NO FACTOR IX INHIBITORS DEVELOPED

Clinical trial* experience of previously treated patients

No patients developed factor IX inhibitors when switching to IXINITY® in a clinical trial1

The body may form inhibitors to any factor IX product. Patients should be monitored for the development of factor IX inhibitors if expected factor IX activity plasma levels are not attained, or if bleeding is not controlled with the recommended dose of IXINITY.1

No drug-drug, drug-food, or other interactions with factor IX products are known2

*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, including 55 patients with more than 50 exposure days and 45 of those patients with more than 100 exposure days.1

†No subjects developed inhibitors to factor IX when administered IXINITY in a clinical trial, including 55 patients with more than 50 exposure days and 45 patients with more than 100 exposure days to IXINITY.1

ESTABLISHED SAFETY PROFILE

Headache was the most common adverse reaction—observed in
2.6% (2/77) of patients in a clinical trial1

8% (6/77) of patients reported a total of 14 adverse reactions out of 9641 infusions of IXINITY administered during the clinical trial. These were reported as probably or possibly drug-related.1

MANUFACTURING PROCESS

The IXINITY manufacturing process is designed for product
purity and safety

  • Third-generation factor IX treatment
  • Purified by a chromatography purification process
  • Employs a validated 3-step viral inactivation/removal process
    • Solvent/detergent treatment
    • Chromatographic step
    • Nanofiltration
  • Utilizes a validated HIC step to reduce the presence of CHO proteins

HIC: Hydrophobic interaction chromatography’
CHO: Chinese hamster ovary

‡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.

ADDITIONAL WARNINGS AND PRECAUTIONS

Hypersensitivity reactions, including anaphylaxis, has occurred with IXINITY. Discontinue use of IXINITY if hypersensitivity symptoms occur, and initiate appropriate treatment.

Thromboembolism has occurred with IXINITY (e.g., pulmonary embolism, venous thrombosis, and arterial thrombosis).

Patients should be monitored for factor IX activity levels by the one-stage clotting assay to confirm that adequate factor IX levels have been achieved and maintained, when clinically indicated.

EXPLORE MORE ABOUT IXINITY

Reference: 1. IXINITY [coagulation factor IX (recombinant)] prescribing information. Chicago, IL: Medexus Pharma, Inc.; February 2021. 2. Collins PW, Quon DVK, Makris M, et al. Pharmacokinetics, safety and efficacy of a recombinant factor IX product, trenonacog alfa in previously treated Haemophilia. 2018;24:104-112. 3. Data on file. Chicago, IL: Medexus Pharma, Inc.