Fibryga Adverse Reactions

Summary of the safety profile: There are no robust data on the frequency of adverse reactions from clinical trials with this product.
In clinical studies, the following adverse reactions have been reported: pyrexia, drug eruption, phlebitis and thrombosis.
The following adverse reactions have been reported for FIBRYGA and other fibrinogen concentrates: (See Table 5.)

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For safety in respect to transmissible agents, see Precautions.
Paediatric population: 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.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.