• Bleeding disorders

Ixinity Generic Name & Formulations

General Description

Coagulation Factor IX (recombinant) 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU; per vial; lyophilized pwd for IV inj after reconstitution; preservative-free.

Pharmacological Class

Clotting factor.

How Supplied

Single-use vials—1 (w. diluent, supplies)


Generic Availability


Ixinity Indications


Prevention and control of bleeding in hemophilia B. Peri-operative management in patients with hemophilia B.

Ixinity Dosage and Administration

Adults and Children

<12yrs: not established. Dosage Required (IU) = Body Weight (kg) x Desired Factor IX increase (% of normal or IU/dL) x reciprocal of observed recovery (IU/kg per IU/dL). Give by IV infusion over ~5mins at a max rate of 10mL/min. ≥12yrs: Minor bleeds: 30–60% increase every 24hrs for 1–3 days until healing achieved. Moderate: 40–60% increase every 24hrs for 2–7 days until healing achieved. Major: 60–100% increase every 12–24hrs for 2–14 days until healing achieved. Peri-op: Minor surgery (pre-op): 50–80% increase; (post-op): 30–80% increase every 24hrs for 1–5 days. Major (pre-op): 60–80% increase; (post-op): 20–40% increase every 8–24hrs for 7–14 days, or 30–50% increase every 8–24hrs for 4–6 days, or 40–60% increase every 8–24hrs for 1–3 days.

Ixinity Contraindications


Hamster protein hypersensitivity.

Ixinity Boxed Warnings

Not Applicable

Ixinity Warnings/Precautions


Not for immune tolerance induction. Discontinue immediately if allergic or anaphylactic-type reactions occur. Monitor for Factor IX inhibitors; increased risk of anaphylaxis. Fibrinolysis, disseminated intravascular coagulation (DIC), liver disease, or during peri-op status; increased risk of thromboembolic events. Pregnancy. Nursing mothers.

Ixinity Pharmacokinetics

See Literature

Ixinity Interactions

Ixinity Adverse Reactions

Adverse Reactions

Headache, dysgeusia, lethargy, asthenia, inj site discomfort, influenza, apathy, depression, pruritic rash; hypersensitivity reactions, inhibitor development, nephrotic syndrome, thrombosis.

Ixinity Clinical Trials

See Literature

Ixinity Note

Not Applicable

Ixinity Patient Counseling

See Literature