symptoms; or
    • weight gain.

    This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    See also: Nexplanon side effects (in more detail)

    What other drugs will affect Nexplanon (etonogestrel (implant))?

    Some drugs can make etonogestrel less effective, which may result in pregnancy. Before receiving this implant, tell your doctor if you are using any of the following drugs:

    • bosentan (Tracleer);

    • dexamethasone (Cortastat, Dexasone, Solurex, DexPak);
    • griseofulvin (Fulvicin, Grifulvin);
    • rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), or rifapentine (Priftin);
    • antifungal medication such as itraconazole (Sporanox) or ketoconazole (Nizoral);
    • a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton);
    • drugs to treat hepatitis C, HIV, or AIDS;
    • medicines to treat narcolepsy, such as armodafinil (Nuvigil) or modafinil (Progivil);
    • St. John’s wort; or
    • seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin), or primidone (Mysoline).

    This list is not complete and other drugs may interact with etonogestrel. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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    Nexplanon

    Nexplanon

    Generic Name: etonogestrel

    Dosage Form: implant

    For ProfessionalsSide EffectsInteractionsMore…

    Indications and Usage for Nexplanon

    Nexplanon® is indicated for use by women to prevent pregnancy.

    Nexplanon Dosage and Administration

    The efficacy of Nexplanon does not depend on daily, weekly or monthly administration.

    All healthcare providers should receive instruction and training prior to performing insertion and/or removal of Nexplanon.

    A single Nexplanon implant is inserted subdermally in the upper arm. To reduce the risk of neural or vascular injury, the implant should be inserted at the inner side of the non-dominant upper arm about 8-10 cm (3-4 inches) above the medial epicondyle of the humerus. The implant should be inserted subdermally just under the skin to avoid the large blood vessels and nerves that lie deeper in the subcutaneous tissues in the sulcus between the triceps and biceps muscles. Nexplanon must be inserted by the expiration date stated on the packaging. Nexplanon is a long-acting (up to 3 years), reversible, hormonal contraceptive method. The implant must be removed by the end of the third year and may be replaced by a new implant at the time of removal, if continued contraceptive protection is desired.

    Initiating Contraception With Nexplanon

    IMPORTANT: Rule out pregnancy before inserting the implant.

    Timing of insertion depends on the woman’s recent contraceptive history, as follows:

    No preceding hormonal contraceptive use in the past month

    Nexplanon should be inserted between Day 1 (first day of menstrual bleeding) and Day 5 of the menstrual cycle, even if the woman is still bleeding.

    If inserted as recommended, back-up contraception is not necessary. If deviating from the recommended timing of insertion, the woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.

    Switching contraceptive method to Nexplanon

    Combination hormonal contraceptives:

    Nexplanon should preferably be inserted on the day after the last active tablet of the previous combined oral contraceptive or on the day of removal of the vaginal ring or transdermal patch. At the latest, Nexplanon should be inserted on the day following the usual tablet-free, ring-free, patch-free or placebo tablet interval of the previous combined hormonal contraceptive.

    If inserted as recommended, back-up contraception is not necessary. If deviating from the recommended timing of insertion, the woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.

    Progestin-only contraceptives:

    There are several types of progestin-only methods. Nexplanon should be inserted as follows:

    • Injectable Contraceptives: Insert Nexplanon on the day the next injection is due.
    • Minipill: A woman may switch to Nexplanon on any day of the month. Nexplanon should be inserted within 24 hours after taking the last tablet.
    • Contraceptive implant or intrauterine system (IUS): Insert Nexplanon on the same day the previous contraceptive implant or IUS is removed.

    If inserted as recommended, back-up contraception is not necessary. If deviating from the recommended timing of insertion, the woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.

    Following abortion or miscarriage

    • First Trimester: Nexplanon should be inserted within 5 days following a first trimester abortion or miscarriage.
    • Second Trimester: Insert Nexplanon between 21 to 28 days following second trimester abortion or miscarriage.

    If inserted as recommended, back-up contraception is not necessary. If deviating from the recommended timing of insertion, the woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.

    Postpartum

    • Not Breastfeeding: Nexplanon should be inserted between 21 to 28 days postpartum. If inserted as recommended, back-up contraception is not necessary. If deviating from the recommended timing of insertion, the woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.
    • Breastfeeding: Nexplanon should be inserted after the fourth postpartum week [see Use in Specific Populations (8.3)]. The woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.

    Insertion of Nexplanon

    The basis for successful use and subsequent removal of Nexplanon is a correct and carefully performed subdermal insertion of the single, rod-shaped implant in accordance with the instructions. Both the healthcare provider and the woman should be able to feel the implant under the skin after placement.

    All healthcare providers performing insertions and/or removals of Nexplanon should receive instructions and training prior to inserting or removing the implant. Information concerning the insertion and removal of Nexplanon will be sent upon request free of charge [1-877-467-5266].

    Preparation

    Prior to inserting Nexplanon carefully read the instructions for insertion as well as the full prescribing information.

    Before insertion of Nexplanon, the healthcare provider should confirm that:

    • The woman is not pregnant nor has any other contraindication for the use of Nexplanon [see Contraindications (4)].
    • The woman has had a medical history and physical examination, including a gynecologic examination, performed.
    • The woman understands the benefits and risks of Nexplanon.
    • The woman has received a copy of the Patient Labeling included in packaging.
    • The woman has reviewed and completed a consent form to be maintained with the woman’s chart.
    • The woman does not have allergies to the antiseptic and anesthetic to be used during insertion.

    Insert Nexplanon under aseptic conditions.

    The following equipment is needed for the implant insertion:

    • An examination table for the woman to lie on
    • Sterile surgical drapes, sterile gloves, antiseptic solution, sterile marker (optional)
    • Local anesthetic, needles, and syringe
    • Sterile gauze, adhesive bandage, pressure bandage

    Insertion Procedure

    Step 1. Have the woman lie on her back on the examination table with her non-dominant arm flexed at the elbow and externally rotated so that her wrist is parallel to her ear or her hand is positioned next to her head (Figure 1).

    Figure 1

    Step 2. Identify the insertion site, which is at the inner side of the non-dominant upper arm about 8-10 cm (3-4 inches) above the medial epicondyle of the humerus (Figure 2). The implant should be inserted subdermally just under the skin to avoid the large blood vessels and nerves that lie deeper in the subcutaneous tissue in the sulcus between the triceps and biceps muscles [see Warnings and Precautions (5.1)].

    Step 3. Make two marks with a sterile marker: first, mark the spot where the etonogestrel implant will be inserted, and second, mark a spot a few centimeters proximal to the first mark (Figure 2). This second mark will later serve as a direction guide during insertion.

    Figure 2

    Step 4. Clean the insertion site with an antiseptic solution.

    Step 5. Anesthetize the insertion area (for example, with anesthetic spray or by injecting 2 mL of 1% lidocaine just under the skin along the planned insertion tunnel).

    Step 6. Remove the sterile preloaded disposable Nexplanon applicator carrying the implant from its blister. The applicator should not be used if sterility is in question.

