Jivi FDA Approval History
Last updated by Judith Stewart, BPharm on May 26, 2025.
FDA Approved: Yes (First approved August 30, 2018)
Brand name: Jivi
Generic name: antihemophilic factor [recombinant] PEGylated-aucl
Dosage form: Injection
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Hemophilia A
Jivi (antihemophilic factor (recombinant), PEGylated-aucl) is a recombinant DNA-derived, factor VIII concentrate used to treat and control bleeding in patients with hemophilia A.
- Jivi is indicated for use in previously treated adults and pediatric patients 7 years of age and older with hemophilia A (congenital Factor VIII deficiency) for:
- on-demand treatment and control of bleeding episodes
- perioperative management of bleeding
- routine prophylaxis to reduce the frequency of bleeding episodes
Jivi is not indicated for use in:
- children < 7 years of age due to a greater risk for hypersensitivity reactions and/or loss of efficacy.
- previously untreated patients (PUPs).
- treatment of von Willebrand disease. - Jivi is a recombinant factor VIII (rFVIII) replacement therapy. It works by replacing the reduced or missing FVIII (a protein needed to form blood clots) in hemophilia A patients.
- Through its site-specific PEGylation, Jivi has an extended half-life of 17.9 hours allowing for twice-weekly initial dosing, with the ability to dose every five days and further individually adjust to less or more frequent dosing based on bleeding episodes.
- Jivi is administered by intravenous injection.
- Warnings and precautions associated with Jivi include hypersensitivity reactions, development of factor VIII neutralizing antibodies, and an immune response to polyethylene glycol (PEG).
- Common adverse reactions (incidence ≥ 5%) include headache, fever, cough, and abdominal pain.
Development timeline for Jivi
Further information
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