• Bleeding disorders

Jivi Generic Name & Formulations

General Description

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.

Pharmacological Class

Clotting factor.

How Supplied

Single-use vial─1 (w. diluent, supplies)


Generic Availability


Jivi Indications


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.

Jivi Contraindications


Mouse or hamster protein sensitivity.

Jivi Boxed Warnings

Not Applicable

Jivi Warnings/Precautions


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 Pharmacokinetics

See Literature

Jivi Interactions

Not Applicable

Jivi Adverse Reactions

Adverse Reactions

Headache, cough, nausea, fever, vomiting; antibody formation.

Jivi Clinical Trials

See Literature

Jivi Note

Not Applicable

Jivi Patient Counseling

See Literature