    Step 7. Hold the applicator just above the needle at the textured surface area. Remove the transparent protection cap by sliding it horizontally in the direction of the arrow away from the needle (Figure 3). If the cap does not come off easily, the applicator should not be used. You can see the white colored implant by looking into the tip of the needle. Do not touch the purple slider until you have fully inserted the needle subdermally, as it will retract the needle and prematurely release the implant from the applicator.

    Figure 3

    Step 8. With your free hand, stretch the skin around the insertion site with thumb and index finger (Figure 4).

    Figure 4

    Step 9. Puncture the skin with the tip of the needle angled about 30° (Figure 5).

    Figure 5

    Step 10. Lower the applicator to a horizontal position. While lifting the skin with the tip of the needle (Figure 6), slide the needle to its full length. You may feel slight resistance but do not exert excessive force. If the needle is not inserted to its full length, the implant will not be inserted properly.

    You can best see movement of the needle if you are seated and are looking at the applicator from the side and NOT from above. In this position, you can clearly see the insertion site and the movement of the needle just under the skin.

    Figure 6

    Step 11. Keep the applicator in the same position with the needle inserted to its full length. If needed, you may use your free hand to keep the applicator in the same position during the following procedure. Unlock the purple slider by pushing it slightly down. Move the slider fully back until it stops (Figure 7). The implant is now in its final subdermal position, and the needle is locked inside the body of the applicator. The applicator can now be removed. If the applicator is not kept in the same position during this procedure or if the purple slider is not completely moved to the back, the implant will not be inserted properly.

    Figure 7

    Step 12. Always verify the presence of the implant in the woman’s arm immediately after insertion by palpation. By palpating both ends of the implant, you should be able to confirm the presence of the 4 cm rod (Figure 8).

    Figure 8

    If you cannot feel the implant or are in doubt of its presence,

    • Check the applicator. The needle should be fully retracted and only the purple tip of the obturator should be visible.
    • Use other methods to confirm the presence of the implant. Suitable methods are: two-dimensional X-ray, X-ray computerized tomography (CT scan), ultrasound scanning (USS) with a high-frequency linear array transducer (10 MHz or greater) or magnetic resonance imaging (MRI). If these methods fail, call 1-877-467-5266 for information on the procedure for measuring etonogestrel blood levels.

    Until the presence of the implant has been verified, the woman should be advised to use a non-hormonal contraceptive method, such as condoms.

    Step 13. Place a small adhesive bandage over the insertion site. Request that the woman palpate the implant.

    Step 14. Apply a pressure bandage with sterile gauze to minimize bruising. The woman may remove the pressure bandage in 24 hours and the small bandage over the insertion site after 3 to 5 days.

    Step 15. Complete the USER CARD and give it to the woman to keep. Also, complete the PATIENT CHART LABEL and affix it to the woman’s medical record.

    Step 16. The applicator is for single use only and should be disposed in accordance with the Center for Disease Control and Prevention guidelines for handling of hazardous waste.

    Removal of Nexplanon

    Preparation

    Before initiating the removal procedure, the healthcare provider should carefully read the instructions for removal and consult the USER CARD and/or the PATIENT CHART LABEL for the location of the implant. The exact location of the implant in the arm should be verified by palpation. If the implant is not palpable, two-dimensional X-ray can be performed to verify its presence.

    A non-palpable implant should always be first located prior to removal. Suitable methods for localization include: two-dimensional X-ray, X-ray computer tomography (CT), ultrasound scanning (USS) with a high-frequency linear array transducer (10 MHz or greater) or magnetic resonance imaging (MRI). If these imaging methods fail to locate the implant, etonogestrel blood level determination can be used for verification of the presence of the implant. For details on etonogestrel blood level determination, call 1-877-467-5266 for further instructions.

    After localization of a non-palpable implant, consider conducting removal with ultrasound guidance.

    There have been occasional reports of migration of the implant; usually this involves minor movement relative to the original position. This may complicate localization of the implant by palpation, CT, USS and/or MRI, and removal may require a larger incision and more time.

    Exploratory surgery without knowledge of the exact location of the implant is strongly discouraged. Removal of deeply inserted implants should be conducted with caution in order to prevent injury to deeper neural or vascular structures in the arm and be performed by healthcare providers familiar with the anatomy of the arm.

    Before removal of the implant, the healthcare provider should confirm that:

    • The woman does not have allergies to the antiseptic or anesthetic to be used.

    Remove the implant under aseptic conditions.

    The following equipment is needed for removal of the implant:

    • An examination table for the woman to lie on
    • Sterile surgical drapes, sterile gloves, antiseptic solution, sterile marker (optional)
    • Local anesthetic, needles, and syringe
    • Sterile scalpel, forceps (straight and curved mosquito)
    • Skin closure, sterile gauze, adhesive bandage and pressure bandages

    Removal Procedure

    Step 1. Clean the site where the incision will be made and apply an antiseptic. Locate the implant by palpation and mark the distal end (end closest to the elbow), for example, with a sterile marker (Figure 9).

    Figure 9

    Step 2. Anesthetize the arm, for example, with 0.5 to 1 mL 1% lidocaine at the marked site where the incision will be made (Figure 10). Be sure to inject the local anesthetic under the implant to keep it close to the skin surface.

    Figure 10

    Step 3. Push down the proximal end of the implant (Figure 11) to stabilize it; a bulge may appear indicating the distal end of the implant. Starting at the distal tip of the implant, make a longitudinal incision of 2 mm towards the elbow.

    Figure 11

    Step 4. Gently push the implant towards the incision until the tip is visible. Grasp the implant with forceps (preferably curved mosquito forceps) and gently remove the implant (Figure 12).

    Figure 12

    Step 5. If the implant is encapsulated, make an incision into the tissue sheath and then remove the implant with the forceps (Figures 13 and 14).

      
    Figure 13 Figure 14

    Step 6. If the tip of the implant does not become visible in the incision, gently insert a forceps into the incision (Figure 15). Flip the forceps over into your other hand (Figure 16).

    Figure 15 Figure 16

    Step 7. With a second pair of forceps carefully dissect the tissue around the implant and grasp the implant (Figure 17). The implant can then be removed.

    Figure 17

    Step 8. Confirm that the entire implant, which is 4 cm long, has been removed by measuring its length. If a partial implant (less than 4 cm) is removed, the remaining piece should be removed by following the instructions in section 2.3. [See Dosage and Administration (2.3).] If the woman would like to continue using Nexplanon, a new implant may be inserted immediately after the old implant is removed using the same incision [see Dosage and Administration (2.4)].

    Step 9. After removing the implant, close the incision with a steri-strip and apply an adhesive bandage.

    Step 10. Apply a pressure bandage with sterile gauze to minimize bruising. The woman may remove the pressure bandage in 24 hours and the small bandage in 3 to 5 days.

    Replacing Nexplanon

    Immediate replacement can be done after removal of the previous implant and is similar to the insertion procedure described in section 2.2 Insertion of Nexplanon.

    The new implant may be inserted in the same arm, and through the same incision from which the previous implant was removed. If the same incision is being used to insert a new implant, anesthetize the insertion site [for example, 2 mL lidocaine (1%)] applying it just under the skin along the ‘insertion canal.’

    Follow the subsequent steps in the insertion instructions [see Dosage and Administration (2.2)].

