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Pathology and Laboratory Medicine
Product Catalogue

​Fibryga®

Transfusion Medicine

​Class:
Fibrinogen Concentrate
​Alternate Product Name:
  • Fibrinogen Concentrate (Human)
​Company/Supplier:
Octapharma Canada Inc.

​Routes
​Intravenous
​Other
​Direct IV
Intermittent
IV Infusion​
Continuous
Infusion​
​SC
IM
Other​
Acceptable Routes
Yes​
Yes * see administration
No
No
No
N/A


Description
  • Fibryga® (Fibrinogen Concentrate [Human]) is a sterile, freeze dried preparation of highly purified fibrinogen.
  • Fibryga® is prepared from large pools of human plasma employing precipitation, filtration and chromatographic steps. Pathogen inactivation/removal is accomplished by a solvent detergent (S/D) method and nanofiltration (20 nm).
​Availability
  • Vial sizes/dosages:
    • 1 gram per vial reconstituted with 50 mL sterile water for diluent
  • Supplied by Canadian Blood Services
  • Contact your local laboratory/ transfusion laboratory service regarding in-house stock availability at your site
​Indications
  • Treatment of acute bleeding episodes and perioperative prophylaxis in adult and pediatric patients with congenital afibrinogenemia and hypofibronogenemia
  • Treatment of uncontrolled bleeding due to acquired fibrinogen deficiency in the setting of surgical interventions
  • Treatment of uncontrolled bleeding due to acquired fibrinogen deficiency in the setting of postpartum hemorrhage or consumptive coagulopathy (ex.: disseminated intravascular coagulation, acute presentation of acute promyelocytic leukemia) - off-label
​Contraindications
  • Patients who have a history of severe immediate hypersensitivity reaction (including anaphylaxis) to this product or to any ingredient in the formulation
​Warnings
  • Hypersensitivity reactions, including anaphylaxis, are possible. Should symptoms occur, discontinue treatment and follow adverse even protocol. See Nursing Policy and Procedure Blood Components and Plasma Protein Product - Administration of (#1141)
  • Products made from human plasma may contain infectious agents, such as viruses and, theoretically, the variant Creutzfeldt-Jakob Disease (vCJD) agent that can cause disease. The risk that such products will transmit and infectious agent has been reduced by plasma donor screening, testing for the presence of certain current viruses, and by viral inactivation/removal steps. There is also the possibility that unknown infectious agents may be present in such products
  • There is a risk of thrombosis in patients with congenital or acquired fibrinogen deficiency receiving human fibrinogen concentrate, particularly with high doses or repeated dosing. Exercise caution when administering this product to patients with a history of deep vein thrombosis, pulmonary embolism, arterial thrombosis, or liver disease as there is a theoretical increase in thrombosis risk. Patients receiving Fibryga® should be monitored for signs and symptoms of thrombosis (See WARNINGS AND PRECAUTIONS AND ADVERSE EVENTS in product monograph).

​Dosage
  • Dosage should be determined by a physician experienced in the care of patients with congenital or acquired fibrinogen deficiency
  • Fibrinogen Concentrate administration should be considered in bleeding patients with the following serum fibrinogen levels:
    • Non-pregnant patient- 1.5 g/L or less
    • Pregnant or post-partum patient - 2 g/L or less
  • The recommended initial dose of Fibrinogen Concentrate in the setting of fibrinogen deficiency is 4 g IV for adults (50 kg or greater) and 30-60 mg/kg (to a maximum 4g dose) for children
    • Fibrinogen Concentrate 4 grams = fibrinogen in 10 units Cryoprecipitate
  • Individual dosing in the setting of congenital fibrinogen deficiency may vary based on the body weight, laboratory values, and the patients clinical condition. Consultation with a Hematologist familiar with factor dosing in the setting of congenital bleeding disorders is strongly recommended
  • For further information about dosage please review the Product Monograph
  • Consultation with the Transfusion Medicine Physician on-call to discuss dosing is strongly recommended and available through switchboard at (306)655-1000
​Pre-Administration Testing Requirements
  • Determination of the patient fibrinogen level using an appropriate method (e.g., Clauss fibrinogen assay) or pattern consistent with hypofibrinogenemia demonstrated by thromboelastography (TEG) is recommended before and during the treatment with Fibrinogen Concentrate to avoid overdosing
  • Link to the Test Catalogue for Fibrinogen level specimen requirements
  • As directed by most responsible health practitioner (MRHP)
​Ordering
​Forms Required
  • Informed Consent for Blood Components and/or Plasma Protein Products #101479
  • Plasma Protein Product Request Form #103221
  • Transfusion/Infusion Administration and Assessment Record #101059
  • Saskatchewan Transfusion Adverse Event Report Form #103695 (only needed if adverse event occurs
  • Notification of Administration of Blood and/or Blood Products Form #103854.
  • Forms can be located in the Lab Services Manual or Forms on Demand​
​Supplies Required
  • The product package contains:
    • One single-use Fibryga® vial
    • One single-use sterile Water for Injection (WFI) vial 50 mL
  • Additional supplies needed:
    • Patient to have an IV in place
    • Octajet transfer device
    • One luer lock syringe (appropriate size based on volume) for administration
    • Sterile alcohol swabs (for cleaning the tops of the vials)
    • Labels (to affix onto infusion syringe)
​Administration
  • Blood consent: is required due to human plasma component
  • Pre-infusion: Ensure recent patient weight is on file and pertinent laboratory results are available​
  • Perform all other appropriate pre-administration checks per protocol, detailed in the Nursing Policy and Procedure Blood Components and Plasma Protein Product - Administration of #1141

