Acute Renal Dysfunction and Acute Renal Failure
Instruct patients to immediately report symptoms of decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath. Such symptoms may suggest kidney damage (see BOXED WARNING, WARNINGS AND PRECAUTIONS).
Instruct patients to immediately report symptoms of thrombotic events. These symptoms include acute chest pain, shortness of breath, leg pain, and swelling of the legs/feet (see WARNINGS AND PRECAUTIONS).
Aseptic Meningitis Syndrome (AMS)
Instruct patients to immediately report signs and symptoms of AMS. These symptoms include severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea and vomiting (see WARNINGS AND PRECAUTIONS).
Instruct patients to immediately report signs and symptoms of hemolysis. These symptoms include fatigue, increased heart rate, yellowing of skin or eyes, dark-colored urine (see WARNINGS AND PRECAUTIONS).
Transfusion-Related Acute Lung Injury (TRALI)
Instruct patients to immediately report signs and symptoms of TRALI. These symptoms include trouble breathing, chest pain, blue lips or extremities, fever (see WARNINGS AND PRECAUTIONS).
Transmissible Infectious Agents
Inform patients that BIVIGAM is made from human plasma and may contain infectious agents that can cause disease. While the risk that BIVIGAM can transmit an infection has been reduced by screening plasma donors for prior exposure, testing donated plasma, and inactivating or removing certain viruses during manufacturing, patients should report any symptoms that concern them (see DESCRIPTION and WARNINGS AND PRECAUTIONS).
Live Virus Vaccines
Inform patients that BIVIGAM can interfere with their immune response to live viral vaccines (e.g., measles, mumps, rubella, and varicella), and instruct patients to notify their healthcare professional of this potential interaction when they are receiving vaccinations (see DRUG INTERACTIONS).
Last reviewed on RxList: 1/28/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Bivigam Information
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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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