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

Antihemophilic Factor (Recombinant) FC-VWF-XTEN Fusion Protein-EHTL is a recombinant DNA-derived, Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital factor VIII deficiency) for:

• Routine prophylaxis to reduce the frequency of bleeding episodes
• On-demand treatment & control of bleeding episodes
  Perioperative management of bleeding

Antihemophilic Factor (Recombinant) FC-VWF-XTEN Fusion Protein-EHTL 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.

Antihemophilic Factor (Recombinant) FC-VWF-XTEN Fusion Protein-EHTL is typically dosed as follows:

• For routine prophylaxis: 50 IU/kg once weekly

Antihemophilic Factor (Recombinant) FC-VWF-XTEN Fusion Protein-EHTL 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 severe hypersensitivity reactions, including anaphylaxis, to Antihemophilic Factor (Recombinant) FC-VWF-XTEN Fusion Protein-EHTL or excipients of Antihemophilic Factor (Recombinant) FC-VWF-XTEN Fusion Protein-EHTL.

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

• Fever
• Headache
• Cough
• Sore throat, runny nose, and other symptoms of the common cold
• Joint pain

Serious side effects are rare with Antihemophilic Factor (Recombinant) FC-VWF-XTEN Fusion Protein-EHTL. 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-VWF-XTEN Fusion Protein-EHTL. 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-VWF-XTEN Fusion Protein-EHTL will harm your unborn baby. Tell your healthcare provider if you become pregnant while taking Antihemophilic Factor (Recombinant) FC-VWF-XTEN Fusion Protein-EHTL.

• Altuviiio