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 ≥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.