Immune Globulin Intravenous (Human) solution (Rhophylac)
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Immune Globulin Intravenous (Human) solution (Rhophylac)

Rhophylac® (immune globulin intravenous human solution)
(Rh0(D) Immune Globulin Intravenous (Human))
For Intravenous or Intramuscular Injection Preservative-free, Latex-free, Ready-to-use Prefilled Syringe

DRUG DESCRIPTION

Rhophylac® (immune globulin intravenous human solution) is a sterile Rh0(D) Immune Globulin Intravenous (Human) solution in a ready-to-use prefilled 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® (immune globulin intravenous human solution) 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® (immune globulin intravenous human solution) 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® (immune globulin intravenous human solution) is produced by an ion-exchange chromatography isolation procedure7, 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.8,9 Rhophylac® (immune globulin intravenous human solution) 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.

Table 3: Virus Inactivation and Removal in Rhophylac® (immune globulin intravenous human solution)

Virus HIV 1 PRV 1 BVDV 1 MVM
Genome RNA DNA RNA DNA
Envelope Yes Yes Yes No
Size 80-100 nm 120-200 nm 40-70 nm 18-24 nm
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
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; MVM, minute virus of mice, a model for B19V and other small, non-enveloped DNA viruses.

Rhophylac® (immune globulin intravenous human solution) 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® (immune globulin intravenous human solution) has a purity greater than 95% IgG. Rhophylac® (immune globulin intravenous human solution) 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® (immune globulin intravenous human solution) contains no preservative. Human albumin is manufactured from pooled plasma of US donors by cold ethanol fractionation, followed by pasteurization.

What are the possible side effects of RHo (D) immune globulin?

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...

Read All Potential Side Effects and See Pictures of Rhophylac »

Last reviewed on RxList: 5/18/2007
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Suppression of Rh Isoimmunization

Pregnancy and Obstetric Conditions

Rhophylac® (immune globulin intravenous (human) solution) 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® (immune globulin intravenous (human) solution) 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 Rh0(D)-positive 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® (immune globulin intravenous (human) solution) .

Immune Thrombocytopenic Purpura (ITP)

Rhophylac® (immune globulin intravenous (human) solution) is indicated in Rh0(D)-positive, non-splenectomized adult patients with chronic ITP to raise platelet counts.

DOSAGE AND ADMINISTRATION

As with all blood products, patients should be observed for at least 20 minutes following administration of Rhophylac® (immune globulin intravenous (human) solution) .

Preparation and Handling

Bring Rhophylac® (immune globulin intravenous (human) solution) to room temperature before use.

Rhophylac® (immune globulin intravenous (human) solution) is a clear or slightly opalescent, colorless to pale yellow solution. Rhophylac® (immune globulin intravenous (human) solution) should be inspected visually for particulate matter and discoloration prior to administration. Do not use if the solution is cloudy or contains particulates. Do not use solution that has been frozen.

Rhophylac® (immune globulin intravenous (human) solution) is for single use only. Dispose of any unused product or waste material in accordance with local requirements.

Suppression of Rh Isoimmunization

Rhophylac® (immune globulin intravenous (human) solution) 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® (immune globulin intravenous (human) solution) 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)
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
IU, international units; mcg, micrograms.
* A 1500 IU (300 mcg) dose of Rhophylac® (immune globulin intravenous (human) solution) will suppress the immunizing potential of ≥ 15 mL of Rh0(D)-positive RBCs.1
† The dose of Rhophylac® (immune globulin intravenous (human) solution) 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.

ITP

For treatment of ITP, Rhophylac® (immune globulin intravenous (human) solution) must be administered by the intravenous route.

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

Dose (IU) x body weight (kg) = Total IU / 1500 IU per syringe = # of syringes

Rhophylac® (immune globulin intravenous (human) solution) 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 syringe

HOW SUPPLIED

Storage and Handling

Rhophylac® (immune globulin intravenous (human) solution) 1500 IU (300 mcg) is supplied in packages of one or 10 latex-free, ready-to-use, prefilled syringes, each containing 2 mL of preservative-free liquid. Each syringe is accompanied by a SafetyGlide™ needle for intravenous or intramuscular use.

