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For patients with primary humoral immunodeficiency (PI) it's what's inside that counts
asceniv_designed_to_deliver_bottle_v2

For patients with primary humoral immunodeficiency (PI) it's what's inside that counts

ASCENIV™ is the only IVIG produced from blending RSV plasma and normal source plasma*1

asceniv_designed_to_deliver_bottle_v2

*ADMA BIOLOGICS PATENTS ISSUED 9,107,906 - 9,714,283 - 9,815,886.

FDA=US Food and Drug Administration; IGIV=immune globulin intravenous.

FOR PATIENTS WITH PRIMARY HUMORAL IMMUNODEFICIENCY (PI)

Whats Inside
asceniv_designed_to_deliver_bottle_v2

FOR PATIENTS WITH PRIMARY HUMORAL IMMUNODEFICIENCY (PI)

Whats Inside

ASCENIV™ is the only IVIG produced from blending RSV plasma and normal source plasma*1

asceniv_designed_to_deliver_bottle_v2

*ADMA BIOLOGICS PATENTS ISSUED 9,107,906 - 9,714,283 - 9,815,886.

FDA=US Food and Drug Administration; IGIV=immune globulin intravenous.

Indication

ASCENIV (immune globulin intravenous, human – slra) is a 10% immune globulin liquid for intravenous injection, indicated for the treatment of primary humoral immunodeficiency (PI) in adults and adolescents (12 to 17 years of age). PI includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID).

 

Important Safety Information for ASCENIV™

WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE

  • Thrombosis may occur with immune globulin (IGIV) products, including ASCENIV. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.
  • Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of IVIG products in predisposed patients.
  • Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. ASCENIV does not contain sucrose.
  • For patients at risk of thrombosis, renal dysfunction or renal failure, administer ASCENIV at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
Reference:
 1. Data on file, ADMA Biologics.