Data from FDA - Curated by Toby Galbraith - Last updated 19 April 2017

Licensing authority

FDA (Food and Drug Administration, USA)

Indication(s)

Corifact is a Factor XIII concentrate indicated for adult and pediatric patients with congenital Factor XIII deficiency for:
• Routine prophylactic treatment
• Peri-operative management of surgical bleeding (1).

Full Prescribing information

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Advisory information

contraindications

• Do not use in patients with known anaphylactic or severe systemic reactions to human plasma-derived products (4).

Special warnings and precautions

• Hypersensitivity reaction may occur (5.1).
• Inhibitory antibodies have been detected in patients receiving Corifact (5.2).
• Thrombotic events have been reported with Corifact (5.3).
• May carry a risk of transmitting infectious agents e.g., viruses, and theoretically, the Creutzfeldt-Jakob Disease (CJD) agent (5.4).

Adverse reactions

• The most common adverse reactions reported in clinical trials (>1%) were joint inflammation, hypersensitivity, rash, pruritus, erythema, hematoma, arthralgia, headache, elevated thrombin-antithrombin levels, and increased blood lactate dehydrogenase (6).
• Serious adverse reactions reported in clinical trials were hypersensitivity, acute ischemia, and neutralizing antibodies against FXIII (5.1, 6).

Usage information

Dosing and administration

For intravenous use only.
Dose (2.1)
• 40 International Units (IU) per kg body weight; rate not to exceed 4 mL per min.
• Adjust dose ±5 IU per kg to maintain 5% to 20% trough level of FXIII activity.

Dose Adjustment Using the Berichrom Activity Assay (2.1)

FXIII Activity Trough Level (%) Dosage Change
One trough level of <5% Increase by 5 IU per kg
Trough level of 5% to 20% No change
Two trough levels of >20% Decrease by 5 IU per kg
One trough level of >25% Decrease by 5 IU per kg

Administration (2.2)
• Administer at a rate not exceeding 4 mL per minute
• For routine prophylaxis, administer every 28 days
• For peri-operative management of surgical bleeding, individualize dose based on the patient’s FXIII activity level, type of surgery, and clinical response
• Following are dose adjustment examples for peri-operative management in reference to the patient’s last prophylactic dose:

Dose Adjustment for Peri-operative Management

Time Since Last Dose 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
Use in special populations
• Pregnancy: No human or animal data. Use only if clearly needed (8.1).
• Pediatric: Shorter half-life and faster clearance compared to adults. Dose adjustment may be needed (8.4).

More information

Category Value
Authorisation number BLA125385
Orphan designation No
Product NDC 63833-518
Date First Approved 17-02-2011
Marketing authorisation holder CSL Behring, GmbH