Jivi Generic Name & Formulations
Legal Class
Rx
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)
Manufacturer
Generic Availability
NO
Jivi Indications
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
Contraindications
Mouse or hamster protein sensitivity.
Jivi Boxed Warnings
Not Applicable
Jivi Warnings/Precautions
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
Images
