FIBRYGA- fibrinogen (human) powder, for solution

Octapharma USA, Inc.

FIBRYGA is a human fibrinogen concentrate indicated for:

• fibrinogen supplementation in bleeding patients with acquired fibrinogen deficiency

• treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia ( 1 ).

• Limitation of Use:

• FIBRYGA is not indicated for dysfibrinogenemia ( 1 ).

Store FIBRYGA for up to 48 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.