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    Open Instructions For Use

    Watch how to reconstitute IXINITY.

    Before starting, you will need the following items for reconstitution and administration:

    • One (or more) vial(s) of IXINITY® 500, 1000, 1500, or 3000 IU powder, as prescribed by your healthcare provider
    • One 10 mL syringe, pre-filled with 5 mL of Sterile Water for Injection (Pre-filled Syringe) with plunger rod attached
    • Sterile vial adapter with filter
    • Alcohol swabs
    • Sterile infusion set
    • Sterile gauze pad
    • Sterile bandage

    IXINITY is supplied in kits that include single use vials of IXINITY (500, 1000, 1500, or 3000 IU of powder), a 10 mL syringe pre-filled with 5 mL of Sterile Water for Injection with plunger rod attached (to be used for reconstitution only), and a sterile vial adapter with filter.1

    Need supplies or something specific? Get Custom Ancillaries.

    If you use multiple vials of IXINITY for each infusion, reconstitute each vial following steps described in the IXINITY Instructions for Use.

    Reference: 1. IXINITY [coagulation factor IX (recombinant)] prescribing information. Chicago, IL: Medexus Pharma, Inc.; March 2024.

    INDICATIONS AND IMPORTANT SAFETY INFORMATION

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    What is IXINITY?

    IXINITY [coagulation factor IX (recombinant)] is a medicine used to replace clotting factor (factor IX) that is missing in adults and children with hemophilia B. Hemophilia B is also called congenital factor IX deficiency or Christmas disease. Hemophilia B is an inherited bleeding disorder that prevents clotting. For children and adults, your healthcare provider may give you IXINITY for on-demand treatment and control of bleeding episodes, when you have surgery, or for routine prophylaxis to prevent bleeding episodes.

    IXINITY is not indicated for induction of immune tolerance in patients with hemophilia B.

    IMPORTANT SAFETY INFORMATION for IXINITY

    • You should not use IXINITY if you are allergic to hamsters or any ingredients in IXINITY.

    • You should tell your healthcare provider if you have or have had medical problems, take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements, or herbal remedies, have any allergies, including allergies to hamsters, are nursing, are pregnant or planning to become pregnant, or have been told that you have inhibitors to factor IX.

    • You can experience an allergic reaction to IXINITY. Contact your healthcare provider or get emergency treatment right away if you develop a rash or hives, itching, tightness of the throat, chest pain, or tightness, difficulty breathing, lightheadedness, dizziness, nausea, or fainting.

    • Your body may form inhibitors to IXINITY. An inhibitor is part of the body's defense system. If you develop inhibitors, it may prevent IXINITY from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for development of inhibitors to IXINITY.

    • If you have risk factors for developing blood clots, the use of IXINITY may increase the risk of abnormal blood clots.

    • Call your healthcare provider right away about any side effects that bother you or do not go away, or if your bleeding does not stop after taking IXINITY.

    • The most common side effect that was reported with IXINITY during clinical trials was headache.

    • These are not all the side effects possible with IXINITY. You can ask your healthcare provider for information that is written for healthcare professionals.


    For more information about IXINITY, please see full Prescribing Information.

    You are encouraged to report adverse events related to Medexus Pharma products by calling 1-844-859-6675. If you prefer, you may contact the Food and Drug Administration directly. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.