FIBRYNA is a human fibrinogen concentrate indicated for the treatment of acute bleeding episodes in adults and adolescents with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.
FIBRYNA is not indicated for dysfibrinogenemia.
DOSAGE AND ADMINISTRATION
For intravenous use after reconstitution. Reconstitute prior to use.
FIBRYNA 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.
FIBRYNA 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 formula (see Pharmacokinetics):
Dose (mg/kg body weight) = [Target fibrinogen level (mg/dL) - measured fibrinogen level (mg/dL)] /1.8 (mg/dL per mg/kg body weight)
FIBRYNA Dose When Baseline Fibrinogen Level Is Not Known
If the patientâ€™s fibrinogen level is not known, the recommended dose is 70 mg per kg of body weight administered intravenously.
Monitor the patientâ€™s fibrinogen level during treatment with FIBRYNA.
Additional infusions of FIBRYNA 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
FIBRYNA package contains:
- 1 single-use bottle of FIBRYNA concentrate
- 1 transfer device (Octajet)
- 1 particle filter
Reconstitute FIBRYNA with 50 mL of sterile Water for Injection (not provided).
Do not use FIBRYNA beyond the expiration date. FIBRYNA contains no preservatives. Use aseptic technique when preparing and reconstituting FIBRYNA.
The procedures below are provided as general guidelines for preparation and reconstitution of FIBRYNA.
Reconstitute FIBRYNA 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 FIBRYNA 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 FIBRYNA bottle. Place the device while in the outer package onto the center of the FIBRYNA bottle until the clips of the product spike (colorless) are locked. While holding onto the FIBRYNA 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 FIBRYNA bottle. (Fig. 1)
5. With the FIBRYNA 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 FIBRYNA bottle.
Figure 3 and Figure 4
7. When transfer of the sWFI is complete, gently swirl the FIBRYNA 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 (both directions possible) 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 FIBRYNA bottle (Fig. 6) and withdraw the solution through the particle filter into the syringe. (Fig. 7,8)
Figure 6,7 and 8
10. Detach the filled syringe from the particle filter and discard the empty bottle and the filter.
- After reconstitution, the FIBRYNA solution should be almost colorless and slightly opalescent. Inspect the reconstituted FIBRYNA 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 FIBRYNA solution. Use the reconstituted FIBRYNA solution immediately or within 4 hours after reconstitution. Discard any remaining FIBRYNA solution.
For intravenous use only after reconstitution.
- Do not administer FIBRYNA in the same tubing or container as other medications.
- Use aseptic technique when administering FIBRYNA.
- Administer FIBRYNA at room temperature by slow intravenous injection at a rate not exceeding 5 mL per minute.
Dosage Forms And Strengths
FIBRYNA is a sterile, lyophilized powder for reconstitution for intravenous injection. FIBRYNA is provided in single-use bottles containing approximately 1 g fibrinogen concentrate for reconstituition with 50 mL of sterile Water for Injection.
FIBRYNA is supplied in a single-use bottle.
The following nominal dosage form is available:
Carton NDC Number: 68982-347-01
- The actual potency of fibrinogen in mg is stated on each FIBRYNA carton and bottle.
- FIBRYNA is supplied in a package with a single-dose bottle of powder together with an Octajet transfer device and a particle filter.
- Components used in the packaging of FIBRYNA are not made with natural rubber latex.
Storage And Handling:
- Store FIBRYNA for up to 30 months at +2°C to + 25°C (36°F to 77°F) from the date of manufacture.
- Do not use FIBRYNA 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 FIBRYNA solution. Use the reconstituted FIBRYNA solution immediately or within 4 hours after reconstitution.
- Dispose of any unused product or waste material in accordance with local requirements.
Manufactured by: Octapharma Pharmazeutika Produktionsges.m.b.H., Oberlaaer Strasse 235, A-1100 Vienna, Austria, U.S. License No. 1646. Distributed by:Octapharma USA Inc. 121 River Street, Suite 1201, Hoboken, NJ 07030. Revised: Jun 2017