Bleeding disorders:
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.
IDELVION Contraindications:
Hamster protein sensitivity.
IDELVION Warnings/Precautions:
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.
IDELVION Classification:
Clotting factor.
Adverse Reactions:
Headache, dizziness, hypersensitivity, rash, eczema.
Generic Drug Availability:
NO
How Supplied:
Kit—1 (single-use vial + diluent, supplies)
