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Asceniv FDA Approval History

Last updated by Judith Stewart, BPharm on April 15, 2019.

FDA Approved: Yes (First approved April 1, 2019)
Brand name: Asceniv
Generic name: immune globulin intravenous, human – slra
Dosage form: Injection
Company: ADMA Biologics, Inc.
Treatment for: Primary Immunodeficiency Syndrome

Asceniv (immune globulin intravenous, human – slra) is a 10% immune globulin liquid for intravenous injection, indicated for the treatment of primary humoral immunodeficiency (PI).

  • The Asceniv product label carries a boxed warning advising healthcare professionals of the risk of thrombosis, renal dysfunction, and acute renal failure.
  • Patients taking Asceniv should immediately report any signs or symptoms of thrombosis, acute renal dysfunction, acute renal failure, aseptic meningitis syndrome, hemolysis, and transfusion-related acute lung injury (TRALI).
  • Severe hypersensitivity reactions may occur with IGIV products, including Asceniv. In the case of a hypersensitivity reaction, Asceniv should be discontinued immediately, and appropriate treatment administered.
  • Because Asceniv is made from human blood, it may carry a risk of transmitting infectious agents, such as viruses, the variant Creutzfeldt-Jakob disease (vCJD) and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
  • Common adverse reactions include headache, sinusitis, diarrhea, gastroenteritis viral, nasopharyngitis, upper respiratory tract infection, bronchitis, and nausea.
  • Development timeline for Asceniv

    Dec 13, 2022Approval ADMA Biologics Announces FDA Approval for Room Temperature Storage of Asceniv & Bivigam
    Apr  1, 2019Approval FDA Approves Asceniv (immune globulin intravenous, human) for Primary Humoral Immunodeficiency

    Further information

    Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.