Fibryga Dosage

Dosage

Acquired Fibrinogen Deficiency:

The recommended dose is as follows:

• For adults: 4g
• For adolescents age ≥ 12 years: 50 mg/kg body weight
• For children age <12 years: 70 mg/kg body weight

Administer additional doses of 4 g in adults, 50 mg/kg body weight in adolescents 12 years of age and above, and 70 mg/kg body weight in children <12 years of age as needed to bleeding patients when plasma fibrinogen level is ≤200 mg/dL or thromboelastometry FIBTEM A10 is ≤10 mm (or equivalent values generated by other viscoelastic testing methods). Dosing may be adjusted depending on plasma fibrinogen levels or viscoelastic testing, severity of bleeding, body weight, or patient’s clinical condition.

Monitor the patient’s plasma fibrinogen level or the viscoelastic properties of the fibrin-based clot during treatment with FIBRYGA.

Congenital Fibrinogen Deficiency:

FIBRYGA dosing, duration of dosing, and frequency of administration should be individualized based on the extent of bleeding, laboratory values, and the clinical condition of the patient.

The recommended target plasma fibrinogen level is 100 mg/dL for minor bleeding and 150 mg/dL for major bleeding.

FIBRYGA dose when baseline fibrinogen level is known

Dose should be individually calculated for each patient based on the target plasma fibrinogen level for the type of bleeding, actual measured plasma fibrinogen level and body weight , using the following age-specific formulas :

Adults and adolescents 12 years of age and above:

Children <12 years of age:

FIBRYGA dose when baseline fibrinogen level is not known

If the patient’s fibrinogen level is not known, the recommended dose is 70 mg/kg of body weight administered intravenously.

Monitor the patient’s fibrinogen level during treatment with FIBRYGA.

Additional infusions of FIBRYGA should be administered if the plasma fibrinogen level is below the accepted lower limit (80 mg/dL for minor bleeding, 130 mg/dL for major bleeding) of the target level until hemostasis is achieved.

Preparation and Handling

FIBRYGA package contains:

• 1 single-dose bottle of FIBRYGA concentrate
• 1 vial of diluent (sterile Water for Injection)
• 1 transfer device (Nextaro ® )

Reconstitute FIBRYGA with diluent (sterile Water for Injection).

Do not use FIBRYGA beyond the expiration date. FIBRYGA contains no preservatives. Use aseptic technique when preparing and reconstituting FIBRYGA.

The procedures below are provided as general guidelines for preparation and reconstitution of FIBRYGA.

Reconstitute FIBRYGA as follows:

	1. Warm both the powder and sterile Water for Injection (sWFI) in their closed bottles to room temperature. This temperature should be maintained during reconstitution. If a water bath is used for warming, prevent water from coming into contact with the rubber stoppers or the caps of the bottles. The temperature of the water bath should not exceed +37°C (98°F). 2. Remove the flip cap from the FIBRYGA bottle and the sWFI vial and disinfect the rubber stoppers with an alcohol swab and allow to dry. 3. Open the Nextaro ® transfer device package by peeling off the lid (Fig. 1). To maintain sterility, do not remove the Nextaro ® transfer device from the blister package. Do not touch the spike.
	4. Place the diluent vial on an even, clean surface and hold it firmly. Without removing the blister package, place the blue part of the transfer device on top of the diluent vial. Press straight and firmly down until it snaps into place (Fig. 2). Do not twist while attaching. Note: The transfer device must be attached to the diluent vial first and then to the lyophilized powder bottle. Otherwise, loss of vacuum occurs, and transfer of the diluent does not take place. If diluent is not completely transferred to the lyophilized powder bottle during this process, contact your Octapharma representative.
	5. While holding onto the diluent vial, carefully remove the blister package from the Nextaro ® transfer device by pulling vertically upwards. Make sure to leave the transfer device attached firmly to the diluent vial (Fig. 3).
	6. Place the FIBRYGA bottle on an even, clean surface and hold it firmly. Take the diluent vial with the attached transfer device and turn it upside down. Place the white part of the transfer device connector on top of the FIBRYGA bottle and press firmly down until it snaps into place (Fig. 4). Do not twist while attaching. The diluent will flow automatically into the FIBRYGA bottle.
	7. With the diluent vial still attached, gently swirl the FIBRYGA bottle until the powder is fully dissolved. To avoid foam formation, do not shake the bottle. The powder should be dissolved completely within approx. 5 minutes. Unscrew the Nextaro ® transfer device (blue part) counterclockwise into two parts (Fig. 5). Do not touch the Luer lock connector on the white part of the transfer device. 8. Dispose of the empty diluent vial together with the blue part of the transfer device.

• After reconstitution, the FIBRYGA solution should be almost colorless and slightly opalescent. Inspect the reconstituted FIBRYGA solution in the syringe for visible particulate matter and discoloration prior to administration. Do not use if particulate matter or discoloration are observed.

The powder should be reconstituted only directly before injection. After reconstitution, do not refrigerate or freeze the FIBRYGA solution. Use the reconstituted FIBRYGA solution immediately or within 4 hours after reconstitution. Discard any remaining FIBRYGA solution.

Administration

For intravenous use only after reconstitution.

Instructions for infusion:

	1. Carefully attach a syringe to the Luer lock connector on the white part of the Nextaro ® transfer device (Fig. 6).
	2. Turn the FIBRYGA bottle upside down and draw the solution into the syringe (Fig. 7).
	3. Once the solution has been transferred, firmly hold the barrel of the syringe (keeping the syringe plunger facing down) and remove the syringe from the Nextaro ® transfer device (Fig. 8). 4. Dispose of the white part of the transfer device together with the empty FIBRYGA bottle.

• Do not administer FIBRYGA in the same tubing or container as other medications.
• Use aseptic technique when administering FIBRYGA.
• Administer FIBRYGA at room temperature by slow intravenous injection at a rate not exceeding 20 mL per minute in patients with acquired fibrinogen deficiency and 5 mL per minute in patients with congenital fibrinogen deficiency.
• No blood should enter the syringe due to the risk of fibrin clot formation.