Anti-Inhibitor, Factor VIIa & IX critical-care products ...

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IVIG, SCIG, IGIM FACTOR VIIa, VIII, IX ALBUMIN HYPERIMMUNES FLU VACCINE OTHER VACCINES ANTITHROMBIN III C1 ESTERASE INHIBITOR OTHER SPECIALTY BIOLOGICALS With a perfect safety track record of 26 counterfeit-free years, FFF continues to set the standard for patient safety, product efficacy and fair pricing for the critical-care products and vaccines that improve the quality of life for the patients we serve. PATIENT SAFETY + PRODUCT EFFICACY + FAIR PRICING The nation's largest and most trusted distributor of plasma products, vaccines and critical-care biopharmaceuticals. you need, when you need them. TO THE MARKETPLACE Anti-Inhibitor, Factor VIIa & IX The critical-care products Reference Chart BRINGING TRUST Verified Electronic PedigreeOnline Drug Pedigree www.FFFenterprises.com Lot-TrackProduct Tracking & Notification Service (800) 843-7477 IG Living Magazine Immune Globulin Information www.IGLiving.com MyFluVaccineFlu Vaccine Program www.MyFluVaccine.com VaxAmericaVaccination Program www.VaxAmerica.com NuFACTOR® Specialty Pharmacy www.NuFACTOR.com BioSupply Trends Quarterly Magazine Marketplace News www.BSTQuarterly.com Wow! Customer Care Questions & Orders (800) 843-7477 (800) 843-7477 Emergency Orders 24/7/365 Place an Order FFFenterprises.com MyFluVaccine.com Online Ordering FAX (800) 418-4333 EMAIL [email protected] REGULAR ORDERING HOURS 8am - 8pm ET | 7am - 7pm CT | 6am - 6pm MT | 5am - 5pm PT SHIPPING FOB Origin - Standard: Overnight or 2 day delivery FOB Destination - Expedited: Same day Wow! Customer Care Ordering FFF Enterprises is the nation’s most trusted supplier of biopharmaceuticals, plasma products, vaccines and clinical trial drugs. Our partners include all manufacturers of influenza vaccines, and we serve over 80% of U.S. hospitals and supply the nation’s leading non-acute care GPO members. FFF Enterprises is committed to improving and stabilizing the supply of specialty pharmaceuticals through our Guaranteed Channel Integrity™. FFF Enterprises’ commitment to Guaranteed Channel Integrity includes our secure supply channel, a dedicated Customer Care Team and FFF’s Advisor Lines, which offer reimbursement and infusion support to healthcare providers in all sites of care. Infusion Advisor Line Our infusion specialist will answer your questions about the principles of intravenous and subcutaneous infusion therapy, cost-effective care and improving patient outcomes at (800) 843-7477. Pharmacy Advisor Line We know that when you have a product or dosing question, you need it answered right away. FFF’s on-call pharmacists are experienced with every drug we provide and available to answer your questions at any time of day at (800) 843-7477. Reimbursement Advisor Line FFF’s Reimbursement Services office is staffed by expert reimbursement specialists, ready to resolve your questions and guide you through the complexities of biopharmaceutical reimbursement, from 8am to 5pm PT, at (800) 843-7477. Service Directory ©2014 FFF Enterprises, Inc. Products and trademarks are the property of their respective owners. Reflects prescribing information for products as of June 2014. FL175 Rev0614 Now in our 26th counterfeit-free year, Guaranteed Channel Integrity™ is the result of our long-term commitment to purchase only from manufacturers and ship only to healthcare providers to protect you and your patients from the risks of counterfeiting, drug diversion and irresponsible pricing. Our proprietary Verified Electronic Pedigree™ system and Lot-Track™ service provide reliable and accurate verification of our secure channel. Our Verified Inventory Program™ utilizes RFID technology to monitor high-value medication inventory and eliminate carrying costs through a consignment-based model.

Transcript of Anti-Inhibitor, Factor VIIa & IX critical-care products ...

Page 1: Anti-Inhibitor, Factor VIIa & IX critical-care products ...

IVIG, SCIG, IGIM

FACTOR VIIa, VIII, IX

ALBUMIN

HYPERIMMUNES

FLU VACCINE

OTHER VACCINES

ANTITHROMBIN III

C1 ESTERASE INHIBITOR

OTHER SPECIALTY BIOLOGICALS

With a perfect safety track record of 26 counterfeit-free years, FFF continues to set the standard

for patient safety, product efficacy and fair pricing for the critical-care products and vaccines

that improve the quality of life for the patients we serve.

