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Intended for US Healthcare Professionals Only.Important Safety Information

IXINITY® dosing & administration

Reconstitution Kit: Convenience in preparation.

  • Preassembled syringe with plunger attached
  • Secure syringe-to-vial connection
  • Vacuum seal for ease of drawing diluent into vial
  • See the INSTRUCTIONS FOR USE section of the IXINITY package insert for reconstitution, pooling, and administration instructions.
dosing contents
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Watch Brian reconstitute IXINITY.

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Planet-friendly packaging takes
the patient’s world into account.

IXINITY comes in a fully collapsible, 100% recyclable carton.

Flexibility of IXINITY vial strengths

IXINITY is available in 500, 1000, 1500, and 3000 IU single-use vials, which are color-coded by vial strength.1

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To learn more about how to order IXINITY, call Core Connections at 1-855-IXINITY (1-855-494-6489).

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Storage and handling1

  • Store at 2°C–25°C (36°F to 77°F)
    • May be stored at room temperature or under refrigerated conditions
  • 36-month shelf life from date of manufacture
  • Do not freeze
  • Keep the vial in the carton and protect from light
  • Reconstituted solution should be infused immediately or within 3 hours of storage at room temperature after reconstitution
  • Do not refrigerate after reconstitution

Custom ancillaries

  • Patients choose the supplies they want delivered with IXINITY, such as:
    • Butterfly needles
    • Bandages, alcohol wipes, gauzes
    • Tourniquets
  • Delivered in a reusable bag
  • Can be delivered to the pharmacy for inclusion in shipment of product
  • No cost to patient, prescriber, or pharmacy
  • Download form online; NPI signature required
Download the IXINITY Custom Ancillary Request Form

Reference: 1. IXINITY [coagulation factor IX (recombinant)]. Prescribing information. Chicago, IL: Medexus Pharma, Inc.; March 2024.

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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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