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Rhogam (IgG Anti-D (Anti-Rh)) - Warnings and Precautions

 
 



WARNINGS

RhoGAM® and MICRhoGAM® are made from human plasma. Because these products are made from human blood, they may carry a risk of transmitting infectious agents, e.g., viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. 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 removing certain viruses during the manufacturing process. Following fractionation, an additional viral-clearance filtration step is incorporated into the manufacturing process. This filtration step removes viruses via a size-exclusion mechanism utilizing a patented Viresolve 180 ultrafiltration membrane with a defined pore-size distribution of 12-18 nanometers. The filter is inert to the product. This virus removal process has been shown in laboratory spiking studies to reduce the levels of some viruses ranging from 18-200 nanometers in size, including enveloped viruses as well as non-enveloped viruses. 4 All of the above steps are designed to increase product safety by reducing the risk of transmission of lipid-enveloped and non-lipid-enveloped viruses. 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 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. RhoGAM and MICRhoGAM are manufactured and distributed by Ortho-Clinical Diagnostics, Inc., Raritan, NJ 08869.

PRECAUTIONS

For intramuscular use only. Do not inject RhoGAM® or MICRhoGAM® intravenously. In the case of postpartum use, the product is intended for maternal administration. Do not inject the newborn infant.

Patients should be observed for at least 20 minutes after administration.

Allergic responses to RhoGAM or MICRhoGAM may occur. Patients should be informed of the early signs of hypersensitivity reactions, including hives, generalized urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. The treatment depends upon the nature and severity of the reaction.

RhoGAM and MICRhoGAM contain a small quantity of IgA (less than 15 µg per dose).9 Although high doses of intravenous immunoglobulin containing IgA at levels of 270-720 µg/mL have been given without incident during treatment of patients with high-titered antibodies to IgA, 17 the attending physician must weigh the benefit against the potential risks of hypersensitivity reactions.

The presence of passively acquired anti-D in the maternal serum may cause a positive antibody screening test. This does not preclude further antepartum or postpartum prophylaxis.

Some babies born of women given Rho(D) Immune Globulin (Human) antepartum have weakly positive direct antiglobulin (Coombs) tests at birth.

Fetal-maternal hemorrhage may cause false blood typing results in the mother. Late in pregnancy or following delivery, there may be sufficient fetal Rh-positive red blood cells in the circulation of the Rh-negative mother to cause a positive antiglobulin test for weak D (Du). When there is any doubt as to the patient's Rh type, RhoGAM or MICRhoGAM should be administered.

PREGNANCY CATEGORY C

Animal reproduction studies have not been conducted with RhoGAM or MICRhoGAM. The available evidence suggests that Rho(D) Immune Globulin (Human) does not harm the fetus or affect future pregnancies or the reproduction capacity of the maternal recipient.18,19

Page last updated: 2006-09-25

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