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, 2022||Approval ADMA Biologics Announces FDA Approval for Room Temperature Storage of Asceniv & Bivigam|
|Apr 1, 2019||Approval FDA Approves Asceniv (immune globulin intravenous, human) for Primary Humoral Immunodeficiency|
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.