0.98 recovery and peak factor levels for active patients.

0.98 IU/dL mean incremental recovery. Higher recovery may allow lower doses.1*

How recovery impacts infusion dose.

Dose (IU) = body weight x desired factor IX increase x (1/recovery)1

*The pharmacokinetics of IXINITY have been evaluated in 32 previously treated patients ≥12 years of age with severe to moderately severe hemophilia B.1

Description is not of an actual patient. Individual dose will vary. Patient who weighs 75 kg with a desired factor IX increase of 50% and a baseline factor level of <1%.

24-hour half-life helps active patients achieve peak factor levels when they need them.1

In a clinical trial, the mean terminal half-life of IXINITY® was 24 hours.1

Effective control and prevention of bleeding episodes.

Selected Important Safety Information
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.

71% of bleeds resolved with 1 IXINITY infusion.1

Patients rated bleed control as excellent or good in 84% of all bleeds treated.1

More details

A total of 508 bleeding episodes were treated with IXINITY, of which 286 bleeds were recorded for patients on the routine treatment regimen and 222 on the on-demand regimen.1

Excellent was defined as a dramatic response with abrupt pain relief and clear reduction in joint or hemorrhage site size, and good was defined as pain relief or reduction in hemorrhage site size that may have required an additional infusion for resolution.1

Clinically proven bleed control in major surgeries.

In a clinical trial of IXINITY used in major surgeries, including knee and elbow arthroplasties and arthroscopic synovectomies1:

  • In each case the performing surgeon characterized blood loss during the procedure as either "expected" or "less than expected" (no surgeons characterized the loss as "more than expected").
  • No patients treated with IXINITY required transfusions during surgery.
  • Hemostasis was rated as better than adequate or adequate at 12 and 24 hours post-surgery.

IXINITY clinical trial design.

The efficacy and safety of IXINITY was evaluated in a prospective, open-label, uncontrolled, multicenter trial1


  • A total of 77 male subjects were exposed to IXINITY for treatment of hemophilia B or for perioperative management.
  • Of the 77 subjects, 68 male previously treated patients (PTPs) between 7 and 64 years of age received IXINITY either as routine treatment or on-demand treatment.

More details

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

Of the 68 PTPs, subjects were primarily prescribed a routine treatment (n=58) or an on-demand regimen (n=9) and one subject was unassigned a regimen. Subjects were allowed to switch regimens during the course of the trial. As a result, 61 patients were treated with a routine treatment and 12 were treated with an on-demand regimen.1

Patients in the routine treatment group received an intravenous 55.0 ± 12.8 IU/kg dose of IXINITY twice weekly. Patients in the on-demand therapy group received doses of 60.0 ± 18.2 IU/kg for bleeding episodes. The mean number of exposure days (ED), was 138.2, with a median of 127.5, including 45 subjects with ≥100 ED and 55 subjects with ≥50 ED.1

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INDICATIONS AND IMPORTANT SAFETY INFORMATION

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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 control and prevention of bleeding episodes, and for perioperative management.

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, may occur following IXINITY administration. 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 may occur when using 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.

Medical Affairs e-mail: MedicalAffairs@apvo.com

To report an adverse event, please call 1-844-859-6675.

Reference: 1. IXINITY [coagulation factor IX (recombinant)] prescribing information. Berwyn, PA: Aptevo BioTherapeutics LLC; April 2018.