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ALPROLIX^® prophylaxis for kids

ALPROLIX was studied in more previously treated children than any other factor IX EHL

Previously treated patients (PTPs) ≤11 years

Median overall bleeds per year
(Kids B-LONG trial)

Median overall bleeds
(B-YOND trial, Year 4)*

Median spontaneous bleeds per year
(Kids B-LONG trial)

Median joint bleeds per year
(Kids B-LONG trial)

Zero bleeds for 1 in 3 children
(Kids B-LONG trial)†

Kids B-LONG was a phase 3 study that investigated the safety and efficacy of ALPROLIX in 30 previously treated children with severe to moderately severe hemophilia B. 15 children were 1 to 5 years of age; 15 children were 6 to 11 years of age. All children were treated with individualized prophylaxis.

B-YOND was an open-label extension trial that studied the long-term safety and efficacy of ALPROLIX over 5 years in 120 adults, adolescents, and kids 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).

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

^*In a 4-year subanalysis of the pediatric prophylaxis arm of B-YOND, 10 patients ≤11 years achieved a median bleed rate of 0 (0-2.2) for Year 4.
^†10 out of 30 children, or 33%, reported no bleeds at all during the Kids B-LONG trial.

EHL=extended half-life.

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ALPROLIX Dosing

ALPROLIX prophy offers flexible dosing options to keep pace with your lifestyle.

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ALPROLIX offers trusted bleed protection^‡ in kids who have not been previously treated

Previously untreated patients (PUPs) ≤2 years
Start ALPROLIX with confidence

1.2

Median overall bleeds per year
(PUPs B-LONG trial)^§

Median spontaneous bleeds per year
(PUPs B-LONG trial)^§

Median traumatic joint bleeds per year
(PUPs B-LONG trial)^§

The PUPs B-LONG study evaluated ALPROLIX efficacy and safety in 33 children 2 years old or less 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).

^‡ALPROLIX has been proven to help prevent bleeding episodes in people using prophylaxis.
^§From the prophylaxis arm of the PUPs B-LONG trial.

For kids starting prophylaxis, ALPROLIX keeps dosing simple

It's the same once-weekly schedule as other EHLs, so patients and caregivers can switch with confidence.

Flexibility for their growing needs. Simplicity for their caregivers.

Dosing schedule may be adjusted based on individual response, especially in children under 6.

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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.

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© 2025 Sanofi. All rights reserved. ALPROLIX, Sanofi, and HemAssist are trademarks or registered trademarks of Sanofi or an affiliate. All the other trademarks above are the property of their respective owners, who have no affiliation or relationship with Sanofi. MAT-US-2021804-v9.0-10/2025 Last updated: October 2025

ALPROLIX® prophylaxis for kids