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Intended for US Healthcare Professionals Only.Important Safety Information

IXINITY clinical trial overview

The efficacy (n=68) and safety (n=77) of IXINITY have been evaluated in a prospective, open-label, uncontrolled, multicenter trial of previously treated patients (PTPs) aged 7 to 64 who received IXINITY in a routine or on-demand regimen.1#

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exposure-days

The mean number of exposure days (ED) to IXINITY was 138.2, including 45 subjects with more than 100 ED and 55 subjects with more than 50 ED.1

PTPs were defined as patients with a minimum of 150 ED to another factor IX preparation. All subjects had severe or moderately severe (factor IX level ≤2 IU/dL) hemophilia B.1

#Patients in the routine therapy group received mean intravenous doses of 55 ± 12.8 IU/kg of IXINITY twice weekly. Patients in the on-demand therapy group received mean intravenous doses of 60 ±18.2 IU/kg for bleeding episodes. The mean number of ED was 138.2, with a median of 127.5, including 45 subjects with more than 100 ED and 55 subjects with more than 50 ED.1

Bleed control for surgery

Significant efficacy demonstrated in perioperative management

In a substudy using IXINITY in major surgical procedures, 16 PTPs with hemophilia B between 12 and 56 years of age underwent 19 surgical procedures.1

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PTPs were defined as patients with a minimum of 150 ED to another factor IX preparation. All subjects had severe or moderately severe (factor IX level ≤2 IU/dL) hemophilia B.1

Surgical substudy design details3

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  • Nonrandomized, open-label study of 16 PTPs
  • 19 major surgical procedures were included
  • Patients received either bolus infusions or continuous infusions with bolus as needed
  • Bolus regimen
    • Preop: up to 120 IU/kg
    • Postop: 60 IU/kg every 12h for a minimum of 3 days
  • Continuous regimen
    • Preop: bolus of up to 120 IU/kg
    • Postop: continuous infusion with target plasma factor IX of 70 IU/dL-110 IU/dL; additional bolus infusions as needed

Successful surgical procedures

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Effective hemostasis was reported with the following major surgical procedures1:

  • Knee and elbow arthroplasty
  • Knee amputation
  • Percutaneous Achilles tendon lengthening
  • Arthroscopic synovectomy
  • Debridement (ankle, knee)
  • Open inguinal hernia repair
  • Tibiotalar fusion
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Dosing targets remained consistent with World Federation of Hemophilia (WFH) guidelines

WFH guidelines target 60 IU/dL-80 IU/dL preoperatively, then range from 20 IU/dL-60 IU/dL postoperatively.2

Factor levels after surgery

IXINITY successfully maintained factor IX levels above 50% for up to 3 days postsurgery

In a clinical substudy, PTPs undergoing major surgical procedures were administered IXINITY in either a bolus regimen or a continuous regimen with bolus as needed, both demonstrating effective results.2

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#Bolus regimen was administered in 13 procedures.2

**Continuous regimen with bolus as needed was administered in 6 procedures.2

††Timing of factor IX level relative to dose adjustment not captured after 24 hours.

References: 1. IXINITY [coagulation factor IX (recombinant)]. Prescribing information. Chicago, IL: Medexus Pharma, Inc.; March 2024. 2. Collins PW, Quon DVK, Makris M, et al. Pharmacokinetics, safety and efficacy of a recombinant factor IX product, trenonacog alfa in previously treated haemophilia B patients. Haemophilia. 2018;24:104-112. 3. 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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