#
Fibryga
  • Professionals
  • FDA PI

Fibryga

Generic name:fibrinogen (human)
Dosage form: injection
Drug class:Miscellaneous coagulation modifiers

Medically reviewed by Drugs.com. Last updated on Dec 1, 2020.

Indications and Usage for Fibryga

Fibryga is a human fibrinogen concentrate indicated for the treatment of acute bleeding episodes in adults and children with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

Fibryga is not indicated for dysfibrinogenemia.

Fibryga Dosage and Administration

For intravenous use only after reconstitution.

Dosage

Fibryga dosing, duration of dosing, and frequency of administration should be individualized based on the extent of bleeding, laboratory values, and the clinical condition of the patient.

The recommended target fibrinogen plasma level is 100 mg/dL for minor bleeding and 150 mg/dL for major bleeding.

Fibryga dose when baseline fibrinogen level is known

Dose should be individually calculated for each patient based on the target plasma fibrinogen level for the type of bleeding, actual measured plasma fibrinogen level and body weight , using the following age-specific formulas (see Pharmacokinetics [ 12.3 ] ):

Adults and adolescents 12 years of age and above:

Children 0 to <12 years of age:


Fibryga dose when baseline fibrinogen level is not known

If the patient’s fibrinogen level is not known, the recommended dose is 70 mg/kg of body weight administered intravenously.

Monitor the patient’s fibrinogen level during treatment with Fibryga.

Additional infusions of Fibryga should be administered if the plasma fibrinogen level is below the accepted lower limit (80 mg/dL for minor bleeding, 130 mg/dL for major bleeding) of the target level until...