    Dosage Forms and Strengths

    Single, white/off-white, soft, radiopaque, flexible, ethylene vinylacetate (EVA) implant, 4 cm in length and 2 mm in diameter containing 68 mg etonogestrel and 15 mg of barium sulfate.

    Contraindications

    Nexplanon should not be used in women who have

    • Known or suspected pregnancy
    • Current or past history of thrombosis or thromboembolic disorders
    • Liver tumors, benign or malignant, or active liver disease
    • Undiagnosed abnormal genital bleeding
    • Known or suspected breast cancer, personal history of breast cancer, or other progestin-sensitive cancer, now or in the past
    • Allergic reaction to any of the components of Nexplanon [see Adverse Reactions (6)]

    Warnings and Precautions

    The following information is based on experience with either the non-radiopaque etonogestrel implant (IMPLANON), other progestin-only contraceptives, or experience with combination (estrogen plus progestin) oral contraceptives.

    Complications of Insertion and Removal

    Nexplanon should be inserted subdermally so that it will be palpable after insertion, and this should be confirmed by palpation immediately after insertion. Failure to insert Nexplanon properly may go unnoticed unless it is palpated immediately after insertion. Undetected failure to insert the implant may lead to an unintended pregnancy. Complications related to insertion and removal procedures, such as pain, paresthesias, bleeding, hematoma, scarring or infection, may occur.

    If Nexplanon is inserted too deeply (intramuscular or in the fascia), neural or vascular injury may occur. To reduce the risk of neural or vascular injury, Nexplanon should be inserted at the inner side of the non-dominant upper arm about 8-10 cm (3-4 inches) above the medial epicondyle of the humerus. Nexplanon should be inserted subdermally just under the skin to avoid the large blood vessels and nerves that lie deeper in the subcutaneous tissues in the sulcus between the triceps and biceps muscles. Deep insertions of the non-radiopaque etonogestrel implant (IMPLANON) have been associated with paraesthesia (due to neural injury) and migration of the implant (due to intramuscular or fascial insertion), and in a very few cases with intravascular insertion. If infection develops at the insertion site, start suitable treatment. If the infection persists, the implant should be removed. Incomplete insertions or infections may lead to expulsion.

    Implant removal may be difficult or impossible if the implant is not inserted correctly, is inserted too deeply, not palpable, encased in fibrous tissue, or has migrated. Deep insertions may lead to difficult localization of the implant and may also result in the need for a surgical procedure in an operating room in order to remove the implant. Exploratory surgery without knowledge of the exact location of the implant is strongly discouraged. Removal of deeply inserted implants should be conducted with caution in order to prevent injury to deeper neural or vascular structures in the arm and be performed by healthcare providers familiar with the anatomy of the arm. Failure to remove the implant may result in continued effects of etonogestrel, such as compromised fertility, ectopic pregnancy, or persistence or occurrence of a drug-related adverse event.

    Changes in Menstrual Bleeding Patterns

    After starting Nexplanon, women are likely to have a change from their normal menstrual bleeding pattern. These may include changes in bleeding frequency (absent, less, more frequent or continuous), intensity (reduced or increased) or duration. In clinical trials of the non-radiopaque etonogestrel implant (IMPLANON), bleeding patterns ranged from amenorrhea (1 in 5 women) to frequent and/or prolonged bleeding (1 in 5 women). The bleeding pattern experienced during the first three months of Nexplanon use is broadly predictive of the future bleeding pattern for many women. Women should be counseled regarding the bleeding pattern changes they may experience so that they know what to expect. Abnormal bleeding should be evaluated as needed to exclude pathologic conditions or pregnancy.

    In clinical studies of the non-radiopaque etonogestrel implant, reports of changes in bleeding pattern were the most common reason for stopping treatment (11.1%). Irregular bleeding (10.8%) was the single most common reason women stopped treatment, while amenorrhea (0.3%) was cited less frequently. In these studies, women had an average of 17.7 days of bleeding or spotting every 90 days (based on 3,315 intervals of 90 days recorded by 780 patients). The percentages of patients having 0, 1-7, 8-21, or >21 days of spotting or bleeding over a 90-day interval while using the non-radiopaque etonogestrel implant are shown in Table 1.

    Table 1: Percentages of Patients With 0, 1-7, 8-21, or >21 Days of Spotting or Bleeding Over a 90-Day Interval While Using the Non-Radiopaque Etonogestrel Implant (IMPLANON)
    Total Days of Spotting or Bleeding Percentage of Patients
    Treatment Days 91-180

    (N = 745)

    Treatment Days 271-360

    (N = 657)

    Treatment Days 631-720

    (N = 547)

    0 Days 19% 24% 17%
    1-7 Days 15% 13% 12%
    8-21 Days 30% 30% 37%
    >21 Days 35% 33% 35%

    Bleeding patterns observed with use of the non-radiopaque etonogestrel implant for up to 2 years, and the proportion of 90-day intervals with these bleeding patterns, are summarized in Table 2.

    Table 2: Bleeding Patterns Using the Non-Radiopaque Etonogestrel Implant (IMPLANON) During the First 2 Years of Use*
    BLEEDING PATTERNS DEFINITIONS %†
    *
    Based on 3315 recording periods of 90 days duration in 780 women, excluding the first 90 days after implant insertion
    % = Percentage of 90-day intervals with this pattern
      Infrequent Less than three bleeding and/or spotting episodes in 90 days (excluding amenorrhea) 33.6
      Amenorrhea No bleeding and/or spotting in 90 days 22.2
      Prolonged Any bleeding and/or spotting episode lasting more than 14 days in 90 days 17.7
      Frequent More than 5 bleeding and/or spotting episodes in 90 days 6.7

    In case of undiagnosed, persistent, or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy.

    Ectopic Pregnancies

    As with all progestin-only contraceptive products, be alert to the possibility of an ectopic pregnancy among women using Nexplanon who become pregnant or complain of lower abdominal pain. Although ectopic pregnancies are uncommon among women using Nexplanon, a pregnancy that occurs in a woman using Nexplanon may be more likely to be ectopic than a pregnancy occurring in a woman using no contraception.

    Thrombotic and Other Vascular Events

    The use of combination hormonal contraceptives (progestin plus estrogen) increases the risk of vascular events, including arterial events (strokes and myocardial infarctions) or deep venous thrombotic events (venous thromboembolism, deep venous thrombosis, retinal vein thrombosis, and pulmonary embolism). Nexplanon is a progestin-only contraceptive. It is unknown whether this increased risk is applicable to etonogestrel alone. It is recommended, however, that women with risk factors known to increase the risk of venous and arterial thromboembolism be carefully assessed.

    There have been postmarketing reports of serious arterial and venous thromboembolic events, including cases of pulmonary emboli (some fatal), deep vein thrombosis, myocardial infarction, and strokes, in women using the non-radiopaque etonogestrel implant. Nexplanon should be removed in the event of a thrombosis.

    Due to the risk of thromboembolism associated with pregnancy and immediately following delivery, Nexplanon should not be used prior to 21 days postpartum. Women with a history of thromboembolic disorders should be made aware of the possibility of a recurrence.

    Evaluate for retinal vein thrombosis immediately if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions.

    Consider removal of the Nexplanon implant in case of long-term immobilization due to surgery or illness.

