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Intended for US Healthcare Professionals Only.Important Safety Information

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.1¶

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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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INDICATIONS AND IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE: IXINITY® [coagulation factor IX (recombinant)] Lyophilized Powder for Solution for Intravenous Injection is a coagulation factor IX (recombinant) indicated in adults and children with hemophilia B for on-demand treatment and control of bleeding episodes, perioperative management, and for routine prophylaxis to reduce the frequency of bleeding episodes.

IXINITY is not indicated for induction of immune tolerance in patients with hemophilia B.

CONTRAINDICATIONS: IXINITY is contraindicated in patients who have known hypersensitivity to IXINITY or its excipients, including hamster protein.

WARNINGS AND PRECAUTIONS: Hypersensitivity reactions, including anaphylaxis, has occurred with IXINITY. Discontinue use of IXINITY if hypersensitivity symptoms occur, and initiate appropriate treatment. Regularly evaluate patients for the development of factor IX inhibitors by appropriate clinical observations and laboratory tests. If expected factor IX activity plasma levels are not attained, or, if bleeding is not controlled as expected with a certain dose, perform an assay that measures factor IX inhibitor concentration. An association between the occurrence of a factor IX inhibitor and allergic reactions has been reported. Individuals with factor IX inhibitors may be at increased risk of severe hypersensitivity reactions or anaphylaxis if re-challenged.

Nephrotic syndrome may occur with IXINITY. Nephrotic syndrome has been reported following attempted immune tolerance induction in hemophilia B patients with factor IX inhibitors and a history of allergic reactions.

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

Patients may develop hypersensitivity to hamster (CHO) protein as IXINITY contains trace amounts.

The most common adverse drug reaction observed in >2% of patients in clinical trials was headache.

Please see full Prescribing Information.

You are encouraged to report adverse events related to Medexus Pharma products by calling 1-844-859-6675. If you prefer, you may contact the Food and Drug Administration directly. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

The information in this section is intended for healthcare providers in the United States. I certify that I am a healthcare provider in the United States.

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