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Rhogam Ultra-Filtered Plus

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Rhogam Ultra-Filtered Plus

Rhogam Ultra-Filtered Plus

SIDE EFFECTS

Adverse events (AE) after administration of RhoGAM and MICRhoGAM are rare.

The most frequently reported AEs are anti-D formation and injection site reactions, such as swelling, induration, redness and mild pain or warmth. Possible systemic reactions are skin rash, body aches or a slight elevation in temperature. Severe systemic allergic reactions are extremely rare. Patients should be observed for at least 20 minutes after administration. There have been no reported fatalities due to anaphylaxis or any other cause related to RhoGAM or MICRhoGAM administration.

As with any Rho(D) Immune Globulin (Human), administration to patients who are Rh-positive or have received Rh-positive red blood cells may result in signs and symptoms of a hemolytic reaction, including fever, back pain, nausea and vomiting, hypo- or hypertension, hemoglobinuria/emia, elevated bilirubin and creatinine and decreased haptoglobin.

RhoGAM and MICRhoGAM contain a small quantity of IgA (less than 15 g per dose).10 Although high doses of intravenous immune globulin containing IgA at levels of 270- 720 g/mL have been given without incident during treatment of patients with high-titered antibodies to IgA,11 the attending physician must weigh the benefit against the potential risks of hypersensitivity reactions.

Read the Rhogam Ultra-Filtered Plus (rho(d) immune globulin (human)) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Immune globulin preparations including Rho(D) Immune Globulin (Human) may impair the efficacy of live vaccines such as measles, mumps and varicella. Administration of live vaccines should generally be delayed until 12 weeks after the final dose of immune globulin. If an immune globulin is administered within 14 days after administration of a live vaccine, the immune response to the vaccination may be inhibited.12

Because of the importance of rubella immunity among women of childbearing age, the postpartum vaccination of rubella-susceptible women with rubella or MMR vaccine should not be delayed because of the receipt of Rho(D) Immune Globulin (Human) during the last trimester of pregnancy or at delivery. Vaccination should occur immediately after delivery and if possible, testing should be performed after 3 or more months to ensure immunity to rubella and if necessary, to measles.12

REFERENCES

10  Data on file at Ortho-Clinical Diagnostics, Inc.

11  Cunningham-Rundles C, Zhuo Z, Mankarious S, Courter S. Long-term use of IgA- depleted intravenous immunoglobulin in immunodeficient subjects with anti-IgA antibodies. J Clin Immunol 1993;13:272-78.

12  Centers for Disease Control and Prevention. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices and the American Academy of Family Physicians. MMWR 2002;51 (No. RR-2):6-7.

Read the Rhogam Ultra-Filtered Plus Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 5/9/2008
This monograph has been modified to include the generic and brand name in many instances.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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