Product Conversion Resource Centre · Canada
This page walks blood bank managers, transfusion safety officers, and LIS analysts through every practical step of the fibryga conversion — in the order you'll actually need it.
A reference for your team covering storage, handling, and key parameters — everything needed to update your product specifications and brief staff on differences.
| Parameter | Other FC | fibryga® |
|---|---|---|
| Presentation | Lyophilized powder, single-use vial | Lyophilized powder, single-use vial + Nextaro® transfer device + sterile water for injection (co-packaged) |
| Fibrinogen content | Variable per lot (range stated on label) | ~1 g per vial (1 g/50 mL or 2 g/100 mL); actual potency printed on every vial and carton |
| Storage temperature | 2°C–25°C | 2°C–25°C (refrigerator or room temperature) No refrigeration required |
| Shelf life | Up to 36 months from manufacture | Up to 48 months from manufacture (4-year shelf life) |
| Post-reconstitution stability | Use promptly; do not refrigerate | 24 hours at ≤25°C — do not refrigerate or freeze reconstituted solution |
| Reconstitution device | Standard transfer spike / filter needle | Nextaro® device (co-packaged, fully protected spike, dual integrated filter, solvent-first connection) |
| Reconstitution time | ~10–15 minutes | <5 minutes at room temperature |
| Administration route | IV injection | IV injection at room temperature — max 20 mL/min (AFD) or 5 mL/min (CFD) |
| IV line | Flush with normal saline before/after | Flush with normal saline before and after; do not allow blood into syringe (risk of fibrin clot formation) |
| Preservatives | None | None — single use, discard unused portion |
| Latex | — | No natural rubber latex in packaging |
| Plasma source | Pooled human plasma, virus-inactivated | Pooled human plasma; S/D virus inactivation + 20 nm nanofiltration (Planova 20N or Pegasus SV4) |
| Canadian authorization | Health Canada authorized | Health Canada authorized (Product Monograph Oct 24, 2024) — AFD and CFD indications |
Biochemical composition — fibryga 4g vs. Other Available FC
| Component | fibryga® 4g | Other Available FC |
|---|---|---|
| Fibrinogen Antigen (g) | 3.0 | 3.3 |
| Fibronectin (mg) | 2.1 | 140 |
| VWF Antigen (U) | 30 | 570 |
| FXIII Activity (U) | 585 | 165 |
Based on in vitro studies. Source: Neisser-Svae et al. Differences in the biochemical composition of three plasma-derived human fibrinogen concentrates. Thrombosis Research. 2021;205:44–46. Consult the fibryga® Product Monograph for full prescribing information.
Pre-drafted procedural language for each step of the fibryga workflow. Review with your medical director before adoption. Replace all [bracketed fields] with your facility's values.
Upon receipt of fibryga [Fibrinogen Concentrate (Human)], the blood bank technologist shall verify against the packing slip and vial label: product name, lot number, actual fibrinogen potency (printed in mg on vial and carton), expiration date, and condition of the Nextaro® transfer device packaging.
Any unit arriving with a compromised temperature indicator, damaged packaging, visible particulate matter, or turbidity shall be quarantined and the supervisor notified. Disposition shall follow [FACILITY NAME] non-conformance policy [SOP#]. Do not enter quarantined units into usable inventory.
Acceptable units shall be entered into the LIS under product code [ISBT 128 CODE — see Step 4] and assigned to storage location [STORAGE LOCATION] within [FACILITY-DEFINED TIMEFRAME] of receipt. Storage: 2°C–25°C. Do not freeze. Keep in original container, protected from light.
fibryga shall be stored at 2°C–25°C in its original sealed container. Refrigeration is not required; room temperature storage is acceptable provided conditions remain within the approved range. Temperature monitoring shall be documented via [MONITORING SYSTEM/LOG] per [FREQUENCY].
