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BayRab

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BayRab

WARNINGS

Rabies Immune Globulin (Human) — BayRab® is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, 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. 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. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C. 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 Bayer Corporation [1-888-765-3203]. The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering it to the patient.

BayRab (rabies immune globulin (human) solvent/detergent treated) should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations.

The attending physician who wishes to administer BayRab (rabies immune globulin (human) solvent/detergent treated) to persons with isolated immunoglobulin A (IgA) deficiency must weigh the benefits of immunization against the potential risks of hypersensitivity reactions.

Such persons have increased potential for developing antibodies to IgA and could have anaphylactic reactions to subsequent administration of blood products that contain IgA.25

As with all preparations administered by the intramuscular route, bleeding complications may be encountered in patients with thrombocytopenia or other bleeding disorders.

PRECAUTIONS

General

BayRab (rabies immune globulin (human) solvent/detergent treated) should not be administered intravenously because of the potential for serious reactions. Although systemic reactions to immunoglobulin preparations are rare, epinephrine should be available for treatment of acute anaphylactoid symptoms.

Pregnancy Category C

Animal reproduction studies have not been conducted with BayRab (rabies immune globulin (human) solvent/detergent treated) . It is also not known whether BayRab (rabies immune globulin (human) solvent/detergent treated) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. BayRab (rabies immune globulin (human) solvent/detergent treated) should be given to a pregnant woman only if clearly needed.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established.

REFERENCES

25. Fudenberg HH: Sensitization to immunoglobulins and hazards of gamma globulin therapy. In: Merler E (ed.): Immunoglobulins: biologic aspects and clinical uses. Washington, DC, Nat Acad Sci, 1970, pp 211-20.

Last reviewed on RxList: 10/28/2009
This monograph has been modified to include the generic and brand name in many instances.

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