    Ovarian Cysts

    If follicular development occurs, atresia of the follicle is sometimes delayed, and the follicle may continue to grow beyond the size it would attain in a normal cycle. Generally, these enlarged follicles disappear spontaneously. On rare occasion, surgery may be required.

    Carcinoma of the Breast and Reproductive Organs

    Women who currently have or have had breast cancer should not use hormonal contraception because breast cancer may be hormonally sensitive [see Contraindications (4)]. Some studies suggest that the use of combination hormonal contraceptives might increase the incidence of breast cancer; however, other studies have not confirmed such findings.

    Some studies suggest that the use of combination hormonal contraceptives is associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. However, there is controversy about the extent to which these findings are due to differences in sexual behavior and other factors.

    Women with a family history of breast cancer or who develop breast nodules should be carefully monitored.

    Liver Disease

    Disturbances of liver function may necessitate the discontinuation of hormonal contraceptive use until markers of liver function return to normal. Remove Nexplanon if jaundice develops.

    Hepatic adenomas are associated with combination hormonal contraceptives use. An estimate of the attributable risk is 3.3 cases per 100,000 for combination hormonal contraceptives users. It is not known whether a similar risk exists with progestin-only methods like Nexplanon.

    The progestin in Nexplanon may be poorly metabolized in women with liver impairment. Use of Nexplanon in women with active liver disease or liver cancer is contraindicated [see Contraindications (4)].

    Weight Gain

    In clinical studies, mean weight gain in U.S. non-radiopaque etonogestrel implant (IMPLANON) users was 2.8 pounds after one year and 3.7 pounds after two years. How much of the weight gain was related to the non-radiopaque etonogestrel implant is unknown. In studies, 2.3% of the users reported weight gain as the reason for having the non-radiopaque etonogestrel implant removed.

    Elevated Blood Pressure

    Women with a history of hypertension-related diseases or renal disease should be discouraged from using hormonal contraception. For women with well-controlled hypertension, use of Nexplanon can be considered. Women with hypertension using Nexplanon should be closely monitored. If sustained hypertension develops during the use of Nexplanon, or if a significant increase in blood pressure does not respond adequately to antihypertensive therapy, Nexplanon should be removed.

    Gallbladder Disease

    Studies suggest a small increased relative risk of developing gallbladder disease among combination hormonal contraceptive users. It is not known whether a similar risk exists with progestin-only methods like Nexplanon.

    Carbohydrate and Lipid Metabolic Effects

    Use of Nexplanon may induce mild insulin resistance and small changes in glucose concentrations of unknown clinical significance. Carefully monitor prediabetic and diabetic women using Nexplanon.

    Women who are being treated for hyperlipidemia should be followed closely if they elect to use Nexplanon. Some progestins may elevate LDL levels and may render the control of hyperlipidemia more difficult.

    Depressed Mood

    Women with a history of depressed mood should be carefully observed. Consideration should be given to removing Nexplanon in patients who become significantly depressed.

    Return to Ovulation

    In clinical trials with the non-radiopaque etonogestrel implant (IMPLANON), the etonogestrel levels in blood decreased below sensitivity of the assay by one week after removal of the implant. In addition, pregnancies were observed to occur as early as 7 to 14 days after removal. Therefore, a woman should re-start contraception immediately after removal of the implant if continued contraceptive protection is desired.

    Fluid Retention

    Hormonal contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention. It is unknown if Nexplanon causes fluid retention.

    Contact Lenses

    Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.

    Monitoring

    A woman who is using Nexplanon should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated health care.

    Drug-Laboratory Test Interactions

    Sex hormone-binding globulin concentrations may be decreased for the first six months after Nexplanon insertion followed by gradual recovery. Thyroxine concentrations may initially be slightly decreased followed by gradual recovery to baseline.

    Adverse Reactions

    The following adverse reactions reported with the use of hormonal contraception are discussed elsewhere in the labeling:

    • Changes in Menstrual Bleeding Patterns [see Warnings and Precautions (5.2)]
    • Ectopic Pregnancies [see Warnings and Precautions (5.3)]
    • Thrombotic and Other Vascular Events [see Warnings and Precautions (5.4)]
    • Liver Disease [see Warnings and Precautions (5.7)]

    Clinical Trials Experience

    Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

    In clinical trials involving 942 women who were evaluated for safety, change in menstrual bleeding patterns (irregular menses) was the most common adverse reaction causing discontinuation of use of the non-radiopaque etonogestrel implant (IMPLANON) (11.1% of women).

    Adverse reactions that resulted in a rate of discontinuation of ≥1% are shown in Table 3.

    Table 3: Adverse Reactions Leading to Discontinuation of Treatment in 1% or More of Subjects in Clinical Trials of the Non-Radiopaque Etonogestrel Implant (IMPLANON)
    Adverse Reactions All Studies

    N = 942

    *
    Includes “frequent”, “heavy”, “prolonged”, “spotting”, and other patterns of bleeding irregularity.
    Among US subjects (N=330), 6.1% experienced emotional lability that led to discontinuation.
    Among US subjects (N=330), 2.4% experienced depression that led to discontinuation.
    Bleeding Irregularities* 11.1%
    Emotional Lability† 2.3%
    Weight Increase 2.3%
    Headache 1.6%
    Acne 1.3%
    Depression‡ 1.0%

    Other adverse reactions that were reported by at least 5% of subjects in the non-radiopaque etonogestrel implant clinical trials are listed in Table 4.

    Table 4: Common Adverse Reactions Reported by ≥5% of Subjects in Clinical Trials With the Non-Radiopaque Etonogestrel Implant (IMPLANON)
    Adverse Reactions All Studies

    N = 942

    Headache 24.9%
    Vaginitis 14.5%
    Weight increase 13.7%
    Acne 13.5%
    Breast pain 12.8%
    Abdominal pain 10.9%
    Pharyngitis 10.5%
    Leukorrhea 9.6%
    Influenza-like symptoms 7.6%
    Dizziness 7.2%
    Dysmenorrhea 7.2%
    Back pain 6.8%
    Emotional lability 6.5%
    Nausea 6.4%
    Pain 5.6%
    Nervousness 5.6%
    Depression 5.5%
    Hypersensitivity 5.4%
    Insertion site pain 5.2%

    In a clinical trial of Nexplanon, in which investigators were asked to examine the implant site after insertion, implant site reactions were reported in 8.6% of women. Erythema was the most frequent implant site complication, reported during and/or shortly after insertion, occurring in 3.3% of subjects. Additionally, hematoma (3.0%), bruising (2.0%), pain (1.0%), and swelling (0.7%) were reported.

    Postmarketing Experience

    The following additional adverse reactions have been identified during post-approval use of the non-radiopaque etonogestrel implant (IMPLANON). Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

    Gastrointestinal disorders: constipation, diarrhea, flatulence, vomiting.

    General disorders and administration site conditions: edema, fatigue, implant site reaction, pyrexia.

    Immune system disorders: anaphylactic reactions.

    Infections and infestations: rhinitis, urinary tract infection.

    Investigations: clinically relevant rise in blood pressure, weight decreased.

    Metabolism and nutrition disorders: increased appetite.

    Musculoskeletal and connective tissue disorders: arthralgia, musculoskeletal pain, myalgia.

