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Rhophylac

Rhophylac(rho (d) immune globulin) – CSL Behring

BOXED WARNING

Intravascular hemolysis (IVH) leading to death reported in patients treated for immune thrombocytopenic purpura (ITP). IVH can lead to anemia and multi-system organ failure including acute respiratory distress syndrome. Serious complications including severe anemia, acute renal insufficiency, renal failure, and disseminated intravascular coagulation (DIC) reported. Closely monitor patients treated for ITP ≥8 hrs after administration for signs/symptoms of IVH (eg, back pain, shaking chills, fever, discolored urine, or hematuria); absence of these signs/symptoms within 8 hrs does not indicate IVH cannot occur subsequently. Perform a dipstick urinalysis at baseline, 2 hrs, and 4 hrs after administration, and prior to the end of the monitoring period. Perform post-treatment laboratory tests (eg, plasma Hgb, haptoglobin, lactate dehydrogenase, direct/indirect bilirubin) if IVH is present or suspected.

THERAPEUTIC CLASS

Immuneglobulin

INDICATIONS

Suppression of Rh (rhesus) isoimmunization in non-sensitized Rh0(D)-negative women with an Rh-incompatible pregnancy. Suppression of Rh isoimmunization in Rh0(D)-negative individuals transfused with Rh0(D)-positive RBCs or blood components containing Rh0(D)-positive RBCs. Raise platelet counts in Rh0(D)-positive, non-splenectomized adults with chronic ITP.

ADULT DOSAGE

Adults: Suppression of Rh Isoimmunization: IV/IM: Rh-Incompatible Pregnancy: Antepartum Prophylaxis: 1500 IU (300mcg) at 28-30 weeks gestation. Postpartum Prophylaxis (if newborn is Rh0(D)-positive): 1500 IU (300mcg) within 72 hrs of birth. Obstetric Complications/Invasive or Obstetric Manipulative Procedures: 1500 IU (300mcg) within 72 hrs of at-risk event. Excessive Fetomaternal Hemorrhage: 1500 IU (300mcg) + 100 IU (20mcg)/mL fetal RBCs >15mL (excess transplacental bleeding quantified) or 1500 IU (300mcg) (excess transplacental bleeding not quantified) within 72 hrs of complication. Exposure to >15mL of Rh0(D)-Positive RBCs (in postpartum prophylaxis, obstetric complications/invasive/manipulative procedures): Increase dose based on guidelines for excessive fetomaternal hemorrhage. Incompatible Transfusions: 100 IU (20mcg)/2mL transfused blood or per 1mL erythrocyte concentrate within 72 hrs of exposure. ITP: IV: 250 IU (50mcg)/kg. Refer to PI for recommended dosage calculation.

HOW SUPPLIED

Inj: 1500 IU (300mcg)/2mL [prefilled syringe]

CONTRAINDICATIONS

IgA deficiency with antibodies to IgA and a history of hypersensitivity.

WARNINGS/PRECAUTIONS

Allergic or hypersensitivity reactions may occur; d/c immediately and institute appropriate treatment. May affect results of blood typing, antibody screening and direct antiglobulin (Coombs') tests; antepartum administration to mother can also affect these tests in the newborn. May contain antibodies to other Rh antigens. May carry a risk of transmitting infectious agents (eg, viruses, Creutzfeldt-Jakob disease agent). (Suppression of Rh Isoimmunization) Do not give to newborn infant. (ITP) Safety unknown in patients with pre-existing anemia; weigh benefits against risks of increasing severity of the anemia. If transfusions are required due to hemolysis and severe anemia following administration, use Rh0(D)-negative packed RBCs.

ADVERSE REACTIONS

IVH, anemia, renal insufficiency/failure, DIC, nausea, dizziness, headache, inj site pain, malaise, chills, pyrexia/increased body temperature, increased bilirubin, decreased Hgb/haptoglobin.

DRUG INTERACTIONS

May impair immune response to live, attenuated virus vaccines.

PREGNANCY

Category C, (Suppression of Rh Isoimmunization) safe in nursing. (ITP) Safety not known in nursing.

MECHANISM OF ACTION

Immune globulin; not established. (ITP) Thought to involve formation of Rh0(D) immune globulin RBC complexes removed by reticuloendothelial system (spleen) resulting in Fc receptor blockade, sparing antibody coated platelets.

PHARMACOKINETICS

Absorption: (IV) Cmax=62-84ng/mL (IM) Cmax=7-46ng/mL, Tmax=2-7 days; absolute bioavailability (69%). Elimination: T1/2=16 days (IV), 18 days (IM).

ASSESSMENT

Assess for IgA deficiency with antibodies to IgA and history of hypersensitivity, anaphylactic/severe systemic reactions to human immune globulin, pre-existing anemia, and possible drug interactions. Perform baseline dipstick urinalysis.

MONITORING

Monitor for signs/symptoms of IVH, hypersensitivity reactions, anemia, acute renal insufficiency, renal failure, DIC, and transmission of infectious agents. Monitor patients treated for ITP for ≥8 hrs after administration. Perform a dipstick urinalysis 2 hrs and 4 hrs after administration, and prior to the end of the monitoring period.

PATIENT COUNSELING

Inform to immediately report symptoms of IVH, hives, chest tightness, wheezing, hypotension, anaphylaxis, symptoms related to viral infection. Advise to inform other healthcare providers of interference with response to live virus vaccines. Inform that product may contain disease causing infectious agents.

ADMINISTRATION/STORAGE

Administration: IV/IM route. (IM) Administer in divided doses at different sites with doses >5mL. (ITP) Administer IV only at rate of 2mL/15-60 sec. Refer to PI for preparation and handling instructions. Storage: 2-8°C (36-46°F); do not freeze. Protect from light.


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    Rhophylac

    Rhophylac

    Generic Name: human rho(d) immune globulin

    Dosage Form: injection

    For ProfessionalsSide EffectsInteractionsMore…

    Rhophylac®

    Rh0(D) Immune Globulin Intravenous (Human)

    WARNING: INTRAVASCULAR HEMOLYSIS IN ITP

    This warning does not apply to Rh0(D)-negative patients treated for the suppression of Rh isoimmunization.

    • Intravascular hemolysis leading to death has been reported in Rh0(D)-positive patients treated for immune thrombocytopenic purpura (ITP) with Rh0(D) Immune Globulin Intravenous (Human) products.1
    • Intravascular hemolysis can lead to clinically compromising anemia and multi-system organ failure including acute respiratory distress syndrome (ARDS).
    • Serious complications, including severe anemia, acute renal insufficiency, renal failure, and disseminated intravascular coagulation (DIC), have also been reported.
    • Closely monitor patients treated for ITP with Rhophylac in a healthcare setting for at least 8 hours after administration. Perform a dipstick urinalysis at baseline, 2 hours and 4 hours after administration, and prior to the end of the monitoring period. Alert patients to, and monitor them for, the signs and symptoms of intravascular hemolysis, including back pain, shaking chills, fever, and discolored urine or hematuria. Absence of these signs and/or symptoms within 8 hours does not indicate IVH cannot occur subsequently. If signs and/or symptoms of intravascular hemolysis are present or suspected after Rhophylac administration, perform post-treatment laboratory tests, including plasma hemoglobin, haptoglobin, LDH, and plasma bilirubin (direct and indirect).

