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IXINITY
Bleeding disorders
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Drug Name:

IXINITY Rx

Generic Name and Formulations:
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.

Company:
Aptevo Therapeutics

Therapeutic Use:

Indications for IXINITY:

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

Adult:

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. 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.

Children:

Not established.

Contraindications:

Hamster protein hypersensitivity.

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.

Pharmacological Class:

Clotting factor.

Adverse Reactions:

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

Generic Availability:

NO

How Supplied:

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

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