May 27, 2017
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"The U.S. Food and Drug Administration today approved a new use for Jakafi (ruxolitinib) to treat patients with polycythemia vera, a chronic type of bone marrow disease. Jakafi is the first drug approved by the FDA for this condition.





(See Boxed Warning and WARNINGS and PRECAUTIONS Sections)

Inform patients to immediately report the following to their physician:

  • signs and symptoms of renal failures, such as decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath
  • signs and symptoms of aseptic meningitis, such as headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea, and vomiting
  • signs and symptoms of hemolysis, such as fatigue, increased heart rate, yellowing of the skin or eyes, and dark-colored urine
  • signs and symptoms of TRALI, such as severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever. TRALI typically occurs within 1 to 6 hours following transfusion

Inform patients that GAMUNEX is made from human plasma and may contain infectious agents that can cause disease (e.g., viruses, and, theoretically, the CJD agent). Inform patients that the risk GAMUNEX (immune globulin intravenous (human) 10%) may transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing the donated plasma for certain virus infections and by inactivating and/or removing certain viruses during manufacturing..

Inform patients that administration of IgG may interfere with the response to live viral vaccines such as measles, mumps and rubella. Inform patients to notify their immunizing physician of therapy with GAMUNEX (immune globulin intravenous (human) 10%) .

Last reviewed on RxList: 10/2/2008
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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