Fibryga Dosage/Direction for Use

Treatment should be initiated under the supervision of a physician experienced in the treatment of coagulation disorders.
Posology: The dosage and duration of the substitution therapy depend 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.
1. Prophylaxis in patients with congenital hypo- or afibrinogenaemia and known bleeding tendency.
Adult and Adolescent (≥12 years old) Population: 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: (See Equation 1.)

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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.
FIBRYGA dose when baseline fibrinogen level is not known: If the patient's fibrinogen level is not known, the recommended dose is 60 mg/kg of body weight.
Paediatric population (<12 years old): In case of surgical procedure or treatment of a bleeding episode, the dose in adolescents should be calculated according to the formula previously described for adults, while the dose in children <12 years of age should be calculated as follows: (See Equation 2.)

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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.
2. Treatment of bleeding: Bleeding in patients with congenital hypo- or afibrinogenaemia: Bleeding episodes should be treated according to the formulas previously mentioned 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: 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 (<18 years old): The dosage should be determined according to the body weight and clinical need but is usually 20-30 mg/kg.
Method of administration: Intravenous infusion or injection.
FIBRYGA should be administered slowly intravenously at a recommended maximum rate of 5 mL per minute for patients with congenital hypo- or afibrinogenaemia and at a recommended maximum rate of 10 mL per minute for patients with acquired fibrinogen deficiency.
For instructions on reconstitution of the medicinal product before administration, see Special precautions for disposal and other handling under Cautions for Usage.