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11Power ofrapid control inemergencysituationsAsk for Fast Reconstituting Fibryga,the only fibrinogen concentrate with a provenmean reconstitution time of 5 minutes.TRAINING DOCUMENT: IT MAY CONTAIN UNPUBLISHED INFORMATION. NOT FOR FURTHER DISTRIBUTIONConfidential
2 FIBRYGAIntroductionConfidential
3ContentIntroduction to FibrygaProduct ProfileProduct AdministrationProduct ComparisonTools & ResourcesConfidential
FIBRYGA : A MODERN FIBRINOGEN CONCENTRATE (FC)Double virusinactivatedincludingCOVID-194Higher purityand fibrinogenactivityMost extensivelystudied FC incongenital & acquiredfibrinogen deficiencyConfidentialFibryga Canadian Product Monograph, August 10, 2018
5PATHOGEN SAFETY- INCLUDING COVID-19Dedicated 2-steppathogen removalFibryga Canadian Product Monograph, August 10, 2018S/D treatment inactivatesenveloped viruses such as humanimmunodeficiency virus (HIV),hepatitis B (HBV) and hepatitis Cvirus (HCV)Nanofiltration (20 nm) for removal ofboth enveloped viruses andnon-enveloped viruses—such ashepatitis A virus (HAV) andparvovirus B19, COVID-19 andpotentially infectious prion proteinConfidential
6HEALTH CANADA APPROVALAPPROVED INDICATIONAcute bleeding episodes and perioperativeprophylaxis in adult and pediatric patients withcongenital afibrinogenemia and hypofibrinogenemia.DOSAGE FORM1 g powderFIBRINOGEN CONTENT 20 mg/ml after reconstitutionwith 50 ml WFICOMPOSITIONHuman fibrinogen: 1 gSodium chloride: 300 mgSodium citrate dihydrate: 75 mgWFI Water For Injection.Fibryga Canadian Product Monograph, August 10, 2018Glycine: 500 mgL-Arginine hydrochloride: 500 mgAFD INDICATION: UNDER REVIEWConfidential
FIBRYGA : CLINICAL EVIDENCE7EVIDENCE IN BOTH CONGENITAL AND ACQUIRED FDCFDFORMA-01Phase II,comparative,pharmacokinetic(PK) study vs.RiaSTAP COMPLETEDAFDFORMA-02FORMA-04FIBRESFORMA-05Phase III safetyand efficacy studyfor on-demandtreatment of bleedsand for preventingbleeding in surgeryPhase IIIb study toevaluate theefficacy and safetyin acute bleedingin patients aged 12 yearsPhase IIIb noninferiority studycomparing Fibryga to cryoprecipitate incardiac surgeryProspective,randomized,controlled phase IIpilot study onefficacy inPseudomyxomaPeritonei (PMP)COMPLETEDCOMPLETEDCOMPLETEDLissitchkov T et al. Efficacy and safety of a new human fibrinogen concentrate in patients with congenital fibrinogen deficiency: an interim analysis of a phase III trial. Transfusion 2017; DOI: 10.1111/trf.14421COMPLETEDConfidential
FIBRYGA : PACKAGE CONTENTS8WHAT COMES IN YOUR FIBRYGA PACKAGE?Fibryga Powder VialOctajet Transfer DeviceParticle FilterLeaflet*Components used in Fibryga packaging are latex-freeFibryga Canadian Product Monograph, August 10, 2018Confidential
FIBRYGA : PRACTICAL CONSIDERATIONSWATER FOR INJECTION (WFI) FOR THE RECONSTITUTION OF FIBRYGA WFI will be delivered by CBSalongside Fibryga WFI Specifications: Water for Injection USP (Sterile) 50 mL per vial DIN 00402257 Code: L10010028 10 Vials (units) per package Shelf life: 48 months from date of production Storing: Store between 15-30ºC. Do not freeze Manufacturer: Omega Laboratory Ltd.Omega Laboratories. Sterile Water for Injection: Medical Safety Data Sheet, December 21, 2015Confidential9
FIBRYGA : DOSING & ADMINISTRATION10Recommended dosing and infusion speedRECOMMENDED TARGET FIBRINOGENMinor bleeding or minor surgery:100 mg/dLMajor bleeding or major surgery:150 mg/dLRECOMMENDED DOSEINITIALDOSINGWhen baseline fibrinogen level is known:Dose (mg/kg body weight) [Target level (mg/dL) – measured level (mg/dL)]1.8 (mg/dL per mg/kg body weight)When baseline fibrinogen level is not known:60 mg/kg body weightFibryga Canadian Product Monograph, August 10, 2018INFUSIONSPEED5 mL/min(max)Confidential