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

Store at 2-8°C (36-46°F). If stored at this temperature, Rhophylac® (immune globulin intravenous (human) solution) has 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. Do not freeze. Keep Rhophylac® (immune globulin intravenous (human) solution) in its original carton to protect it from light.

Manufactured by: ZLB Behring AG., Berne, Switzerland US License No. 1710
Distributed by: ZLB 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
FDA rev date: 3/26/2007

Last reviewed on RxList: 5/18/2007
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

The most serious adverse reactions in patients receiving Rh0(D) immune globulin have been observed in the treatment of ITP. These reactions include intravascular hemolysis, clinically compromising anemia, acute renal insufficiency, and, very rarely, DIC and death (see Warnings and Precautions ).

The most common adverse reactions observed in the use of Rhophylac® (immune globulin intravenous (human) solution) for suppression of Rh isoimmunization are nausea, dizziness, headache, injection-site pain, and malaise.

The most common adverse reactions observed in the treatment of ITP are chills, pyrexia/increased body temperature, and headache. Mild extravascular hemolysis (manifested by an increase in bilirubin and a decrease in hemoglobin) 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® (immune globulin intravenous (human) solution) 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).

The most common adverse reactions 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. All adverse reactions were mild to moderate in intensity.

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 ). Premedication to alleviate infusion-related side effects was not used except in a single subject who received acetaminophen and diphenhydramine.

Adverse reactions were mild to moderate in intensity with the exception of one case of severe headache. 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 extravascular hemolysis, manifested as an increase in bilirubin, a decrease in hemoglobin, or a decrease in haptoglobin, was observed, as expected when an anti-D product is given to an Rh-positive individual. 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® (immune globulin intravenous (human) solution) .

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 (%) Witha Drug-Related TEAE*
n=98
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%)
* Defined as TEAEs with a possible, probable, definite, or unknown relationship to the study drug.

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 reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to product exposure. Evaluation and interpretation of these postmarketing reactions is confounded by underlying diagnosis, concomitant medications, pre-existing conditions, and inherent limitations of passive surveillance.

Suppression of Rh Isoimmunization

The following adverse reactions have been identified during postapproval use of Rhophylac® (immune globulin intravenous (human) solution) for 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, and, rarely, diarrhea and back pain. 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® (immune globulin intravenous (human) solution) for ITP.

Read the Rhophylac (immune globulin intravenous (human) solution) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Live Virus Vaccines

Immunoglobulin administration may transiently impair the efficacy of live attenuated virus vaccines such as measles, mumps, rubella, and varicella. The immunizing physician should be informed of recent therapy with Rhophylac® so that appropriate measures can be taken (see Patient Counseling Information ).

Last reviewed on RxList: 5/18/2007
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

No information provided.

PRECAUTIONS

Both Indications

Allergic Reactions

Allergic 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, immediately discontinue administration. The treatment required depends on the nature and severity of the side effect. If necessary, the current medical standards for shock treatment should be observed (see Patient Counseling Information).

Selective IgA Deficiency

Individuals with selective IgA deficiency can develop antibodies to IgA and anaphylactic reactions (including anaphylaxis and shock) after administration of blood components containing IgA. Although the concentration of IgA was found to be below the detection limit of 5 mcg/mL, Rhophylac® (immune globulin intravenous (human) solution) may contain trace amounts of IgA (see Description).

Those with known antibodies to IgA may have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. Therefore, the physician must weigh the expected benefits of treatment with Rhophylac® (immune globulin intravenous (human) solution) against the potential risks.

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® (immune globulin intravenous (human) solution) can contain antibodies to other Rh antigens (e.g., anti-C antibodies), which might be detected by sensitive serological tests following administration.

