"The U.S. Food and Drug Administration yesterday approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [FVII] deficiency).
Patient Counseling Information
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).
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.
Additional Rhophylac Information
Report Problems to the Food and Drug Administration
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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