Data from FDA - Curated by Toby Galbraith - Last updated 19 April 2017
FDA (Food and Drug Administration, USA)
• Do not use in patients with known anaphylactic or severe systemic reactions to human plasma-derived products (4).
• 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).
• 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).
For intravenous use only.
• 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|
• 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|
• Pediatric: Shorter half-life and faster clearance compared to adults. Dose adjustment may be needed (8.4).
|Date First Approved||17-02-2011|
|Marketing authorisation holder||CSL Behring, GmbH|