factor XIII concentrate, human (Rx)

Brand and Other Names:Corifact
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Dosing & Uses

AdultPediatric

Dosing Form & Strengths

powder for reconstitution, injection

  • 1000-1600 units/single-use vial

Congenital Factor XIII Deficiency

Indicated for routine prophylaxis and perioperative management of surgical bleeding in adults and pediatric patients with congenital factor XIII (FXIII) deficiency

Routine prophylaxis

  • Initial dose: 40 units/kg IV; infuse at rate not to exceed 4 mL/min
  • Subsequent doses administered q28Day and are based on maintaining trough FXIII activity level at ~5-20% (use Berichrom activity assay)

Perioperative management of surgical bleeding

  • Dosing should be individualized based on the patient’s Factor XIII activity level and time elapsed since last prophylactic dose, type of surgery, and clinical response
  • Monitor Factor XIII activity levels during and after surgery

Dosage Modifications

Using Berichrom activity assay

  • 1 trough level <5%: Increase by 5 units/kg
  • Trough level 5-20%: No change
  • 2 trough levels >20%: Decrease by 5 units/kg
  • 1 trough level >25%: Decrease by 5 units/kg

Perioperative management

  • Dosing based on time since last dose
  • Within 7 days: Additional dose may not be needed
  • 8-21 days: Additional partial or full dose may be needed based on FXIII activity level
  • 21-28 days: Full prophylactic dose

Dosing Form & Strengths

powder for reconstitution, injection

  • 1000-1600 units/single-use vial

Congenital Factor XIII Deficiency

Indicated for routine prophylaxis and perioperative management of surgical bleeding in adults and pediatric patients with congenital factor XIII (FXIII) deficiency

Routine prophylaxis

  • Initial dose: 40 units/kg IV; infuse at rate not to exceed 4 mL/min
  • Subsequent doses administered q28Day and are based on maintaining trough FXIII activity level at ~5-20% (use Berichrom activity assay)

Perioperative management of surgical bleeding

  • Dosing should be individualized based on the patient’s Factor XIII activity level and time elapsed since last prophylactic dose, type of surgery, and clinical response
  • Monitor Factor XIII activity levels during and after surgery

Dosage Modifications

Using Berichrom activity assay

  • 1 trough level <5%: Increase by 5 units/kg
  • Trough level 5-20%: No change
  • 2 trough levels >20%: Decrease by 5 units/kg
  • 1 trough level >25%: Decrease by 5 units/kg

Perioperative management

  • Dosing based on time since last dose
  • Within 7 days: Additional dose may not be needed
  • 8-21 days: Additional partial or full dose may be needed based on FXIII activity level
  • 21-28 days: Full prophylactic dose
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Adverse Effects

>1%

Hypersensitivity reactions

Chills

Fever

Erythema

Arthralgia

Rash

Headache

Hematoma

Increases blood lactate dehydrogenase

Elevated thrombin-antithrombin levels

Increase in hepatic enzymes

Postmarketing Reports

Allergic/anaphylactic reaction (including cutaneous reactions, alteration in blood pressure, nausea, dyspnea, fever, and chills)

Pyrexia

Factor XIII neutralizing antibodies formation

Thrombosis

Embolism

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Warnings

Contraindications

Contraindicated in patients with known anaphylactic or severe systemic reactions to human plasma-derived products or to any components in the formulation

Cautions

For IV use only

Hypersensitivity

Development of inhibitory antibodies against factor XIII has been detected; monitor for signs and symptoms of inadequate response to treatment (ie, inadequate factor XIII levels, breakthrough bleeding)

Increased risk of thromboembolic complications; assess benefits and risks of therapy in patients with hypercoagulable conditions (eg, pregnancy)

Made from human blood and may carry a risk of transmitting infectious agents (eg, viruses, and theoretically Creutzfeldt-Jakob disease [CJD] agent)

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Pregnancy & Lactation

Pregnancy Category: C

Benefits and risks should be carefully assessed in pregnant women because of their hypercoagulable state and potential for increased risk of thromboembolic events

Lactation: Unknown if distributed in breast milk, caution advised

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Temporarily replaces missing clotting factor XIII which corrects and/or prevents bleeding

Factor XIII is a proenzyme activated by calcium ion, by thrombin cleavage of the A-subunit to become activated factor XIII (FXIIIa); promotes cross-linking of fibrin during coagulation and is essential to the physiological protection of the clot against fibrinolysis

Pharmacokinetics

Half-Life: 6.6 ± 2.29 days

Vd: 51.1 ± 12.61 mL/kg

Peak Plasma Time: 1.7 ± 1.44 hr

Clearance:  0.25 mL/hr/kg

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Administration

IV Preparation

IV infusion

Prior to reconstitution, allow Corifact and the supplied diluent to reach room temperature

Use the Mix2VialTM system as directed with provided diluent (ie, 20 mL of sterile water for injection)

Do not shake the vial to reconstitute – gently swirl until the powder is completely dissolved

IV Administration

Infuse through a separate infusion line; Y-site administration not advised

Infuse at a rate not to exceed 4 mL/min

Administer within 4 hr of reconstitution

Storage

Unreconstituted product

  • Store in a refrigerator at 2-8˚C (36-46˚F) – stable for up to 24 months within the expiration date
  • Can be stored at room temperature not to exceed 25˚C (77˚F) for up to 6 months within the expiration date; do not return product to refrigerator after stored at room temperature (clearly mark beginning date of room temperature storage)
  • Do not freeze
  • Protect from light

Reconstituted product

  • Contains no preservatives
  • Product must be used within 4 hr after reconstitution
  • Do not refrigerate or freeze the reconstituted solution
  • Discard partially used vials
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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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