P A T I E N T S A F E T Y + P R O D U C T E F F I C A C Y + F A I R P R I C I N G

The nation's largest and most trusted

distributor of plasma products, vaccines and

critical-care biopharmaceuticals.

you need, when you need them.

T O T H E M A R K E T P L A C E

Anti-Inhibitor,Factor VIIa & IX The critical-care products

Reference Chart

B R I N G I N G T R U S T

Veri�ed Electronic Pedigree™

Online Drug Pedigreewww.FFFenterprises.com

Lot-Track™

Product Tracking &Notification Service

(800) 843-7477

IG Living MagazineImmune Globulin

Informationwww.IGLiving.com

MyFluVaccine™

Flu Vaccine Programwww.MyFluVaccine.com

VaxAmerica™

Vaccination Programwww.VaxAmerica.com

NuFACTOR®Specialty Pharmacy

www.NuFACTOR.com

BioSupply Trends Quarterly Magazine

Marketplace Newswww.BSTQuarterly.com

Wow! Customer CareQuestions & Orders

(800) 843-7477

(800) 843-7477Emergency Orders 24/7/365

Place an Order

FFFenterprises.comMyFluVaccine.com

Online Ordering

FAX (800) 418-4333 EMAIL [email protected]

REGULAR ORDERING HOURS8am - 8pm ET | 7am - 7pm CT | 6am - 6pm MT | 5am - 5pm PT

SHIPPINGFOB Origin - Standard: Overnight or 2 day deliveryFOB Destination - Expedited: Same day

Wow! Customer Care Ordering

FFF Enterprises is the nation’s most trusted supplier of biopharmaceuticals, plasma products, vaccines and clinical trial drugs. Our partners include all manufacturers of influenza vaccines, and we serve over 80% of U.S. hospitals and supply the nation’s leading non-acute care GPO members. FFF Enterprises is committed to improving and stabilizing the supply of specialty pharmaceuticals through our Guaranteed Channel Integrity™.

FFF Enterprises’ commitment to Guaranteed Channel Integrity includes our secure supply channel, a dedicated Customer Care Team and FFF’s Advisor Lines, which offer reimbursement and infusion support to healthcare providers in all sites of care.

Infusion Advisor Line Our infusion specialist will answer your questions about the principles of intravenous and subcutaneous infusion therapy, cost-effective care and improving patient outcomes at (800) 843-7477.

Pharmacy Advisor Line We know that when you have a product or dosing question, you need it answered right away. FFF’s on-call pharmacists are experienced with every drug we provide and available to answer your questions at any time of day at(800) 843-7477.

Reimbursement Advisor Line FFF’s Reimbursement Services office is staffed by expert reimbursement specialists, ready to resolve your questions and guide you through the complexities of biopharmaceutical reimbursement, from 8am to 5pm PT, at (800) 843-7477.

Service Directory

©2014 FFF Enterprises, Inc. Products and trademarks are the property of their respective owners. Reflects prescribing information for products as of June 2014. FL175 Rev0614

Now in our 26th counterfeit-free year, Guaranteed Channel Integrity™

is the result of our long-term commitment to purchase only from

manufacturers and ship only to healthcare providers to protect

you and your patients from the risks of counterfeiting,

drug diversion and irresponsible pricing.

Our proprietary Verified Electronic Pedigree™ system and Lot-Track™

service provide reliable and accurate verification of our secure channel.

Our Verified Inventory Program™ utilizes RFID technology to monitor

high-value medication inventory and eliminate carrying costs

through a consignment-based model.

Page 2: Anti-Inhibitor, Factor VIIa & IX critical-care products ...

SOURCES •Manufacturers'fullprescribinginformation •RegistryofClottingFactorConcentrates,9thEdition,April2012.

KEYAICC anti-inhibitorcoagulantcomplex

DIC disseminatedintravascularcoagulation

IU internationalunit

MI myocardialinfarction

NOTES 1 Referalsotofullprescribinginformation.

2 ClinicalexperiencesuggeststhatpatientswithfactorVIIIinhibitorslessthan5BethesdaUnits(BU)maybesuccessfullytreatedwithantihemophilicfactor.Patientswithtitersrangingbetween5and 10BUmayeitherbetreatedwithantihemophilicfactororFEIBANF.CaseswithfactorVIIIinhibitortitersgreaterthan10BUhavegenerallybeenrefractorytotreatmentwithantihemophilicfactor.

