Treatment and peri-operative prophylaxis of bleeding in patients with congenital fibrinogen deficiency. In acquired hypofibrinogenemia due to major surgery or trauma, many Canadian centres use fibrinogen concentrate within protocol as part of goal-directed bleeding management.

Known hypersensitivity to the product. Avoid use if there is uncontrolled disseminated intravascular coagulation unless directed by a specialist team. 

Yes, where your local protocol incorporates fibrinogen concentrate guided by Clauss fibrinogen or viscoelastic testing. Follow local MHP sequencing. 

According to current Ontario recommendations, fibrinogen concentrate should be issued as soon as lab results indicate a need, and it is often included in the third cooler of the MHP pack.  

Many centres prefer fibrinogen concentrate for rapid, standardized dosing, small volume, no need for thawing, and reduced transfusion reactions. Use what your local protocol specifies.

Yes when indicated for hypofibrinogenemia in obstetric hemorrhage within protocol. Coordinate with obstetrics, anesthesia, and transfusion medicine. 

Yes for congenital deficiency. For acquired indications in children, follow local specialist guidance. 

To read clinical studies behind pediatric use, follow the monograph. 

No routine correction. Coagulation in liver disease is rebalanced. Treat only for active bleeding or procedures with specialist advice.

Restore fibrinogen to a functional target that supports clot formation. Typical targets are at least 1.5 g per litre for major bleeding or invasive procedures, and at least 1.0 g per litre for lesser-risk situations, aligned with local policy.

Use: 
Dose in grams = [Target g per L − Measured g per L] × Plasma volume factor 
A practical bedside rule: 1 g of fibrinogen raises Clauss fibrinogen by about 0.25 g per L in a 70 kg adult. That is approximately 0.0036 g per kg per mg per dL increment. Many sites use 50 to 70 mg per kg for major bleeding when baseline is unknown. 

Use your site’s protocol. Example starting doses for major bleeding or urgent surgery: 

If your site uses ROTEM, a common trigger is FIBTEM A20 at or below 12 mm for significant bleeding. Set a post-dose goal per local protocol, often above 12 to 14 mm.

Re-check Clauss fibrinogen about 10 to 20 minutes after infusion completion or repeat viscoelastic testing at the next cycle. Base re-dosing on laboratory recovery and clinical hemostasis.

If the target is not reached or bleeding persists, give an additional 25 to 50 mg per kg, adjusted to lab results and ongoing blood loss. Avoid unbounded cumulative dosing. Follow your site’s maximum planned cumulative dose.

A 75 kg patient with Clauss 0.9 g per L, target 1.5 g per L. Difference 0.6 g per L. Using the 1 Can you provide a worked example with a known baseline? g raises 0.25 g per L rule, estimated requirement is about 2.4 g. Round to 2.5 g and re-check labs.

Initial 50 to 70 mg per kg, then maintenance to sustain above the target per local specialist direction.

Estimate how many units of cryoprecipitate you would have used, then convert to grams. One pooled adult dose of cryo in many Canadian centres delivers roughly 2 to 4 g of fibrinogen depending on preparation. If your usual approach was “two pools of cryo for major bleeding” you likely gave about 4 to 8 g total. Start Fibryga at 50 to 70 mg per kg or dose to deliver a similar gram amount, then re-check fibrinogen and adjust. This aligns practice while you transition to concentrate-based protocols. 

Clauss fibrinogen is the reference. Where available, ROTEM or TEG may guide both the trigger and the effect of therapy with faster turnaround.

For ongoing major bleeding, re-check after the first dose, then at intervals dictated by hemorrhage severity, often every 4 to 6 hours in the first day or at the next viscoelastic cycle.

Consider ongoing consumption, dilution, hyperfibrinolysis, laboratory timing relative to infusion, or sampling issues. Reassess dosing and consult hematology.

Reconstitute using the supplied solvent with the provided transfer system. Gently swirl until fully dissolved. Do not shake vigorously. Inspect for particulate matter and clarity. For a step by step guide, follow the reconstitution guide. 

Additional required items may include a luer lock syringe for administration and alcohol wipes for aseptic vial preparation. For pooling, an IV mini-bag can be used for transfer.  

Please consult your transfusion medicine team regarding your institutions best practices and what is provided with your blood products.  

