Molecule
Fibrinogen human is a human blood coagulation factor indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia, among other approved uses. MedsAcross supplies Fibrinogen human 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.
RIASTAP ®, Fibrinogen Concentrate (Human) is a human blood coagulation factor indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. RIASTAP is not indicated for dysfibrinogenemia. Limitation of Use RIASTAP is not indicated for dysfibrinogenemia.
Source: US FDA prescribing information
During the coagulation process, thrombin cleaves the Aα and Bβ chains releasing fibrinopeptides A and B (FPA and FPB, respectively). 2 FPA is separated rapidly and the remaining molecule is a soluble fibrin monomer (fibrin I). The slower removal of FPB results in formation of fibrin II that is capable of polymerization that occurs by aggregation of fibrin monomers. 2 The resulting fibrin is stabilized in the presence of calcium ions and by activated factor XIII, which acts as a transglutaminase. Factor XIIIa-induced cross-linking of fibrin polymers renders the fibrin clot more elastic and more resistant to fibrinolysis. 3 Cross-linked fibrin is the end result of the coagulation cascade, and provides tensile strength to a primary hemostatic platelet plug and structure to the vessel wall.
Source: US FDA prescribing information
For intravenous use only. Dose (mg/kg body weight) = [Target level (mg/dL) - measured level (mg/dL)] 1.7 (mg/dL per mg/kg body weight) Dose when fibrinogen level is unknown: 70 mg/kg body weight. Monitoring of patient's fibrinogen level is recommended during treatment. A target fibrinogen level of 100 mg/dL should be maintained until hemostasis is obtained. Injection rate should not exceed 5 mL per minute.
Source: US FDA prescribing information
RIASTAP is contraindicated in patients with known anaphylactic or severe systemic reactions to human plasma-derived products. Known anaphylactic or severe systemic reactions to human plasma-derived products
Source: US FDA prescribing information
Monitor patients for early signs of anaphylaxis or hypersensitivity reactions and if necessary, discontinue administration and institute appropriate treatment. Thrombotic events have been reported in patients receiving RIASTAP. Weigh the benefits of administration versus the risks of thrombosis. Because RIASTAP 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 serious adverse reactions reported in clinical studies or through postmarketing surveillance following RIASTAP treatment are thromboembolic episodes, including myocardial infarction, pulmonary embolism, deep vein thrombosis, arterial thrombosis, and allergic-anaphylactic reactions. The most common adverse reactions observed in more than one subject in clinical trials (frequency >1%) were fever and headache. The most serious adverse reactions observed are thrombotic episodes (pulmonary embolism, myocardial infarction, deep vein thrombosis) and anaphylactic reactions. The most common adverse reactions observed in clinical studies (frequency >1%) were fever and headache.
Source: US FDA prescribing information
When stored at temperatures of 2-8°C (36-46°F), RIASTAP is stable for the period indicated by the expiration date on the carton and vial label (up to 60 months). Do not freeze. Protect from light.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
4 presentations of Fibrinogen human, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| TISSEEL Fibrin Sealant kit | Baxter Healthcare | US FDA | Available on request |
| Fibryga 20 mg/mL powder for injectionIntravenous | Octapharma | US FDA | Available on request |
| RiaSTAP 1300 mg/50 mL powder for injectionIntravenous Cold chain | CSL Behring | US FDA | Available on request |
| Riastap 2600 mg/100 mL injectionSubcutaneous Cold chain | CSL Behring | US FDA | Available on request |
3 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 4 presentations of Fibrinogen human and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 4 brand names for Fibrinogen human, including Fibryga, RiaSTAP, Riastap, TISSEEL Fibrin Sealant.
At least one listed presentation of Fibrinogen human must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Fibrinogen human is classified under ATC code B02BB01 (Fibrinogen).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.