Fibrinogen is a prescription medicine indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including hypo- or afibrinogenemia, among other approved uses. MedsAcross supplies Fibrinogen 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.
FESILTY is indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including hypo- or afibrinogenemia. Limitations of Use: FESILTY is not indicated for dysfibrinogenemia. FESILTY is a human blood coagulation factor indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including hypo- or afibrinogenemia.
Source: US FDA prescribing information
Fibrinogen (Factor I) is a soluble plasma protein that, during the coagulation process, is converted to fibrin, one of the key components of the blood clot. Fibrinogen is a heterohexamer with a molecular weight of 340 kDa and composed of two sets of alpha, beta, and gamma polypeptide chains. Fibrinogen plays a fundamental role in achieving and maintaining overall hemostasis. Following coagulation activation and thrombin generation, fibrinogen is cleaved by thrombin at specific sites on the alpha and beta chains to remove fibrinopeptide A (FPA) and fibrinopeptide B (FPB). The removal of FPA and FPB exposes binding sites on the fibrinogen molecule and leads to the formation of fibrin monomers that subsequently undergo polymerization.
Source: US FDA prescribing information
Intravenous use after reconstitution only. Calculate the dose in mg fibrinogen per kg of BW for each patient individually. The target plasma fibrinogen level is 100 mg/dL for minor bleeding and 150 mg/dL for major bleeding. When plasma fibrinogen level is known: Patient Age Calculation for Recommended Dose (mg/kg BW) Adults and pediatric patients ≥ 6 years of age [Target fibrinogen level (mg/dL) – Measured fibrinogen level (mg/dL)] /1.8 (mg/dL per mg/kg BW) Pediatric patients < 6 years of age [Target fibrinogen level (mg/dL) – Measured fibrinogen level (mg/dL)] /1.6 (mg/dL per mg/kg BW) When plasma fibrinogen is not known: Dose: 70 mg/kg BW for patients of all ages Frequency and duration of dosing: Monitor fibrinogen levels. Individualize the frequency and duration of dosing based on the extent of bleeding, plasma fibrinogen level, and the clinical condition of the patient.
Source: US FDA prescribing information
FESILTY is contraindicated in patients who have severe hypersensitivity reactions, including anaphylaxis, to FESILTY or its components (arginine hydrochloride, polysorbate 80, sodium citrate dihydrate, trehalose dihydrate). Severe hypersensitivity reactions, including anaphylaxis, to FESILTY or its components (arginine hydrochloride, polysorbate 80, sodium citrate dihydrate, trehalose dihydrate)
Source: US FDA prescribing information
Hypersensitivity reactions have occurred in patients receiving FESILTY. Should symptoms occur, discontinue FESILTY and administer appropriate treatment. Thrombotic events have been reported in patients receiving FESILTY. Weigh the benefits of administration versus the risks of thrombosis. FESILTY is made from pooled human plasma and may carry the risk of transmitting infectious agents. All infections thought to be transmitted by FESILTY should be reported to Grifols at 1-800-520-2807,
Source: US FDA prescribing information
The most common adverse reactions (incidence > 2%) were pain in extremity, back pain, hypersensitivity reactions, pyrexia, thrombosis, fibrin D dimer increased, headache, and vomiting.
Source: US FDA prescribing information
Do not freeze. Store between 2 o C and 30 o C (36 o F and 86 o F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Fibrinogen, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Fesilty kit | Grifols | US FDA | Available on request |
| Fibryga kitIntravenous | Octapharma | US FDA | Available on request |
2 brand names across 1 markets.
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 2 presentations of Fibrinogen and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 2 brand names for Fibrinogen, including Fesilty, Fibryga.
No listed presentation of Fibrinogen is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Fibrinogen 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.