Dosage and Administration

Convenience in clinical practice

  • Rapid reconstitution1
  • Accurate and consistent dosing1
  • Low infusion volume (50 mL)1
  • Storage at +2°C to +25°C for up to 30 months1
  • Use the reconstituted fibryga solution immediately or within 4 hours after reconstitution1
  • Convenient transfer device with protective vacuum seal (Octajet)1

Dosage forms and strengths1

  • Fibryga is a sterile, lyophilized powder for reconstitution for intravenous injection provided in single-use bottles containing approximately 1g fibrinogen concentrate with 50 mL of sterile Water for Injection
  • Do not use fibryga beyond the expiration date. Fibryga contains no preservatives
  • Use aseptic technique when preparing and reconstituting fibryga

Recommended dosing1

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.  Functional fibrinogen level should be determined to calculate dosage.

Recommended target fibrinogen plasma level:

  • 100 mg/dL for minor bleeding
  • 150 mg/dL for major bleeding
Fibryga dose when baseline fibrinogen level is known Fibryga dose when baseline fibrinogen level is not 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 formula

Dose
(mg/kg/body weight)

=

[Target level (mg/dL) − measured level (mg/dL)]


1.8 (mg/dL per mg/kg body weight)

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

Administration1

For intravenous use only after reconstitution

  • Do not administer fibryga in the same tubing or container as other medications
  • Use aseptic technique when administering fibryga
  • Administer fibryga at room temperature by slow intravenous injection at a rate not exceeding 5 mL per minute

Monitoring1

  • 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 of the target level until hemostasis is achieved
    • 80 mg/dL for minor bleeding
    • 130 mg/dL for major bleeding
References:
  1. Fibryga full Prescribing Information. Hoboken, NJ: Octapharma USA, Inc.; rev 2017.