Dosing & Uses
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
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
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)
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.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
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
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