Vial options and factor storage

ALPROLIX is supplied in single-use vials labeled 250, 500, 1000, 2000, 3000 or 4000 International Units (IU) per vial of ALPROLIX as lyophilized powder. Liquid diluent comes in a prefilled syringe.

vLine

Graphic not representative of actual drug product vials.

Always talk to your healthcare provider and follow Instructions for Use when infusing.

vLine

This ALPROLIX Reconstitution Kit is ideal if you're on the go or infusing at home.

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How To Store ALPROLIX
  • Store ALPROLIX in the original package in order to protect it from light
  • Store ALPROLIX vials at 2°C to 8°C (36°F–46°F). Do not freeze
  • ALPROLIX vials may also be stored at room temperature up to 30°C (86°F) for a single 6-month period
  • If you choose to store ALPROLIX at room temperature, record the date that ALPROLIX is removed from refrigeration on the carton in the area provided
  • After storage at room temperature, do not return the product to the refrigerator
  • Do not use product or diluent after the expiration date printed on the carton, vial, or syringe
After Reconstitution
  • Use the reconstituted product as soon as possible; however, you may store the reconstituted product at room temperature up to 30°C (86°F) for up to 3 hours
    • Protect the reconstituted product from direct sunlight
    • Discard any product not used within 3 hours after reconstitution
  • Do not use ALPROLIX if the reconstituted solution is cloudy, contains particles, or is not colorless
Disposing After Use
How do I dispose of ALPROLIX after use?
  • Dispose of all unused solution, empty vial(s), and other used medical supplies in an appropriate medical waste container
Where can I get a medical waste container?
  • Call MyALPROLIX at 1-855-MyALPROLIX (692-5776) Monday through Friday, 8 AM to 8 PM, ET to speak to a MyALPROLIX Coordinator about how to obtain a medical waste container
Follow community guidelines
  • When your sharps disposal container is almost full, you will need to follow your community guidelines for the correct way to dispose of it
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.