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Intended for US Healthcare Professionals Only.Important Safety Information

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*Previously treated patients (PTPs) receiving routine prophylactic treatment of 40 IU/kg to 70 IU/kg of IXINITY twice weekly demonstrated a median annualized spontaneous bleeding rate (AsBR) of 0, and a median total annualized bleeding rate (ABR) of 1.52.2

†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 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.2

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Connect with your local IXINITY Specialist and see if IXINITY is the right treatment for your patients.

‡Up to 20,000 IU.

Reference 1: Data on file. Chicago, IL: Medexus Pharma, Inc. 2. IXINITY [coagulation factor IX (recombinant)] prescribing information. Chicago, IL: Medexus Pharma, Inc.; November 2022.

Consider switching your patients to IXINITY. Call Core Connections™ to start their FREE trial. 1​-8​55​-I​X​INITY (1​-8​55​-4​94-​6​489).

Medexus Pharma, Inc., Chicago, IL 60606

IXINITY® [coagulation factor IX (recombinant)] and any and all Medexus Pharma, Inc. brand, product, service and feature names, logos, and slogans are trademarks or registered trademarks of Medexus Pharma, Inc. in the United States and/or other countries.

©2023 Medexus Pharma, Inc.  All rights reserved.  MP-IX-0408

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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 ≥12 years of age 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, have 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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