What is the recommended administration protocol for fibrinogen (Fibrinogen) intravenous (IV) infusion?

Fibrinogen IV Infusion Administration Protocol

For fibrinogen IV infusion, administer an initial dose of 3-4 g or 50 mg/kg at a maximum rate of 20 mL per minute for acquired fibrinogen deficiency and 5 mL per minute for congenital fibrinogen deficiency. 1, 2

Preparation and Reconstitution

• Remove the flip cap from the fibrinogen concentrate bottle and diluent vial, disinfect the rubber stoppers with an alcohol swab and allow to dry 2
• Use the transfer device to connect the diluent vial first, then connect to the fibrinogen powder bottle (the diluent will flow automatically into the fibrinogen bottle) 2
• Gently swirl the bottle until the powder is fully dissolved (approximately 5 minutes); do not shake to avoid foam formation 2
• After reconstitution, the solution should be almost colorless and slightly opalescent; inspect for particulate matter and discoloration prior to administration 2
• Use the reconstituted solution immediately or within 4 hours after reconstitution; do not refrigerate or freeze after reconstitution 2

Administration Procedure

• Attach a syringe to the transfer device connector and draw the reconstituted solution 2
• Use aseptic technique when administering fibrinogen concentrate 2
• Do not administer fibrinogen in the same tubing or container as other medications 2
• Administer by slow intravenous injection at the appropriate rate based on the patient's condition 2
• For acquired fibrinogen deficiency (such as trauma or surgical bleeding): maximum rate of 20 mL per minute 2
• For congenital fibrinogen deficiency: maximum rate of 5 mL per minute 2

Dosing Guidelines

• For significant bleeding with plasma fibrinogen level <1 g/L: initial dose of 3-4 g or 50 mg/kg 1
• For surgical prophylaxis: 25-50 mg/kg 1
• Repeat doses should be guided by laboratory assessment of fibrinogen levels 1
• Target fibrinogen level should be maintained above 1.5-2.0 g/L for effective hemostasis 1, 3

Monitoring

• Monitor fibrinogen levels before and after administration to guide dosing 1, 3
• Laboratory assessment of fibrinogen concentration or viscoelastic monitoring of functional fibrinogen is recommended before additional fibrinogen concentrate administration 1
• Do not administer additional fibrinogen if plasma concentration is over 1.5 g/L or if there is no evidence of functional fibrinogen deficiency on viscoelastic point-of-care analysis 1

Special Considerations

• For management of symptomatic intracranial bleeding after alteplase administration: administer 10 units of cryoprecipitate infused over 10-30 minutes; give additional dose if fibrinogen level is <200 mg/dL 1
• No blood should enter the syringe during administration due to risk of fibrin clot formation 2
• There are no specific adverse events related to administration of fibrinogen in patients with hypofibrinogenemia, though allergic reactions and anaphylaxis are potential concerns as with any blood product 1

Documentation

• After infusion, remove the peel-off label containing the batch number from the fibrinogen bottle and place it in the log book for record keeping 2
• Document the dose administered, time of administration, and patient response 2