May 27, 2017
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"An investigational long-acting form of recombinant human growth hormone (rhGH) given twice a month has achieved efficacy and safety at 2 years, new data show.

The novel long-acting recombinant human growth hormone fusion protein somav"...




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 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., (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: 12/5/2016
This monograph has been modified to include the generic and brand name in many instances.

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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