Safety

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*

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

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:

  • 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 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.

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