ALPROLIX is the only extended half-life Factor IX therapy that has been chosen by over 1,000 patients.*
ALPROLIX offers extended protection from bleeds. In the clinical trial, that level of protection led to 1 or fewer spontaneous bleeds per year.
The recommended starting regimen is every 7 days at 50 IU/kg or 10 days at 100 IU/kg with the potential to extend to 14 days based on your response.
The recommended starting prophylaxis regimens are either 50 IU/kg once weekly, or 100 IU/kg once every 10 days. Dosing regimen can be adjusted based on individual response.
In the clinical study, 54% of people in the individualized prophy arm extended to ≥14-day dosing. The overall median dosing interval on study was 12.5 days. The median interval during the last six months in 26 subjects who were on study for at least nine months was 13.8 days.
*Data on file. Waltham, MA; Bioverativ Therapeutics Inc.
†ALPROLIX has been proven to help patients prevent bleeding episodes using a prophylaxis regimen.
indications and important facts about alprolix
What is the most important information i should know about ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein]? 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.
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, 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.
THE MOST COMMON SIDE EFFECTS OF ALPROLIX 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. These are not all the possible side effects of ALPROLIX. Talk to your healthcare provider for more information and about any side effect that bothers you or does not go away.
WHAT SHOULD I TELL MY HEALTHCARE PROVIDER BEFORE STARTING ALPROLIX?
Tell your healthcare provider about all your health conditions, including if you:
AFTER STARTING ALPROLIX:
If your bleeding is not controlled and you experience a lack of clinical response to Factor IX therapy, call your healthcare provider right away.
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.
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.
HOW SHOULD I RECEIVE 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 ALPROLIX by themselves or with the help of a family member. See the booklet called "Instructions for Use" packaged in your ALPROLIX for directions on infusing ALPROLIX. If you are unsure of the procedure, please ask your healthcare provider.
IMPORTANT FACTS ABOUT ALPROLIX
Please read this information carefully before using ALPROLIX and each time you get a refill, as there may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
The risk information provided here is not comprehensive. To learn more, talk about ALPROLIX with your healthcare provider or pharmacist.
The FDA-approved product labeling can be found at www.alprolix.com or 1-855-MyALPROLIX (692-5776).
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Bioverativ Therapeutics Inc.
Waltham, MA 02451 USA
U.S. License #2078
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