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Landmark Rh Immune Globulin Celebrates 40 Years of Saving Babies' Lives
Date:2/9/2009

in such products. All infections thought by a physician possibly to have been transmitted by these products should be reported by the physician or other healthcare provider in the United States to Ortho-Clinical Diagnostics, Inc. at 1-800-421-3311. Outside the United States, the company distributing these products should be contacted. The physician should discuss the risks and benefits of these products with the patient.

ADVERSE REACTIONS

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 micro grams per dose). Although high doses of intravenous immune globulin containing IgA at levels of 270-720 micro grams/mL have been given without incident during treatment of patients with high-titered antibodies to IgA, the attending physician must weigh the benefit against the potential risks of hypersensitivity reactions.

DRUG INTERACTIONS

Immune globulin preparations including Rho(D) Immune Globulin (Human) may impair the efficacy
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SOURCE Ortho-Clinical Diagnostics, Inc.
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