FIBRYGA Powder and solvent for solution for injection/infusion Ref.[27529] Active ingredients: Human fibrinogen

Traceability

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

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

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 Level

This medicinal product contains up to 132 mg sodium per bottle, equivalent to 6.6% of the 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

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. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.

The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV, and for the non-enveloped virus HAV. The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19. Parvovirus B19 infection may be serious for pregnant women (fetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g. haemolytic anaemia).

Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of human plasma-derived products.

Immunogenicity

In the case of replacement therapy with coagulation factors in other congenital deficiencies, antibody reactions have been observed, but there is currently no data with fibrinogen concentrate.

No interactions of human fibrinogen products with other medicinal products are known.

Pregnancy

The safety of FIBRYGA for use in human pregnancy has not been established in controlled clinical trials. Clinical experience with fibrinogen products in the treatment of obstetric complications suggests that no harmful effects on the course of the pregnancy or health of the fetus or the neonate are to be expected. Animal reproduction studies have not been conducted with FIBRYGA (see section 5.3). Since the active substance is of human origin, it is catabolized in the same manner as the patient’s own protein. These physiological constituents of the human blood are not expected to induce adverse effects on reproduction or on the fetus.

The benefit of FIBRYGA during pregnancy must be evaluated taking into consideration that clinical experience with fibrinogen concentrates is available but data from controlled clinical trials are missing.

Lactation

It is unknown whether FIBRYGA is excreted in human milk. However, because of the nature of the substance, no effects on the breastfed newborn/infant are anticipated.

Thus, a decision must be made whether FIBRYGA therapy is indicated during breast-feeding taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Fertility

There are no data on fertility available.

FIBRYGA has no influence on the ability to drive and use machines.

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: mild pyrexia, reported from one patient, and drug eruption, in form of mild skin reaction of itchiness and redness after product administration, also reported from one patient.

The following adverse reactions have been reported for FIBRYGA and other fibrinogen concentrates:

^* Frequency unknown as it could not be calculated from the available data. Mild pyrexia and skin reaction were single occurrences during clinical studies. Allergic or anaphylactic-type reactions, thromboembolic episodes (including myocardial infarction and pulmonary embolism) and thrombophlebitis are class effects.

For safety in respect to transmissible agents, see section 4.4.

Paediatric population

Eight patients, 12 to 18 years of age, were included in the congenital fibrinogen deficiency safety analysis.

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

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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

This medicinal product must not be mixed with other medicinal products.