Transmissible Infectious Agents

Rhophylac® (immune globulin intravenous (human) solution) is made from human plasma. Products made from human plasma may contain infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses during manufacturing through solvent/detergent treatment and virus filtration. The solvent/detergent treatment step is effective in inactivating enveloped viruses such as hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV). The virus filtration step is effective in removing both enveloped and non-enveloped viruses (see Description, Patient Counseling Information ).

Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. All infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to ZLB Behring at 1-800-504-5434. The physician should discuss the risks and benefits of this product with the patient.

Suppression of Rh Isoimmunization

Postpartum Use Following an Rh-incompatible Pregnancy Rhophylac® (immune globulin intravenous (human) solution) should not be given to the newborn infant (see Pediatric Use for pediatric use in incompatible transfusions and in ITP).

ITP

Intravascular Hemolysis

Intravascular hemolysis has occurred in a clinical study with Rhophylac® (immune globulin intravenous (human) solution) . All cases resolved completely. However, as reported in the literature, some patients treated with Rh0(D) immune globulin (anti-D) developed clinically compromising anemia, acute renal insufficiency, and, very rarely, disseminated intravascular coagulation (DIC) and death.2

Following administration of Rhophylac® (immune globulin intravenous (human) solution) , patients should be monitored for signs and/or symptoms of intravascular hemolysis and its complications including clinically compromising anemia, acute renal insufficiency, and DIC. Patients experiencing intravascular hemolysis may present with back pain, shaking chills, fever, and, most consistently, hemoglobinuria (see Patient Counseling Information ).

ITP patients presenting with signs and/or symptoms of intravascular hemolysis and its complications after Rh0(D) immune globulin administration should have confirmatory laboratory tests. 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® (immune globulin intravenous (human) solution) are to be transfused, Rh0(D)-negative packed RBCs should be used to avoid exacerbating ongoing hemolysis.

Pre-existing Anemia

The safety of Rhophylac® (immune globulin intravenous (human) solution) in the treatment of ITP has not been established in patients with pre-existing anemia. The physician must weigh the benefits of Rhophylac® (immune globulin intravenous (human) solution) against the potential risk of increasing the severity of the anemia.

Use In Specific Populations

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with Rhophylac® (immune globulin intravenous (human) solution) .

Suppression of Rh Isoimmunization

The available evidence suggests that Rhophylac® (immune globulin intravenous (human) solution) 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.

ITP

Rhophylac® (immune globulin intravenous (human) solution) has not been evaluated in pregnant women with ITP.

Nursing Mothers

Suppression of Rh Isoimmunization

Rhophylac® (immune globulin intravenous (human) solution) is used in nursing mothers for the suppression of Rh isoimmunization. No undesirable effects on a nursing infant are expected during breastfeeding.

ITP

Rhophylac® (immune globulin intravenous (human) solution) has not been evaluated in nursing mothers with ITP.

Pediatric Use

Suppression of Rh Isoimmunization in Incompatible Transfusions

The safety and effectiveness of Rhophylac® (immune globulin intravenous (human) solution) 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® (immune globulin intravenous (human) solution) , particularly in girls whose later pregnancies may be affected if Rh isoimmunization occurs.

ITP

Studies have demonstrated the safe and effective use of Rh0(D) Immune Globulin in children with ITP.3-6

Geriatric Use

Suppression of Rh Isoimmunization in Incompatible Transfusions

Rhophylac® (immune globulin intravenous (human) solution) 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), 19% were 65 years of age and older. No overall differences in effectiveness or safety were observed between these subjects and younger subjects.

Last reviewed on RxList: 5/18/2007
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

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 risk of hemolysis.

CONTRAINDICATIONS

Individuals known to have had an anaphylactic or severe systemic reaction to the administration of human immune globulin products should not receive Rh0(D) immune globulin.

Last reviewed on RxList: 5/18/2007
This monograph has been modified to include the generic and brand name in many instances.

