In the clinical trial people infusing prophylactically experienced a median of 1 or fewer spontaneous bleeds per year.*
Switching to ALPROLIX resolved 100% of patients' target joints in clinical studies.
ALPROLIX is the only extended half-life Factor IX therapy chosen by over 1,100 people in the US, § and proven over 4 years of real-world experience.
The recommended adult and adolescent starting regimen is every 7 or 10 days with the potential to extend to 14 days based on your response.‖
Talk to your doctor to see if ALPROLIX is right for you.
*The overall median annual bleed rate (ABR) in the weekly arm was 3 bleeds per year (n=61) and 1.4 bleeds per year in the 10 day arm (n=26).
†ALPROLIX has been proven to help patients prevent bleeding episodes using a prophylaxis regimen.
‡37/37 patients with target joints at the baseline of the B-LONG study achieved target joint resolution with ALPROLIX. These subjects had ≥12 months of consecutive follow-up time and did not undergo joint surgery within 12 months of the start of follow-up.
A target joint is defined as a major joint with 3 or more bleeding episodes in a consecutive 3-month period. Target joint resolution is defined as 2 or less spontaneous bleeds in a 12-month period.
§Data on file. Waltham, MA; Bioverativ Therapeutics Inc., an affiliate of Sanofi. Based on US Prescription Data.
‖The recommended starting prophylaxis regimens are either 50 IU/kg once weekly, or 100 IU/kg once every 10 days. In children under 12 years of age, start at 60 IU/kg once weekly. Dosing regimen can be adjusted based on your 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.
We'd like to send you helpful information on hemophilia B and ALPROLIX from time to time. If you're still considering ALPROLIX we'll send you a Bluetooth® speaker to listen to patient stories or if you're already on ALPROLIX, a cooler bag for factor.
Sanofi Genzyme Community Relations and Education Managers (CoRe, for short) live and work all across the United States. CoRe team members are parents, social workers or people with hemophilia. They're available to answer your questions, educate, or just to talk. Use our handy CoRe Locator to find the CoRe team member nearest you.
INDICATIONS: ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein] 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.
indications and important facts about alprolix
IMPORTANT SAFETY INFORMATION
Do not use ALPROLIX if you are allergic to ALPROLIX or any of the other ingredients in ALPROLIX.
Tell your healthcare provider if you have or have had any medical problems, take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines, have any allergies and all your medical conditions, including if you are pregnant or planning to become pregnant, are breastfeeding or have been told you have inhibitors (antibodies) to Factor IX.
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 right away about any side effects that bothers you or does not go away, and if bleeding is not controlled using ALPROLIX.
Allergic reactions may occur with ALPROLIX. 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.
Your body can also make antibodies called "inhibitors" against ALPROLIX, which may stop ALPROLIX from working properly.
ALPROLIX may increase the risk of formation of 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.
ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein] 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.
Bioverativ Therapeutics Inc.
Waltham, MA 02451 USA
U.S. License #2078
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