Fibryga
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Fibryga
Quick facts
- Dosing:
4g
- Administration:
Intravenous, maximum rate of 20 mL per minute.
- Storage:
+2°C to +25°C for up to 48 months from the date of manufacture
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Indications
Indications
- 1
Treatment of acute bleeding episodes and perioperative prophylaxis in adult and pediatric patients with congenital afibrinogenemia and hypofibrinogenemia.
- 2
Complementary therapy during the management of uncontrolled severe bleeding in patients with acquired fibrinogen deficiency in the course of surgical interventions.
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Contraindications
Contraindications
- 1
Contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
- 2
Contraindicated in individuals who have manifested severe immediate hypersensitivity reactions, including anaphylaxis to FIBRYGA® or its components.
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Dosing
Dosing for Acquired Fibrinogen Deficiency
- 1
Recommended initial dose for patients with uncontrolled severe bleeding in the course of surgical interventions is 4 g.
- 2
Additional doses of 4 g are to be administered as needed to bleeding patients when fibrinogen plasma level is ≤200 mg/dL or FIBTEM A20 is ≤12 mm (or equivalent values generated by other thromboelastometry/thrombelastography methods).
Dosing for Congenital Afibrinogenemia and Hypofibrinogenemia
Baseline fibrinogen is known (12+)
= (target level – measured level)/ 1.8Baseline fibrinogen is known (<12)
= (target level – measured level)/ 1.4Baseline fibrinogen not known
60 mg/ kg of body weight
Baseline fibrinogen is known (12+)
Dose
Baseline fibrinogen is known (<12)
Dose
Baseline fibrinogen not known
Dose
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Preparation and handling
For Blood Bank
- 1
Do not freeze. Protect from exposure to light. Keep in a safe place out of the reach and sight of children.
- 2
Fibryga® can be stored at +2°C to +25°C for up to 48 months from the date of manufacture.
- 3
Do not use product after expiry date.
- 4
Stability of the reconstituted solution has been demonstrated for up to 24 hours at +25°C.
For Clinicians
- 1
Prior to use, allow Fibryga® to reach ambient room temperature.
- 2
Inspect the solution visually for particulate matter and discoloration prior to administration.
- 3
Do not use non-homogenous solutions, or those that have a deposit.
- 4
Fibryga ® should not be mixed with other medicinal products.
- 5
A separate intravenous line should be used for injection.
- 6
Do not use the product after expiry date
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Safety
Safety measures
- 1
Risk of infectious agents with products made from human plasma.
- 2
Risk of allergic reaction.
- 3
Patients should be monitored for risk of thrombosis.
- 4
Safety has not been established for use in human pregnancy.
- 5
Benefits and risks to pregnant women should be carefully weighed.
- 6
Safety has not been established for use in nursing women. Should be given with caution.
- 7
Determination of the patient’s fibrinogen level using an appropriate method (e.g., Clauss fibrinogen assay) is recommended before and during the treatment to avoid overdosing or underdosing.
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