Jivi Generic Name & Formulations
Antihemophilic Factor VIII (recombinant), PEGylated-aucl 500 IU, 1000 IU, 2000 IU, 3000 IU; per vial; lyophilized pwd for IV inj after reconstitution; preservative-free.
Single-use vial─1 (w. diluent, supplies)
In previously treated patients with Hemophilia A: for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes.
Limitations of Use
Not for use in children <12yrs of age or in previously untreated patients. Not for treatment of von Willebrand disease.
Jivi Dosage and Administration
Adults and Children
Dosage Required (IU) = Body Weight (kg) × Desired Factor VIII Increase (IU/dL or % of Normal) × Reciprocal of expected recovery (or observed recovery, if available). Individualize. Infuse over 1–15mins (max infusion rate 2.5mL/min). Max dose per infusion: 6000 IU. Bleeding (Minor): obtain 20–40% FVIII increase; give 10–20 IU/kg every 24–48hrs until resolved; (Moderate): obtain 30–60% FVIII increase; give 15–30 IU/kg every 24–48hrs until resolved; (Major): obtain 60–100% FVIII increase; give 30–50 IU/kg every 8–24hrs until resolved. Perioperative (Minor): obtain 30–60% (pre- and post-op) FVIII increase; give 15–30 IU/kg every 24hrs for at least 1 day until healed; (Major): obtain 80–100% (pre- and post-op) FVIII increase; give 40–50 IU/kg every 12–24hrs until adequate healing completed, then continue for at least 7 days to maintain FVIII activity of 30–60%. Routine prophylaxis: initially 30–40 IU/kg twice weekly; may adjust to 45–60 IU/kg every 5 days based on bleeding episodes, then may further adjust individually.
Mouse or hamster protein sensitivity.
Jivi Boxed Warnings
Immediately discontinue if hypersensitivity reactions occur. Monitor for development of Factor VIII inhibitors. Immune response to PEG; discontinue and switch to previously effective FVIII product. Pregnancy. Nursing mothers.
Jivi Adverse Reactions
Headache, cough, nausea, fever, vomiting; antibody formation.
Jivi Clinical Trials
Jivi Patient Counseling