Safety
Studied for safety.
No factor IX inhibitors developed.1
In a clinical trial of 98 patients, IXINITY® was studied in children, adolescents, and adults that were previously treated with another recombinant therapy.1*
![adult silhouette](https://www.ixinity.com/hs-fs/hubfs/IXINITY_Website-HCP_March2024/adult_silhouette_headshot.webp?width=166&name=adult_silhouette_headshot.webp)
![kid silhouette](https://www.ixinity.com/hs-fs/hubfs/IXINITY_Website-HCP_March2024/kid_silhouette_headshot.webp?width=159&name=kid_silhouette_headshot.webp)
Average number of exposure days to IXINITY1
![138 Days](https://www.ixinity.com/hs-fs/hubfs/IXINITY_Website-HCP_March2024/avg-number-of-exposure-days-138.webp?width=208&name=avg-number-of-exposure-days-138.webp)
All were previously treated patients with at least 150 exposure days to another factor IX before switching to IXINITY.1
![159 Days](https://www.ixinity.com/hs-fs/hubfs/IXINITY_Website-HCP_March2024/avg-number-of-exposure-days-159.webp?width=208&name=avg-number-of-exposure-days-159.webp)
All were previously treated patients with at least 50 exposure days to another factor IX before switching to IXINITY.
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 7-64 years of age were divided into 2 regimens: routine prophylaxis (90%) and on-demand (10%).1
Patients under 12 years of age were divided into 2 groups: <6 years of age or 6 to <12 years of age.1
In an IXINITY clinical trial,* previously treated patients experienced:
![No Factor IX Inhibitors](https://www.ixinity.com/hs-fs/hubfs/IXINITY_Website-HCP_March2024/no-factor-ix-inhibitors.webp?width=120&name=no-factor-ix-inhibitors.webp)
- 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 Known Interactions](https://www.ixinity.com/hs-fs/hubfs/IXINITY_Website-HCP_March2024/no-known-interactions.webp?width=120&name=no-known-interactions.webp)
- 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% of patients.1
7% (7/98) of patients reported a total of 15 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
In children, the efficacy and safety of IXINITY have been evaluated in a prospective, multicenter, multicountry trial in 21 PTPs (<6 years and 6 to <12 years) who received once or twice weekly prophylaxis treatment with IXINITY for a mean of 159 exposure days.1
†IXINITY is FDA approved for adolescents and adults 12 years of age or older and children under 12 years of age.1
Reference: 1. IXINITY [coagulation factor IX (recombinant)] prescribing information. Chicago, IL: Medexus Pharma, Inc.; March 2024.