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Anitihemophilic Factor (Recombinant) Pegylated AUCL is available as a single-use vial containing 500 IU, 1000 IU, 2000 IU, or 3000 IU.

Anitihemophilic Factor (Recombinant) Pegylated AUCL is a recombinant DNA-derived, Factor VIII concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) 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

Anitihemophilic Factor (Recombinant) Pegylated AUCL 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.

Anitihemophilic Factor (Recombinant) Pegylated AUCL is typically dosed as follows:

• The recommended initial regimen is 30–40 IU/kg twice weekly
• Based on the bleeding episodes:
• The regimen may be adjusted to 45–60 IU/kg every 5 days.
  A regimen may be further individually adjusted to less or more frequent dosing

Anitihemophilic Factor (Recombinant) Pegylated AUCL 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 a history of hypersensitivity reactions to the
active substance, polyethylene glycol (PEG), mouse or hamster proteins, or other constituents of the product.

Common side effects of Anitihemophilic Factor (Recombinant) Pegylated AUCL:

• Headache
• Cough
• Fever
• Nausea

Serious side effects are rare with Anitihemophilic Factor (Recombinant) Pegylated AUCL. 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 Anitihemophilic Factor (Recombinant) Pegylated AUCL. 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 Anitihemophilic Factor (Recombinant) Pegylated AUCL will harm your unborn baby. Tell your healthcare provider if you are pregnant or plan to become pregnant while using Anitihemophilic Factor (Recombinant) Pegylated AUCL.

• Jivi