    Indications and Usage for Rhophylac

    Rhophylac is an Rh0(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the suppression of Rh isoimmunization in non-sensitized Rh0(D)-negative patients and for the treatment of immune thrombocytopenic purpura (ITP) in Rh0(D)-positive patients.

    Suppression of Rh Isoimmunization

    Pregnancy and Obstetric Conditions

    Rhophylac is indicated for suppression of rhesus (Rh) isoimmunization in non-sensitized Rh0(D)-negative women with an Rh-incompatible pregnancy, including:

    • Routine antepartum and postpartum Rh prophylaxis
    • Rh prophylaxis in cases of:
      Obstetric complications (e.g., miscarriage, abortion, threatened abortion, ectopic pregnancy or hydatidiform mole, transplacental hemorrhage resulting from antepartum hemorrhage)
      Invasive procedures during pregnancy (e.g., amniocentesis, chorionic biopsy) or obstetric manipulative procedures (e.g., external version, abdominal trauma)

    An Rh-incompatible pregnancy is assumed if the fetus/baby is either Rh0(D)-positive or Rh0(D)-unknown or if the father is either Rh0(D)-positive or Rh0(D)-unknown.

    Incompatible Transfusions

    Rhophylac is indicated for the suppression of Rh isoimmunization in Rh0(D)-negative individuals transfused with Rh0(D)-positive red blood cells (RBCs) or blood components containing Rh0(D)-positive RBCs.

    Treatment can be given without a preceding exchange transfusion when the transfused blood represents less than 20% of the total circulating RBCs. If the volume exceeds 20%, an exchange transfusion should be considered prior to administering Rhophylac.

    ITP

    Rhophylac is indicated in Rh0(D)-positive, non-splenectomized adult patients with chronic ITP to raise platelet counts.

    Rhophylac Dosage and Administration

    As with all blood products, patients should be observed for at least 20 minutes following administration of Rhophylac.

    Preparation and Handling

    • Rhophylac is a clear or slightly opalescent, colorless to pale yellow solution. Inspect Rhophylac visually for particulate matter and discoloration prior to administration. Do not use if the solution is cloudy or contains particulates.

    • Prior to intravenous use, ensure that the needle-free intravenous administration system is compatible with the tip of the Rhophylac glass syringe.
    • Do not freeze.
    • Bring Rhophylac to room temperature before use.
    • Rhophylac is for single use only. Dispose of any unused product or waste material in accordance with local requirements.

    Suppression of Rh Isoimmunization

    Rhophylac should be administered by intravenous or intramuscular injection. If large doses (greater than 5 mL) are required and intramuscular injection is chosen, it is advisable to administer Rhophylac in divided doses at different sites.

    Table 1 provides dosing guidelines based on the condition being treated.

    Table 1: Dosing Guidelines for Suppression of Rh Isoimmunization
    Indication Timing of Administration Dose*

    (Administer by Intravenous or Intramuscular Injection)

    IU, international units; mcg, micrograms.
    *
    A 1500 IU (300 mcg) dose of Rhophylac will suppress the immunizing potential of ≥15 mL of Rh0(D)-positive RBCs.2
    The dose of Rhophylac must be increased if the patient is exposed to >15 mL of Rh0(D)-positive RBCs; in this case, follow the dosing guidelines for excessive fetomaternal hemorrhage.
    Rh-incompatible pregnancy
     
    Routine antepartum prophylaxis
    At Week 28-30 of gestation 1500 IU (300 mcg)
     
    Postpartum prophylaxis

    (required only if the newborn is Rh0(D)-positive)

    Within 72 hours of birth 1500 IU (300 mcg)†
     
    Obstetric complications

    (e.g., miscarriage, abortion, threatened abortion, ectopic pregnancy or hydatidiform mole, transplacental hemorrhage resulting from antepartum hemorrhage)

    Within 72 hours of complication 1500 IU (300 mcg)†
     
    Invasive procedures during pregnancy (e.g., amniocentesis, chorionic biopsy) or obstetric manipulative procedures (e.g., external version, abdominal trauma)
    Within 72 hours of procedure 1500 IU (300 mcg)†
     
    Excessive fetomaternal hemorrhage

    (>15 mL)

    Within 72 hours of complication 1500 IU (300 mcg) plus:

    • 100 IU (20 mcg) per mL fetal RBCs in excess of 15 mL if excess transplacental bleeding is quantified

      or

    • An additional 1500 IU (300 mcg) dose if excess transplacental bleeding cannot be quantified
    Incompatible transfusions Within 72 hours of exposure 100 IU (20 mcg)

    per 2 mL transfused blood or per 1 mL erythrocyte concentrate

    ITP

    For treatment of ITP, ADMINISTER Rhophylac BY THE INTRAVENOUS ROUTE ONLY (see Preparation and Handling [2.1]). Do not administer intramuscularly.

    A 250 IU (50 mcg) per kg body weight dose of Rhophylac is recommended for patients with ITP. The following formula can be used to calculate the recommended amount of Rhophylac to administer:

    Dose (IU) × body weight (kg) = Total IU / 1500 IU per syringe = Number of syringes

    Rhophylac should be administered at a rate of 2 mL per 15 to 60 seconds.

    Dosage Forms and Strengths

    1500 IU (300 mcg) per 2 mL prefilled, ready-to-use, glass syringe

    Contraindications

    • Rhophylac is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin.
    • Rhophylac is contraindicated in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity.

    Warnings and Precautions

    Both Indications

    5.1.1 Hypersensitivity

    Severe hypersensitivity reactions may occur. If symptoms of allergic or early signs of hypersensitivity reactions (including generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis) occur, discontinue Rhophylac administration immediately and institute appropriate treatment. Medications such as epinephrine should be available for immediate treatment of acute hypersensitivity reactions.

    Rhophylac contains trace amounts of IgA (less than 5 mcg/mL) (see Description [11]). Patients with known antibodies to IgA have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. Rhophylac is contraindicated in patients with antibodies against IgA and a history of hypersensitivity reactions (see Contraindications [4]).

    5.1.2 Interference with Laboratory Tests

    The administration of Rh0(D) immune globulin may affect the results of blood typing, the antibody screening test, and the direct antiglobulin (Coombs’) test. Antepartum administration of Rh0(D) immune globulin to the mother can also affect these tests in the newborn infant.

    Rhophylac can contain antibodies to other Rh antigens (e.g., anti-C antibodies), which might be detected by sensitive serological tests following administration.

