Ixinity Generic Name & Formulations
Legal Class
Rx
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)
Manufacturer
Generic Availability
NO
Ixinity Indications
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
Contraindications
Hamster protein hypersensitivity.
Ixinity Boxed Warnings
Not Applicable
Ixinity Warnings/Precautions
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
Not Applicable
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