FIBRYGA : STORAGE & RECONSTITUTION BENEFITS11EASY HANDLING AND RECONSTITUTIONFast reconstitution 5 minutes* to reconstituteusing the Octajet transferdevice Less time to prepare Less repetitive strainFibryga Reconstitution VideoBetter Reconstitution Experience* Under ideal conditions with a trained professional1. Fibryga Canadian Product Monograph, August 10, 20182. CBS: Clinical Guide to Transfusion, Chapter 2 Blood Components: Sept. 2017Confidential
FIBRYGA : DOSING & ADMINISTRATION12HELPFUL TIPSDODO NOTUse intravenously onlyUse solutions that arecloudy or have depositsUse a separateintravenous lineMix with othermedicinal productsFibryga Canadian Product Monograph, August 10, 2018Confidential
FIBRYGA : STORAGE & STABILITY BENEFITS13IMPROVED STORAGE AND STABILITY AFTER RECONSTITUTIONStorageFibryga : 2 25ºCRiaSTAP : 2-8ºCCryoprecipitate: -18ºCShelf LifeFibryga : 3 yearsRiaSTAP : 5 yearsCryoprecipitate: 1 yearStability afterReconstitutionFibryga : 24h at 25ºCRiaSTAP : 8h at 25ºCCryoprecipitate: 4h1. Fibryga Canadian Product Monograph, August 10, 2018 ; 2. Schulz P et al. Biochemical characterization, stability and pathogen safety of a new fibrinogen concentrate(Fibryga ). Biologicals 2017; 3. Octapharma data on file. Pending publication; 4. RiaSTAP Canadian Product Monograph, May 22, 2019; 5. CBS Customer Letter # 2019-08:May 2019; 6. CBS: Clinical Guide to Transfusion, Chapter 2 Blood Components: Sept. 2017Confidential
PRODUCT COMPARISON14FIBRYGA VERSUS CRYOPRECIPITATEFibryga FasterReconstitution 5 minutes 30-35 minutesStorageRoom temperature or fridgeFrozenStability afterReconstitution24 hours at room temperatureOnce thawed and pooled:4 hoursCurrent standard of care:LesswastagePredictablevolumeSafeNo impacton productionof platelets1.2.3.CryoprecipitateFibrinogen contentHigher fibrinogen activityStandard dose (4 g): 4 gVariability in inter-donor levels of fibrinogencontentStandard dose (10 units): 2.85 ( 0.88) gConsistency ofother coagulationfactorsStandardized levels of FactorVIII/VWF, FXIII and Fibronectin.No albuminVariable amounts of additional coagulationfactors such as Factor VIII/VWF, FactorXIII, Fibronectin and Platelet microparticlesPathogen InactivationPathogen inactivatedNo pathogen inactivationImpact on plateletproductionNoneLoss of 1 U of platelet per 1 U ofcryoprecipitateSchulz P et al. Biochemical characterization, stability and pathogen safety of a new fibrinogen concentrate (Fibryga ). Biologicals 2017; .NAC Statement on Fibrinogen Concentrate, July 19, 2018Roy A. et al; Protocol for a prospective, randomized, controlled phase 2 pilot study investigating hemostatic efficacy and safety of fibrinogen concentrate and cryoprecipitate in patients undergoing cytoreductive surgery forpseudomyxoma peritonei: the FORMA-05 study. Poster session presented at ISTH SSC, 18–21 July 2018, Dublin Ireland.Confidential
FIBRYGA : RESOURCES15FAST RECONSTITUTIONRECONSTITUTION TOOLSVIDEOTEAR OFF SHEETSFibryga Reconstitution VideoDEMO KITBetter Reconstitution ExperienceConfidential
FIBRYGA : RESOURCES16AVAILABLE IN-SERVICES AND EDUCATIONAL TOOLSCLINICAL SUPPORTSLIDE DECKPUBLICATIONSTHOUGHT LEADERSSUPPORTIn-services by Key Account ManagersConfidential
17 fibrygaASK FOR FAST!ConfidentialNOT FOR FURTHER DISTRIBUTION
