Licensing authority

FDA (Food and Drug Administration, USA)

Indication(s)

ELOCTATE, Antihemophilic Factor (Recombinant), Fc Fusion Protein, is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency) for:
• On-demand treatment and control of bleeding episodes
• Perioperative management of bleeding
• Routine prophylaxis to reduce the frequency of bleeding episodes.

Limitation of Use
ELOCTATE is not indicated for the treatment of von Willebrand disease. (1)

Full Prescribing information

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Advisory information

contraindications
Do not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to ELOCTATE. (4)
Special warnings and precautions

• Hypersensitivity reactions, including anaphylaxis, are possible. Should symptoms occur, immediately discontinue ELOCTATE and initiate appropriate treatment. (5.1)
• Development of Factor VIII neutralizing antibodies (inhibitors) may occur. If expected plasma Factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures Factor VIII inhibitor concentration. (5.2, 5.3)

Adverse reactions

The most frequently occurring adverse reactions (>0.5% of subjects) in clinical trials were arthralgia, malaise, myalgia, headache, and rash. (6)

Usage information

Dosing and administration

For intravenous use after reconstitution only.

• Each vial of ELOCTATE is labeled with the amount of recombinant Factor VIII in international units (IU or unit). One unit per kilogram body weight will raise the Factor VIII level by 2% IU/dL. (2.1)

• For on-demand treatment and control of bleeding episodes and perioperative management, calculate dose using the following formulas:

Estimated Increment of Factor VIII (IU/dL or % of normal) = [Total Dose (IU)/body weight (kg)] x 2 (IU/dL per IU/kg)
OR
Required Dose (IU) = Body Weight (kg) x Desired Factor VIII Rise (IU/dL or % of normal) x 0.5 (IU/kg per IU/dL)

• For routine prophylaxis: 50 IU/kg every 4 days. Adjust dose based on patient response with dosing in the range of 25-65 IU/kg at 3-5 day intervals.

• For routine prophylaxis in children less than 6 years of age: 50 IU/kg twice weekly. Adjust dose based on patient response with dosing in the range of 25-65 IU/kg at 3-5 day intervals. More frequent or higher doses up to 80 IU/kg may be required. (2.1)

Use in special populations

Pediatric: Clearance (based on per kg body weight) is higher (75%) in pediatric patients 1 to 5 years of age. Higher or more frequent dosing may be needed. (8.4)

More information

Category Value
Authorisation number BLA125487
Orphan designation
Product NDC 64406-801; 64406-802; 64406-803; 64406-804; 64406-805; 64406-806; 64406-807; 64406-808; 64406-809; 64406-810
Date First Approved 14-07-2014
Marketing authorisation holder Biogen Inc.