Dosing & Administration

This page is intended for healthcare professionals based in the United Kingdom only. If you are a member of the public, please click here.
Click here for Prescribing Information and Adverse Event Reporting statement.

Homepage
Dosing & Administration

Optimal dosing and administration of fibryga®

Two HPCs in white coats discuss medications, examining prescription of fibryga against a blurred background.

Fibryga® recommended dosing

As recommended by guidelines, fibrinogen replacement therapy should be guided by point-of-care and/or laboratory assays.1-7 This will ensure a targeted replacement treatment plan individualised to your patient.

Fibryga® is a human fibrinogen concentrate supplied as a 1g lyophilised powder with 50mL water for injection (WFI) for reconstitution into a 20 mg/mL solution for intravenous infusion.8 Please click on the link at the top of this page to consult the Summary of Product Characteristics (SmPC) before prescribing.

Congenital Fibrinogen Deficiency

Prophylaxis in patients with congenital hypo- or afibrinogenaemia and known bleeding tendency9

Adults and adolescents
As per British Committee for Standards in Haematology (BCSH) guidelines, prophylactic treatment with fibrinogen concentrate is recommended to prevent excessive bleeding during surgical procedures, maintaining fibrinogen levels to 1 g/L.8,9

When using fibryga®, 1 g/L fibrinogen levels should be maintained until haemostasis is achieved and above 0.5 g/L until wound healing is complete.8

Treatment dose for an individual adult and adolescent patient can be calculated as follows:8

Dose (mg/kg body weight) = [target level (g/L – measured level (g/L)] 0.018 (g/L per mg/kg body weight)
Dose (mg/kg body weight) = [target level (g/L – measured level (g/L)] 0.018 (g/L per mg/kg body weight)

In fibryga® clinical trials of adolescent and adult patients with congenital fibrinogen deficiency, the mean (SD) treatment doses were 76.88 (0.60) mg/kg (FORMA-01)10 and 65.51 (26.47) mg/kg (FORMA-02).11

The biological half-life of fibrinogen is 3–4 days. Thus, in the absence of consumption, repeated treatment with human fibrinogen is not usually required. Given the accumulation that occurs in case of repeated administration for prophylactic use, the dose and the frequency should be determined according to your patient-specific therapeutic goals.8

Paediatric population
In case of surgical procedure or treatment of a bleeding episode, the dose of fibryga® in children <12 years of age should be calculated as follows:8

Dose (mg/kg body weight) = [target level (g/L – measured level (g/L)] 0.014 (g/L per mg/kg body weight)
Dose (mg/kg body weight) = [target level (g/L – measured level (g/L)] 0.014 (g/L per mg/kg body weight)

Clinical trial data for the use of fibryga® in paediatric patients with congenital fibrinogen deficiency reported a median (range) treatment dose per bleeding episode of 73.91 (47.75–262.50) mg/kg (FORMA-04).12

Elderly patients
Clinical studies of fibryga® did not include patients aged 65 years and over to provide conclusive evidence as to whether or not they respond differently than younger patients.

Treatment of bleeding in patients with congenital hypo- or afibrinogenaemia
Bleeding episodes should be treated according to the formulae above for adults/adolescents and children, respectively, to achieve a recommended target fibrinogen plasma level of 1 g/L. This level should be maintained until haemostasis is secured.8

Acquired Fibrinogen Deficiency

Treatment of bleeding
UK and European guidelines for the management of major haemorrhage recommend fibrinogen replacement therapy when fibrinogen levels fall to <1.5 g/L (or <2.0 g/L in obstetric haemorrhage).1-5 Point of care testing is used to determine individualised doses for goal-directed coagulation therapy.1-7

Adult patients
When using fibryga®, generally 1–2g is administered initially with subsequent infusions as required. In case of severe haemorrhage (e.g. major surgery), larger amounts (4–8g) of fibrinogen may be required.8

Paediatric population
The dosage of fibryga® should be determined according to body weight and clinical need but is usually 20–30 mg/kg.8

Fibryga® reconstitution steps

Fibryga® is reconstituted in approximately 5 minutes and is supplied with the Nextaro® transfer device (with integrated filters) and 50mL WFI.8 To reconstitute ready for infusion/injection, you will also need alcohol swabs and a 50mL syringe.

Watch the video for step-by-step instructions on reconstituting fibryga® using the Nextaro® transfer device.

Electronic and print materials to support the reconstitution process for fibryga® are also available on request via our Contact Us page.