    Nervous system disorders: convulsions, migraine, somnolence.

    Pregnancy, puerperium and perinatal conditions: ectopic pregnancy.

    Psychiatric disorders: anxiety, insomnia, libido decreased.

    Renal and urinary disorders: dysuria.

    Reproductive system and breast disorders: breast discharge, breast enlargement, ovarian cyst, pruritus genital, vulvovaginal discomfort.

    Skin and subcutaneous tissue disorders: angioedema, aggravation of angioedema and/or aggravation of hereditary angioedema, alopecia, chloasma, hypertrichosis, pruritus, rash, seborrhea, urticaria.

    Vascular disorders: hot flush.

    Complications related to insertion or removal of the non-radiopaque etonogestrel implant reported include: bruising, slight local irritation, pain or itching, fibrosis at the implant site, paresthesia or paresthesia-like events, scarring and abscess.

    Drug Interactions

    Changes in Contraceptive Effectiveness Associated With Coadministration of Other Products

    Drugs or herbal products that induce enzymes, including CYP3A4, that metabolize progestins may decrease the plasma concentrations of progestins, and may decrease the effectiveness of Nexplanon. In women on long-term treatment with hepatic enzyme inducing drugs, it is recommended to remove the implant and to advise a contraceptive method that is unaffected by the interacting drug.

    Some of these drugs or herbal products that induce enzymes, including CYP3A4, include:

    • barbiturates
    • bosentan
    • carbamazepine
    • felbamate
    • griseofulvin
    • oxcarbazepine
    • phenytoin
    • rifampin
    • St. John’s wort
    • topiramate

    HIV Antiretrovirals

    Significant changes (increase or decrease) in the plasma levels of progestin have been noted in some cases of co-administration with HIV protease inhibitors or with non-nucleoside reverse transcriptase inhibitors. Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.

    Increase in Plasma Concentrations of Etonogestrel Associated With Coadministered Drugs

    CYP3A4 inhibitors such as itraconazole or ketoconazole may increase plasma concentrations of etonogestrel.

    Changes in Plasma Concentrations of Coadministered Drugs

    Hormonal contraceptives may affect the metabolism of other drugs. Consequently, plasma concentrations may either increase (for example, cyclosporin) or decrease (for example, lamotrigine). Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.

    USE IN SPECIFIC POPULATIONS

    Pregnancy

    Nexplanon is not indicated for use during pregnancy [see Contraindications (4)].

    Teratology studies have been performed in rats and rabbits using oral administration up to 390 and 790 times the human etonogestrel dose (based upon body surface), respectively, and revealed no evidence of fetal harm due to etonogestrel exposure.

    Studies have revealed no increased risk of birth defects in women who have used combination oral contraceptives before pregnancy or during early pregnancy. There is no evidence that the risk associated with etonogestrel is different from that of combination oral contraceptives.

    Nexplanon should be removed if maintaining a pregnancy.

    Nursing Mothers

    Based on limited clinical data, Nexplanon may be used during breastfeeding after the fourth postpartum week. Use of Nexplanon before the fourth postpartum week has not been studied. Small amounts of etonogestrel are excreted in breast milk. During the first months after insertion of Nexplanon, when maternal blood levels of etonogestrel are highest, about 100 ng of etonogestrel may be ingested by the child per day based on an average daily milk ingestion of 658 mL. Based on daily milk ingestion of 150 mL/kg, the mean daily infant etonogestrel dose one month after insertion of the non-radiopaque etonogestrel implant (IMPLANON) is about 2.2% of the weight-adjusted maternal daily dose, or about 0.2% of the estimated absolute maternal daily dose. The health of breastfed infants whose mothers began using the non-radiopaque etonogestrel implant during the fourth to eighth week postpartum (n=38) was evaluated in a comparative study with infants of mothers using a non-hormonal IUD (n=33). They were breastfed for a mean duration of 14 months and followed up to 36 months of age. No significant effects and no differences between the groups were observed on the physical and psychomotor development of these infants. No differences between groups in the production or quality of breast milk were detected.

    Healthcare providers should discuss both hormonal and non-hormonal contraceptive options, as steroids may not be the initial choice for these patients.

    Pediatric Use

    Safety and efficacy of Nexplanon have been established in women of reproductive age. Safety and efficacy of Nexplanon are expected to be the same for postpubertal adolescents. However, no clinical studies have been conducted in women less than 18 years of age. Use of this product before menarche is not indicated.

    Geriatric Use

    This product has not been studied in women over 65 years of age and is not indicated in this population.

    Hepatic Impairment

    No studies were conducted to evaluate the effect of hepatic disease on the disposition of Nexplanon. The use of Nexplanon in women with active liver disease is contraindicated [see Contraindications (4)].

    Renal Impairment

    No studies were conducted to evaluate the effect of renal disease on the disposition of Nexplanon.

    Overweight Women

    The effectiveness of the etonogestrel implant in women who weighed more than 130% of their ideal body weight has not been defined because such women were not studied in clinical trials. Serum concentrations of etonogestrel are inversely related to body weight and decrease with time after implant insertion. It is therefore possible that Nexplanon may be less effective in overweight women, especially in the presence of other factors that decrease serum etonogestrel concentrations such as concomitant use of hepatic enzyme inducers.

    Overdosage

    Overdosage may result if more than one implant is inserted. In case of suspected overdose, the implant should be removed.

    Nexplanon Description

    Nexplanon is a radiopaque, progestin-only, soft, flexible implant preloaded in a sterile, disposable applicator for subdermal use. The implant is white/off-white, non-biodegradable and 4 cm in length with a diameter of 2 mm (see Figure 18). Each implant consists of an ethylene vinylacetate (EVA) copolymer core, containing 68 mg of the synthetic progestin etonogestrel and barium sulfate (radiopaque ingredient), surrounded by an EVA copolymer skin. Once inserted subdermally, the release rate is 60-70 mcg/day in week 5-6 and decreases to approximately 35-45 mcg/day at the end of the first year, to approximately 30-40 mcg/day at the end of the second year, and then to approximately 25-30 mcg/day at the end of the third year. Nexplanon is a progestin-only contraceptive and does not contain estrogen. Nexplanon does not contain latex.

    Figure 18 (Not to scale)

    Etonogestrel [13-Ethyl-17-hydroxy-11-methylene-18,19-dinor-17α-pregn-4-en-20-yn-3-one], structurally derived from 19-nortestosterone, is the synthetic biologically active metabolite of the synthetic progestin desogestrel. It has a molecular weight of 324.46 and the following structural formula (Figure 19).

    Figure 19

    Nexplanon – Clinical Pharmacology

    Mechanism of Action

    The contraceptive effect of Nexplanon is achieved by suppression of ovulation, increased viscosity of the cervical mucus, and alterations in the endometrium.

    Pharmacodynamics

    Exposure-response relationships of Nexplanon are unknown.

    Pharmacokinetics

    Absorption

    After subdermal insertion of the etonogestrel implant, etonogestrel is released into the circulation and is approximately 100% bioavailable.

