sed in the packaging for ASCENIV are not madewith natural rubber latex. ASCENIV is supplied in 50 mL size containing 5 grams of protein.
• Refrigerate between 2 to 8°C (36 to 46°F).
• Do not freeze or heat. Do not use any solutions that have been frozen or heated.
• Do not use after expiration date.
17 PATIENT COUNSELING INFORMATION
Instruct patients taking ASCENIV to immediately report symptoms of:
•Thrombosis which includes pain and/or swelling of an arm or legs/feet with warmth over the affected area, discoloration ofan 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 Warning and Precaution [5.2]).
•Acute Renal Dysfunction and Acute Renal Failure which includes decreased urine output, sudden weight gain, fluidretention/edema, and/or shortness of breath. Such symptoms may suggest kidney damage (see Boxed Warning,Warnings and Precautions [5.3]).
•Aseptic Meningitis Syndrome (AMS) which includes severe headache, neck stiffness, drowsiness, fever, sensitivity tolight, painful eye movements, nausea and vomiting (see Warnings and Precautions [5.5]).
•Hemolysis which includes fatigue, increased heart rate, yellowing of skin or eyes, dark- colored urine (see Warnings andPrecautions [5.5]).
•Transfusion-Related Acute Lung Injury (TRALI) which includes trouble breathing, chest pain, blue lips or extremities,fever (see Warnings 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 ASCENIVcan transmit an infection has been reduced by screening plasma donors for prior exposure, testing donated plasma, andinactivating or removing certain viruses during manufacturing, patients should report any symptoms that concern them(see Description [11] and Warnings and Precautions [5]).
•Can interfere with their immune response to live viral vaccines (e.g., measles, mumps, rubella, and varicella). Instructpatients to notify their healthcare professional of this potential interaction when they are receiving vaccinations (see DrugInteractions [7]).
Manufactured by ADMA Biologics
Boca Raton, FL 33487 USA
U.S. License No. XXXX
RM-5640 Rev.000 |
