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ASCENIV- human immunoglobulin g liquid

  1. Instruct Patients Taking Asceniv To Immediately Report Symptoms Of:
  2. Inform Patients That Asceniv:

Instruct Patients Taking Asceniv To Immediately Report Symptoms Of: 

  • Thrombosiswhich includes 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 (seeWarning and Precaution [5.2]).
  • Acute Renal Dysfunction and Acute Renal Failurewhich includes 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]).
  • Aseptic Meningitis Syndrome (AMS)which includes severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea and vomiting (seeWarnings and Precautions [5.5]).
  • Hemolysiswhich includes fatigue, increased heart rate, yellowing of skin or eyes, dark- colored urine (seeWarnings and Precautions [5.5]).
  • Transfusion-Related Acute Lung Injury (TRALI)which includes trouble breathing, chest pain, blue lips or extremities, fever (seeWarnings and Precautions [5.7])

Inform Patients That Asceniv: 

  • Is made from human plasma and may contain infectious agents that can cause disease. While the risk that ASCENIV 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]).
  • Can interfere with their immune response to live viral vaccines (e.g., measles, mumps, rubella, and varicella). Instruct patients to notify their healthcare professional of this potential interaction when they are receiving vaccinations (seeDrug Interactions [7]).

Manufactured by ADMA Biologics
Boca Raton, FL 33487 USA
U.S. License No. 2019

RM-5640 Rev.000

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