3 ActualnumberofunitsoffactorVIIIinhibitorbypassingactivityisstatedonthelabelofeachvial.

4 AlphaNineSDcontainslow,non-therapeuticlevelsoffactorsII,VIIandX,andthereforeisnotindicatedforthetreatmentoffactorII,VIIorXdeficiencies.Notindicatedforthereversalofcoumarin anticoagulant-inducedhemorrhage,northetreatmentofhemophiliaApatientswithinhibitorstofactorVIII.

5BebulinisnotindicatedforthetreatmentoffactorVIIdeficiency.NoclinicalstudieshavebeenconductedtoshowbenefitfromproductfortreatingdeficienciesotherthanfactorIXdeficiency.

6BeneFIXisnotindicatedforreversalofcoumarin-inducedanticoagulationortreatmentof(1)otherfactordeficiencies,(2)hemophiliaApatientswithinhibitorstofactorVIII,or(3)bleedingdue tolowlevelsofliver-dependentcoagulationfactors.

7 Mononineisnotindicated(1)inthetreatmentorprophylaxisofhemophiliaApatientswithinhibitorstofactorVIII,(2)asreplacementtherapyoffactorsII,VIIorX,or(3)inthetreatmentor reversalofcoumarin-inducedanticoagulationorinahemorrhagicstatecausedbyhepatitis-inducedlackofproductionofliver-dependentcoagulationfactors.

Theinformationpresentedinthisguideisnotmeanttoserveasaguidelineforpatientmanagement.Anyprocedures,medicationsorothercoursesofdiagnosisortreatmentdiscussedorsuggestedinthisguideshouldnotbeusedbyclinicianswithoutfullevaluationoftheirpatients’conditionsandpossiblecontraindicationsondangersinuse,reviewofanyapplicablemanufacturer’sproductinformation,andcomparisonwithrecommendationsofotherauthorities.

Anti-Inhibitor, Factor VIIa & IX ReferenceChart (800) 843-7477Emergency Orders 24/7/365

Place an Order

FFFenterprises.comMyFluVaccine.com

Online Ordering FAX (800) 418-4333 EMAIL [email protected]

REGULAR ORDERING HOURS8am - 8pm ET | 7am - 7pm CT | 6am - 6pm MT | 5am - 5pm PT

SHIPPING

FOB Origin - Standard: Overnight or 2 day delivery

FOB Destination - Expedited: Same day

Wow! Customer Care Ordering

PreventionandcontrolofbleedinginpatientswithfactorIXdeficiencyduetohemophiliaB.4

Inspectvisuallyforparticulatematteranddiscolorationpriortoadministration.Administerwithin3hoursafterreconstitution.

Donotrefrigerateafterreconstitution.UseplasticluerlocksyringesbecauseproteinsuchasFEIBAtendstostick

tothesurfaceofall-glasssyringes.

FEIBA®

Baxter

(800) 423-2090 (877) 668-6777

InhemophiliaAandBpatientswithinhibitors:

1) Controlandpreventionofbleedingepisodes2) Perioperativemanagement3) Routineprophylaxistopreventorreducethe frequencyofbleedingepisodes.2

InadultsandchildrenwithhemophiliaB:

1) Controlandpreventionofbleedingepisodes2) Perioperativemanagement3) Routineprophylaxistopreventorreduce thefrequencyofbleedingepisodes

500,1000and2500units3

1) KnownanaphylacticorseverehypersensitivityreactionstoFEIBAor anyofitscomponents,includingfactorsofthekiningeneratingsystem.2) Disseminatedintravascularcoagulation(DIC).3) Acutethrombosisorembolism(includingMI).

35nmnanofiltrationandvaporheattreatment

Notstatedinprescribinginformation

Trisodiumcitrate

Mustnotexceed2unitsperkgofbodyweightperminute.

20mLor50mL(inaccordancewithproductpotency)

SterileWaterforInjection,USP,andaBAXJECTIIHi-FlowNeedlelessTransferDevice

Storeatroomtemperature,nottoexceed25˚C(77˚F).

Alprolix™AlphaNine® SD

Biogen IdecGrifols

(855) 692-5776(800) 520-2807

500IU,1000IU,2000IU,3000IU500IU,1000IU,1500IU

Individualswhohaveaknownhistoryofhypersensitivityreactions,includinganaphylaxis,totheproductoritsexcipients.Noneknown

Nanofiltration,columnchromatographypurificationSolvent/detergent,nanofiltration

66.40to86.52hours(variesbyagerange;seeprescribinginformation)~21hours

Mannitol,L-histidineandpolysorbate-20andsucroseDextroseandpolysorbate-80

Shouldbedeterminedbythepatient'scomfortlevel,andnofasterthan10mLperminute.Nottoexceed10mL/minute.

