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CORIFACT
Bleeding disorders
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Drug Name:

CORIFACT Rx

Generic Name and Formulations:
Factor XIII concentrate (human); 1000–1600 units; per vial; powder for IV injection after reconstitution; preservative-free.

Company:
CSL Behring, LLC

Therapeutic Use:

Indications for CORIFACT:

Routine prophylactic treatment and peri-operative management of surgical bleeding in patients with congenital Factor XIII (FXIII) deficiency.

Adults and Children:

Give by slow IV injection at a rate of ≤4mL/min. Initially 40units/kg. Adjust ±5units/kg to maintain 5–20% trough FXIII activity levels using Berichrom Activity Assay: One trough level of <5%: increase by 5units/kg; trough level of 5–20%: no change; two trough levels of >20%: decrease by 5units/kg; one trough level of >25%: decrease by 5units/kg. Routine prophylaxis: give every 28 days. Peri-operative management: individualized based on patient's FXIII activity level, surgery type, and clinical response; dose adjustment: see full labeling.

Warnings/Precautions:

Contains human plasma; monitor for possible infection transmission. Long-term therapy: consider appropriate vaccination (hepatitis A and B virus). Monitor FXIII activity levels during and after surgery. Monitor for development of inhibitory antibodies, thromboembolic events. Pregnancy (Cat. C). Nursing mothers.

Pharmacological Class:

Clotting factor.

Adverse Reactions:

Joint inflammation, hypersensitivity, rash, pruritus, erythema, hematoma, arthralgia, headache, elevated thrombin-antithrombin levels, increased blood lactate dehydrogenase; acute ischemia, neutralizing antibodies.

Generic Availability:

NO

How Supplied:

Single-use vial—1

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