Overall safety profile of fibryga®

Adverse reactions:
There are no robust data on the frequency of adverse reactions from clinical trials with fibryga®. In clinical studies, the following adverse reactions have been reported: pyrexia, drug eruption, phlebitis and thrombosis.¹

Adverse reactions reported for fibryga® and other fibrinogen concentrates¹

Paediatric population:¹

Twenty-six patients, 1 to <18 years of age, were included in the congenital fibrinogen deficiency safety analysis, of which 12 adolescents 12 to <18 years of age, 8 children 6 to <12 years of age and 6 children 1 to <6 years of age.

The overall safety profile does not differ between adults, adolescents and children.

There are no data on use of fibryga® in paediatric patients with acquired fibrinogen deficiency.

Contraindications:¹

• Hypersensitivity to the active substance or to any of the excipients listed in the fibryga® Summary of Product Characteristics

Special warnings and precautions for use

Traceability:¹

• In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded

 Thromboembolism:¹

• There is a risk of thrombosis when patients, with either congenital or acquired deficiency, are treated with human fibrinogen particularly with high dose or repeated dosing. Patients given human fibrinogen should be observed closely for signs or symptoms of thrombosis

• In patients with a history of coronary heart disease or myocardial infarction, in patients with liver disease, in peri- or post-operative patients, in neonates, or in patients at risk of thromboembolic events or disseminated intravascular coagulation, the potential benefit of treatment with human plasma fibrinogen should be weighed against the risk of thromboembolic complications. Caution and close monitoring should also be performed

• Acquired hypofibrinogenaemia is associated with low plasma concentrations of all coagulation factors (not only fibrinogen) and inhibitors and so treatment with blood products containing coagulation factors should be considered. Careful monitoring of the coagulation system is necessary

 Allergic or anaphylactic-type reactions:¹

• If allergic or anaphylactic-type reactions occur, the injection/infusion should be stopped immediately. In case of anaphylactic shock, standard medical treatment for shock should be implemented

 Sodium content:¹

• This medicinal product contains up to 132 mg sodium per bottle, equivalent to 6.6% of the World Health Organisation (WHO) recommended maximum daily intake of 2 g sodium for an adult

• To be taken into consideration by patients on a controlled sodium diet

 Virus safety:¹

• Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation / removal of viruses

UK-FIB-2500024 | May 2026

Abbreviations
AFD, acquired fibrinogen deficiency; CFD, congenital fibrinogen deficiency; WHO, World Health Organisation.

References

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