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Intended for US Healthcare Professionals Only.Important Safety 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, including 55 patients with more than 50 exposure days and 45 of those patients with more than 100 exposure days.1

† No subjects developed inhibitors to factor IX when administered IXINITY in a clinical trial, including 55 patients with more than 50 exposure days and 45 patients with more than 100 exposure days to IXINITY.1

Established safety profile

Headache was the most common adverse reaction—observed in 2.6% (2/77) of patients in a clinical trial1

8% (6/77) of patients reported a total of 14 adverse reactions out of 9641 infusions of IXINITY administered during the clinical trial. These were reported as probably or possibly drug-related.1

Adverse reaction Number of subjects Number of events
Headache 2 5
Apathy 1 1
Asthenia 1 1
Depression 1 1
Dysgeusia 1 1
Hemophilia (ie, lack of efficacy) 1 1
Influenza 1 1
Injection site discomfort 1 1
Lethargy 1 1
Rash pruritic 1 1

Manufacturing process

The IXINITY manufacturing process is designed for product purity and safety

  • Third-generation‡ factor IX treatment
  • Purified by a chromatography purification process
  • Employs a validated 3-step viral inactivation/removal process
    • Solvent/detergent treatment
    • Chromatographic step
    • Nanofiltration
  • Utilizes a validated HIC step to reduce the presence of CHO proteins

Working Cell Bank to Harvest Concentration

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Viral Inactivation

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Chromatographic Purification

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Hydrophobic Interaction Chromatography

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Viral Filtration

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Formulation and Filtration

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Finished IXINITY®

HIC = Hydrophobic interaction chromatography; CHO = Chinese hamster ovary.

‡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.

ADDITIONAL WARNINGS AND PRECAUTIONS

Hypersensitivity reactions, including anaphylaxis, have occurred with IXINITY. Discontinue use of IXINITY if hypersensitivity symptoms occur, and initiate appropriate treatment.

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

Patients should be monitored for factor IX activity levels by the one-stage clotting assay to confirm that adequate factor IX levels have been achieved and maintained, when clinically indicated.

References: 1. IXINITY [coagulation factor IX (recombinant)]. Prescribing information. Chicago, IL: Medexus Pharma, Inc.; November 2022. 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 ≥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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