5mLforalldosagestrengths10mL

Prefilledsyringecontaining5mLdiluent(sealedwithplungerstopperandtip-cap)andasterilevialadapter(reconstitutiondevice).10mLSterileWaterforInjection,USPandMix2Vial™filtertransferset

Storeat2°Cto8°C(36°Fto46°F).Ifstoredatroomtemperature(RT),donotexceed30°C(86°F)forasingle6monthperiod.Donotplaceproduct

backintorefrigerationafterwarmingtoRT.ReconstitutedproductmaybestoredatRT,nottoexceed30°C(86°F)fornolongerthan3hours.

Donotfreezetopreventdamagetodiluentsyringe.

Storeattemperaturesbetween2–8°C(36–46°F).Donotfreezetopreventdamagetothediluentvial.Maybestored

atroomtemperaturenottoexceed30°C(86°F)for1month.

Administerwithin3hoursofreconstitution.Donotrefrigerateafterreconstitution.Keepawayfromdirectsunlight.Inspectforparticulate

matteranddiscolorationpriortoadministration.Donotadministerinthesametubingorcontainerwithothermedicinalproducts.

Warmdiluentandconcentratevialtoatleastroomtemperaturebeforereconstitution(butnotabove37˚C).Inspectforparticulate

matteranddiscolorationpriortoadministration.Usereconstitutedproductwithin3hoursofreconstitution.

Profilnine®

Grifols

(800) 520-2807

PreventionandcontrolofbleedinginpatientswithfactorIXdeficiency(hemophiliaB).

500IU,1000IU,1500IU

Noneknown

Solventdetergent

Nottoexceed10mL/minute.

500IU=5mL;1000IU=10mL;1500IU=10mL

SterileWaterforInjection,USPandMix2Vial™filtertransferset

Stablefor3years,uptotheexpirationdateprintedonitslabel,providedthatthestoragetemperaturedoesnotexceed

25°C(77°F).Donotfreeze.

Inspectvisuallyforparticulatematteranddiscolorationpriortoadministration.Administeratroomtemperature.Ensurethat

concentrateanddiluentareatroomtemperature(butnotabove37°C)beforereconstitution.Whilestablefor3hoursafterreconstitution,

promptadministrationisrecommended.

BeneFIX®

Pfizer

(800) 438-1985

1) Controlandpreventionofbleedingepisodesinadultand pediatricpatientswithhemophiliaB(congenitalfactorIX deficiencyorChristmasdisease).2) Peri-operativemanagementofadultand pediatricpatientswithhemophiliaB.6

250IU,500IU,1000IU,2000IU,3000IU

Patientswhohavemanifestedlife-threatening,immediatehypersensitivityreactions,includinganaphylaxis,totheproduct

oritscomponents,includinghamsterprotein

Nanofiltration

~18.8hours±5.4hours;range11to36hours

L-histidine,glycine,sucroseandpolysorbate-80

Administeroveraperiodofseveralminutes;adaptratetothecomfortlevelofeachindividualpatient.

5mLforalldosagestrengths

Sterileprefilleddiluentsyringe,vialadapterreconstitutiondevice,sterileinfusionset,2alcoholswabs,1bandageand1gauzepad.

Productmaybelabeledforeitherroomtemperaturestorageorrefrigeration;forstorageandhandlinginformationrefer

tofullprescribinginformationaccompanyingproduct.Donotfreezetopreventdamagetothediluentsyringe.

Inspectforparticulatematteranddiscolorationpriortoadministration.Reconstitutedproductshouldappearclearandcolorless.Administeratroomtemperature.Useproductwithin3hoursofreconstitution.Ifredbloodcellagglutinationisobservedinthetubingorsyringe,discard

allmaterials(tubing,syringeandBeneFIXsolution)andresumeadministrationwithanewpackage.

Mononine®

CSL Behring

(800) 504-5434

PreventionandcontrolofbleedinginfactorIXdeficiency,alsoknownashemophiliaBorChristmasdisease.7

500IU,1000IU

Knownhypersensitivitytomouseprotein

Monoclonalantibodyimmunoaffinitychromatography,sodiumthiocyanateandultrafiltration

Histidine,mannitolandpolysorbate-80

Therateofadministrationshouldbedeterminedbytheresponseandcomfortofthepatient;intravenousdosageadministrationratesofupto

225IU/minutehavebeenregularlytoleratedwithoutincident.Whenreconstitutedasdirected,i.e.,toapproximately100IU/mL,Mononineshouldbeadministeredatarateofapproximately2.0mLperminute.