Follow the monograph and local policy. Provide a bedside example for a 70 kg adult so nursing can proceed without calculation delays.

The reconstitution device supplied with Fibryga has a dual integrated filter, thus, administration of Fibryga does not require a separate filtration process. Check local instructions for the supplied kit.

No specific manufacturer studies exist for rapid infusers. If local policy allows, use clinical judgement, a dedicated line, and close observation. 

Do not mix with other medicinal products in the same line. Use a separate lumen. If unavoidable, stop other infusions, flush with a compatible fluid, administer Fibryga, then flush.

Normal saline is preferred where specified. Confirm any alternatives in local policy. Avoid concurrent calcium administration through the same lumen.

Yes if separate lumens are used and there is no mixing in the line. 

Record every lot. When pooling, maintain traceability for each vial used.

Administer as soon as possible. If a delay is unavoidable, stability of the reconstituted solution has been demonstrated for up to 24 hours at +25°C, provided sterility of the stored product is maintained. Follow the monograph and site policy limits. Routine ward storage is discouraged.

Check the monograph for exact sodium per vial. This is usually considerably less than cryoprecipitate or plasma volumes.

Allergic reactions, theoretical thrombosis risk when over-corrected in prothrombotic states, and very rarely transmission of infectious agents despite robust viral safety steps. 

Observe during infusion and for a period after administration for rash, pruritus, dyspnoea, hypotension, or chest discomfort. Stop infusion if reactions occur and treat per protocol.

Thrombotic events are uncommon but possible. Use target-based dosing and avoid overshooting in patients with high thrombotic risk.

Only under specialist direction when active bleeding requires targeted fibrinogen replacement as part of comprehensive DIC management.

If viscoelastic testing or Clauss supports low fibrinogen, give 50 to 70 mg per kg, then re-check. Integrate with MHP components.

Use protocolized dosing guided by Clauss or ROTEM. Coordinate with perfusion and transfusion medicine. 

Treat when fibrinogen is below target. Early replacement is associated with improved hemostasis. Coordinate with obstetrics and anesthesia.

Target-based dosing guided by Clauss or viscoelastic testing within surgical and transfusion protocols.

Consult pediatric hematology. Dosing is weight-based and guided by lab targets.

Manage per protocol. Fibryga restores substrate for clot formation but does not treat fibrinolysis. Use antifibrinolytics as indicated.

Translate your typical cryo order into grams, then give an equivalent amount as concentrate, or start with 50 to 70 mg per kg when baseline is unknown. Re-check and adjust to target rather than repeating the old cryo habit.

Immediate availability without thawing, standardized content per vial, small volume, and reduced transfusion reactions allow faster, predictable correction during time-critical care.

Fibryga is made from pooled plasma with multiple dedicated pathogen reduction steps and validated viral inactivation or removal across the manufacturing process, and each lot is tested before release. Cryoprecipitate is derived from plasma components with standard donor screening and testing but does not undergo the same dedicated viral inactivation steps used in solvent-detergent plasma or certain concentrates. Residual risk with modern screening is already very low for both, and concentrates add further reduction through process design. Follow local blood service guidance.

Product name, total grams, time, indication, infusion rate, pre and post fibrinogen or viscoelastic values, all lot numbers, adverse events, and prescriber identity.

Report through institutional pharmacovigilance and to the manufacturer’s medical information line with complete lot and clinical details.

Issue time, receipt confirmation, storage conditions if any delay, complete lot traceability, and the indication provided.

Transfusion Medicine service, with some sites stocking limited quantities in ED or OR under transfusion oversight.

Call Transfusion with indication, weight, and latest fibrinogen or ROTEM status if available. Provide a contact number for post-dose results.

Policies vary by hospital and province. Confirm with your Transfusion service. 

Do not retain on wards. Return to Transfusion if permitted and within time limits. Otherwise discard per protocol and document.

Explain that Fibryga is a human plasma-derived fibrinogen concentrate used to restore a key clotting protein rapidly to control bleeding. Describe benefits and risks, including rare allergic reactions and very low residual infection risk. Document consent or emergency exception.

Indication, amount given, lab values before and after, re-check plan, and signs to watch for. State the overall bleeding control status and the next laboratory target time.

Octapharma Canada provides a patient support program called Procare, for more information regarding his program, email medinfo.canada@octapharma.com 

Access to Procare is evaluated based on priority and patient requirements.