Inventory shall be managed first-expiry, first-out (FEFO). Units with the shortest remaining shelf life shall be positioned at the front of storage. Staff shall be alerted to units within [THRESHOLD — e.g., 30 days] of expiry via [LIS ALERT / MANUAL FLAG].
Par levels shall be set based on [FACILITY USAGE DATA] and reviewed [QUARTERLY / ANNUALLY] in collaboration with pharmacy and the transfusion committee. Note: fibryga's 4-year shelf life allows for more flexible par-level planning compared to products with shorter stability windows.
During transition, maintain a depletion schedule for remaining Other FC inventory. Do not mix products in the same storage bin. Label bins clearly with product name and lot range.
Ensure the powder vial and sterile water for injection (SWI) diluent vial are at room temperature. Do not use beyond the printed expiration date. Use aseptic technique throughout. Note for staff transitioning from Other FC: fibryga uses the Nextaro® device — do not use the transfer device from Other FC. See Step 5 for the full reconstitution guide and video.
Procedure: (1) Remove flip caps; disinfect rubber stoppers with alcohol swab, allow to dry. (2) Attach blue part of the Nextaro® device to the diluent vial — press firmly straight down until it snaps. Do not twist. (3) Remove blister packaging by pulling vertically. (4) Invert the diluent vial with device; attach white connector to the powder vial and press down firmly. (5) Gently swirl — do not shake — for approximately 5 minutes until fully dissolved. (6) Remove diluent vial; transfer solution to syringe via the Luer lock connector.
The reconstituted solution should be clear to slightly opalescent, colourless to pale yellow. Discard if cloudy, discoloured, or contains visible particles. Reconstituted solution is stable for 24 hours at ≤25°C. Do not refrigerate or freeze the reconstituted solution.
Document in [LIS / PAPER LOG]: lot number, potency, time of reconstitution, technologist ID.
fibryga shall be issued against a valid physician order. Before issue, verify in the LIS: patient identity, ordered dose (g or mg/kg), indication, body weight, and plasma fibrinogen level or viscoelastic test result (FIBTEM A10) if available.
Calculate the number of vials required based on the ordered dose and the actual potency printed on each vial label — do not assume a fixed value per vial. Partial vials shall be discarded per [FACILITY WASTE POLICY]; fibryga contains no preservatives and is single-use only.
Label at issue with patient name, MRN, date/time, and issuing technologist ID per [FACILITY LABELING SOP]. Document issue in the LIS.
Administer fibryga at room temperature by slow IV injection. Flush the infusion line with normal saline before and after. Do not allow blood to enter the syringe — risk of fibrin clot formation in the line.
Maximum infusion rate: ≤20 mL/min for AFD (delivers 4 g dose in approximately 10 minutes). ≤5 mL/min for CFD. Do not mix fibryga with other medications or IV solutions. Administer through a separate IV site.
Monitor throughout infusion and for [FACILITY-DEFINED OBSERVATION PERIOD] post-completion for: urticaria, rash, chest tightness, wheezing, hypotension, or anaphylaxis. If a reaction occurs, discontinue immediately and manage per [FACILITY TRANSFUSION REACTION POLICY].
Monitor fibrinogen level and/or FIBTEM A10 post-infusion. For AFD: re-dose if fibrinogen ≤200 mg/dL or FIBTEM A10 ≤10 mm. Document in EMR: lot number, dose given, start/end time.
Reactions to monitor: Most serious: thromboembolic episodes and anaphylactic-type reactions. Warn patients and monitor for risk of thrombosis, particularly in CFD with fibrinogen targets near 150 mg/dL. Allergic reactions have been reported. Safety in pregnancy and nursing has not been fully established — weigh benefits and risks.
Recommended monitoring: Fibrinogen level using Clauss fibrinogen assay before and during treatment to avoid over- or under-dosing. Viscoelastic testing (e.g., FIBTEM A10 ≤10 mm) may be used as equivalent trigger.
