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IDELVION
Bleeding disorders
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Drug Name:

IDELVION Rx

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.

Company:
CSL Behring, LLC

Therapeutic Use:

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.

Contraindications:

Hamster protein sensitivity.

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.

Pharmacological Class:

Clotting factor.

Adverse Reactions:

Headache, dizziness, hypersensitivity, rash, eczema.

Generic Availability:

NO

How Supplied:

Kit—1 (single-use vial + diluent, supplies)

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