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® (immune globulin intravenous (human) solution) 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® (immune globulin intravenous (human) solution) 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.10

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® (immune globulin intravenous (human) solution) at Week 28 of gestation.11

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® (immune globulin intravenous (human) solution) 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® (immune globulin intravenous (human) solution) .

ITP

Pharmacokinetic studies with Rhophylac® (immune globulin intravenous (human) solution) were not performed in Rh0(D)-positive subjects with ITP. Rh0(D) immune globulin binds rapidly to Rh0(D)-positive erythrocytes.12

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® (immune globulin intravenous (human) solution) 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 - Eight of the women who participated in the pharmacokinetic study (see Clinical Pharmacology ) gave birth to an Rh0(D)-positive baby and received the postpartum dose of 1500 IU (300 mcg) of Rhophylac® (immune globulin intravenous (human) solution) .11 Antibody tests performed 6 to 8 months later were negative for all women. This suggests that no Rh0(D) immunization occurred.
  • Study 2 - 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® (immune globulin intravenous (human) solution) either as an intravenous or intramuscular injection (two randomized groups of 216 women each).13 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 x 109L or less were treated with Rhophylac® (immune globulin intravenous (human) solution) . 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 x 109L as well as an increase of >20 x 109L within 15 days after treatment with Rhophylac® (immune globulin intravenous (human) solution) . Secondary efficacy endpoints included the response rate defined as an increase in platelet counts to ≥ 50 x 109L 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% 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(x 109/L) Total No. Subjects No. (%) Subjects Achievinga Platelet Count of ≥ 30 x 109/L and an Increase of >20 x 109L No. (%) Subjects With an Increase in Platelet Counts to ≥ 50 x 109/L
≤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)
* Reflects subjects with a platelet count of <30 × 109/L at screening but >30 × 109L immediately before treatment.

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.   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.

2.   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.

3.   Tarantino MD, Young G, Bertolone SJ, et al; Acute ITP Study Group. Single dose of anti-D immune globulin at 75 µg/kg is as effective as intravenous immune globulin at rapidly raising the platelet count in newly diagnosed immune thrombocytopenic purpura in children. J Pediatr. 2006;148:489-94.

4.   Scaradavou A, Woo B, Woloski BM, et al. Intravenous anti-D treatment of immune thrombocytopenic purpura: experience in 272 patients. Blood. 1997 15;89:2689-2700.

5.   Andrew M, Blanchette VS, Adams M, et al. A multicenter study of the treatment of childhood chronic idiopathic thrombocytopenic purpura with anti-D. J Pediatr. 1992;120:522-5277.

6.   Blanchette V, Imbach P, Andrew M, et al. Randomised trial of intravenous immunoglobulin G, intravenous anti-D, and oral prednisone in childhood acute immune thrombocytopenic purpura. Lancet. 1994;344:703-707.

7.   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.

8.   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.

9.   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.

10. Lazarus AH, Crow AR. Mechanism of action of IVIG and anti-D in ITP. Transfus Apher Sci. 2003;28:249-255.

11. Bichler J, Schondorfer G, Pabst G, Andresen I. Pharmacokinetics of anti-D IgG in pregnant RhD-negative women. BJOG. 2003;110:39-45.

12. Ware RE, Zimmerman SA. Anti-D: mechanisms of action. Semin Hematol. 1998;35:14-22.

13. 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.

Last reviewed on RxList: 5/18/2007
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Patient Counseling Information

Both Indications

Allergic Reactions

Inform patients of the early signs of allergic or hypersensitivity reactions to Rhophylac® (immune globulin intravenous (human) solution) including hives, chest tightness, wheezing, hypotension, and anaphylaxis (see Warnings and Precautions) and advise them to notify their physician if they experience any of these symptoms.

Transmissible Infectious Agents

Inform patients that Rhophylac® (immune globulin intravenous (human) solution) is made from human plasma (part of the blood) and may contain infectious agents that can cause disease (e.g., viruses and, theoretically, the CJD agent). Explain that the risk that Rhophylac® (immune globulin intravenous (human) solution) may transmit an infectious agent has been reduced by screening the plasma donors, by testing the donated plasma for certain virus infections, and by inactivating and/or removing certain viruses during manufacturing (see Warnings and Precautions ).

