Share this page
Dosing and Administration
)
Recommended dose and dosage adjustment
fibryga® dosing and treatment duration depends on the severity of the disorder, location and extent of bleeding, and the patient’s clinical condition.
The functional fibrinogen level should be determined in order to calculate individual dosage and the amount and frequency of administration should be determined on an individual patient basis by regular measurement of plasma fibrinogen level and continuous monitoring of the clinical condition of the patient and other replacement therapies used.
In case of major surgical intervention, precise monitoring of replacement therapy by coagulation assays is essential.
Prophylaxis
In patients with congenital hypo- or afibrinogenaemia and known bleeding tendency.
To prevent excessive bleeding during surgical procedures, prophylactic treatment is recommended to raise fibrinogen levels to 1 g/L and maintain fibrinogen at this level until haemostasis is secured and above 0.5 g/L until wound healing is complete.
In case of surgical procedure or treatment of a bleeding episode, the dose should be calculated as follows:
Subsequent posology (doses and frequency of injections) should be adapted based on the patient's clinical status and laboratory results.
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 a prophylactic use, the dose and the frequency should be determined according to the therapeutic goals of the physician for a given patient.
Paediatric population
In case of surgical procedure or treatment of a bleeding episode, the dose in adolescents should be calculated according to the formula described for adults above, while the dose in children <12 years of age should be calculated as follows:
Subsequent posology should be adapted based on the patient's clinical status and laboratory results.
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
Bleeding in patients with congenital hypo- or afibrinogenaemia
Bleeding episodes should be treated according to the formulas 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.
Bleeding in patients with acquired fibrinogen deficiency
Adults patients
Generally 1-2 g is administered initially with subsequent infusions as required. In case of severe haemorrhage e.g. major surgery, larger amounts (4-8 g) of fibrinogen may be required.
Paediatric population
The dosage should be determined according to the body weight and clinical need but is usually 20-30 mg/kg.
Administration
fibryga® should be administered intravenously.
Recommended infusion rate for patients with congenital hypo- or afibrinogenaemia: 5 mL per minute.
Recommended maximum infusion rate for patients with acquired fibrinogen deficiency: 10 mL per minute.
Reference
SPC
Clinical Guidelines
On Bleeding Management
