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GAMMAGARD S/D (immune globulin intravenous- human kit


Inform Patients To Immediately Report The Following Signs And Symptoms To Their Healthcare Provider:

  • Decreased urine output, sudden weight gain, fluid retention/edema, or shortness of breath. [SeeWarnings and Precautions (5.2)]
  • Instruct patients to immediately report symptoms of thrombosis. These symptoms may include pain or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, numbness or weakness on one side of the body. [SeeWarnings and Precautions (5.3)]
  • Severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea, and vomiting. [SeeWarnings and Precautions (5.4)]
  • Increased heart rate, fatigue, yellowing of the skin or eyes, and dark-colored urine. [SeeWarnings and Precautions (5.5)]
  • Trouble breathing, chest pain, blue lips or extremities, fever. [SeeWarnings and Precautions (5.6)]
  • Inform patients that GAMMAGARD S/D is made from human blood and may contain infectious agents that can cause disease agents e.g., viruses, the variant Creutzfelt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The risk of GAMMAGARD S/D transmitting an infectious agent 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 or that might be caused by infections. [SeeWarnings and Precautions (5.7)]
  • Inform patients that GAMMAGARD S/D can interfere with their immune response to live viral vaccines such as measles, mumps, and rubella. Inform patients to notify their healthcare professional of this potential interaction when they are receiving vaccinations. [SeeDrug Interactions (7)]

To enroll in the confidential, industry-wide Patient Notification System, call 1-888-873-2838.

BAXALTAand GAMMAGARD S/Dare trademarks of Baxalta Incorporated, a wholly-owned, indirect subsidiary of Shire plc.
SHIRE and the Shire Logo are trademarks or registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates.
Viaflex is a trademark of Baxter International Inc.

Baxalta US Inc.
Lexington, MA 02421 USA
U.S. License No. 2020



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