b'FASENRA (benralizumab) injection, for subcutaneous use 4Initial U.S. Approval: 2017 Injectallofthemedicationbypushingin Brief Summary of Prescribing Information. For complete prescribing information consultthe plunger all the way until the plungerofficial package insert.head is completely between the needle guard activation clips. This is necessary to activateINDICATIONS AND USAGEthe needle guard.FASENRA is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype [see Clinical Studies (14) in the full Prescribing Information].Limitations of use: 5 FASENRAisnotindicatedfortreatmentofothereosinophilicconditions. Afterinjection,maintainpressureonthe plunger head and remove the needle from theFASENRAisnotindicatedforthereliefofacutebronchospasmorstatusasthmaticus. skin. Release pressure on the plunger head to DOSAGE AND ADMINISTRATIONallow the needle guard to cover the needle.Recommended Dose Do not re-cap the prefilled syringe.FASENRAisforsubcutaneoususeonly.The recommended dose of FASENRA is 30 mg administered once every 4 weeks for the first 3doses,andthenonceevery8weeksthereafterbysubcutaneousinjectionintotheupper 6Discard the used syringe into a sharps container.arm,thigh,orabdomen. Instructions for Administration of FASENRA PENGeneral Administration Instructions RefertotheFASENRAPENInstructionsforUseformoredetailedinstructionsontheFASENRA is intended for use under the guidance of a healthcare provider. In line with clinicalpreparationandadministrationofFASENRAPEN[See Instructions for Use in the full practice,monitoringofpatientsafteradministrationofbiologicagentsisrecommendedPrescribing Information].Apatientmayself-injectorthepatientcaregivermayadminister[see Warnings and Precautions (5.1) in the full Prescribing Information]. FASENRAPENsubcutaneouslyafterthehealthcareproviderdeterminesitisappropriate.AdministerFASENRAintothethighorabdomen.TheupperarmcanalsobeusedifaCONTRAINDICATIONS healthcareproviderorcaregiveradministerstheinjection.Priortoadministration,warm FASENRAiscontraindicatedinpatientswhohaveknownhypersensitivitytobenralizumaborFASENRAbyleavingcartonatroomtemperatureforabout30minutes.Visuallyinspect any of its excipients [see Warnings and Precautions (5.1) in the full Prescribing Information]. FASENRA for particulate matter and discoloration prior to administration. FASENRA is clearWARNINGS AND PRECAUTIONSto opalescent, colorless to slightly yellow, and may contain a few translucent or white toHypersensitivity Reactionsoff-white particles. Do not use FASENRA if the liquid is cloudy, discolored, or if it containsHypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, rash) have occurred large particles or foreign particulate matter. following administration of FASENRA. These reactions generally occur within hours of Prefilled Syringe administration,butinsomeinstanceshaveadelayedonset(i.e.,days).IntheeventofaTheprefilledsyringeisforadministrationbyahealthcareprovider. hypersensitivityreaction,FASENRAshouldbediscontinued[see Contraindications (4) in the full Prescribing Information].Autoinjector (FASENRA PEN) Acute Asthma Symptoms or Deteriorating DiseaseFASENRAPENisintendedforadministrationbypatients/caregivers.Patients/caregiversFASENRAshouldnotbeusedtotreatacuteasthmasymptomsoracuteexacerbations.Donotmayinjectafterpropertraininginsubcutaneousinjectiontechnique,andafterthehealthcare useFASENRAtotreatacutebronchospasmorstatusasthmaticus.Patientsshouldseekmedical provider determines it is appropriate. advice if their asthma remains uncontrolled or worsens after initiation of treatment with FASENRA.Instructions for Administration of FASENRA Prefilled Syringe (Healthcare Providers) Reduction of Corticosteroid Dosage Refer to Figure 1 to identify the prefilled syringe components for use in the administration