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
- Fibryga full Prescribing Information. Hoboken, NJ: Octapharma USA, Inc.; rev 2017.
- 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.
- 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.