    In a three year clinical trial, Nexplanon and the non-radiopaque etonogestrel implant (IMPLANON) yielded comparable systemic exposure to etonogestrel. For Nexplanon, the mean (± SD) maximum serum etonogestrel concentrations were 1200 (± 604) pg/mL and were reached within the first two weeks after insertion (n=50). The mean (± SD) serum etonogestrel concentration decreased gradually over time, declining to 202 (± 55) pg/mL at 12 months (n=41), 164 (± 58) pg/mL at 24 months (n=37), and 138 (± 43) pg/mL at 36 months (n=32). For the non-radiopaque etonogestrel implant (IMPLANON), the mean (± SD) maximum serum etonogestrel concentrations were 1145 (± 577) pg/mL and were reached within the first two weeks after insertion (n=53). The mean (± SD) serum etonogestrel concentration decreased gradually over time, declining to 223 (± 73) pg/mL at 12 months (n=40), 172 (± 77) pg/mL at 24 months (n=32), and 153 (± 52) pg/mL at 36 months (n=30).

    The pharmacokinetic profile of Nexplanon is shown in Figure 20.

    Figure 20: Mean (± SD) Serum Concentration-Time Profile of Etonogestrel After Insertion of Nexplanon During 3 Years of Use

    Distribution

    The apparent volume of distribution averages about 201 L. Etonogestrel is approximately 32% bound to sex hormone binding globulin (SHBG) and 66% bound to albumin in blood.

    Metabolism

    In vitro data shows that etonogestrel is metabolized in liver microsomes by the cytochrome P450 3A4 isoenzyme. The biological activity of etonogestrel metabolites is unknown.

    Excretion

    The elimination half-life of etonogestrel is approximately 25 hours. Excretion of etonogestrel and its metabolites, either as free steroid or as conjugates, is mainly in urine and to a lesser extent in feces. After removal of the implant, etonogestrel concentrations decreased below sensitivity of the assay by one week.

    Nonclinical Toxicology

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    In a 24-month carcinogenicity study in rats with subdermal implants releasing 10 and 20 mcg etonogestrel per day (equal to approximately 1.8-3.6 times the systemic steady state exposure in women using Nexplanon), no drug-related carcinogenic potential was observed. Etonogestrel was not genotoxic in the in vitro Ames/Salmonella reverse mutation assay, the chromosomal aberration assay in Chinese hamster ovary cells or in the in vivo mouse micronucleus test. Fertility returned after withdrawal from treatment.

    Clinical Studies

    Pregnancy

    In clinical trials of up to 3 years duration that involved 923 subjects, 18-40 years of age at entry, and 1756 women-years of use with the non-radiopaque etonogestrel implant (IMPLANON), the total exposures expressed as 28-day cycle equivalents by study year were:

    Year 1: 10,866 cycles

    Year 2: 8581 cycles

    Year 3: 3442 cycles

    The clinical trials excluded women who:

    • Weighed more than 130% of their ideal body weight
    • Were chronically taking medications that induce liver enzymes

    In the subgroup of women, 18-35 years of age at entry, 6 pregnancies during 20,648 cycles of use were reported. Two pregnancies occurred in each of Years 1, 2, and 3. Each conception was likely to have occurred shortly before or within 2 weeks after removal of the non-radiopaque etonogestrel implant. With these 6 pregnancies, the cumulative Pearl Index was 0.38 pregnancies per 100 women-years of use.

    Return to Ovulation

    In clinical trials with the non-radiopaque etonogestrel implant (IMPLANON), the etonogestrel levels in blood decreased below sensitivity of the assay by one week after removal of the implant. In addition, pregnancies were observed to occur as early as 7 to 14 days after removal. Therefore, a woman should re-start contraception immediately after removal of the implant if continued contraceptive protection is desired.

    Implant Insertion and Removal Characteristics

    Out of 301 insertions of the Nexplanon implant in a clinical trial, the mean insertion time (from the removal of the protection cap of the applicator until retraction of the needle from the arm) was 27.9 ± 29.3 seconds. After insertion, 300 out of 301 (99.7%) Nexplanon implants were palpable. The single, non-palpable implant was not inserted according to the instructions.

    For 112 out of 114 (98.2%) subjects in 2 clinical trials for whom insertion and removal data were available, Nexplanon implants were clearly visible with use of two-dimensional x-ray after insertion. The two implants that were not clearly visible after insertion were clearly visible with two-dimensional x-ray before removal.

    How Supplied/Storage and Handling

    How Supplied

    One Nexplanon package consists of a single implant containing 68 mg etonogestrel that is 4 cm in length and 2 mm in diameter, which is pre-loaded in the needle of a disposable applicator. The sterile applicator containing the implant is packed in a blister pack.

    NDC 0052-0274-01

    Storage and Handling

    Store Nexplanon (etonogestrel implant) Radiopaque at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature]. Avoid storing Nexplanon at temperatures above 30ºC (86ºF).

    Patient Counseling Information

    See FDA-Approved Patient Labeling.

    Information for Patients

    • Counsel women about the insertion and removal procedure of the Nexplanon implant. Provide the woman with a copy of the Patient Labeling and ensure that she understands the information in the Patient Labeling before insertion and removal. A USER CARD and consent form are included in the packaging. Have the woman complete a consent form and retain it in your records. The USER CARD should be filled out and given to the woman after insertion of the Nexplanon implant so that she will have a record of the location of the implant in the upper arm and when it should be removed.
    • Counsel women that Nexplanon does not protect against HIV infection (AIDS) or other sexually transmitted diseases.
    • Counsel women that the use of Nexplanon may be associated with changes in their normal menstrual bleeding patterns so that they know what to expect.

    FDA-Approved Patient Labeling

    See the full patient product information for Nexplanon.

    Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of

    MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

    Manufactured by: N.V. Organon, Oss, The Netherlands, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA

    Copyright © 2011 MSD Oss B.V., a subsidiary of Merck & Co., Inc.

    All rights reserved.

    Revised: 05/2012

    900415-IMPx-IPT-USPI.11

    FDA-Approved Patient Labeling

    Nexplanon® (etonogestrel implant)

    Radiopaque

    Subdermal Use Only

    Nexplanon® does not protect against HIV infection (the virus that causes AIDS) or other sexually transmitted diseases. Read this Patient Information leaflet carefully before you decide if Nexplanon is right for you. This information does not take the place of talking with your healthcare provider. If you have any questions about Nexplanon, ask your healthcare provider.

    What is Nexplanon?

    Nexplanon is a hormone-releasing birth control implant for use by women to prevent pregnancy for up to 3 years. The implant is a flexible plastic rod about the size of a matchstick that contains a progestin hormone called etonogestrel. It also contains a small amount of barium sulfate so that the implant can be seen by X-ray. Your healthcare provider will insert the implant just under the skin of the inner side of your upper arm. You can use a single Nexplanon implant for up to 3 years. Nexplanon does not contain estrogen.

    What if I need birth control for more than 3 years?

    The Nexplanon implant must be removed after 3 years. Your healthcare provider can insert a new implant under your skin after taking out the old one if you choose to continue using Nexplanon for birth control.

    What if I change my mind about birth control and want to stop using Nexplanon before 3 years?

    Your healthcare provider can remove the implant at any time. You may become pregnant as early as the first week after removal of the implant. If you do not want to get pregnant after your healthcare provider removes the Nexplanon implant, you should start another birth control method right away.

