Molecule
Factor xiii concentrate is a prescription medicine indicated for routine prophylactic treatment and peri-operative management of surgical bleeding in adult and pediatric patients with congenital FXIII deficiency. It is available as kits. MedsAcross supplies Factor xiii concentrate for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
CORIFACT is a Factor XIII Concentrate indicated for routine prophylactic treatment and peri-operative management of surgical bleeding in adult and pediatric patients with congenital FXIII deficiency. 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.
Source: US FDA prescribing information
CORIFACT (FXIII) is an endogenous plasma glycoprotein consisting of two A-subunits and two B-subunits. FXIIIa promotes cross-linking of fibrin during coagulation and is essential to the physiological protection of the clot against fibrinolysis. FXIIIa is a transglutaminase enzyme that catalyzes the cross-linking of the fibrin α- and γ-chains for fibrin stabilization and renders the fibrin clot more elastic and resistant to fibrinolysis. 2,3 FXIIIa also cross-links α 2 -plasmin inhibitor to the α-chain of fibrin, resulting in protection of the fibrin clot from degradation by plasmin. Cross-linked fibrin is the end result of the coagulation cascade, and provides tensile strength to a primary hemostatic platelet plug. 3 The B-subunits in plasma have no enzymatic activity, and function as carrier molecules for the A-subunits.
Source: US FDA prescribing information
For intravenous use only. Dose 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. 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.
Source: US FDA prescribing information
CORIFACT is contraindicated in patients with known anaphylactic or severe systemic reactions to human plasma-derived products. Do not use in patients with known anaphylactic or severe systemic reactions to human plasma-derived products.
Source: US FDA prescribing information
Hypersensitivity reaction may occur. Inhibitory antibodies have been detected in patients receiving CORIFACT. Thrombotic events have been reported with CORIFACT. Because CORIFACT is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob Disease (CJD) agent.
Source: US FDA prescribing information
The most common adverse reactions reported in clinical trials (>1%) are joint inflammation, hypersensitivity, rash, pruritus, erythema, hematoma, arthralgia, headache, elevated thrombin-antithrombin levels, and increased blood lactate dehydrogenase. The serious adverse reactions, reported (frequency 0.5%), were hypersensitivity, acute ischemia, and neutralizing antibodies against FXIII. 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. Serious adverse reactions reported in clinical trials were hypersensitivity, acute ischemia, and neutralizing antibodies against FXIII.
Source: US FDA prescribing information
Do not freeze. Within the expiration date, CORIFACT may be stored at room temperature not to exceed 25°C (77°F) for up to 6 months. Do not return the product to the refrigerator after it is stored at room temperature. Clearly mark the beginning date of room temperature storage on the carton label. Do not use beyond the expiration date on the carton and vial labels, or end of the period for room temperature storage, whichever comes first. Keep in original carton to protect from light. Do not refrigerate or freeze the reconstituted solution.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Factor xiii concentrate, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Corifact kit Cold chain | CSL Behring | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | Not recorded | — |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 1 presentations of Factor xiii concentrate and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Factor xiii concentrate, including Corifact.
At least one listed presentation of Factor xiii concentrate must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.