LIVE IT YOUR WAY.
LIVE IT YOUR WAY.
Kids B-LONG was a phase 3 study that investigated the safety and efficacy of ALPROLIX in 30 previously treated pediatric patients with severe to moderately severe hemophilia B. 15 patients were 1 to 5 years of age; 15 patients were 6 to 11 years of age. All patients were treated with individualized prophylaxis.
The PUPs B-LONG study evaluated ALPROLIX efficacy and safety in people <18 years old with severe hemophilia who had never used an infused factor IX product before, sometimes called previously untreated patients, or PUPs. These children (range: 0.1 to 2 years) were treated with a once-weekly ALPROLIX prophylaxis regimen and experienced an ABR of 0 bleeds per year.
Studies have not been conducted to assess the safety or efficacy of ALPROLIX compared to BeneFIX.
22 patients in the B-LONG study received consecutive single IV doses of 50 IU/kg of BeneFIX and ALPROLIX at the beginning of the study for direct comparison. For both ALPROLIX and BeneFIX, peak activity was reached in approximately 10 minutes after the start of the injection.
Children: 88.7% (n=47/53) | Adults & Adolescents: 83.7% (n=513/613) | PUPs: 91% (n=72/79)
*Responses are based on number of first injections for a bleed episode with an evaluation. Excellent response was defined as abrupt pain relief and / or improvement in signs of bleeding. Good response was defined as definite pain relief and / or improvement in signs of bleeding but possibly requiring another injection in 1-2 days.
Rethink Your Routine.
Dosing every 10 days with ALPROLIX = around 3 preventative infusions per month
In the B-LONG study, adults and adolescents in the 10-day interval-adjusted prophylaxis group experienced 87% fewer bleeds vs. the on-demand group.
- People in the on-demand group experienced an overall median ABR of 17.7 bleeds per year.
- People in the individualized prophylaxis group experienced an overall median ABR of 1.4 bleeds per year and a median AsBR of 0.9 bleeds per year.
BLEED PER YEAR
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.
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.
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.
Please see full Prescribing Information
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Bioverativ Therapeutics Inc.
Waltham, MA 02451 USA
U.S. License #2078
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