    How does Nexplanon work?

    Nexplanon prevents pregnancy in several ways. The most important way is by stopping the release of an egg from your ovary. Nexplanon also thickens the mucus in your cervix and this change may keep sperm from reaching the egg. Nexplanon also changes the lining of your uterus.

    How well does Nexplanon work?

    When the Nexplanon implant is placed correctly, your chance of getting pregnant is very low (less than 1 pregnancy per 100 women who use Nexplanon for 1 year). It is not known if Nexplanon is as effective in very overweight women because studies did not include many overweight women.

    The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.

    Who should not use Nexplanon?

    Do not use Nexplanon if you:

    • Are pregnant or think you may be pregnant

    • Have, or have had blood clots, such as blood clots in your legs (deep venous thrombosis), lungs (pulmonary embolism), eyes (total or partial blindness), heart (heart attack), or brain (stroke)
    • Have liver disease or a liver tumor
    • Have unexplained vaginal bleeding
    • Have breast cancer or any other cancer that is sensitive to progestin (a female hormone), now or in the past
    • Are allergic to anything in Nexplanon

    Tell your healthcare provider if you have or have had any of the conditions listed above. Your healthcare provider can suggest a different method of birth control.

    In addition, talk to your healthcare provider about using Nexplanon if you:

    • Have diabetes
    • Have high cholesterol or triglycerides
    • Have headaches
    • Have gallbladder or kidney problems
    • Have a history of depressed mood
    • Have high blood pressure
    • Have an allergy to numbing medicines (anesthetics) or medicines used to clean your skin (antiseptics). These medicines will be used when the implant is placed into or removed from your arm.

    Interaction with Other Medicines

    Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Certain medicines may make Nexplanon less effective, including:

    • barbiturates
    • bosentan
    • carbamazepine
    • felbamate
    • griseofulvin
    • oxcarbazepine
    • phenytoin
    • rifampin
    • St. John’s wort
    • topiramate
    • HIV medicines

    Ask your healthcare provider if you are not sure if your medicine is one listed above.

    If there are medicines that you have been taking for a long time, that make Nexplanon less effective, tell your healthcare provider. Your healthcare provider may remove the Nexplanon implant and recommend a birth control method that can be used effectively with these medicines.

    When you are using Nexplanon, tell all of your healthcare providers that you have Nexplanon in place in your arm.

    How is the Nexplanon implant placed and removed?

    Your healthcare provider will place and remove the Nexplanon implant in a minor surgical procedure in his or her office. The implant is placed just under the skin on the inner side of your upper arm.

    The timing of insertion is important. Your healthcare provider may:

    • Perform a pregnancy test before inserting Nexplanon
    • Schedule the insertion at a specific time of your menstrual cycle (for example, within the first days of your regular menstrual bleeding)

    Immediately after the Nexplanon implant has been placed, you and your healthcare provider should check that the implant is in your arm by feeling for it.

    If you and your healthcare provider cannot feel the Nexplanon implant, use a non-hormonal birth control method (such as condoms) until your healthcare provider confirms that the implant is in place. You may need special tests to check that the implant is in place or to help find the implant when it is time to take it out.

    Your healthcare provider will cover the site where Nexplanon was placed with 2 bandages. Leave the top bandage on for 24 hours. Keep the smaller bandage clean, dry, and in place for 3 to 5 days.

    You will be asked to review and sign a consent form prior to inserting the Nexplanon implant. You will also get a USER CARD to keep at home with your health records. Your healthcare provider will fill out the USER CARD with the date the implant was inserted and the date the implant is to be removed. Keep track of the date the implant is to be removed. Schedule an appointment with your healthcare provider to remove the implant on or before the removal date.

    Be sure to have checkups as advised by your healthcare provider.

    What are the most common side effects I can expect while using Nexplanon?

    Changes in Menstrual Bleeding Patterns (menstrual periods)

    The most common side effect of Nexplanon is a change in your normal menstrual bleeding pattern. In studies, one out of ten women stopped using the implant because of an unfavorable change in their bleeding pattern. You may experience longer or shorter bleeding during your periods or have no bleeding at all. The time between periods may vary, and in between periods you may also have spotting.

    Tell your healthcare provider right away if:

    • You think you may be pregnant
    • Your menstrual bleeding is heavy and prolonged

    Besides changes in menstrual bleeding patterns, other frequent side effects that caused women to stop using the implant include:

    • Mood swings
    • Weight gain
    • Headache
    • Acne
    • Depressed mood

    Other common side effects include:

    • Headache
    • Vaginitis (inflammation of the vagina)
    • Weight gain
    • Acne
    • Breast pain
    • Viral infections such as sore throats or flu-like symptoms
    • Stomach pain
    • Painful periods
    • Mood swings, nervousness, or depressed mood
    • Back pain
    • Nausea
    • Dizziness
    • Pain
    • Pain at the site of insertion

    This is not a complete list of possible side effects. For more information, ask your healthcare provider for advice about any side effects that concern you. You may report side effects to the FDA at 1-800-FDA-1088.

    What are the possible risks of using Nexplanon?

    Problems with Insertion and Removal

    The implant may not be placed in your arm at all due to a failed insertion. If this happens, you may become pregnant. Immediately after insertion, and with help from your healthcare provider, you should be able to feel the implant under your skin. If you can’t feel the implant, tell your healthcare provider.

    Removal of the implant may be very difficult or impossible because the implant is not where it should be. Special procedures, including surgery in the hospital, may be needed to remove the implant. If the implant is not removed, then the effects of Nexplanon will continue for a longer period of time.

    Other problems related to insertion and removal are:

    • Pain, irritation, swelling, or bruising at the insertion site
    • Scarring, including a thick scar called a keloid around the insertion site
    • Infection
    • Scar tissue may form around the implant making it difficult to remove
    • The implant may come out by itself. You may become pregnant if the implant comes out by itself. Use a back up birth control method and call your healthcare provider right away if the implant comes out.
    • The need for surgery in the hospital to remove the implant
    • Injury to nerves or blood vessels in your arm
    • The implant breaks making removal difficult

    Ectopic Pregnancy

    If you become pregnant while using Nexplanon, you have a slightly higher chance that the pregnancy will be ectopic (occurring outside the womb) than do women who do not use birth control. Unusual vaginal bleeding or lower stomach (abdominal) pain may be a sign of ectopic pregnancy. Ectopic pregnancy is a medical emergency that often requires surgery. Ectopic pregnancies can cause serious internal bleeding, infertility, and even death. Call your healthcare provider right away if you think you are pregnant or have unexplained lower stomach (abdominal) pain.

    Ovarian Cysts

    Cysts may develop on the ovaries and usually go away without treatment but sometimes surgery is needed to remove them.

    Breast Cancer

    It is not known whether Nexplanon use changes a woman’s risk for breast cancer. If you have breast cancer now, or have had it in the past, do not use Nexplanon because some breast cancers are sensitive to hormones.

    Serious Blood Clots

    Nexplanon may increase your chance of serious blood clots, especially if you have other risk factors such as smoking. It is possible to die from a problem caused by a blood clot, such as a heart attack or a stroke.

