How Supplied / Storage

Fibryga is supplied in a single-use bottle1

The following nominal dosage form is available:
Carton NDC Number
Fibryga 1 g    68982-347-01

 

  • The actual potency of fibrinogen in mg is stated on each fibryga carton and bottle
  • Fibryga is supplied in a package with a single-dose bottle of powder together with an Octajet transfer device and a particle filter
  • Components used in the packaging of fibryga are not made with natural rubber latex

Storage and handling1

  • Store fibryga for up to 30 months at +2°C to + 25°C (36°F to 77°F)
    from the date of manufacture
  • Do not use fibryga beyond the expiration date printed on the carton and bottle
  • Do not freeze. Store in the original container to protect from light.
  • After reconstitution, do not refrigerate or freeze the fibryga solution. Use the reconstituted fibryga solution immediately or within 4 hours after reconstitution.
  • Dispose of any unused product or waste material in accordance with local requirements
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References:
  1. Fibryga full Prescribing Information. Hoboken, NJ: Octapharma USA, Inc.; rev 2017.
  2. Ross C, Rangarajan S, Karimi M, et al. Pharmacokinetics, clot strength and safety of a new fibrinogen concentrate: randomized comparison with active control in congenital fibrinogen deficiency. J Thromb Haemost. 2018;16:253-261.
  3. Lissitchkov T, Madan B, Djambas Khayat C, et al. Efficacy and safety of a new human fibrinogen concentrate in patients with congenital fibrinogen deficiency: an interim analysis of a Phase III trial. Transfusion. 2018;58:413-422.