human fibrinogen: clinical use

Prescribing considerations

• Confirm that the product’s licence covers the clinical context; acquired hypofibrinogenaemia during surgical haemorrhage is included only in the selected FIBRYGA licence.
• Treatment should be supervised by a clinician experienced in coagulation disorders and guided by functional fibrinogen, clinical haemostasis and the wider coagulation defect.
• Record the product and batch number. Consider hepatitis A and B vaccination for regular or repeated recipients of plasma-derived products.
• Account for product-specific sodium content when clinically relevant.

Contraindications and cautions

• Hypersensitivity to human fibrinogen or any product-specific excipient.
• Carefully balance benefit and thrombosis risk in coronary disease, previous myocardial infarction, liver disease, disseminated intravascular coagulation, neonates, peri-operative patients and others predisposed to thrombosis.

Monitoring

• Functional plasma fibrinogen before and after treatment as clinically appropriate.
• Clinical bleeding, haemostasis and other coagulation abnormalities, particularly during major surgery or acquired deficiency.
• Signs of thrombosis and allergic or anaphylactic reactions.
• Product name and batch number for biological traceability.

Clinical pharmacology

Human fibrinogen is immediately available after intravenous administration and behaves like endogenous factor I. Thrombin, activated factor XIII and calcium convert it into a stable fibrin clot. Consumption and paediatric pharmacokinetics can alter recovery and persistence.

Formulation and product differences

• FIBRYGA and FibCLOT packs include water for injections; Riastap requires separately supplied water for injections.
• Riastap contains human albumin as an excipient; FIBRYGA and FibCLOT do not.
• Sodium content, reconstituted concentration, transfer equipment and permitted handling after reconstitution differ.
• Licences differ: Riastap covers congenital bleeding, FibCLOT adds peri-operative prophylaxis, and FIBRYGA additionally covers acquired hypofibrinogenaemia during severe surgical haemorrhage.

Injection

Route: Parenteral

Strengths: 1 g, 1.5 g