Any suspected adverse reaction shall be documented in the patient EMR and reported to the blood bank per [FACILITY HEMOVIGILANCE SOP]. Report to Octapharma Canada Inc. at 1-888-627-8272 and to Health Canada MedEffect at 1-866-234-2345 or canada.ca/medeffect.
📄 Need the full SOP package in editable Word format? Request it through the Get Support section below, or contact your fibryga implementation representative directly.
Ready-to-adapt order set content for the primary clinical scenarios. Use these as the basis for physician order set updates. Dosing is from the fibryga® Product Monograph (Octapharma Canada Inc., Oct 24, 2024).
Bleeding patients with hypofibrinogenemia — surgical, trauma, cardiac surgery, or obstetric haemorrhage settings.
Acute bleeding or perioperative prophylaxis in adults and pediatric patients with afibrinogenemia or hypofibrinogenemia. Not indicated for dysfibrinogenemia.
Per the Canadian FIBRES trial protocol. Included in MHP order sets at major Canadian centres.
Patients with post-CPB bleeding and hypofibrinogenemia. fibryga was non-inferior to cryoprecipitate across 827 patients in the FIBRES RCT (JAMA, 2019) and superior in non-critical cardiac surgery patients.
Postpartum or intrapartum haemorrhage with acquired fibrinogen deficiency. Fibrinogen drops rapidly in PPH. Note: Safety in pregnancy has not been fully established — weigh benefits and risks per Product Monograph.
Lower recovery and faster clearance in children under 12 require weight-based dose adjustment. Higher doses than adults/adolescents may be needed.
** Or equivalent values from other thromboelastometry/thromboelastography methods. Always consult the fibryga® Product Monograph for complete dosing information. Institutional protocols take precedence.
Hand this reference directly to your LIS analyst or IT contact. Validate all entries in a test environment before go-live. Confirm your ISBT 128 product code with your Canadian Blood Services account or Octapharma Canada directly.
⚠ All LIS builds should be validated in a test environment before cutover. If your facility modifies blood products (e.g., pooling), ISBT 128 registration with ICCBBA may be required: iccbba.org. Need LIS build support? Use the contact form in Step 6.
The Nextaro® is new to teams transitioning from Other FC. Staff training on the device is the most common implementation request. Use the resources below alongside a hands-on demo kit.
Reach your fibryga implementation contact, request demo kits and training, or connect with a peer from another blood bank that has already completed this conversion.
Use this form to request Nextaro® demo kits, schedule on-site staff training, or ask for virtual training sessions. A fibryga representative will follow up within 2 business days.
One person, direct line, accountable throughout your conversion window. Available for LIS questions, SOP review, and anything that comes up before go-live.
fibryga is already in use at leading hospitals across Canada. If you'd like to hear how another blood bank managed their conversion — order set updates, staff training, LIS configuration, or anything else — write to the Blood Bank Leaders Network. A peer who has completed this transition will respond.
Peer responses may take a few days. The Blood Bank Leaders Network is a voluntary peer network — not a Octapharma-managed service. Responses reflect individual institutional experience only.
FIBRYGA® [Fibrinogen Concentrate (Human)] is indicated for the treatment of acute bleeding episodes and perioperative prophylaxis in adult and pediatric patients with congenital afibrinogenemia and hypofibrinogenemia, and for the management of bleeds in Acquired Fibrinogen Deficiency (AFD). FIBRYGA is not indicated for dysfibrinogenemia.
Contraindicated in patients with known hypersensitivity to fibryga or any of its components.
Please consult the fibryga® Product Monograph for complete information on adverse reactions, drug interactions, and dosing. To report a suspected adverse reaction: contact Octapharma Canada at 1-888-627-8272 or Health Canada MedEffect at 1-866-234-2345 / canada.ca/medeffect.
This resource is intended for Canadian healthcare professionals involved in blood bank and transfusion service operations. It is not a substitute for the Product Monograph or institutional clinical practice guidelines. All clinical decisions remain the responsibility of the treating clinician.