Intended for US Audiences Only

 

Connect With Us

    Studied for safety. No factor IX inhibitors developed.1

    IXINITY was studied in a clinical trial involving patients previously treated with another recombinant therapy.1*

    Silhouettes 77 PATIENTS
    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

    Calendar 138 DAYS
    AVERAGE NUMBER OF EXPOSURE DAYS TO IXINITY1

    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 were divided into 2 regimens: routine (90%) and on-demand (10%).1

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

    NO 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 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 2.6% of patients.1

    • 8% (6/77) of patients reported a total of 14 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

    IXINITY is FDA approved for adults and children at least 12 years of age.1

    Reference: 1. IXINITY [coagulation factor IX (recombinant)] prescribing information. Chicago, IL: Medexus Pharma, Inc.; November 2022.

    Call 1-855-IXINITY (1-855-494-6489) to speak with your IXperience™ Concierge for more information on IXINITY.

    Medexus Pharma, Inc., Chicago, IL 60606

    IXINITY [coagulation factor IX (recombinant)] and any and all Medexus Pharma, Inc. brand, product, service and feature names, logos, and slogans are trademarks or registered trademarks of Medexus Pharma, Inc. in the United States and/or other countries.

    ©2023 Medexus Pharma, Inc.
    All rights reserved. MP-IX-0334

    INDICATIONS AND IMPORTANT SAFETY INFORMATION

    Expand

    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 at least 12 years of age 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. Your healthcare provider may give you IXINITY for routine prophylaxis, for on demand treatment to control bleeding episodes or when you have surgery.

    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, including Important Patient 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.