Antihemophilic Factor (Recombinant [Fc Fusion Protein])

Use antihemophilic factor as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a vein.
• This medicine may be given at home.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Follow how to use as you have been told by the doctor or read the package insert.
• Wash your hands before and after use.
• If stored in a refrigerator, let this medicine come to room temperature before mixing. Do not heat antihemophilic factor.
• This medicine needs to be mixed before use. Follow how to mix as you were told by the doctor.
• Do not shake.
• Use within 3 hours of making.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.
• After mixing, do not refrigerate.
• Throw away any part of opened vial not used after use.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous [preservative free]:

Eloctate: 250 units (1 ea); 500 units (1 ea); 750 units (1 ea); 1000 units (1 ea); 1500 units (1 ea); 2000 units (1 ea); 3000 units (1 ea); 4000 units (1 ea); 5000 units (1 ea); 6000 units (1 ea)

• Eloctate

Life-threatening hypersensitivity to antihemophilic factor or any component of the formulation.

Refer to adult dosing.

There are no dosage adjustments provided in the manufacturer’s labeling.

If refrigerated, the dried concentrate and diluent should be warmed to room temperature before reconstitution. Gently agitate or rotate vial after adding diluent, do not shake vigorously. Refer to product specific labeling for reconstitution instructions and for detailed information regarding compatibility with administration sets.

Prior to reconstitution, store refrigerated at 2°C to 8°C (36°F to 46°F); do not freeze. May also store at room temperature (not to exceed 30°C [86°F]) up to 6 months; do not return to refrigerator. Store in original package to protect from light. Use within 3 hours of reconstitution; do not refrigerate after reconstitution.

Concerns related to adverse effects:

• Antibody formation: The development of factor VIII antibodies has been reported with antihemophilic factors; monitor for signs of formation of antibodies to factor VIII; may occur at any time but more common in young children with severe hemophilia. Suspect factor VIII antibodies if the plasma factor VIII level does not increase as expected or if bleeding is not controlled after administration.

• Hypersensitivity reactions: Allergic hypersensitivity reactions (including anaphylaxis) may occur; discontinue if hypersensitivity symptoms occur and administer appropriate treatment.

Dosage form specific issues:

• Sucrose: May contain sucrose.

Other warnings/precautions:

• Dose requirements: The dosage requirement will vary in patients with factor VIII inhibitors; optimal treatment should be determined by clinical response.