Live Virus Vaccines

Inform patients that administration of immunoglobulin may temporarily impair the effectiveness of live virus vaccines (e.g., measles, mumps, rubella, and varicella) and to notify their immunizing physician of recent therapy with Rhophylac® (see Drug Interactions).

Suppression of Rh Isoimmunization

Standard Dosing for Rh Isoimmunization

Inform patients receiving the antepartum dose of Rhophylac® (immune globulin intravenous (human) solution) 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 (see Dosage and Administration for Suppression of Rh Isoimmunization).

ITP

Intravascular Hemolysis

Instruct patients being treated with Rhophylac® (immune globulin intravenous (human) solution) 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 (see Warnings and Precautions).

Last reviewed on RxList: 5/18/2007
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

Patient Counseling Information

Both Indications

Allergic Reactions

Inform patients of the early signs of allergic or hypersensitivity reactions to Rhophylac® (immune globulin intravenous (human) solution) including hives, chest tightness, wheezing, hypotension, and anaphylaxis (see Warnings and Precautions) and advise them to notify their physician if they experience any of these symptoms.

Transmissible Infectious Agents

Inform patients that Rhophylac® (immune globulin intravenous (human) solution) is made from human plasma (part of the blood) and may contain infectious agents that can cause disease (e.g., viruses and, theoretically, the CJD agent). Explain that the risk that Rhophylac® (immune globulin intravenous (human) solution) may transmit an infectious agent has been reduced by screening the plasma donors, by testing the donated plasma for certain virus infections, and by inactivating and/or removing certain viruses during manufacturing (see Warnings and Precautions ).

Live Virus Vaccines

Inform patients that administration of immunoglobulin may temporarily impair the effectiveness of live virus vaccines (e.g., measles, mumps, rubella, and varicella) and to notify their immunizing physician of recent therapy with Rhophylac® (see Drug Interactions).

Suppression of Rh Isoimmunization

Standard Dosing for Rh Isoimmunization

Inform patients receiving the antepartum dose of Rhophylac® (immune globulin intravenous (human) solution) 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 (see Dosage and Administration for Suppression of Rh Isoimmunization).

ITP

Intravascular Hemolysis

Instruct patients being treated with Rhophylac® (immune globulin intravenous (human) solution) 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 (see Warnings and Precautions).

Last reviewed on RxList: 5/18/2007
This monograph has been modified to include the generic and brand name in many instances.

Rhophylac® (immune globulin intravenous human solution)
(Rh0(D) Immune Globulin Intravenous (Human))
For Intravenous or Intramuscular Injection Preservative-free, Latex-free, Ready-to-use Prefilled Syringe

DRUG DESCRIPTION

Rhophylac® (immune globulin intravenous human solution) is a sterile Rh0(D) Immune Globulin Intravenous (Human) solution in a ready-to-use prefilled 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® (immune globulin intravenous human solution) 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® (immune globulin intravenous human solution) 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® (immune globulin intravenous human solution) is produced by an ion-exchange chromatography isolation procedure7, 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.8,9 Rhophylac® (immune globulin intravenous human solution) 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.

Table 3: Virus Inactivation and Removal in Rhophylac® (immune globulin intravenous human solution)

Virus HIV 1 PRV 1 BVDV 1 MVM
Genome RNA DNA RNA DNA
Envelope Yes Yes Yes No
Size 80-100 nm 120-200 nm 40-70 nm 18-24 nm
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
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; MVM, minute virus of mice, a model for B19V and other small, non-enveloped DNA viruses.

Rhophylac® (immune globulin intravenous human solution) 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® (immune globulin intravenous human solution) has a purity greater than 95% IgG. Rhophylac® (immune globulin intravenous human solution) 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® (immune globulin intravenous human solution) contains no preservative. Human albumin is manufactured from pooled plasma of US donors by cold ethanol fractionation, followed by pasteurization.