    5.1.3 Transmissible Infectious Agents

    Because Rhophylac is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The risk of infectious agent transmission has been reduced by screening plasma donors for prior exposure to certain viruses, testing for the presence of certain current virus infections, and including virus inactivation/removal steps in the manufacturing process for Rhophylac.

    Report any infections thought to be possibly transmitted by Rhophylac to CSL Behring Pharmacovigilance at 1-866-915-6958.

    Suppression of Rh Isoimmunization

    5.2.1 Postpartum Use Following an Rh-incompatible Pregnancy

    Administer Rhophylac to the mother only. Do not administer to the newborn infant (see Pediatric Use [8.4]).

    ITP

    5.3.1 Intravascular Hemolysis

    Intravascular hemolysis has occurred in a clinical study with Rhophylac. All cases resolved completely. However, as reported in the literature, some Rh0(D)-positive patients treated with Rh0(D) Immune Globulin Intravenous (Human) for ITP developed clinically compromising anemia, acute renal insufficiency, and, very rarely, disseminated intravascular coagulation (DIC) and death.1 Note: This warning does not apply to Rh0(D)-negative patients treated for the suppression of Rh isoimmunization.

    Closely monitor patients in a healthcare setting for at least 8 hours after administration of Rhophylac. Perform a dipstick urinalysis at baseline, 2 hours and 4 hours after administration, and prior to the end of the monitoring period.

    Alert patients to, and monitor them for, the signs and symptoms of intravascular hemolysis, including back pain, shaking chills, fever, and discolored urine or hematuria. Absence of these signs and/or symptoms of intravascular hemolysis within 8 hours do not indicate intravascular hemolysis cannot occur subsequently.

    If signs and/or symptoms of intravascular hemolysis are present or suspected after Rhophylac administration, perform post-treatment laboratory tests, including plasma hemoglobin, haptoglobin, LDH, and plasma bilirubin (direct and indirect). DIC may be difficult to detect in the ITP population; the diagnosis is dependent mainly on laboratory testing.

    If patients who develop hemolysis with clinically compromising anemia after receiving Rhophylac are to be transfused, Rh0(D)-negative packed RBCs should be used to avoid exacerbating ongoing hemolysis.

    5.3.2 Pre-existing Anemia

    The safety of Rhophylac in the treatment of ITP has not been established in patients with pre-existing anemia. The physician must weigh the benefits of Rhophylac against the potential risk of increasing the severity of the anemia.

    Adverse Reactions

    The most serious adverse reactions in patients receiving Rh0(D) Immune Globulin Intravenous (Human) have been observed in the treatment of ITP and include intravascular hemolysis, clinically compromising anemia, acute renal insufficiency, and, very rarely, DIC and death (see Boxed Warning, Warnings and Precautions [5.3.1]).1

    The most common adverse reactions observed in the use of Rhophylac for suppression of Rh isoimmunization (≥0.5% of subjects) are nausea, dizziness, headache, injection-site pain, and malaise.

    The most common adverse reactions observed in the treatment of ITP (>14% of subjects) are chills, pyrexia/increased body temperature, and headache. Mild hemolysis (manifested by an increase in bilirubin, a decrease in hemoglobin, or a decrease in haptoglobin) was also observed.

    Clinical Studies Experience

    Because clinical studies are conducted under different protocols and widely varying conditions, adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in practice.

    Suppression of Rh Isoimmunization

    In two clinical studies, 447 Rh0(D)-negative pregnant women received either an intravenous or intramuscular injection of Rhophylac 1500 IU (300 mcg) at Week 28 of gestation. A second 1500 IU (300 mcg) dose was administered to 267 (9 in Study 1 and 258 in Study 2) of these women within 72 hours of the birth of an Rh0(D)-positive baby. In addition, 30 women in Study 2 received at least one extra antepartum 1500 IU (300 mcg) dose due to obstetric complications (see Clinical Studies [14.1]).

    The most common adverse reactions in study subjects were nausea (0.7%), dizziness (0.5%), headache (0.5%), injection-site pain (0.5%), and malaise (0.5%). A laboratory finding of a transient positive anti-C antibody test was observed in 0.9% of subjects.

    ITP

    In a clinical study, 98 Rh0(D)-positive adult subjects with chronic ITP received an intravenous dose of Rhophylac 250 IU (50 mcg) per kg body weight (see Clinical Studies [14.2]). Premedication to alleviate infusion-related side effects was not used except in a single subject who received acetaminophen and diphenhydramine.

    Eighty-four (85.7%) subjects experienced 392 treatment-emergent adverse events (TEAEs). Sixty-nine (70.4%) subjects had 186 drug-related TEAEs (defined as TEAEs with a probable, possible, definite, or unknown relationship to the study drug). Within 24 hours of dosing, 73 (74.5%) subjects experienced 183 TEAEs, and 66 (67%) subjects experienced 156 drug-related TEAEs.

    Mild hemolysis (manifested as an increase in bilirubin, a decrease in hemoglobin, or a decrease in haptoglobin) was observed. An increase in blood bilirubin was seen in 21% of subjects. The median decrease in hemoglobin was greatest (0.8 g/dL) at Day 6 and Day 8 following administration of Rhophylac.

    Table 2 shows the most common TEAEs observed in the clinical study.

    Table 2: Most Common Treatment-Emergent Adverse Events (TEAEs) in Subjects with ITP
    TEAE Number of Subjects (%) With a TEAE

    n=98

    Number of Subjects (%) With a Drug-Related TEAE*

    n=98

    *
    Defined as TEAEs with a possible, probable, definite, or unknown relationship to the study drug.
    Chills 34 (34.7%) 34 (34.7%)
    Pyrexia/ Increased body temperature 32 (32.6%) 30 (30.6%)
    Increased blood bilirubin 21 (21.4%) 21 (21.4%)
    Headache 14 (14.3%) 11 (11.2%)

    Serious adverse events (SAEs) were reported in 10 (10.2%) subjects. SAEs considered to be drug-related were intravascular hemolytic reaction (hypotension, nausea, chills and headache, and a decrease in haptoglobin and hemoglobin) in two subjects; headache, dizziness, nausea, pallor, shivering, and weakness requiring hospitalization in one subject; and an increase in blood pressure and severe headache in one subject. All four subjects recovered completely.

    Postmarketing Experience

    Because postmarketing adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to product exposure. The following adverse reactions have been identified during post-approval use of Rhophylac:

    Suppression of Rh Isoimmunization

    Hypersensitivity reactions, including rare cases of anaphylactic shock or anaphylactoid reactions, headache, dizziness, vertigo, hypotension, tachycardia, dyspnea, nausea, vomiting, rash, erythema, pruritus, chills, pyrexia, malaise, diarrhea and back pain have been reported. Transient injection-site irritation and pain have been observed following intramuscular administration.

    ITP

    Transient hemoglobinuria has been reported in a patient being treated with Rhophylac for ITP.

    Drug Interactions

    Live Virus Vaccines

    Passive transfer of antibodies may transiently impair the immune response to live attenuated virus vaccines such as measles, mumps, rubella, and varicella (see Patient Counseling Information [17.1]).