  • Administration:
    • Congenital fibrinogen deficiency: Administer the entire dose at a maximum rate of 5 mL per minute (approximately 100 mg per minute; 1 reconstituted vial over 10 minutes).
    • Acquired fibrinogen deficiency: Administer the entire dose at a maximum rate of 20 mL per minute (approximately 400 mg per minute; 1 reconstituted vial over 2.5 minutes).
      • Syringe pump: Microbore tubing required. Not to exceed 20 mL per minute (~400 mg/min).
        • SMART pump: select 'blood fibrinogen concent.'
        • Minibag: Not recommended
  • Access: Can be given via CVC, PICC, Port-a-Cath®, or peripheral IV
  • Compatible Solutions: Can flush line with 0.9% normal saline pre and post administration of Fibryga®. No other drugs/solutions (including normal saline) can be co-administered in the same line while Fibryga® is being infused.
  • Preparation and Reconstitution
    NOTE: Reconstitute only immediately before administration
    • Administer within 3 hours after reconstitution
      • DO NOT refrigerate after reconstitution
      • DO NOT further dilute in any IV solutions
      • DO NOT mix with other drugs or IV solutions
  • Use aseptic technique (clean and germ free) when preparing and reconstituting Fibryga®
1. ​Allow the vials of Fibryga® and diluent to reach room temperature before use. This product is stored at room temperature within the Transfusion Medicine Lab. Warming of the vials will ease with dissolving the powder and lessen patient discomfort in the vein when administering

2. Remove the flip caps from both the Fibryga® bottle and the WFI to expose the central portion of the infusion stopper. Scrub the rubber stoppers with an alcohol swab for 15 seconds and allow to dry
Fibryga 1.jpg
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 packaging

4. Take the Octajet in its outer package and invert it over the Fibryga® bottle. Place 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 concentrate bottle, carefully remove the outer package from the Octajet, being careful to not touch the water spike (blue) and leave the Octajet attached firmly to the concentrate bottle
Fibryga 2.jpg
​5. With the Fibryga® bottle held firmly on a level surface, invert the WFI 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 WFI bottle
Fibryga 3.jpg
6. ​While stabilizing the WFI bottle, remove the distance ring
Fibryga 4.jpg
​7. Press the WFI bottle down. WFI will flow into the Fibryga® bottle.
Fibryga 5.jpg
8. ​When transfer of the WFI is complete, gently swirl the product bottle until the powder is fully dissolved. Do not shake the bottle to avoid foam formation. The powder should be dissolved completely within approximately 5 minutes. It should not take longer than 30 minutes to dissolve the powder

9. ​Turn the blue WFI bottle connector (both directions possible) to bring position markers together and remove WFI bottle together with the water spike
Fibryga 6.jpg
​10. Place the provided filter on the remaining luer lock on the concentrate bottle. While holding the provided filter in its outer package, attach a syringe to the filter
Fibryga 7.jpg
​11. Then, connect the filter to the Octajet Luer Lock on the Fibryga® bottle
Fibryga 8.jpg
12. ​Withdraw the solution through the filter into the syringe
Fibryga 9.jpg
13. ​Detach the filled syringe from the filter and discard the empty bottle into a sharps disposal container

​14. Complete patient and product information on the labels provided by Transfusion Medicine and affix to the plastic syringe containing Fibryga®

15. ​Clean the intended injection site with an alcohol swab and attach the luer lock syringe containing Fibryga®. Administer product


  • For additional preparation/reconstitution and administration steps see Administration section of the Product Monograph
  • Lab testing post administration: Determination of the patient's fibrinogen level or pattern evaluating fibrinogen contribution to coagulation as demonstrated by thromboelastography (TEG) is recommended before and during the treatment with Fibryga®
  • Testing Frequency is as directed by MRHP
​Nursing Implications
​Adverse Events
​Comments
  • Consult the Product Monograph for additional information, or contact the Saskatchewan Bleeding Disorders Program at (306)381-4185, Monday to Friday, 0800-1630 for education and administration assistance
References



If you choose to print this information, it is valid only on date of print.

Laboratory Controlled Document LSM-1039 v3


Last Modified: Friday, September 30, 2022 |
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