Bleeding disorders:

Indications for JIVI:

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.

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.

Contraindications:

Mouse or hamster protein sensitivity.

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.

Pharmacologic Class:

Clotting factor.

Adverse Reactions:

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

Generic Availability:

NO

How Supplied:

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