Data from FDA (Food and Drug Administration, USA) - Curated by Toby Galbraith - Last updated 19 April 2017

Indication(s)

IDELVION, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rIX-FP), a recombinant human blood coagulation factor, is indicated in children and adults with hemophilia B (congenital Factor IX deficiency) for:
• On-demand control and prevention of bleeding episodes
• Perioperative management of bleeding
• Routine prophylaxis to prevent or reduce the frequency of bleeding episodes

Limitations of Use:
IDELVION is not indicated for immune tolerance induction in patients with Hemophilia B. (1)

Full Prescribing information

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Advisory information

contraindications

Do not use in patients who have had life-threatening hypersensitivity reactions to IDELVION or its components, including hamster proteins. (4)

Special warnings and precautions

• Hypersensitivity reactions, including anaphylaxis, are possible. Should symptoms occur, discontinue IDELVION and administer appropriate treatment. (5.1)
• Development of neutralizing antibodies (inhibitors) to IDELVION may occur. If expected Factor IX plasma recovery in patient plasma is not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures Factor IX inhibitor concentration. (5.2, 5.5)
• Thromboembolism (e.g., pulmonary embolism, venous thrombosis, and arterial thrombosis) may occur when using Factor IX-containing products. (5.3)
• Nephrotic syndrome has been reported following immune tolerance induction with Factor IX-containing products in hemophilia B patients with Factor IX inhibitors and a history of allergic reactions to Factor IX. (5.4)
• Factor IX activity assay results may vary with the type of activated partial thromboplastin time reagent used. (5.5)

Adverse reactions
The most common adverse reaction (incidence ≥1%) reported in clinical trials was headache. (6)

Usage information

Dosing and administration
For intravenous use after reconstitution only.

• Each vial of IDELVION is labeled with the actual Factor IX potency in international units (IU). (2.1)
• One IU of IDELVION per kg body weight is expected to increase the circulating activity of Factor IX as follows:
- Adolescents and adults: 1.3 IU/dL per IU/kg (2.1)
- Pediatrics (<12 years): 1 IU/dL per IU/kg (2.1)
• Administer intravenously. Do not exceed infusion rate of 10 mL per minute. (2.3)

Control and prevention of bleeding episodes and perioperative management:
• Dosage and duration of treatment with IDELVION depends on the severity of the Factor IX deficiency, the location and extent of bleeding, and the patient’s clinical condition, age and recovery of Factor IX. (2.1)
• Determine the initial dose using the following formula:
Required Dose (IU) = Body Weight (kg) x Desired Factor IX rise (% of normal or IU/dL) x (reciprocal of recovery (IU/kg per IU/dL)) (2.1)
• Adjust dose based on the patient’s clinical condition and response. (2.1)

Routine prophylaxis:
• Patients ≥12 years of age: 25-40 IU/kg body weight every 7 days. Patients who are well-controlled on this regimen may be switched to a 14-day interval at 50-75 IU/kg body weight. (2.1)
• Patients <12 years of age: 40-55 IU/kg body weight every 7 days. (2.1)
Use in special populations
Pediatric: Higher dose per kilogram body weight or more frequent dosing may be needed. (8.4)

More information

Category Value
Authorisation number BLA125582
Orphan designation No
Product NDC 69911-864
Date First Approved 04-03-2016
Marketing authorisation holder CSL Behring Recombinant Facility AG