    USE IN SPECIFIC POPULATIONS

    Pregnancy

    Pregnancy Category C. Animal reproduction studies have not been conducted with Rhophylac.

    Suppression of Rh Isoimmunization

    The available evidence suggests that Rhophylac does not harm the fetus or affect future pregnancies or reproduction capacity when given to pregnant Rh0(D)-negative women for suppression of Rh isoimmunization.3

    ITP

    Rhophylac has not been evaluated in pregnant women with ITP.

    Nursing Mothers

    Suppression of Rh Isoimmunization

    Rhophylac is used in nursing mothers for the suppression of Rh isoimmunization. No undesirable effects on a nursing infant are expected during breastfeeding.

    ITP

    Rhophylac has not been evaluated in nursing mothers with ITP.

    Pediatric Use

    Suppression of Rh Isoimmunization in Incompatible Transfusions

    The safety and effectiveness of Rhophylac have not been established in pediatric subjects being treated for an incompatible transfusion. The physician should weigh the potential risks against the benefits of Rhophylac, particularly in girls whose later pregnancies may be affected if Rh isoimmunization occurs.

    Geriatric Use

    Suppression of Rh Isoimmunization in Incompatible Transfusions

    Rhophylac has not been evaluated for treating incompatible transfusions in subjects 65 years of age and older.

    ITP

    Of the 98 subjects evaluated in the clinical study of Rhophylac for treatment of ITP (see Clinical Studies [14.2]), 19% were 65 years of age and older. No overall differences in effectiveness or safety were observed between these subjects and younger subjects.

    Overdosage

    There are no reports of known overdoses in patients being treated for suppression of Rh isoimmunization or ITP. Patients with incompatible transfusion or ITP who receive an overdose of Rh0(D) immune globulin should be monitored because of the potential risk for hemolysis.

    Rhophylac Description

    Rhophylac is a sterile Rh0(D) Immune Globulin Intravenous (Human) (anti-D) solution in a ready-to-use prefilled glass syringe for intravenous or intramuscular injection. One syringe contains at least 1500 IU (300 mcg) of IgG antibodies to Rh0(D) in a 2 mL solution, sufficient to suppress the immune response to at least 15 mL of Rh-positive RBCs.1 The product potency is expressed in IUs by comparison to the World Health Organization (WHO) standard, which is also the US and the European Pharmacopoeia standard.

    Plasma is obtained from healthy Rh0(D)-negative donors who have been immunized with Rh0(D)-positive RBCs. The donors are screened carefully to reduce the risk of receiving donations containing blood-borne pathogens. Each plasma donation used in the manufacture of Rhophylac is tested for the presence of HBV surface antigen (HBsAg), HIV-1/2, and HCV antibodies. In addition, plasma used in the manufacture of Rhophylac is tested by FDA-licensed Nucleic Acid Testing (NAT) for HIV and HCV and found to be negative. An investigational NAT for HBV is also performed on all source plasma used and found to be negative; however, the significance of a negative result has not been established. The source plasma is also tested by NAT for hepatitis A virus (HAV) and B19 virus (B19V).

    Rhophylac is produced by an ion-exchange chromatography isolation procedure4, using pooled plasma obtained by plasmapheresis of immunized Rh0(D)-negative US donors. The manufacturing process includes a solvent/detergent treatment step (using tri-n-butyl phosphate and Triton X-100) that is effective in inactivating enveloped viruses such as HIV, HCV, and HBV.5,6 Rhophylac is filtered using a Planova® 15 nanometer (nm) virus filter that has been validated to be effective in removing both enveloped and non-enveloped viruses. Table 3 presents viral clearance and inactivation data from validation studies, expressed as the mean log10 reduction factor (LRF).

    Table 3: Virus Inactivation and Removal in Rhophylac
    HIV PRV BVDV MVM
    HIV, a model for HIV-1 and HIV-2; PRV, pseudorabies virus, a model for large, enveloped DNA viruses (e.g., herpes virus); BVDV, bovine viral diarrhea virus, a model for HCV and West Nile virus; MVM, minute virus of mice, a model for B19V and other small, non-enveloped DNA viruses.
    Virus property
    Genome RNA DNA RNA DNA
    Envelope Yes Yes Yes No
    Size (nm) 80-100 120-200 40-70 18-24
    Manufacturing step Mean LRF
    Solvent/detergent treatment ≥6.0 ≥5.6 ≥5.4 Not tested
    Chromatographic process steps 4.5 ≥3.9 1.6 ≥2.6
    Virus filtration ≥6.3 ≥5.6 ≥5.5 3.4
    Overall reduction

    (log10 units)

    ≥16.8 ≥15.1 ≥12.5 ≥6.0

    Rhophylac contains a maximum of 30 mg/mL of human plasma proteins, 10 mg/mL of which is human albumin added as a stabilizer. Prior to the addition of the stabilizer, Rhophylac has a purity greater than 95% IgG. Rhophylac contains less than 5 mcg/mL of IgA, which is the limit of detection. Additional excipients are approximately 20 mg/mL of glycine and up to 0.25 M of sodium chloride. Rhophylac contains no preservative. Human albumin is manufactured from pooled plasma of US donors by cold ethanol fractionation, followed by pasteurization.

    Rhophylac – Clinical Pharmacology

    Mechanism of Action

    Suppression of Rh Isoimmunization

    The mechanism by which Rh0(D) immune globulin suppresses immunization to Rh0(D)-positive RBCs is not completely known.

    In a clinical study of Rh0(D)-negative healthy male volunteers, both the intravenous and intramuscular administration of a 1500 IU (300 mcg) dose of Rhophylac 24 hours after injection of 15 mL of Rh0(D)-positive RBCs resulted in an effective clearance of Rh0(D)-positive RBCs. On average, 99% of injected RBCs were cleared within 12 hours following intravenous administration and within 144 hours following intramuscular administration.

    ITP

    Rhophylac has been shown to increase platelet counts and to reduce bleeding in non-splenectomized Rh0(D)-positive subjects with chronic ITP. The mechanism of action is thought to involve the formation of Rh0(D) immune globulin RBC complexes, which are preferentially removed by the reticuloendothelial system, particularly the spleen. This results in Fc receptor blockade, thus sparing antibody-coated platelets.7

    Pharmacokinetics

    Suppression of Rh Isoimmunization

    In a clinical study comparing the pharmacokinetics of intravenous versus intramuscular administration, 15 Rh0(D)-negative pregnant women received a single 1500 IU (300 mcg) dose of Rhophylac at Week 28 of gestation.8

    Following intravenous administration, peak serum levels of Rh0(D) immune globulin ranged from 62 to 84 ng/mL after 1 day (i.e., the time the first blood sample was taken following the antepartum dose). Mean systemic clearance was 0.20 ± 0.03 mL/min, and half-life was 16 ± 4 days.