500IU=5mL;1000IU=10mL

SterileWaterforInjectionUSPdiluent,double-endedneedleforreconstitution,ventedfilterspikeforwithdrawal,wingedinfusionsetandalcoholswabs

Whenstoredatrefrigeratortemperatureof2–8°C(36–46°F),Mononineisstablefortheperiodindicatedbytheexpirationdateonitslabel.

Withinthisperiod,Mononinemaybestoredatroomtemperaturenottoexceed25°C(77°F),forupto1month.Avoidfreezing,which

maydamagecontainerforthediluent.

Inspectforparticulatematteranddiscolorationpriortoadministration.Usereconstitutedproductwithin3hoursofreconstitution.

Useofplasticdisposablesyringesisrecommended.

Bebulin®

Baxter

(800) 423-2090

PreventionandcontrolofhemorrhagicepisodesinhemophiliaBpatients.5

FactorIXactivityinIUsisstatedonthelabelofeachvial

Knownhistoryofhypersensitivityreactionstotheproduct.Knownallergytoheparin.Knownhistoryofheparin-inducedthrombocytopenia.

19.97hours±8.24hours

Heparinadded

Nanofiltrationandvaporheattreatment

Administerataratecomfortabletopatient.Maximumrate2mL/minute.

20mLforalldosagestrengths

SterileWaterforInjection,USPdiluent,double-endedneedleandfilterneedleforreconstitutionandwithdrawal

Storeatrefrigeratortemperature,2–8˚C(36–46˚F).Donotfreeze.

Inspectforparticulatematteranddiscolorationpriortoadministration.Administeratroomtemperature.Donotrefrigerateafterreconstitution.

Usereconstitutedproductwithin3hoursofreconstitution.

Administrationshouldtakeplacewithin3hoursafterreconstitution.Inspectvisuallyforparticulatematteranddiscolorationpriortoadministration.

Donotmixwithinfusionsolutions.IflineneedstobeflushedbeforeorafterNovoSevenRTadministration,use0.9%SodiumChlorideInjection,USP.

Refertofullprescribinginformation;administerasaslowbolusinjectionover2to5minutes,dependingonthedoseadministered.

Novo Nordisk

1)TreatmentofbleedingepisodesinhemophiliaAorBpatientswithinhibitorstofactorVIIIorfactorIXandinpatientswithacquiredhemophilia,2)PreventionofbleedinginsurgicalinterventionsorinvasiveproceduresinhemophiliaAorBpatientswithinhibitorstofactorVIIIorfactorIXandinpatientswithacquiredhemophilia,3)Treatmentofbleedingepisodesinpatientswithcongenitalfactor

VII(FVII)deficiency,4)PreventionofbleedinginsurgicalinterventionsorinvasiveproceduresinpatientswithcongenitalFVIIdeficiency.

1mg(1000mcg),2mg(2000mcg),5mg(5000mcg)and8mg(8000mcg)

NovoSevenRTpurificationprocess

HemophiliaAorB:2.3hours(range1.7–2.7).CongenitalfactorVIIdeficiency:2.82to3.11hours.

Mannitol,L-histidine,sucrose,polysorbate-80andcalciumchloridedihydrate

NovoSevenRT:1vialofhistidinediluent

NovoSevenRTwithMixPro™:1prefilledhistidinediluentsyringewithsterilevialadapter

Priortoreconstitution,storeNovoSevenRTpowderandhistidinediluentbetween2–25°C(36–77°F).Donotfreeze.Storeprotectedfromlight.

Afterreconstitution,NovoSevenRTmaybestoredeitheratroomtemperatureorrefrigeratedforupto3hours.Donotfreeze

reconstitutedproductorstoreinsyringes.

NovoSeven® RTAICC VIIa IXIX IX IX IX IX

10mmolsolutionofL-histidineinwaterforinjection

Anti-InhibitorCoagulantComplex CoagulationFactorVIIa(Recombinant)RoomTemperature-Stable CoagulationFactorIX(Recombinant),FcFusionProteinCoagulationFactorIX(Human) FactorIXComplex,NanofilteredandVaporHeated CoagulationFactorIX(Recombinant) CoagulationFactorIX(Human),MonoclonalAntibodyPurified FactorIXComplex,Solvent/DetergentTreated/Nanofiltered

None

~22.6hours ~24.68hours±8.29hours

Polysorbate-80

Contraindications

ProductName

Manufacturer

ManufacturerContactNumber

ProductDescriptor

Indications

ViralRemoval/Inactivation

Stabilization

OtherAdministrationConsiderations1

DosageStrengths

SerumHalf-Life(Mean)

OtherPackageContents

DiluentVolume

Storage

RateofAdministration1