Studied for safety.
    No factor IX inhibitors developed.1

    In a clinical trial of 98 patients, IXINITY® was studied in children, adolescents, and adults that were previously treated with another recombinant therapy.1*

    adult silhouette 77 Patients 7-64 years of age1
    kid silhouette 21 Patients Under 12 years of age1

    Average number of exposure days to IXINITY1

    138 Days 7-64 years of age1

    All were previously treated patients with at least 150 exposure days to another factor IX before switching to IXINITY.1

    159 Days Under 12 years of age1

    All were previously treated patients with at least 50 exposure days to another factor IX before switching to IXINITY.

    Exposure day: A day during which a patient receives a factor IX infusion.
    All had moderately severe or severe hemophilia B (factor IX level ≤2 IU/dL).1
    Patients 7-64 years of age were divided into 2 regimens: routine prophylaxis (90%) and on-demand (10%).1
    Patients under 12 years of age were divided into 2 groups: <6 years of age or 6 to <12 years of age.1

    In an IXINITY clinical trial,* previously treated patients experienced:

    No Factor IX Inhibitors
    • Your body may form inhibitors to factor IX.
    • Patients should be monitored for the development of factor IX inhibitors if1:
      • Expected factor IX activity plasma levels are not attained.
      • Bleeding is not controlled with the recommended dose of IXINITY.
    No Known Interactions
    • No drug-drug, drug-food, or other interactions with factor IX products are known.1

    The most common side effect in people using IXINITY in clinical trials was headache—observed in 2% of patients.1

    7% (7/98) of patients reported a total of 15 adverse reactions. These were reported as probably or possibly drug-related.1

    IXINITY: Manufacturing process designed for product purity and safety.

    • Third-generation factor IX treatment
    • No additional human or animal proteins are added during manufacturing.
    • Employs a validated 3-step viral inactivation & removal process:
      • Solvent/detergent treatment, chromatographic step, nanofiltration
    • Utilizes a validated step to reduce the presence of CHO proteins

    Third-generation product: Defined by the National Hemophilia Foundation Medical and Scientific Advisory Council as recombinant factor IX (rFIX) produced in Chinese hamster ovary cells; no human or animal plasma-derived proteins are used in the manufacturing process.

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

    *The efficacy (n=68) and safety (n=77) of IXINITY have been evaluated in a prospective, open-label, uncontrolled, multicenter trial in which previously treated patients (PTPs) between 7 and 64 years of age received IXINITY in either a routine or on-demand regimen.1

    In children, the efficacy and safety of IXINITY have been evaluated in a prospective, multicenter, multicountry trial in 21 PTPs (<6 years and 6 to <12 years) who received once or twice weekly prophylaxis treatment with IXINITY for a mean of 159 exposure days.1

    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.



    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.


    • 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, or call 1-800-FDA-1088.