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Antihemophilic Factor (Recombinant) FC-Fusion Protein is available as a 250 IU, 500 IU, 750 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU, 4000 IU, 5000 IU, or 6000 IU single-dose vial.

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

Antihemophilic Factor (Recombinant) FC-Fusion Protein is a clotting factor replacement for people who are missing special blood-clotting proteins called factor VIII (FVIII) due to hemophilia A. By replacing the missing clotting factor (FVIII, or antihemophilic factor) in people who naturally don’t have it, bleeding episodes can be reduced or treated.

The typical dose ranges from 25 IU/kg to 65 IU/kg given IV twice weekly to every 4 days.

Antihemophilic Factor (Recombinant) FC-Fusion Protein is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. Do not use in patients who have had life-threatening hypersensitivity reactions,
including anaphylaxis, to Antihemophilic Factor (Recombinant) FC-Fusion Protein or excipients of Antihemophilic Factor (Recombinant) FC-Fusion Protein (sucrose, sodium chloride, L-histidine, calcium chloride and polysorbate 20).

Common side effects of Antihemophilic Factor (Recombinant) FC-Fusion Protein:

• Fever
• Headache
• Rash
• Joint and muscle pain
• Fatigue

Serious side effects are rare with Antihemophilic Factor (Recombinant) FC-Fusion Protein.Contact your healthcare provider immediately if you experience any of the following.

• Serious allergic reaction (anaphylaxis): difficulty breathing, hives, itching, fast heartbeat, nausea, stomach pain, dizziness, lightheadedness, swelling in the face or tongue

• There are no major drug interactions listed for Antihemophilic Factor (Recombinant) FC-Fusion Protein. However, always let your physician and pharmacist know about any other medications or supplements (including prescribed and over-the-counter medications, vitamins, and dietary or herbal supplements) that you are currently taking

Various FDA-approved generic manufacturers

It is not known if Antihemophilic Factor (Recombinant) FC-Fusion Protein will harm your unborn baby. Tell your healthcare provider if you become pregnant while taking Antihemophilic Factor (Recombinant) FC-Fusion Protein.

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