Generic Name and Formulations:
Coagulation Factor IX (recombinant), albumin fusion protein 250 IU, 500 IU, 1000 IU, 2000 IU; per vial; lyophilized pwd for IV inj after reconstitution; preservative-free.
CSL Behring, LLC
Indications for IDELVION:
In patients with Hemophilia B: to control and prevent bleeding episodes, for perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
Limitations Of use:
Not for immune tolerance induction.
Adults and Children:
Dose (IU) = body weight (kg) x desired FIX increase (% of normal or IU/dL) x reciprocal of recovery (IU/dL per IU/kg). Dose adjustment may be necessary in children <12yrs. Individualize. Max infusion rate: 10mL/min. Bleeding: Minor/Moderate: 30–60% required; repeat every 48–72hrs for ≥1 day until bleeding stops and healing is achieved. Major: 60–100% required; repeat every 48–72hrs for 7–14 days until bleeding stops and healing is achieved; give maintenance dose weekly. Perioperative: Minor: 50–80% required; repeat every 48–72hrs for ≥1 day or until healing is achieved. Major: initially 60–100% required; every 48–72hrs for 7–14 days or until bleeding stops and healing is achieved; may repeat every 48–72hrs for the first week or until healing is achieved; give maintenance dose 1–2 times weekly. Routine prophylaxis: ≥12yrs: 25–40 IU/kg every 7 days or if well-controlled, may give 50–75 IU/kg every 14 days; <12yrs: 40–55 IU/kg every 7 days.
Hamster protein sensitivity.
Discontinue and treat if hypersensitivity symptoms occur. Monitor for development of Factor IX inhibitors. Liver disease, fibrinolysis, perioperative status, risk factors for thromboembolic events or disseminated intravascular coagulation; monitor for thromboembolism and consumptive coagulopathy. Pregnancy. Nursing mothers.
Headache, dizziness, hypersensitivity, rash, eczema.
Kit—1 (single-use vial + diluent, supplies)
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