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    For children under 12 years of age BLEED CONTROL AND PROTECTION

    ZERO spontaneous bleeds.1*
    More spontaneous possibilities.

    Ever wonder what life would be like for a child with ZERO spontaneous bleeds? Explore the possibilities with IXINITY®.

    Use IXINITY as prophylaxis for bleed control before a child needs it,1 and discover the confidence that comes from proven bleed protection.

    0 spontaneous bleeds. Take control of their treatment. IXINITY with flexible dosing achieved ZERO spontaneous bleeds.

    * Previously treated patients (PTPs) receiving routine prophylactic treatment of 35 IU/kg to 75 IU/kg of IXINITY once to twice weekly demonstrated a median (interquartile range [IQR]) annualized spontaneous bleeding rate (AsBR) of 0, and a median total annualized bleeding rate (ABR) of 0.86. IQR (range: 0-1.96) (N=21).1-3

    IXINITY resolves most bleeds with 1 infusion

    In a clinical trial1:

    86.5%

    of bleeds were resolved with zero to two infusions

    95%

    of patients rated bleed control as “excellent” or “good” for bleeds needing treatment1†

    †A total of 52 bleeding episodes were treated with IXINITY.1

    IXINITY provides predictable bleed control for children’s active, unpredictable life.

    79% RECOVERY 16.3 HOUR HALF-LIFE
    79% Recovery Graphic
    79%
    Recovery Higher recovery may allow lower doses‡
     
    IXINITY has an average incremental recovery of 79%.1
    Higher recovery may allow lower doses.

    Incremental Recovery: The increase in plasma concentration per IU/kg of factor administered.2 Plasma-derived factor products have an incremental recovery close to 1 or 100%.2,3

    Selected Important Safety Information
    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.

    How recovery impacts infusion dose.§

    Hypothetical example: Shannon’s son Kevin weighs 65 lbs (about 30 kg), and needs a 50% factor IX increase (correction).

    Recovery factor 1 and 2
    Factor 1 Factor 2
    Kevin’s dose is 307 IU LOWER§

      Dose (IU)=body weight x desired factor IX increase x (1/recovery).1

    ‡ IXINITY recovery is an average based on lab tests of patients in the clinical study.1 Because each child’s actual recovery may be different, their dose may be different, too. Speak with your healthcare professional about the exact dose for them.

    § Description is not of an actual patient. Individual dose will vary. Patient with baseline factor level of <1%.

    Ask your doctor to do an individual PK test to determine your recovery with IXINITY.
    79% Recovery Graphic

    Peak factor level: Point when the highest concentration of factor in the blood is reached.4 Matching peak factor level timing with peak activity level may help support an active lifestyle.

    Terminal half-life: Time it takes for the drug’s activity to decrease by half after factor has been distributed throughout the body. The longer the terminal half-life, the longer factor is active in your system.4

    50% of peak factor level remains after 16.3 hours

    Recovery factor 1 and 2

    Individual response may very; therefore, number of days between dosing may very.

    Discover the bleed control and protection IXINITY delivers in adolescent and adult patients Learn More

    References: 1. IXINITY [coagulation factor IX (recombinant)]. Prescribing information. Chicago, IL: Medexus Pharma, Inc.; March 2024. 2. Björkman S. A commentary on the differences in pharmacokinetics between recombinant and plasma-derived factor IX and their implications for dosing. Haemophilia. 2011;17:179-184. 3. Roth DA, Kessler CM, Pasi KJ, Rup B, Courter SG, Tubridy KL. Human recombinant factor IX: safety and efficacy studies in hemophilia B patients previously treated with plasma-derived factor IX concentrates. Blood. 2001;98(13):3600-3606. 4. Tracy TS. Pharmacokinetics. In: Craig CF, Stitzel RE. Modern Pharmacology With Clinical Applications. 6th ed. Hagerstown, MD: Lippincott Williams & Wilkins; 2004.

    Call 1-855-IXINITY (1-855-494-6489) to speak with your Concierge at Core Connections 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.

    ©2024 Medexus Pharma, Inc.
    All rights reserved. MP-IX-0525

    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.