Fibryga Dosage

Dosage

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 fibrinogen plasma 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 (see Pharmacokinetics [ 12.3 ] ):

Adults and adolescents 12 years of age and above:

Children 0 to <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 transfer device (Octajet)
• 1 17-micron particle filter

Reconstitute FIBRYGA with 50 mL of sterile Water for Injection (not provided).

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 cap from the FIBRYGA bottle and the sWFI bottle to expose the central portion of the rubber stoppers. Clean the rubber stoppers with an alcohol swab and allow the rubber stoppers to dry.

3. Peel away the lid of the outer package of the Octajet transfer device. To maintain sterility, leave the Octajet device in the clear outer package.

4. Take the Octajet in its outer package and invert it over the FIBRYGA bottle. Place the device while in the outer package onto the center of the FIBRYGA bottle until the clips of the product spike (colorless) are locked. While holding onto the FIBRYGA bottle, carefully remove the outer package from the Octajet, being careful not to touch the water spike (blue) and leave the Octajet attached firmly to the FIBRYGA bottle. (Fig. 1)

5. With the FIBRYGA bottle held firmly on a level surface, invert the sWFI bottle and place it at the center of the water spike. Push the blue plastic cannula of the Octajet firmly through the rubber stopper of the sWFI bottle. (Fig. 2)

6. Remove the distance ring (Fig. 3) and press the sWFI bottle down (Fig. 4). sWFI will flow into the FIBRYGA bottle.

7. When transfer of the sWFI is complete, 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 approximately 5 to 10 minutes.

8. Turn the blue sWFI bottle connector (in either direction) to bring the position markers together and remove the sWFI bottle together with the water spike (Fig. 5). Keep the concentrate bottle upright to avoid leaking.

9. Firmly connect the provided particle filter on the remaining Luer Lock on the FIBRYGA bottle (Fig. 6) and withdraw the solution through the particle filter into a syringe. (Fig. 7, 8)

10. Detach the filled syringe from the particle filter and discard the empty bottle and the filter.

• 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.

• 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 5 mL per minute.