"The U.S. Food and Drug Administration today approved Tretten, Coagulation Factor XIII A-Subunit (Recombinant), the first recombinant product for use in the routine prevention of bleeding in adults and children who have a rare clotting disorder, k"...
ALPROLIX™ /all' pro liks /
[Coagulation Factor IX (Recombinant), Fc Fusion Protein]
Please read this Patient Information carefully before using ALPROLIX™ and each time you get a refill, as there may be new information. This Patient Information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What is ALPROLIX™?
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.
Who should not use ALPROLIX™?
You should not use ALPROLIX™ if you are allergic to ALPROLIX™ or any of the other ingredients in ALPROLIX™. Tell your healthcare provider if you have had an allergic reaction to any Factor IX product prior to using ALPROLIX™.
What should I tell my healthcare provider before using ALPROLIX™?
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.
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).
How should I use ALPROLIX™?
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™.
What are the possible side effects of ALPROLIX™?
Common side effects of ALPROLIX™ include headache and abnormal sensation in the mouth. 19
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.
ALPROLIX™ may increase the risk of forming abnormal blood clots in your body if you have risk factors for developing blood clots.
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 from time to time.
These are not all the possible side effects of ALPROLIX™.
Talk to your healthcare provider about any side effect that bothers you or that does not go away.
How should I store ALPROLIX™?
Store ALPROLIX™ vials at 2°C to 8°C (36°F to 46°F). Do not freeze.
ALPROLIX™ vials may also be stored at room temperature up to 30°C (86°F) for a single 6 month period.
If you choose to store ALPROLIX™ at room temperature:
- Note on the carton the date on which the product was removed from refrigeration.
- Use the product before the end of this 6 month period or discard it.
- Do not return the product to the refrigerator.
Do not use product or diluent after the expiration date printed on the carton, vial or syringe.
- Use the reconstituted product as soon as possible; however, you may store the reconstituted product at room temperature up to 30°C (86°F) for up to 3 hours. Protect the reconstituted product from direct sunlight. Discard any product not used within 3 hours after reconstitution.
- Do not use ALPROLIX™ if the reconstituted solution is cloudy, contains particles or is not colorless.
What else should I know about ALPROLIX™?
Medicines are sometimes prescribed for purposes other than those listed here. Do not use ALPROLIX™ for a condition for which it was not prescribed. Do not share ALPROLIX™ with other people, even if they have the same symptoms that you have.
Last reviewed on RxList: 4/10/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Alprolix Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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