Alprolix is an injectable medicine that is used to help control and prevent bleeding in people with hemophilia B. Hemophilia B is also called congenital Factor IX deficiency.

Your healthcare provider may give you Alprolix when you have surgery.

Alprolix should be administered as ordered by your healthcare provider. You should be trained on how to do infusions by your healthcare provider. Many people with hemophilia B learn to infuse their Alprolix by themselves or with the help of a family member.

See the Instructions for Use for directions on infusing Alprolix. The steps in the Instructions for Use are general guidelines for using Alprolix. Always follow any specific instructions from your healthcare provider. If you are unsure of the procedure, please ask your healthcare provider. Do not use Alprolix as a continuous intravenous infusion.

Contact your healthcare provider immediately if bleeding is not controlled after using Alprolix.

On-demand treatment and control of bleeding episodes:

Perioperative management:

• Minor surgery: a single infusion to reach FIX level of 50–80 IU/dL may be sufficient. Repeat as needed after 24–48 hours until bleeding stops and healing is achieved.
• Major surgery: initial infusion to reach FIX level of 60–100 IU/dL. Consider a repeat dose after 6–10 hours and then every 24 hours for the first 3 days, then every 48 hours until bleeding stops and healing is achieved.

Routine prophylaxis:

For adults and adolescents ≥12 years of age, start at 50 IU/kg once weekly or 100 IU/kg once every 10 days.
For children <12 years of age, start at 60 IU/kg once weekly.
Adjust dosing regimen based on individual response. More frequent or higher doses may be needed in children <12 years of age.

Use: 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.

You should not use Alprolix if you are allergic to Alprolix or any of the other ingredients. Tell your healthcare provider if you have had an allergic reaction to any Factor IX product prior to using Alprolix.

Before using Alprolix

Tell your doctor about all of your medical conditions, including if you:

• are pregnant or planning to become pregnant. It is not known if Alprolix may harm your unborn baby.
• are breastfeeding. It is not known if Alprolix passes into breast milk or if it can harm your baby.
• have been told that you have inhibitors to Factor IX (because Alprolix may not work for you).

Common side effects include headache, abnormal sensation in the mouth, and pain in your side with blood in your urine, which may be a sign of clot formation in the urinary collecting system.

Allergic reactions may occur. Call your healthcare provider or get emergency treatment right away if you have any of the following symptoms: hives, chest tightness, wheezing, difficulty breathing, or swelling of the face.

Redness to the skin at the injection site may also occur.

Alprolix may increase the risk of forming abnormal blood clots in your body, especially if you have risk factors for developing blood clots. Call your healthcare provider or seek emergency care if you have symptoms of a possible abnormal blood clot, which may include: chest pain, difficulty breathing, unexpected swelling of an arm or leg with or without pain or tenderness.

Your body can also make antibodies called "inhibitors" against Alprolix, which may stop Alprolix from working properly. Your healthcare provider may need to test your blood for inhibitors from time to time.

These are not all the possible side effects.

Talk to your healthcare provider about any side effect that bothers you or that does not go away.

Tell your healthcare provider about all of the medicines you take, including all prescription and non-prescription medicines, such as over-the-counter medicines, supplements, or herbal medicines.

There are no known drugs interactions with Alprolix.