steps. Donotdiscontinuesystemicorinhaledcorticosteroidsabruptlyuponinitiationoftherapy withFASENRA.Reductionsincorticosteroiddose,ifappropriate,shouldbegradualand Figure 1 Needle guard Syringe Label with performed under the direct supervision of a physician. Reduction in corticosteroid dose may activation clips body expiration date Needle cover beassociatedwithsystemicwithdrawalsymptomsand/orunmaskconditionspreviouslysuppressedbysystemiccorticosteroidtherapy.Parasitic (Helminth) InfectionEosinophilsmaybeinvolvedintheimmunologicalresponsetosomehelminthinfections.Plunger Patientswithknownhelminthinfectionswereexcludedfromparticipationinclinicaltrials.Itishead unknownifFASENRAwillinfluenceapatientsresponseagainsthelminthinfections.Treatpatientswithpre-existinghelminthinfectionsbeforeinitiatingtherapywithFASENRA.IfpatientsbecomeinfectedwhilereceivingtreatmentwithFASENRAanddonotrespondtoanti-helminth treatment, discontinue treatment with FASENRA until infection resolves.ADVERSE REACTIONS Plunger Finger Viewing Needle Thefollowingadversereactionsaredescribedingreaterdetailinothersections:flange windowHypersensitivityReactions[see Warnings and Precautions (5.1) in the full Prescribing Information]Do not touch the needle guard activation clips to prevent premature activation of the needleClinical Trials ExperienceLorem ipsum safety guard. Because clinical trials are conducted under widely varying conditions, adverse reaction rates 1Grasp the syringe body, not the plunger, to remove prefilled syringe from the tray. Checkobservedintheclinicaltrialsofadrugcannotbedirectlycomparedtoratesintheclinicaltheexpirationdateonthesyringe.Thesyringemaycontainsmallairbubbles;thisis trialsofanotherdrugandmaynotreflecttheratesobservedinpractice.normal. Do notexpeltheairbubblespriortoadministration. Across Trials 1, 2, and 3, 1,808 patients received at least 1 dose of FASENRA [see Clinical NEEDLE GUARD Studies (14) in the full Prescribing Information].Thedatadescribedbelowreflectexposure 2Donotremoveneedlecoveruntilreadytoinject.to FASENRA in 1,663 patients, including 1,556 exposed for at least 24 weeks and 1,387 WINGSHoldthesyringebodyandremovetheneedleexposedforatleast48weeks.ThesafetyexposureforFASENRAisderivedfromtwoPhase3coverbypullingstraightoff.Donotholdthe placebo-controlledstudies(Trials1and2)from48weeksduration[FASENRAevery4weeksplunger or plunger head while removing the (n=841),FASENRAevery4weeksfor3doses,thenevery8weeks(n=822),andplaceboneedle cover or the plunger may move. If the(n=847)]. While a dosing regimen of FASENRA every 4 weeks was included in clinical trials, prefilled syringe is damaged or contaminated FASENRA administered every 4 weeks for 3 doses, then every 8 weeks thereafter is the recom-(for example, dropped without needle cover inmended dose [see Dosage and Administration (2.1) in the full Prescribing Information]. The place), discard and use a new prefilled syringe. population studied was 12 to 75 years of age, of which 64% were female and 79% were white. 3 Adverse reactions that occurred at greater than or equal to 3% incidence are shown in Table 1.Gently pinch the skin and insert the needle Table 1. Adverse Reactions with FASENRA with Greater than or Equal to 3% Incidence attherecommendedinjectionsitein Patients with Asthma (Trials 1 and 2)(i.e.,upperarm,thigh,orabdomen). Adverse Reactions FASENRA Placebo(N=822)(N=847) % %Headache 8 6Pyrexia 3 2Pharyngitis* 5 3Hypersensitivity reactions3 3*Pharyngitiswasdefinedbythefollowingterms:Pharyngitis,Pharyngitisbacterial,Viralpharyngitis,Pharyngitisstreptococcal.HypersensitivityReactionsweredefinedbythefollowingterms:Urticaria,Urticariapapular,andRash[see Warnings and Precautions (5.1) in the full Prescribing Information].US-68979_US-51016 Fasenra US Medicine.indd 2 12/5/22 1:53 PM'