FIBRYGA : IMPORTANT INFORMATION18Indications & Clinical UseFIBRYGA is indicated for the treatment of acute bleeding episodes and perioperative prophylaxis in adult and pediatric patients with congenitalafibrinogenemia and hypofibrinogenemia.Contraindications for FIBRYGA are patients with severe immediate hypersensitivity reactions, including anaphylaxis to FIBRYGA or itscomponents.Clinical studies of FIBRYGA did not include subjects age 65 and over to provide evidence as to whether or not they respond differently thanyounger subjects.FIBRYGA studies have included eight children (12-17 years). No data are available in patients below 12 years of age.The safety of FIBRYGA for use in human pregnancy and during lactation has not been established in controlled clinical trials.Adverse eventsNo serious adverse reactions have been reported in clinical studies with FIBRYGA to dateThe most serious adverse reactions that may potentially be observed for FIBRYGA are thromboembolic episodes and anaphylactic type reactionsThe majority of the adverse events (AEs) were single instances (e.g., vomiting, pyrexia, diarrhea, headache, nasopharyngitis and other respiratorytract infections and muscle pain)Three mild AEs were deemed possibly related to FIBRYGA .These were a case of mild pyrexia and two cases of mild skin reactions, all of whichresolved.Four serious adverse events were reported in two patients, and considered related to the underlying disease (abdominal pain and vaginalhemorrhage) or trauma and not related to the study drugFibryga Canadian Product Monograph, August 10, 2018Confidential
FIBRYGA : IMPORTANT INFORMATION19References1.2.3.Fibryga Canadian Product Monograph, August 10, 2018.Octapharma data on fileSchulz P et al. Biochemical characterization, stability and pathogen safety of a new fibrinogen concentrate (Fibryga ). Biologicals .003.4. Ross et al. Pharmacokinetics, clot strength and safety of a new fibrinogen concentrate: randomized comparison with active control in congenitalfibrinogen deficiency. Journal of Thrombosis and Haemostasis, 16: 253–2615. Haas T et al. Comparison of the efficacy of two human fibrinogen concentrates to treat dilutional coagulopathy in vitro. Br J Anaesth 2017; xxx6. Laurens N et al. Fibrin structure and wound healing. J Thromb Haemost 2006; 4: 932–9397. Lissitchkov T et al. Efficacy and safety of a new human fibrinogen concentrate in patients with congenital fibrinogen deficiency: an interim analysis of aphase III trial. Transfusion 2017; DOI: 10.1111/trf.144218. Kozek-Langenecker et al. Management of severe perioperative bleeding: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol.2013; 30(6):270-382.9. Mosesson MW et al. Fibrinogen and fibrin structure and functions. J.Thromb. Haemost 2005; 3(8):1894-190410. Omega Laboratories. Sterile Water for Injection: Medical Safety Data Sheet, December 21, 201511. CSL Behring Canada. RiaSTAP Canadian Product Monograph, May 22, 201912. Roy A. et al; Protocol for a prospective, randomized, controlled phase 2 pilot study investigating hemostatic efficacy and safety of fibrinogenconcentrate and cryoprecipitate in patients undergoing cytoreductive surgery for pseudomyxoma peritonei: the FORMA-05 study. Poster sessionpresented at ISTH SSC, 18–21 July 2018, Dublin, IrelandConfidential
11. CSL Behring Canada. RiaSTAP Canadian Product Monograph, May 22, 2019 12. Roy A. et al; Protocol for a prospective, randomized, controlled phase 2 pilot study investigating hemostatic efficacy and safety of fibrinogen concentrate and cryoprecipitate in patients undergoing cytoreductive surgery for pseudomyxoma peritonei: the FORMA-05 study.
