Prophylaxis infusion schedules – starting every 7 or 10 days with the potential to extend based on your response

Image Map
Prophylaxis infusion schedules — starting every 7 or 10 days with the potential
to extend based on your response
  • ALPROLIX has a prolonged half-life allowing for a recommended starting prophy regimen of either 50 IU/kg once-weekly, or 100 IU/kg once
    every 10 days. Dosing regimen can be adjusted based on individual response.
  • Based on your response you may be able to extend your dosing interval
  • In the clinical trial, the overall median interval for the individualized prophylaxis arm was 12.5 days. The median interval during the last
    six months in 26 subjects who were on study for at least nine months was 13.8 days.


The amount of time that ALPROLIX is active may be different in children. Children under 12 may have a shorter half-life and lower recovery. Therefore, higher doses or more frequent infusions may be needed.
Selected Important Safety Information
  • Do not use ALPROLIX if you are allergic to ALPROLIX or any of the other ingredients in ALPROLIX.
  • Allergic reactions may occur with ALPROLIX. Call your healthcare provider or get emergency treatment right away
       if you have any of the following symptoms: difficulty breathing, chest tightness, swelling of the face, rash, or hives.
PLEASE SEE FULL IMPORTANT SAFETY INFORMATION.
The recommended starting prophy regimens are either 50 IU/kg once weekly, or 100 IU/kg once every 10 days. Dosing regimen can be adjusted based on individual response.

Children under 12 years of age may have higher factor IX body weight-adjusted clearance, shorter half-life, and lower recovery. Higher dose per kilogram body weight or more frequent dosing may be needed in these children.

Clinical Study Design
Indications
ALPROLIX [Coagulation Factor IX (Recombinant), Fc Fusion Protein] is a recombinant DNA derived, coagulation factor IX concentrate indicated in adults and children with Hemophilia B for:
  • On-demand treatment and control of bleeding episodes
  • Perioperative management of bleeding
  • Routine prophylaxis to reduce the frequency of bleeding episodes
ALPROLIX is not indicated for induction of immune tolerance in patients with Hemophilia B.

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.

Allergic reactions may occur with ALPROLIX. Call your healthcare provider or get emergency treatment right away if you have any of the following symptoms: difficulty breathing, chest tightness, swelling of the face, rash, or hives.

Your body can also make antibodies called “inhibitors” against ALPROLIX, which may stop ALPROLIX from working properly.

ALPROLIX may increase the risk of formation of abnormal blood clots in your body, especially if you have risk factors for developing clots.

Common side effects of ALPROLIX include headache and abnormal sensation of the mouth. These are not all 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, and if bleeding is not controlled using ALPROLIX.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full Prescribing Information.