- Routine prophylactic treatment
- Peri-operative management of surgical bleeding
Corifact®
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Product Information
CORIFACT is a Factor XIII concentrate indicated for adult and pediatric patients with congenital Factor XIII deficiency for:
Do not use in patients with known anaphylactic or severe systemic reactions to human plasma-derived products.
- 40 International Units (IU) per kg body weight.
- Adjust dose ±5 IU per kg to maintain 5% to 20% trough level of FXIII activity.
- For routine prophylaxis, administer every 28 days
| 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 | |
- 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
| 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 |
- For intravenous use only
- Administer at a rate not exceeding 4 mL per minute
- Each vial contains 1000-1600 units of lyophilized powder for reconstitution. The actual FXIII potency for each lot is printed on the vial label and carton.
- The potency expressed in International Units is determined using the Berichrom activity assay, referenced to the current International Standard for Blood Coagulation Factor XIII, Plasma