    Some examples of serious blood clots are blood clots in the:

    • Legs (deep vein thrombosis)
    • Lungs (pulmonary embolism)
    • Brain (stroke)
    • Heart (heart attack)
    • Eyes (total or partial blindness)

    The risk of serious blood clots is increased in women who smoke. If you smoke and want to use Nexplanon, you should quit. Your healthcare provider may be able to help.

    Tell your healthcare provider at least 4 weeks before if you are going to have surgery or will need to be on bed rest. You have an increased chance of getting blood clots during surgery or bed rest.

    Other Risks

    A few women who use birth control that contains hormones may get:

    • High blood pressure
    • Gallbladder problems
    • Rare cancerous or noncancerous liver tumors

    When should I call my healthcare provider?

    Call your healthcare provider right away if you have:

    • Pain in your lower leg that does not go away
    • Severe chest pain or heaviness in the chest
    • Sudden shortness of breath, sharp chest pain, or coughing blood
    • Symptoms of a severe allergic reaction, such as swollen face, tongue or pharynx; trouble swallowing; or hives and trouble breathing
    • Sudden severe headache unlike your usual headaches
    • Weakness or numbness in your arm, leg, or trouble speaking
    • Sudden partial or complete blindness
    • Yellowing of your skin or whites of your eyes, especially with fever, tiredness, loss of appetite, dark colored urine, or light colored bowel movements
    • Severe pain, swelling, or tenderness in the lower stomach (abdomen)
    • Lump in your breast
    • Problems sleeping, lack of energy, tiredness, or you feel very sad
    • Heavy menstrual bleeding

    What if I become pregnant while using Nexplanon?

    You should see your healthcare provider right away if you think that you may be pregnant. It is important to remove the implant and make sure that the pregnancy is not ectopic (occurring outside the womb). Based on experience with other hormonal contraceptives, Nexplanon is not likely to cause birth defects.

    Can I use Nexplanon when I am breastfeeding?

    If you are breastfeeding your child, you may use Nexplanon if 4 weeks have passed since you had your baby. A small amount of the hormone contained in Nexplanon passes into your breast milk. The health of breast-fed children whose mothers were using the implant has been studied up to 3 years of age in a small number of children. No effects on the growth and development of the children were seen. If you are breastfeeding and want to use Nexplanon, talk with your healthcare provider for more information.

    Additional Information

    This Patient Information leaflet contains important information about Nexplanon. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider for information about Nexplanon that is written for healthcare professionals. You may also call 1-877-467-5266 or visit www.Nexplanon-USA.com.

    Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of

    MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

    Manufactured by: N.V. Organon, Oss, The Netherlands, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA

    Copyright © 2011 MSD Oss B.V., a subsidiary of Merck & Co., Inc.

    All rights reserved.

    Revised: 05/2012

    900415-IMPx-IPT-PPI.10

    Nexplanon® (etonogestrel implant)

    Radiopaque

    Subdermal Use Only

    PATIENT CONSENT FORM

    I understand the Patient Labeling for Nexplanon®. I have discussed Nexplanon with my healthcare provider who answered all my questions. I understand that there are benefits as well as risks with using Nexplanon. I understand that there are other birth control methods and that each has its own benefits and risks.

    I also understand that this Patient Consent Form is important. I understand that I need to sign this form to show that I am making an informed and careful decision to use Nexplanon, and that I have read and understand the following points.

    • Nexplanon helps to keep me from getting pregnant.
    • No contraceptive method is 100% effective, including Nexplanon.
    • Nexplanon has an implant that contains a hormone.
    • It is important to have the Nexplanon implant placed in my arm at the right time of my menstrual cycle.
    • After the implant is placed in my arm, I should check that it is in place by gently pressing my fingertips over the skin where the implant was placed. I should be able to feel the implant.
    • The implant must be removed at the end of three years. The implant can be removed sooner if I want.
    • If I have trouble finding a healthcare provider to remove the implant, I can call 1-877-467-5266 for help.
    • The implant is placed under the skin of my arm during a procedure done in my healthcare provider’s office. There is a slight risk of getting a scar or an infection from this procedure.
    • Removal is usually a minor procedure. Sometimes, removal may be more difficult. Special procedures, including surgery in the hospital, may be needed. Difficult removals may cause pain and scarring and may result in injury to nerves and blood vessels. If the implant is not removed, its effects may continue.
    • Most women have changes in their menstrual bleeding patterns while using Nexplanon. I also will likely have changes in my menstrual bleeding pattern while using Nexplanon. My bleeding may be irregular, lighter or heavier, or my bleeding may completely stop. If I think I am pregnant, I should contact my healthcare provider as soon as possible.
    • I understand the warning signs for problems with Nexplanon. I should seek medical attention if any warning signs appear.
    • I should tell all my healthcare providers that I am using Nexplanon.
    • I need to have a medical checkup regularly and at any time I am having problems.
    • Nexplanon does not protect me from HIV infection (AIDS) or any other sexually transmitted diseases.

    After learning about Nexplanon, I choose to use Nexplanon.

                                                                
    (Name of Healthcare Provider)
       
                                                                                                                   
    (Patient Signature) (Date)                    

    WITNESSED BY:

    The patient above has signed this consent in my presence after I counseled her and answered her questions.

                                                                                                                   
    (Healthcare Provider Signature) (Date)                    

    I have provided an accurate translation of this information to the patient whose signature appears above. She has stated that she understands the information and has had an opportunity to have her questions answered.

                                                                                                                   
    (Signature of Translator) (Date)                    

    Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of

    MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

    Manufactured by: N.V. Organon, Oss, The Netherlands, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA

    Copyright © 2011 MSD Oss B.V., a subsidiary of Merck & Co., Inc.

    All rights reserved.

    Revised: 05/2012

    900415-IMPx-IPT-PCF.2

    PRINCIPAL DISPLAY PANEL – 68 mg Carton

    NDC 0052-0274-01

    1 applicator containing 1 subdermal implant

    Nexplanon®

    (etonogestrel implant) 68 mg

    Radiopaque

    Subdermal Use Only

    This product is intended to prevent pregnancy. It does not protect

    against HIV infection (AIDS) and other sexually transmitted diseases.

    Rx only

    Nexplanon 

    etonogestrel implant

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0052-0274
    Route of Administration SUBCUTANEOUS DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    etonogestrel (etonogestrel) etonogestrel 68 mg
    Inactive Ingredients
    Ingredient Name Strength
    barium sulfate  
    Product Characteristics
    Color WHITE (white/off-white) Score     
    Shape Size
    Flavor Imprint Code
    Contains         
    Packaging
    # Item Code Package Description
    1 NDC:0052-0274-01 1 BLISTER PACK in 1 CARTON
    1 1 IMPLANT in 1 BLISTER PACK
    2 NDC:0052-0274-80 1 BLISTER PACK in 1 CARTON
    2 1 IMPLANT in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021529 07/17/2006
    Labeler - Organon Pharmaceuticals USA (002152858)
    Establishment
    Name Address ID/FEI Operations
    N.V. Organon 402157499 MANUFACTURE(0052-0274), API MANUFACTURE(0052-0274)
    Establishment
    Name Address ID/FEI Operations
    N.V. Organon 409664849 API MANUFACTURE(0052-0274)

    Revised: 05/2012   Organon Pharmaceuticals USA

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