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*
68 male 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
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
NO factor IX inhibitors were developed by patients in the clinical trial.
- NO patients developed 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 anaphylactic (severe allergic) reactions reported in people receiving IXINITY.1
- Hypersensitivity reactions, including anaphylaxis, have been reported with factor IX-containing products.1
- You should not use IXINITY if you are allergic to hamsters or any ingredients in IXINITY.1
- 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: Third-generation factor IX treatment.1
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.2
The IXINITY manufacturing process is designed for product purity and safety.
- No additional human or animal proteins are added during manufacturing.1
- Employs a 3-step viral inactivation & removal process.1‡
INDICATIONS AND IMPORTANT SAFETY INFORMATIONExpand
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.
*The efficacy (n=68) and safety (n=77) of IXINITY has 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
‡See Description section of Prescribing Information for more information.
References: 1. IXINITY [coagulation factor IX (recombinant)] prescribing information. Berwyn, PA: Aptevo BioTherapeutics LLC; August 2016. 2. National Hemophilia Foundation Medical and Scientific Advisory Council (MASAC). MASAC recommendations concerning products licensed for the treatment of hemophilia and other bleeding disorders. MASAC Document #230. September 2014.