Studied for safety. No factor IX inhibitors developed.1

In clinical trials*:

  • No subjects developed inhibitors to factor IX, including 55 patients with more than 50 exposure days and 45 patients with more than 100 exposure days to IXINITY®.1
    • Patients should be monitored for the development of inhibitors if expected factor IX activity plasma levels are not attained, or if bleeding is not controlled with the recommended dose of IXINITY.1
  • No anaphylactic reactions were reported in patients receiving IXINITY.1
    • Hypersensitivity reactions, including anaphylaxis, have been reported with factor IX-containing products. IXINITY is contraindicated in patients who have known hypersensitivity to IXINITY or its excipients, including hamster protein.1
  • No drug–drug, drug–food, or other interactions with factor IX products are known.1

The most common adverse reaction in patients using IXINITY was headache—observed in 2.6% of subjects in a clinical trial.1†

  • 8% (6/77) of patients reported a total of 14 adverse reactions. These were reported as probably or possibly drug-related.1

IXINITY is a third-generation recombinant treatment.1

Third-generation product is defined as2:

  • Recombinant factor IX (rFIX) produced in Chinese hamster ovary cells
  • No human or animal plasma-derived proteins are used in the manufacturing process

The IXINITY manufacturing process is designed for product purity and safety.

  • No additional human or animal proteins are added during manufacturing1
  • Employs a validated 3-step viral inactivation & removal process1
    • Solvent/detergent treatment
    • Chromatographic step
    • Nanofiltration
  • Utilizes a validated step to reduce the presence of CHO proteins1

Additional warnings and precautions.

Thromboembolism may occur when using 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.

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 exposures 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

Explore more about IXINITY

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.

*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%.

References: 1. IXINITY [coagulation factor IX (recombinant)] prescribing information. Berwyn, PA: Aptevo BioTherapeutics LLC; April 2018. 2. National Hemophilia Foundation Medical and Scientific Advisory Council (MASAC). MASAC recommendations concerning products licensed for the treatment of hemophilia and other bleeding disorders. MASAC Document #230. September 2014.