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Alprolix is the brand name for coagulation factor IX (recombinant) and is available as an intravenous infusion.

Alprolix is available as a single-dose vial containing 250, 500, 1000, 2000, 3000, or 4000 international units (IU).

Alprolix is a coagulation Factor IX used in adults and children with hemophilia B for:

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

Alprolix is a recombinant DNA derived coagulation Factor IX concentrate. It is a clotting factor replacement used for people who are missing factor IX. Alprolix replaces the missing factor IX to help prevent and treat bleeding in people with hemophilia B.

Alprolix is typically dosed as follows:

• For the routine prevention of bleeding, the typical starting dose is 50 IU/kg to 60 IU/kg given IV once weekly, or 100 IU/kg once every 10 days.
• For the on-demand treatment of bleeding, your provider will determine your dose based on your body weight, how serious your bleed is, where the bleed is, and the desired level of factor IX in your body.

Alprolix 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. You should not use this medication in the following:

• History of hypersensitivity reactions, including anaphylaxis, to the product or its excipients

Common side effects of Alprolix:

• Headache
• Dizziness
• Injection site reaction
• Blockage that makes it hard to produce urine
• Numbness in the mouth

Serious side effects are rare with Alprolix. Contact your healthcare provider immediately if you experience any of the following:

• Serious allergic reaction (anaphylaxis): difficulty breathing, hives, itching, fast heartbeat, tightness in the throat, nausea, stomach pain, dizziness, lightheadedness, swelling in the face or tongue
• Blood clots: lungs (cough, difficulty breathing, chest pain), legs (redness, pain, tenderness, swelling of the skin), heart attack (chest pain, pain in the arms or shoulders, pain in the neck or jaw), stroke (difficulty speaking, numbness on one side of the body, confusion)

There are no major drug interactions listed for this medication. 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.

Sanofi-Aventis U.S.

It is not known whether this medication is safe for you and your unborn baby during pregnancy. Talk to your doctor if you are already pregnant or if you have plans on becoming pregnant. They will recommend what is best for you.

• Coagulation Factor Ix (Recombinant)