    Following intramuscular administration, peak serum levels ranged from 7 to 46 ng/mL and were achieved between 2 and 7 days. Mean apparent clearance was 0.29 ± 0.12 mL/min, and half-life was 18 ± 5 days. The absolute bioavailability of Rhophylac was 69%.

    Regardless of the route of administration, Rh0(D) immune globulin titers were detected in all women up to at least 9 weeks following administration of Rhophylac.

    ITP

    Pharmacokinetic studies with Rhophylac were not performed in Rh0(D)-positive subjects with ITP. Rh0(D) immune globulin binds rapidly to Rh0(D)-positive erythrocytes.9

    Clinical Studies

    Suppression of Rh Isoimmunization

    In two clinical studies, 447 Rh0(D)-negative pregnant women received a 1500 IU (300 mcg) dose of Rhophylac during Week 28 of gestation. The women who gave birth to an Rh0(D)-positive baby received a second 1500 IU (300 mcg) dose within 72 hours of birth.

    • Study 1 (Pharmacokinetic Study) – Eight of the women who participated in the pharmacokinetic study (see Clinical Pharmacology [12.3]) gave birth to an Rh0(D)-positive baby and received the postpartum dose of 1500 IU (300 mcg) of Rhophylac.8 Antibody tests performed 6 to 8 months later were negative for all women. This suggests that no Rh0(D) immunization occurred.
    • Study 2 (Pivotal Study) – In an open-label, single-arm clinical study at 22 centers in the US and United Kingdom, 432 pregnant women received the antepartum dose of 1500 IU (300 mcg) of Rhophylac either as an intravenous or intramuscular injection (two randomized groups of 216 women each).10 Subjects received an additional 1500 IU (300 mcg) dose if an obstetric complication occurred between the routine antepartum dose and birth or if extensive fetomaternal hemorrhage was measured after birth. Of the 270 women who gave birth to an Rh0(D)-positive baby, 248 women were evaluated for Rh0(D) immunization 6 to 11.5 months postpartum. None of these women developed antibodies against the Rh0(D) antigen.

    ITP

    In an open-label, single-arm, multicenter study, 98 Rh0(D)-positive adult subjects with chronic ITP and a platelet count of 30 × 109/L or less were treated with Rhophylac. Subjects received a single intravenous dose of 250 IU (50 mcg) per kg body weight.

    The primary efficacy endpoint was the response rate defined as achieving a platelet count of ≥30 × 109/L as well as an increase of >20 × 109/L within 15 days after treatment with Rhophylac. Secondary efficacy endpoints included the response rate defined as an increase in platelet counts to ≥50 × 109/L within 15 days after treatment and, in subjects who had bleeding at baseline, the regression of hemorrhage defined as any decrease from baseline in the severity of overall bleeding status.

    Table 4 presents the primary response rates for the intent-to-treat (ITT) and per-protocol (PP) populations.

    Table 4: Primary Response Rates (ITT and PP Populations)
    Analysis Population No. Subjects No. Responders Primary Response Rate at Day 15
    % Responders 95% Confidence Interval (CI)
    ITT 98 65 66.3% 56.5%, 74.9%
    PP 92 62 67.4% 57.3%, 76.1%

    The primary efficacy response rate (ITT population) demonstrated a clinically relevant response to treatment, i.e., the lower bound of the 95% confidence interval (CI) was greater than the predefined response rate of 50%. The median time to platelet response was 3 days, and the median duration of platelet response was 22 days.

    Table 5 presents the response rates by baseline platelet count for subjects in the ITT population.

    Table 5: Response Rates By Baseline Platelet Count (ITT Population)
    Response Rates at Day 15
    Baseline Platelet count

    (× 109/L)

    Total No. Subjects No. (%) Subjects Achieving a Platelet Count of ≥30 × 109/L and an Increase of >20 × 109/L No. (%) Subjects With an Increase in Platelet Counts to ≥50 × 109/L
    *
    Reflects subjects with a platelet count of ≤30 × 109/L at screening but >30 × 109/L immediately before treatment.
    ≤10 38 15 (39.5) 10 (26.3)
    >10 to 20 28 22 (78.6) 17 (60.7)
    >20 to 30 27 24 (88.9) 22 (81.5)
    >30* 5 4 (80.0) 5 (100.0)
    Overall

    (all subjects)

    98 65 (66.3) 54 (55.1)

    During the study, an overall regression of hemorrhage was seen in 44 (88%, 95% CI: 76% to 94%) of the 50 subjects with bleeding at baseline. The percentage of subjects showing a regression of hemorrhage increased from 20% at Day 2 to 64% at Day 15. There was no evidence of an association between the overall hemorrhage regression rate and baseline platelet count.

    Approximately half of the 98 subjects in the ITT population had evidence of bleeding at baseline. Post-baseline, the percentage of subjects without bleeding increased to a maximum of 70.4% at Day 8.

    REFERENCES

    1. Gaines AR. Disseminated intravascular coagulation associated with acute hemoglobinemia or hemoglobinuria following Rh0(D) immune globulin intravenous administration for immune thrombocytopenic purpura. Blood. 2005;106:1532-1537.
    2. Pollack W, Ascari WQ, Kochesky RJ, O’Connor RR, Ho TY, Tripodi D. Studies on Rh prophylaxis. 1. relationship between doses of anti-Rh and size of antigenic stimulus. Transfusion. 1971;11:333-339.
    3. Thornton JG, Page C, Foote G, Arthur GR, Tovey LAD, Scott JS. Efficacy and long term effects of antenatal prophylaxis with anti-D immunoglobulin. Br Med J. 1989;298:1671-1673.
    4. Stucki M, Moudry R, Kempf C, Omar A, Schlegel A, Lerch PG. Characterisation of a chromatographically produced anti-D immunoglobulin product. J Chromatogr B. 1997;700:241-248.
    5. Horowitz B, Chin S, Prince AM, Brotman B, Pascual D, Williams B. Preparation and characterization of S/D-FFP, a virus sterilized “fresh frozen plasma”. J Thromb Haemost. 1991;65:1163.
    6. Horowitz B, Bonomo R, Prince AM, Chin S, Brotman B, Shulman RW. Solvent/detergent-treated plasma: a virus-inactivated substitute for fresh frozen plasma. Blood. 1992;79:826-831.
    7. Lazarus AH, Crow AR. Mechanism of action of IVIG and anti-D in ITP. Transfus Apher Sci. 2003;28:249-255.
    8. Bichler J, Schöndorfer G, Pabst G, Andresen I. Pharmacokinetics of anti-D IgG in pregnant RhD-negative women. BJOG. 2003;110:39-45.
    9. Ware RE, Zimmerman SA. Anti-D: mechanisms of action. Semin Hematol. 1998;35:14-22.
    10. MacKenzie IZ, Bichler J, Mason GC, et al. Efficacy and safety of a new, chromatographically purified rhesus (D) immunoglobulin. Eur J Obstetr Gynecol Reprod Biol. 2004;117:154-161.

