90.4% of bleeds were treated with just one infusion
97.3% of bleeds were treated with 2 or fewer infusions
100% of bleeds were treated with 3 or fewer infusions
The median overall bleed rate (ABR) for adults and adolescents who treated On Demand was 17.69.
B-LONG was a phase 3 study that investigated the safety and efficacy of ALPROLIX in 123 previously treated adult and adolescent patients with severe hemophilia B. The study included a fixed-interval arm (n=61), a fixed-dose arm (n=26), an episodic arm (n=27), and a surgical arm (n=12).
In the clinical studies of 153 previously treated people, adverse reactions occurred in 14 participants (9.2%).
In the clinical study of 33 previously untreated people, adverse reactions occurred in 2 participants (6.1%).
The most common side effects in previously treated patients were 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, occurred in two people each.
In a study of previously untreated patients who were treated with ALPROLIX, 2 of 33 had adverse drug reactions. One person in the study developed a Factor IX inhibitor and the same person developed an allergic reaction. One additional person in the study developed redness to the skin at the injection site.
These are not all of the possible side effects of ALPROLIX.
0.36 joint bleeds per year on a prophy individualized interval (n=26)
1.11 joint bleeds per year on a prophy fixed weekly interval (n=61)
In the B-LONG study, adults and adolescents who started infusing on a 10-day individualized prophylaxis regimen with ALPROLIX experienced a median annual spontaneous bleed rate (AsBR) of 0.9 bleeds per year. The overall median annual bleed rate (ABR) was 1.4 bleeds per year (n=26).
In the same study, adults and adolescents infusing on a once-weekly prophylaxis regimen with ALPROLIX experienced a median AsBR of 1.04 bleeds per year. The overall median ABR was 3 bleeds per year (n=61).
37/37 patients with target joints at the baseline of the B-LONG study achieved target joint resolution with ALPROLIX during the extension study. 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 fewer spontaneous bleeds in a 12-month period.
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INDICATION: 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.
important safety information and indication
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.
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.
Redness to the skin at the injection site may also occur.
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.
Your body can also make antibodies called "inhibitors" against ALPROLIX, which may stop ALPROLIX from working properly.
These are not all of the possible side effects of ALPROLIX. Talk to your healthcare provider right away about any side effect that bothers you or does not go away, or if bleeding is not controlled using ALPROLIX.
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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