PROVEN BLEED PREVENTION AND CONTROL

IXINITY® delivers durable prophylactic efficacy

In addition to on-demand treatment and perioperative management, IXINITY is indicated for routine prophylaxis for adults—giving healthcare professionals the ability to tailor administration schedules to their patients’ peak activity periods.

*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

EFFECTIVE CONTROL OF BLEEDING EPISODES

Successful on-demand bleed resolution reported in a clinical trial

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).1
§In a clinical trial, 71% of bleeding episodes were resolved with 1 infusion and 13% were resolved with 2 infusions. A total of 508 bleeding episodes were treated with IXINITY.1
Hemostatic efficacy was rated “partially effective” for the remaining 8% of instances. No physician rated IXINITY “not effective.”2

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#

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

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).1
§In a clinical trial, 71% of bleeding episodes were resolved with 1 infusion and 13% were resolved with 2 infusions. A total of 508 bleeding episodes were treated with IXINITY.1
Hemostatic efficacy was rated “partially effective” for the remaining 8% of instances. No physician rated IXINITY “not effective.”2

SURGICAL SUB-STUDY DESIGN DETAILS3

  • Non-randomized, 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

  • Pre-op: up to 120 IU/kg
  • Post-op: 60 IU/kg every 12h for a minimum of 3 days

—Continuous regimen

  • Pre-op: bolus of up to 120 IU/kg
  • Post-op: continuous infusion with target plasma factor IX of 70 IU/dL-110 IU/dL; additional bolus infusions as needed

SUCCESSFUL SURGICAL PROCEDURES

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

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 post-surgery

In a clinical sub-study, 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

††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.

EXPLORE MORE ABOUT IXINITY

Reference: 1. IXINITY [coagulation factor IX (recombinant)] prescribing information. Chicago, IL: Medexus Pharma, Inc.; February 2021. 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. 2018;24:104-112. 3. Data on file. Chicago, IL: Medexus Pharma, Inc.