IXINITY clinical trial overview

The efficacy and safety of IXINITY have been evaluated in a prospective, multicenter, multicountry trial of previously treated patients (PTPs) (<6 years and 6 to <12 years) who received IXINITY in a routine regimen.


Subjects received twice or once weekly prophylaxis treatment with IXINITY for a mean of 159 exposure days.1

PTPs were defined as patients with a minimum of 50 ED to another factor IX preparation. All subjects had severe or moderately severe (factor IX level ≤2 IU/dL) hemophilia B.1

Patients received IXINITY prophylaxis once to twice weekly, the recommended dose range was 35 to 75 IU/kg. Subjects < 6 years received a mean intravenous dose of 58 (45-72) ± 8.9 IU/kg and subjects 6 to <12 years of age received a mean intravenous dose of 52 (46-60) ± 11.6 IU/kg. The mean number of ED was 159 (median 163), including 16 subjects with ≥100 ED and 7 subjects with ≥200 ED.1

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References: 1. IXINITY [coagulation factor IX (recombinant)]. Prescribing information. Chicago, IL: Medexus Pharma, Inc.; March 2024. 2. Data on file. Chicago, IL: Medexus Pharma, Inc.

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