    How Supplied/Storage and Handling

    • Rhophylac 1500 IU (300 mcg) is supplied in packages of one or ten (10) prefilled, ready-to-use, glass syringe(s), each containing 2 mL liquid for injection. Each syringe is accompanied by a SafetyGlide™ needle for intravenous or intramuscular use.
    • Rhophylac contains no preservatives.
    • The prefilled Rhophylac syringe contains no latex.
    • DO NOT FREEZE.
    • Store at 2 to 8°C (36 to 46°F) for a shelf life of 36 months from the date of manufacture, as indicated by the expiration date printed on the outer carton and syringe label.
    • Keep Rhophylac in its original carton to protect it from light.

    The following presentations of Rhophylac are available:

    NDC Number Product Description
    44206-300-01 1 prefilled 2 mL syringe
    44206-300-10 10 prefilled 2 mL syringes

    Patient Counseling Information

    Both Indications

    • Inform patients to immediately report the following signs and symptoms to their physician: hives, chest tightness, wheezing, hypotension, and anaphylaxis.
    • Inform patients that Rhophylac is made from human blood and may contain infectious agents that can cause disease (e.g., viruses and, theoretically, the CJD agent). Explain that the risk Rhophylac may transmit an infectious agent has been reduced by screening all plasma donors, by testing the donated plasma for certain viruses, and by inactivating and/or removing certain viruses during manufacturing. Advise patients to report any symptoms that concern them and that may be related to viral infections.
    • Inform patients that Rhophylac may interfere with the response to live virus vaccines (e.g., measles, mumps, rubella, and varicella), and instruct them to notify their healthcare professional of this potential interaction when they are receiving vaccinations.

    Suppression of Rh Isoimmunization

    • Inform patients receiving the antepartum dose of Rhophylac for suppression of Rh isoimmunization that they will need a second dose within 72 hours of birth if the baby’s blood type is Rh-positive.

    ITP

    • Instruct patients being treated with Rhophylac for ITP to immediately report symptoms of intravascular hemolysis, including back pain, shaking chills, fever, discolored urine, decreased urine output, sudden weight gain, edema, and/or shortness of breath.

    Manufactured by:

    CSL Behring AG

    Bern, Switzerland

    US License No. 1766

    Distributed by:

    CSL Behring LLC

    Kankakee, IL 60901 USA

    Triton is a trademark of The Dow Chemical Company

    Planova® is a registered trademark of Asahi Kasei Medical Co., Ltd.

    SafetyGlide is a trademark of Becton, Dickinson and Company

    PRINCIPAL DISPLAY PANEL – 300 mcg Syringe Label

    Rh0(D) Immune Globulin

    Intravenous (Human)

    300 mcg

    Rhophylac®

    1500 IU per 2 mL

    For IV or IM Injection. Rx only

    CSL Behring AG, Bern, Switzerland

    US License No. 1766

    Rhophylac® 300 mcg

    LOT

    Rhophylac® 300 mcg

    LOT

    LOT

    EXP

    NDC 44206-300-01

    10002552-02/37

    PRINCIPAL DISPLAY PANEL – 300 mcg Syringe Carton

    NDC 44206-300-01

    300 mcg

    Rh0(D) Immune Globulin Intravenous (Human)

    Rhophylac®

    1500 IU

    For Intravenous or Intramuscular Injection. Rx only

    CSL Behring

    Rhophylac 

    human rho(d) immune globulin solution

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:44206-300
    Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HUMAN RHO(D) IMMUNE GLOBULIN (HUMAN RHO(D) IMMUNE GLOBULIN) HUMAN RHO(D) IMMUNE GLOBULIN 1500 [iU]  in 2 mL
    Inactive Ingredients
    Ingredient Name Strength
    Albumin (Human) 10 mg  in 1 mL
    Human Immunoglobulin A  
    Glycine  
    Sodium Chloride  
    Packaging
    # Item Code Package Description
    1 NDC:44206-300-01 1 SYRINGE, GLASS (SYRINGE) in 1 CARTON
    1 2 mL in 1 SYRINGE, GLASS
    2 NDC:44206-300-10 10 SYRINGE, GLASS (SYRINGE) in 1 CARTON
    2 2 mL in 1 SYRINGE, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    BLA BLA125070 01/06/2009
    Labeler - CSL Behring AG (481152762)
    Establishment
    Name Address ID/FEI Operations
    CSL Behring AG 481152762 MANUFACTURE

    Revised: 09/2010   CSL Behring AG

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    Rhophylac

    Rhophylac

    Generic Name: rho(d) immune globulin (human) (roe D ih-MYOON GLAH-byoo-lin)

    Brand Name: Rhophylac

    OverviewSide EffectsInteractionsFor ProfessionalsMore…

    Rhophylac is used for:

    Preventing certain blood problems that may occur during pregnancy or blood transfusion. It is also used to treat a certain type of bleeding disorder (immune thrombocytopenia purpura [ITP]) in some patients. It may also be used for other conditions as determined by your doctor.

    Rhophylac is an immunoglobulin (Ig), which contains antibodies to the Rho(D) antigen. Exactly how it works is unknown.

    Do NOT use Rhophylac if:

    • you are allergic to any ingredient in Rhophylac
    • you have had an allergic reaction to other human immune globulins
    • you have anti-immunoglobulin A (IgA) antibodies

    Contact your doctor or health care provider right away if any of these apply to you.

    Before using Rhophylac:

    Some medical conditions may interact with Rhophylac. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

    • if you are pregnant, plan to become pregnant, or are breast-feeding
    • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
    • if you have allergies to medicines, foods, or other substances
    • if you have had an allergic reaction to blood or blood products
    • if you have other blood problems (eg, anemia), bleeding problems, or IgA deficiency
    • if you are Rho(D) negative or if your spleen has been removed

    Some MEDICINES MAY INTERACT with Rhophylac. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

    • Live vaccines (eg, measles, mumps, and rubella) because their effectiveness may be decreased by Rhophylac

    This may not be a complete list of all interactions that may occur. Ask your health care provider if Rhophylac may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

    How to use Rhophylac:

    Use Rhophylac as directed by your doctor. Check the label on the medicine for exact dosing instructions.

    • Rhophylac is usually given as an injection at your doctor’s office, hospital, or clinic. If you will be using Rhophylac at home, a health care provider will teach you how to use it. Be sure you understand how to use Rhophylac. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
    • Do not use Rhophylac if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
    • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
    • If you miss a dose of Rhophylac, contact your doctor immediately.

    Ask your health care provider any questions you may have about how to use Rhophylac.

    Important safety information:

    • Rhophylac may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Rhophylac with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
    • Avoid vaccinations with live vaccines (eg, measles, mumps, oral polio) for 3 months after using Rhophylac. Vaccinations may be less effective.
    • Rhophylac is made from human plasma. There is an extremely low risk of developing a viral infection or Creutzfeldt-Jakob disease (CJD) after using Rhophylac. Discuss any questions or concerns with your doctor.
    • Rhophylac may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Rhophylac.
    • Lab tests, including blood counts and antibody titers, may be performed while you use Rhophylac. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
    • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discus the benefits and risks of using Rhophylac during while you are pregnant. It is not known if Rhophylac is found in breast milk. If you are or will be breast-feeding while you are using Rhophylac, check with your doctor. Discuss any possible risks to your baby.

