Clinical Study Designs
4 STUDIES. 186 PARTICIPANTS.
CHECK OUT THE DESIGNS
The safety and efficacy of ALPROLIX have been studied in 4 completed studies (B-LONG, Kids B-LONG, B-YOND and PUPS B-LONG) of 186 patients. The B-LONG, Kids B-LONG and B-YOND studies contained 153 previously treated people with severe hemophilia B. There were 126 patients treated for at least 52 weeks and 107 patients for at least 104 weeks.
ALPROLIX was also evaluated in one completed study of 33 previously untreated patients (PUPs) with severe hemophilia B. Median of treatment duration of prophylaxis was 77.5 weeks.
ADULTS AND ADOLESCENTS, 12 YEARS AND OVER
(B-LONG STUDY)
Were studied on the once-weekly prophy regimen
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Started with a once-weekly infusion at 50 IU/kg
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Doses were adjusted to maintain desired Factor IX levels
Were studied to see the efficacy of on-demand dosing
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Infusions were given as needed when bleeding episodes occurred
Were studied on the individualized prophy regimen
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Given 100 IU/kg every 10 days and their intervals were adjusted to maintain desired Factor IX levels
Were studied to see the efficacy during surgery
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Doses were adjusted according to the type of surgery
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ALPROLIX was evaluated in 14 major surgeries and 15 minor surgeries
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4 people in this group did not participate in the other groups
Children, 1 - 11 YEARS
(KIDS B-LONG STUDY)
Were studied on the once-weekly prophy regimen
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All 30 previously treated patients started with once-weekly infusion at 50-60 IU/Kg
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Allowed to adjust the dose up to 100 IU/Kg and interval between once and twice weekly
INFANTS AND CHILDREN, LESS THAN 18 YEARS
(previously untreated patients B-LONG STUDY), median age range 0.6 (0.1 - 2.0)
Were studied on an individualized prophy regimen
Were studied to see the efficacy of on demand dosing
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
MANUFACTURED BY
Bioverativ Therapeutics Inc.
Waltham, MA 02451 USA
U.S. License #2078
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