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Recovery and Half-Life

IXINITY provides predictable bleed control for your active, unpredictable life.

98%RECOVERY*
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HIGHER RECOVERY MAY ALLOW LOWER DOSES

IXINITY® has an average incremental recovery of 98%.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: Keith weighs 155 lb (about 70 kg), and is looking for a 50% factor IX increase (correction).

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

The pharmacokinetics of IXINITY have been evaluated in 32 previously treated patients ≥12 years of age with severe to moderately severe hemophilia B.1

Ask your doctor to do an individual PK test to determine your recovery with IXINITY.

24-hour half-life for peak factor IX levels when you need them.

The average terminal half-life of IXINITY® is 24 hours.1
Individual half-life may vary.

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 full day.

bar graphs

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

IXINITY® resolves most bleeds with 1 infusion.

In a clinical trial1*:

  • 71% of bleeds resolved with 1 infusion
  • Patients rated bleed control as excellent or good in 84% of all bleeds treated1 †

In a clinical trial, IXINITY was used in major surgeries1:

SURGERIES
  • Knee and elbow joint replacements
  • Arthroscopic surgeries to remove inflamed joint tissue
RESULTS
  • “Expected” or “less than expected” blood loss
  • Zero transfusions during surgery
  • Bleed control rated adequate or better than adequate at 12 and 24 hours post-surgery

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

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

References: 1. IXINITY [coagulation factor IX (recombinant)] prescribing information. Berwyn, PA: Aptevo BioTherapeutics LLC; August 2016. 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.

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 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 to control and prevent 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 side effects of prescription drugs to the Food and Drug Administration. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.