Ixinity® is a purified protein analogous to the Thr148 allelic form of plasma-derived factor IX. It is secreted by a genetically engineered mammalian cell line derived from Chinese Hamster Ovary (CHO). All CHO proteins are removed during manufacturing, and no human or animal cells are added during any stage of the manufacturing process. Ixinity replaces factor IX, which is deficient in patients with hemophilia B, enabling a correction of coagulation deficits and a reversal of bleeding tendencies.¹

Ixinity is formulated as a sterile, lyophilized, white or almost-white powder. Each single-use glass vial contains 250, 500, 1000, 1500, 2000, or 3000 IU. The route of administration is intravenous.¹

Indications

Ixinity is indicated for the on-demand treatment and control of episodes of bleeding and the perioperative management of bleeding in adults and children 12 years of age or older with hemophilia B. It is also indicated for routine prophylaxis to reduce the frequency of episodes of bleeding in patients with hemophilia B. It is not indicated for the induction of immune tolerance in patients with hemophilia B.¹

Get full prescribing information for Ixinity at MPR

Efficacy

In 2 uncontrolled trials evaluating the efficacy of Ixinity, the patients who used Ixinity for prophylaxis had a mean annualized bleeding rate (ABR) of 3.55 and a mean spontaneous ABR of 1.07. Approximately 31% of patients had no episodes of bleeding while using Ixinity for prophylaxis. When Ixinity was used to control episodes of bleeding, 70.9% of the episodes resolved after a single infusion, and 13% resolved after 2 infusions. In 4.7% of bleeds, 5 or more transfusions were required to achieve control. When Ixinity was used for perioperative management, blood loss as assessed by the surgeon was rated as “expected” or “less than expected” in 100% of cases.¹

Dosage

Dosing for routine prophylaxis is 40 to 70 IU/kg twice weekly.¹ 

Dosing for on-demand treatment and the control of episodes of bleeding is as follows ¹:

• For minor bleeds: 30 to 60 IU/dL every 24 hours for 1 to 3 days until healing is achieved. Examples are early, uncomplicated hemarthrosis; superficial muscle (except iliopsoas) bleeds with no neurovascular compromise; and other soft tissue bleeds. 
• For moderate bleeds: 40 to 60 IU/dL every 24 hours for 2 to 7 days until healing is achieved. Examples are hemarthrosis of longer duration, recurrent hemarthrosis, mucus membrane bleeds, bleeds from deep lacerations, and hematuria. 
• For major or life-threatening bleeds: 60 to 100 IU/dL every 12 to 24 hours for 2 to 14 days until healing is achieved. Examples include iliopsoas bleeds; deep muscle bleeds with neurovascular injury and substantial blood loss; central nervous system, pharyngeal, retropharyngeal, and retroperitoneal bleeds.

Dosing for perioperative management is as follows¹:

• For minor surgery: 50 to 80 IU/dL preoperatively, then 30 to 80 IU/dL postoperatively every 24 hours for 1 to 5 days, depending on the type of procedure. 
• For major surgery: 60 to 80 IU/dL preoperatively, then 40 to 60 IU/dL every 8 to 24 hours for 1 to 3 days, or 30 to 50 IU/dL every 8 to 24 hours for 4 to 6 days, or 20 to 40 IU/dL every 8 to 24 hours for 7 to 14 days. 

Contraindications/Adverse Events

Ixinity is contraindicated for patients with a known hypersensitivity to Ixinity or its excipients. Hypersensitivity reactions including anaphylaxis, urticaria, angioedema, chest or throat tightness, hypotension, lethargy, nausea, vomiting, dysphagia, paresthesia, restlessness, wheezing, and dyspnea have occurred. Immediately discontinue and treat allergic reactions if these occur. ¹

Other rare adverse events include development of inhibitors, nephrotic syndrome, and thromboembolism. No data are available regarding the use of Ixinity in pregnant or lactating women. Safety and efficacy have also not been established in children younger than 12 years.¹ 

References 

1. IXINITY – package insert. Aptevo BioTherapeutics. Revised February 2021. Accessed December 31, 2021. 

Reviewed by Harshi Dhingra, MD, on 1/2/2022.

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Kyle Habet, MD

Kyle Habet, MD, is a physician at Belize International Institute of Neuroscience where he is a member of a multidisciplinary group of healthcare professionals involved in the care of patients with an array of neurological and psychiatric diseases. He is a published author, researcher and instructor of neuroscience and clinical medicine at Washington University of Health and Science.