![Alprolix® [Coagulation Factor IX (Recombinant), Fc Fusion Protein] logo](/dam/jcr:1b4ca645-c502-4d05-8448-b6ce08e92fbd/Alprolix_logo.svg){kind=logo}
- A target joint was defined as a major joint with ≥3 bleeding episodes over 3 consecutive months
- Target joint resolution was defined as ≤2 spontaneous joint bleeds within 12 months
Benefits of ALPROLIX® prophylaxis
Trusted prophy protection for patients ≥12 years old
Previously treated patients (PTPs) ≥12 years
1.4
Median overall bleeds per year (B-LONG trial)*
(0-3.4)
(median overall annualized bleed rate)
(median overall annualized bleed rate)
0.9
Median spontaneous bleeds per year (B-LONG trial)*
(0-2.3)
(median spontaneous annualized bleed rate)
(median spontaneous annualized bleed rate)
0.4
Median joint bleeds per year
(B-LONG trial)*
(0-3.2)
(median joint annualized bleed rate)
(median joint annualized bleed rate)
B-LONG was a phase 3 study that investigated the safety and efficacy of ALPROLIX in 123 previously treated adult and adolescent patients 12 and older with severe hemophilia B.
The study included a fixed-interval (weekly) arm (n=63), a fixed-dose (interval-adjusted) arm (n=29), an episodic (On Demand) arm (n=27), and a surgical arm (n=12).
The study included a fixed-interval (weekly) arm (n=63), a fixed-dose (interval-adjusted) arm (n=29), an episodic (On Demand) arm (n=27), and a surgical arm (n=12).
42% of adult and adolescent PTPs had 0 bleeds per year on ALPROLIX in the B-LONG trial†
*Interval-adjusted prophylaxis arm for B-LONG.
†11 out of the 26 evaluated patients in the IP arm of B-LONG had an ABR of 0.
†11 out of the 26 evaluated patients in the IP arm of B-LONG had an ABR of 0.
How bleeds, spontaneous bleeds, and joint bleeds were measured in the clinical trials
Overall annualized bleed rate
Median overall ABR was the middle number of all ABRs, when everyone’s ABR was ordered from least to greatest.
Spontaneous annualized bleed rate
Median spontaneous AsBR was the middle number of all spontaneous ABRs, when everyone’s spontaneous ABR was ordered from least to greatest.
Joint annualized bleed rate
Median joint ABR was the middle number of all joint ABRs, when everyone’s joint ABR was ordered from least to greatest.
An analysis of clinical trials showed annualized bleed rates stayed low in adults and adolescents treated with ALPROLIX prophy
Previously treated patients (PTPs) ≥12 years
Year 5 data
1
Median overall bleeds per year
(B-YOND trial)‡
(0-2)
(median overall annualized bleed rate)
(median overall annualized bleed rate)
0
Median spontaneous bleeds per year
(B-YOND trial)‡
(0-1)
(median spontaneous annualized bleed rate)
(median spontaneous annualized bleed rate)
B-YOND was an open-label extension trial that studied the long-term safety and efficacy of ALPROLIX over 5 years in 120 adult, adolescent, and pediatric patients previously treated in Kids B-LONG or B-LONG. The study included a fixed-interval arm (n=74), a fixed-dose arm (n=36), a modified prophylaxis arm (n=17), and an on-demand arm (n=15).
‡In a 5-year subanalysis of the interval-adjusted prophylaxis arm of B-YOND, 17 patients ≥12 years achieved a median ABR of 1 (0-2.0) for Year 5, and a median AsBR of 0 (0-1.0) for Year 5.
ALPROLIX was studied for up to 6.5 years in adult and adolescent patients, from the start of the B-LONG trial to the end of the B-YOND trial
ALPROLIX offers trusted bleed protection§ in previously treated kids
Previously treated patients (PTPs) ≤11 years
2
Median overall bleeds per year (Kids B-LONG trial)||
(0-3.1)
(median overall annualized bleed rate)
(median overall annualized bleed rate)
0
Median spontaneous bleeds per year (Kids B-LONG trial)||
(0-1.2)
(median spontaneous annualized bleed rate)
(median spontaneous annualized bleed rate)
0
Median joint bleeds per year (Kids B-LONG trial)||
(0-1.1)
(median annualized joint bleed rate)
(median annualized joint bleed rate)
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.
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.
Kids ≤11 years were studied up to 4.8 years, from the start of the Kids B-LONG trial to the end of the B-YOND trial, with an overall ABR of 0 (0-2.2) at year 4||
§ALPROLIX has been proven to help patients prevent bleeding episodes using a prophylaxis regimen.
||In a 4-year subanalysis of the pediatric prophylaxis arm of B-YOND, 10 patients ≤11 years achieved a median ABR of 0 (0-2.2) for Year 4.
||In a 4-year subanalysis of the pediatric prophylaxis arm of B-YOND, 10 patients ≤11 years achieved a median ABR of 0 (0-2.2) for Year 4.
Taking ALPROLIX
ALPROLIX prophy offers flexible dosing
options to keep pace with your lifestyle.
options to keep pace with your lifestyle.
Patient stories
See how real ALPROLIX patients
manage hemophilia B.
ALPROLIX offers trusted bleed protection§ in kids who have not been previously treated
Previously untreated patients (PUPs) <18 years
1.2
Median overall bleeds per year (PUPs B-LONG trial)¶
(0-2.5)
(median overall annualized bleed rate)
0
Median spontaneous bleeds per year (PUPs B-LONG trial)¶
(0-0)
(median spontaneous annualized bleed rate)
0
Median traumatic joint bleeds per year (PUPs B-LONG trial)¶
(0-0)
(median traumatic joint annualized bleed rate)
The PUPs B-LONG study evaluated ALPROLIX efficacy and safety in 33 people less than 18 years old 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 studied in a prophylaxis arm (n=28) and an on-demand arm (n=5).
¶From the prophylaxis arm of the PUPs B-LONG trial.
Important Safety Information and Indication
Indication
Important Safety Information
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
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.
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.
Please see full Prescribing InformationLearn more about Sanofi’s commitment to fighting counterfeit drugs
![Alprolix® [Coagulation Factor IX (Recombinant), Fc Fusion Protein] logo](/dam/jcr:fd05fa76-f9b4-440e-84c4-fd5d9bd1f016/alprolix-inverse.svg)
