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BIVIGAM- human immunoglobulin g injection, solution


Patient Information

17.1 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 (seeBoxed Warning,Warnings and Precautions [5.3]).

17.2 Thrombosis

Instruct patients to immediately report symptoms of thrombosis. These symptoms may include: pain and/or swelling of an arm or legs/feet with warmth over the affected area, discoloration of an arm or leg, unexplained shortness of breath, acute chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, numbness or weakness on one side of the body., (seeWarnings and Precautions [5.1]).

17.3 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 (seeWarnings and Precautions [5.5]).

17.4 Hemolysis

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 (seeWarnings and Precautions [5.6]).

17.5 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 (seeWarnings and Precautions [5.7]).

17.6 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 (seeDescription [11]andWarnings and Precautions [5.8]).

17.7 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 (seeDrug Interactions [7]).



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