Fibryga® administration and special precautions overview8

Fibryga® can be administered by or . intravenous infusioninjection Fibryga® should be administered slowly intravenously In patients with , the recommended maximum rate of administration is 5 mL per minute CFD (congenital hypo- or afibrinogenaemia) In patients with , the recommended maximum rate of administration is 10 mL per minute AFD The fibryga® reconstituted solution should be and slightly opalescent. Do not use solutions that are cloudy or have deposits. almost colourless Fibryga® is for. Do not re-use any of the components. single use only For microbiological safety, the solution should be administered . However, should clinical need change, fibryga® can be kept at room temperature for 24h post-reconstitution. immediately after reconstitution The of the reconstituted solution has been demonstrated for 24 hours at room temperature (max. 25° C) chemical and physical in-use stability After reconstitution, the fibryga® solution. do not refrigerate or freeze
Fibryga® can be administered by or . intravenous infusioninjection Fibryga® should be administered slowly intravenously In patients with , the recommended maximum rate of administration is 5 mL per minute CFD (congenital hypo- or afibrinogenaemia) In patients with , the recommended maximum rate of administration is 10 mL per minute AFD The fibryga® reconstituted solution should be and slightly opalescent. Do not use solutions that are cloudy or have deposits. almost colourless Fibryga® is for. Do not re-use any of the components. single use only For microbiological safety, the solution should be administered . However, should clinical need change, fibryga® can be kept at room temperature for 24h post-reconstitution. immediately after reconstitution The of the reconstituted solution has been demonstrated for 24 hours at room temperature (max. 25° C) chemical and physical in-use stability After reconstitution, the fibryga® solution. do not refrigerate or freeze

Wish to arrange a demonstration on how to reconstitute fibryga® for you, and your team?

Contact us today to set this up.
Contact us

UK-FIB-2500025 | May 2026

Abbreviations
AFD, acquired fibrinogen deficiency; BCSH, British Committee for Standards in Haematology; CFD, congenital fibrinogen deficiency; SD, standard deviation; SmPC, Summary of Product Characteristics; WFI, water for injection.

References

  1. Shah A, et al. Association of Anaesthetists guidelines: the use of blood components and their alternatives. Anaesthesia. 2025;80:425–47.

  2. Stanworth SJ, et al. Transfusion Task Force of the British Society for Haematology. Haematological management of major haemorrhage: a British Society for Haematology Guideline. Br J Haematol. 2022;198:654–67.

  3. Kietaibl S, et al. Management of severe peri-operative bleeding: guidelines from the European Society of Anaesthesiology and Intensive Care. Eur J Anaesthesiol. 2023;40:226–304.

  4. Casselman FPA, et al. 2024 EACTS/EACTAIC Guidelines on patient blood management in adult cardiac surgery in collaboration with EBCP. Eur J Cardiothorac Surg. 2025;67(5):ezae352.

  5. Rossaint R, et al. The European guideline on management of major bleeding and coagulopathy following trauma: sixth edition. Crit Care. 2023;27:80.

  6. Curry NS, et al. The use of viscoelastic haemostatic assays in the management of major bleeding: a British Society for Haematology Guideline. Br J Haematol. 2018;182:789–806

  7. Green L, et al. British Society of Haematology Guidelines on the spectrum of fresh frozen plasma and cryoprecipitate products: their handling and use in various patient groups in the absence of major bleeding. Br J Haematol. 2018;181:54–67.

  8. Fibryga® Summary of Product Characteristics (updated 13 Feb 2025). Available at: https://www.medicines.org.uk/emc/product/10315/smpc. Accessed May 2026.

  9. Mumford AD, et al. Guideline for the diagnosis and management of the rare coagulation disorders: a United Kingdom Haemophilia Centre Doctors' Organization guideline on behalf of the British Committee for Standards in Haematology. Br J Haematol. 2014;167:304–26.

  10. Ross C, et al. Pharmacokinetics, clot strength and safety of a new fibrinogen concentrate: randomized comparison with active control in congenital fibrinogen deficiency. J Thromb Haemost. 2018;16:253–61.

  11. Lissitchkov T, et al. Fibrinogen concentrate for treatment of bleeding and surgical prophylaxis in congenital fibrinogen deficiency patients. J Thromb Haemost. 2020;18:815–24.

  12. Djambas Khayat C, et al. Efficacy and safety of fibrinogen concentrate for on-demand treatment of bleeding and surgical prophylaxis in paediatric patients with congenital fibrinogen deficiency. Haemophilia. 2021;27:283–92.

Contact

Legal Statement

Data Privacy Statement

© 2026 Octapharma AG | UK-FIB-2600014 | May 2026