    Possible side effects of Rhophylac:

    All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

    Chills; headache; mild fever; mild pain, swelling, or redness at the injection site.

    Seek medical attention right away if any of these SEVERE side effects occur:

    Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain; blood in the urine; dark urine; decreased urination; fast heartbeat; nausea; severe or persistent fever; shaking chills; shortness of breath; sudden weight gain; swelling; unusual tiredness or weakness; wheezing; vomiting; yellowing of the eyes or skin.

    This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

    If OVERDOSE is suspected:

    Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dark urine; unusual tiredness or weakness; yellowing of the eyes or skin.

    Proper storage of Rhophylac: Rhophylac is usually handled and stored by a health care provider. If you are using Rhophylac at home, store Rhophylac as directed by your pharmacist or health care provider. Keep Rhophylac out of the reach of children and away from pets.

    General information:

    • If you have any questions about Rhophylac, please talk with your doctor, pharmacist, or other health care provider.
    • Rhophylac is to be used only by the patient for whom it is prescribed. Do not share it with other people.
    • If your symptoms do not improve or if they become worse, check with your doctor.
    • Check with your pharmacist about how to dispose of unused medicine.

    This information should not be used to decide whether or not to take Rhophylac or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Rhophylac. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Rhophylac. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Rhophylac.

    Issue Date: March 6, 2013 Database Edition 13.1.1.003 Copyright © 2013 Wolters Kluwer Health, Inc.

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    Rhophylac

    Rhophylac

    Generic Name: rho(d) immune globulin (Injection route, Intramuscular route, Intravenous route)

    roe-dee i-MUNE GLOB-ue-lin

    Intravenous route(Powder for Solution;Solution) Intravascular hemolysis (IVH) leading to death has been reported in patients treated for immune thrombocytopenic purpura (ITP) with Rho(D) immune globulin. IVH can lead to clinically compromising anemia and multi-system organ failure, including acute respiratory distress syndrome (ARDS), acute renal insufficiency, renal failure, and disseminated intravascular coagulation (DIC). Alert patients and closely monitor for the signs and symptoms of IVH in a health care setting for at least eight hours after administration for ITP. Perform a dipstick urinalysis at baseline, 2 hours, 4 hours after administration, and prior to the end of the monitoring period. If signs and/or symptoms of IVH are present or suspected, post-treatment laboratory tests should be performed, including plasma hemoglobin, haptoglobin, LDH, and plasma bilirubin (direct and indirect) .

    OverviewSide EffectsInteractionsFor ProfessionalsMore…

    Commonly used brand name(s)

    In the U.S.

    • BayRho-D
    • HyperRHO S/D
    • MicRhogam Ultra-Filtered
    • Rhogam
    • RhoGAM Ultra-Filtered Plus
    • Rhophylac
    • WinRho SDF

    In Canada

    • Winrho SDF

    Available Dosage Forms:

    • Powder for Solution
    • Solution
    • Injectable

    Therapeutic Class: Immune Serum

    Uses For Rhophylac

    Rho(D) immune globulin is used to treat immune thrombocytopenic purpura (ITP) in patients with Rh-positive blood. ITP is a type of blood disorder where the person has a very low number of platelets. Platelets help to clot the blood. Rho(D) immune globulin is also used to prevent antibodies from forming after a person with Rh-negative blood receives a transfusion with Rh-positive blood, or during pregnancy when a mother has Rh-negative blood and the baby is Rh-positive. It belongs to a group of medicines called immunizing agents. Rho(D) immune globulin works to boost the immune system and prevent excessive bleeding.

    The Rh factor is one part of the red blood cell. A person has either Rh-positive or Rh-negative blood. If you receive the opposite type of blood, your body will create antibodies that can destroy the red blood cells. When a pregnant woman is Rh-negative and her baby is Rh-positive, the baby’s blood can get into her system and cause her to make antibodies. When the same woman has a second baby with Rh-positive blood, the antibodies will destroy the red blood cells in the baby. Rho(D) immune globulin is given to these women during pregnancy or after delivery to prevent them from making antibodies.

    This medicine is to be administered only by or under the supervision of your doctor.

    Before Using Rhophylac

    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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Rho(D) immune globulin in children. It is not recommended for an infant with Rh-positive blood whose mother is Rh-negative.

    Geriatric

    Although appropriate studies on the relationship of age to the effects of Rho(D) immune globulin have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of Rho(D) immune globulin in the elderly. However, elderly patients are more likely to have age-related heart, kidney, or liver problems, and might have conditions that require an adjustment in the dose for patients receiving Rho(D) immune globulin.

    Pregnancy

    Pregnancy Category Explanation
    All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

    Breast Feeding

    Studies in women suggest that this medication poses minimal risk to the infant when used during 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

    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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

    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:

    • Anemia, severe or
    • Blood clotting problems, history of or
    • Breathing problems, severe or
    • Disseminated intravascular coagulation (blood clotting problem) or
    • Kidney problems or
    • Pulmonary edema (fluid in the lungs), history of—Use with caution. May make these conditions worse.
    • Atherosclerosis (hardening of the arteries), history of or
    • Heart or blood vessel problems or
    • Hyperviscosity (thick blood), history of or
    • Stroke—Use with caution. May cause side effects to become worse.
    • Autoimmune hemolytic anemia (bleeding problem) or
    • Hemolysis, active (red blood cells are being destroyed) or
    • Immunoglobulin A (IgA) deficiency with antibodies against IgA—Should not be used in patients with these conditions.
    • Diabetes—The liquid form of WinRho® contains maltose. Some glucose testing systems will not work properly if maltose is in the blood. Discuss this with your doctor.

    Proper Use of rho(d) immune globulin

    This section provides information on the proper use of a number of products that contain rho(d) immune globulin. It may not be specific to Rhophylac. Please read with care.

    A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins or as a shot into one of your muscles.

    Precautions While Using Rhophylac

    It is very important that your doctor check the progress of you or your child at regular visits for any problems or unwanted effects that may be caused by this medicine. Blood and urine tests may be needed to check for unwanted effects.

    Check with your doctor right away if you or your child have back pain; shaking chills; a fever; dark urine; a decreased amount of urine; a sudden weight gain; swelling of the hands or feet; or shortness of breath after receiving this medicine. These may be symptoms of a serious blood problem called intravascular hemolysis (IVH).

    This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made from human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the making of these medicines. Although the risk is low, talk with your doctor if you have concerns.

    This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have itching, a rash, hives, chest pain, dizziness or lightheadedness, trouble breathing, or any swelling of your hands, face, or mouth after you receive this medicine.

