IXINITY® Product Features

    Available in color-coded 500, 1000, 1500, and 3000 IU single-use vials.1

    IXINITY_4vials_angle_whitebkgrd_2019

    You can check out all the details about IXINITY safety and efficacy by reading the full IXINITY  Prescribing Information.

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

    • IXINITY can be refrigerated or stored at room temperature (2°–25°C, 36°–77°F).1
    • IXINITY should not be frozen, and the vial(s) should be kept in the carton and protected from light.1

    Note: Do not refrigerate after reconstitution.1

    The reconstituted solution should be infused immediately or within 3 hours of storage at room temperature after reconstitution.1

    You can check out all the details about IXINITY safety and efficacy by reading the full IXINITY Prescribing Information.

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

    • Pre-assembled syringe with plunger attached
    • Secure syringe-to-vial connection
    • Vacuum seal for ease of drawing diluent into vial

    See how to reconstitute IXINITY.

    Planet-friendly Packaging

    See how using IXINITY means less waste.
    IXINITY comes in a fully collapsible, 100% recyclable carton—so it takes up less space in the recycle bin and is better for the planet.

    recyclable

    You can check out all the details about IXINITY safety and efficacy by reading the full IXINITY Prescribing Information.

    IXINITY is FDA approved for adolescents and adults 12 years of age or older and children under 12 years of age.1

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

    VIAL STRENGTHS: FLEXIBILITY FOR DOSING.

    STORAGE AND HANDLING: NO REFRIGERATION REQUIRED.

    RECONSTITUTION KIT: CONVENIENCE IN PREPARATION.

    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.