Last reviewed on RxList: 5/18/2007
This monograph has been modified to include the generic and brand name in many instances.

Rhophylac® (immune globulin intravenous human solution)
(Rh0(D) Immune Globulin Intravenous (Human))
For Intravenous or Intramuscular Injection Preservative-free, Latex-free, Ready-to-use Prefilled Syringe

DRUG DESCRIPTION

Rhophylac® (immune globulin intravenous human solution) is a sterile Rh0(D) Immune Globulin Intravenous (Human) solution in a ready-to-use prefilled 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® (immune globulin intravenous human solution) 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® (immune globulin intravenous human solution) 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® (immune globulin intravenous human solution) is produced by an ion-exchange chromatography isolation procedure7, 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.8,9 Rhophylac® (immune globulin intravenous human solution) 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.

Table 3: Virus Inactivation and Removal in Rhophylac® (immune globulin intravenous human solution)

Virus HIV 1 PRV 1 BVDV 1 MVM
Genome RNA DNA RNA DNA
Envelope Yes Yes Yes No
Size 80-100 nm 120-200 nm 40-70 nm 18-24 nm
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
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; MVM, minute virus of mice, a model for B19V and other small, non-enveloped DNA viruses.

Rhophylac® (immune globulin intravenous human solution) 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® (immune globulin intravenous human solution) has a purity greater than 95% IgG. Rhophylac® (immune globulin intravenous human solution) 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® (immune globulin intravenous human solution) contains no preservative. Human albumin is manufactured from pooled plasma of US donors by cold ethanol fractionation, followed by pasteurization.

Last reviewed on RxList: 5/18/2007
This monograph has been modified to include the generic and brand name in many instances.

Rhophylac® (immune globulin intravenous human solution)
(Rh0(D) Immune Globulin Intravenous (Human))
For Intravenous or Intramuscular Injection Preservative-free, Latex-free, Ready-to-use Prefilled Syringe

DRUG DESCRIPTION

Rhophylac® (immune globulin intravenous human solution) is a sterile Rh0(D) Immune Globulin Intravenous (Human) solution in a ready-to-use prefilled 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® (immune globulin intravenous human solution) 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® (immune globulin intravenous human solution) 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® (immune globulin intravenous human solution) is produced by an ion-exchange chromatography isolation procedure7, 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.8,9 Rhophylac® (immune globulin intravenous human solution) 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.

Table 3: Virus Inactivation and Removal in Rhophylac® (immune globulin intravenous human solution)

Virus HIV 1 PRV 1 BVDV 1 MVM
Genome RNA DNA RNA DNA
Envelope Yes Yes Yes No
Size 80-100 nm 120-200 nm 40-70 nm 18-24 nm
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
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; MVM, minute virus of mice, a model for B19V and other small, non-enveloped DNA viruses.

Rhophylac® (immune globulin intravenous human solution) 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® (immune globulin intravenous human solution) has a purity greater than 95% IgG. Rhophylac® (immune globulin intravenous human solution) 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® (immune globulin intravenous human solution) contains no preservative. Human albumin is manufactured from pooled plasma of US donors by cold ethanol fractionation, followed by pasteurization.

Last reviewed on RxList: 5/18/2007
This monograph has been modified to include the generic and brand name in many instances.

Rhophylac Patient Information Including Side Effects

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

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

What is RHo (D) immune globulin (Rhophylac)?

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 are the possible side effects of RHo (D) immune globulin?

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.

Read the Rhophylac (immune globulin intravenous (human) solution) Side Effects Center for a complete guide to possible side effects »

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.

Rhophylac Patient Information including How Should I Take

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.

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.

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.

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.

Rhophylac Patient Information including If I Miss a Dose

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.

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.

Where can I get more information?

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


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 4.01. Revision date: 8/4/2011.

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