    This medicine may cause blood clots, especially in patients with a history of blood clotting problems, heart disease, and atherosclerosis (hardening of the arteries) or circulation problems. Patients who stay in bed for a long time because of surgery or illness may also have blood clots. Check with your doctor right away if you or your child suddenly have chest pain, shortness of breath, a severe headache, leg pain, or problems with vision, speech, or walking.

    This medicine may cause a rare and serious lung problem a few hours after it is given. Tell your doctor right away if you or your child have any breathing problems with or without a fever after you receive the medicine.

    While you are being treated with Rho(D) immune globulin, do not have any immunizations (vaccines) without your doctor’s approval. Live virus vaccines should not be given for 3 months after receiving Rho(D) immune globulin.

    Rhophylac 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:

    Rare

    • Bloody urine
    • decreased frequency of urination or amount of urine
    • fever
    • increased blood pressure
    • increased thirst
    • loss of appetite
    • lower back pain
    • nausea or vomiting
    • pale skin
    • swelling of the face, fingers, or lower legs
    • troubled breathing
    • unusual bleeding or bruising
    • unusual tiredness or weakness
    • weight gain

    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:

    Less common

    • Soreness at the place of injection

    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: Rhophylac side effects (in more detail)

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    Rhophylac

    Rhophylac

    Generic Name: RHo (D) immune globulin (ROE D im MYOON GLOB yoo lin)

    Brand Name: HyperRHO S/D Full Dose, HyperRHO S/D Mini Dose, MicRhoGAM, MicRhoGAM Ultra-Filtered Plus, RhoGAM, RhoGAM Ultra-Filtered Plus, Rhophylac, WinRho SDF

    OverviewSide EffectsInteractionsFor ProfessionalsMore…

    What is RHo (D) immune globulin?

    RHo (D) immune globulin is a sterilized solution made from human blood. Rh is a substance that most people have in their blood (Rh positive) but some people don’t (Rh negative). A person who is Rh negative can be exposed to Rh positive blood through a mismatched blood transfusion or during pregnancy when the baby has the opposite blood type. When this exposure happens, the Rh negative blood will respond by making antibodies that will try to destroy the Rh positive blood cells. This can cause medical problems such as anemia (loss of red blood cells), kidney failure, or shock.

    RHo (D) immune globulin is used to prevent an immune response to Rh positive blood in people with an Rh negative blood type. RHo (D) immune globulin may also be used in the treatment of immune thrombocytopenic purpura (ITP).

    RHo (D) immune globulin may also be used for purposes not listed in this medication guide.

    What is the most important information I should know about RHo (D) immune globulin?

    You should not receive this medication if you have ever had an allergic reaction to an immune globulin or if you have immune globulin A (IgA) deficiency with antibody to IgA. You should not receive RHo (D) immune globulin if you have hemolytic anemia (a lack of red blood cells).

    Before you receive this medication, tell your doctor if you have heart disease or a history of coronary artery disease, high triglycerides, a bleeding disorder, or immune globulin A (IgA) deficiency.

    If you are an Rh-negative woman and you become pregnant, you must tell your doctor if you have ever been exposed to Rh-positive blood in your lifetime. This includes exposure from a mismatched blood transfusion, or exposure during your first pregnancy. Your history of exposure and treatment will be extremely important to each and every one of your pregnancies.

    Call your doctor at once if you have a serious side effect such as fever, chills, shaking, back pain, dark colored urine, rapid breathing, feeling short of breath, urinating less than usual, swelling, rapid weight gain, pale skin, easy bruising or bleeding, rapid heart rate, trouble concentrating, feeling light-headed.

    Do not receive a “live” vaccine for at least 3 months after treatment with RHo (D) immune globulin. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

    What should I discuss with my healthcare provider before I receive RHo (D) immune globulin?

    You should not receive this medication if you have ever had an allergic reaction to an immune globulin or if you have immune globulin A (IgA) deficiency with antibody to IgA. You should not receive RHo (D) immune globulin if you have hemolytic anemia (a lack of red blood cells).

    To make sure you can safely receive RHo (D) immune globulin, tell your doctor if you have any of these other conditions:

    • heart disease or a history of coronary artery disease (hardened arteries);

    • high triglycerides (a type of fat in the blood);
    • a bleeding disorder (such as hemophilia); or
    • immune globulin A (IgA) deficiency.

    RHo (D) immune globulin is used during and after pregnancy. This medication is not known to be harmful to a baby during pregnancy or while breast-feeding.

    If you are receiving this medication to treat a mismatched blood transfusion, tell your doctor if you are pregnant or if you ever plan to become pregnant.

    RHo (D) immune globulin is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

    If you are an Rh-negative woman and you become pregnant, you must tell your doctor if you have ever been exposed to Rh-positive blood in your lifetime. This includes exposure from a mismatched blood transfusion, or exposure during your first pregnancy. Your history of exposure and treatment will be extremely important to each and every one of your pregnancies.

    How is RHo (D) immune globulin given?

    RHo (D) immune globulin is injected into a muscle or a vein. You will receive this injection in a clinic or hospital setting.

    Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely for at least 8 hours after you receive immune globulin. Your urine will also need to be tested every 2 to 4 hours.

    For treatment during pregnancy, this medication is usually given at regular intervals during the last half of the pregnancy, and again after the baby is born.

    For treatment of a mismatched blood transfusion, the medication is given when symptoms of an immune response appear (when the body starts making Rh antibodies).

    To be sure this medicine is helping your condition, your blood will need to be tested often. Your liver and kidney function may also need to be tested. Visit your doctor regularly.

    This medication can cause false results with certain lab tests for glucose (sugar) in the blood. Tell any doctor who treats you that you are using RHo (D) immune globulin.

    What happens if I miss a dose?

    Call your doctor for instructions if you miss an appointment for your RHo (D) immune globulin injection.

    What happens if I overdose?

    Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

    What should I avoid while receiving RHo (D) immune globulin?

    Do not receive a “live” vaccine for at least 3 months after treatment with RHo (D) immune globulin. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

    RHo (D) immune globulin side effects

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

    Call your doctor at once if you have a serious side effect such as:

    • fever, chills, shaking, back pain, dark colored urine;

    • rapid breathing, feeling short of breath.
    • urinating less than usual or not at all, swelling, rapid weight gain; or
    • pale skin, easy bruising or bleeding, rapid heart rate, trouble concentrating, feeling light-headed.

    Less serious side effects may include:

    • joint or muscle pain;

    • headache, dizziness;
    • feeling weak or tired;
    • mild itching or skin rash;
    • nausea, diarrhea, vomiting, stomach pain; or
    • pain or tenderness where the medicine was injected.

    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: Rhophylac side effects (in more detail)

    What other drugs will affect RHo (D) immune globulin?

    There may be other drugs that can interact with RHo (D) immune globulin. 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.

    Next Page → Side Effects

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    Where can I get more information?

    • Your doctor or pharmacist can provide more information about RHo (D) immune globulin.

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