b'FASENRA is indicated as an add-on maintenance treatment of patientsONLY FASENRA is Powerful, Precise and Proven12 years and older with severe eosinophilic asthma. In SIROCCO (48 weeks), a 51% reduction was observed in annual rate of asthma exacerbations in patients treated with FASENRA FASENRA is not indicated for treatment of other eosinophilic conditions+ SOC (n=267) vs placebo + SOC (n=267) (0.74 vs 1.52, P0.0001). In CALIMA (56 weeks), a 28% reduction was observed in annual 2,3or for the relief of acute bronchospasm or status asthmaticus. rate of asthma exacerbations in patients treated with FASENRA + SOC (n=239) vs placebo + SOC (n=248) (0.73 vs 1.01, P=0.019). 2,4POWERFUL PRECISE PROVENFor patients with severe eosinophilic asthma FASENRA significantly reducedThe ONLY respiratory biologic thatThe ONLY respiratory biologic FASENRA (benralizumab) patients exacerbations. 2-4 precisely targets eosinophils enablingfor eosinophilic asthma that As observed in MELTEMI over 5 years,the immune system to remove them. 2 demonstrated a proven safety Is Preferred * on Formulary atat least 75% OF PATIENTS had ZEROThe mechanism of action ofprofile through 5 YEARS 5,*EXACERBATIONS each year. 5,*,Resultsbenralizumab in asthma has not been the VA and IHS of this endpoint are descriptive only. definitively established.1From FIRST DOSE 2-4,6, and now with data through 5 YEARS 5,Nucala (mepolizumab) *The MELTEMI open-label, Phase 3 extension study enrolled patients who were previously enrolled in a predecessor clinical trialSIROCCO, CALIMA, or ZONDAand and Dupixent (dupilumab) enrolled in BORA for 16 weeks and 40 weeks and then transitioned to MELTEMI. Results above are specific to the group of patients who received FASENRA Q8W from predecessor studies through MELTEMI. Mean treatment duration for FASENRA Q8W was 3.7 years. The primary endpoint was safety and tolerability. Efficacy analysis is descriptive only and includes patients with bEOS 300 cells/L receiving HD-ICS at baseline. Of the patients receiving FASENRA Q8W, 59% had zero exacerbations Are Non-Formulary 1across the extension study period (n=110; over 304 total follow-up years). Results are descriptive only. 5As observed in MELTEMI, an open-label extension study, the proportion of patients with zero exacerbations (%) in the FASENRA Q8W (first 3 doses Q4W) predecessor Drug or formulary comparisons do not imply comparable efficacy,and extension studies arm was 76% in the pivotal trials (n=110); 75% in Year 2 (n=110); 75% in Year 3 (n=110); 83% in Year 4 (n=93); 87% in Year 5 (n=45).5 In MELTEMI, patients could continue in the study until FASENRA was commercially available in their local market or for 130 weeks in countries in which a marketing application was safety or FDA-approved indications. not submitted. As FASENRA became approved in various markets, patient numbers declined.5Study limitations: There was no control arm and there was potential selection bias. Patients who did not experience benefits with their asthma treatment may have been more likely to discontinue the study vs those who did experience benefits and, similarly, patients who experienced certain serious adverse events in Scan here to see if FASENRA is appropriate for your patients.predecessor studies were not eligible to enter MELTEMI, both of which could contribute to selection bias.5In SIROCCO and CALIMA, statistical significance for FEVimprovement was established at end of treatment. Week 4 results were descriptive only. FASENRA Learn more at www.FasenraHCP.com 1 1compared with placebo at Week 4 (first measured time point after demonstrated greater improvements in change from baseline in prebronchodilator FEVadministration of treatment dose), which were maintained through end of treatment. In a Phase 2 trial, a reduction in blood eosinophil counts was observed 24 hours *Preferred is defined as Tier 1, Tier 2, or Tier 3 when Tier 3 is the lowest branded tier. post dose. In SIROCCO and CALIMA, following administration of FASENRA, blood eosinophils were reduced to a median absolute blood eosinophil count of 0 cells/L. This magnitude of reduction was seen at the first observed time point (4 weeks of treatment) and was maintained throughout the treatment period.2-4,6,7 See Study DesignsIMPORTANT SAFETY INFORMATION STUDY DESIGNSCONTRAINDICATIONS Reduction in corticosteroid dose may be associatedoutcomes in women exposed to FASENRA duringSIROCCO AND CALIMA (Trials 1 and 2) 2-4 care visit because of asthma that needed systemicMELTEMI were aged 18 years or older, had a diagnosis Known hypersensitivity to benralizumab orwith systemic withdrawal symptoms and/orpregnancy. To enroll call 1-877-311-8972 or visitSIROCCO (48-week) and CALIMA (56-week) werecorticosteroids, or inpatient hospital stay of 24 hoursof severe asthma, and were being treated with ICS/excipients. unmask conditions previously suppressed bywww.mothertobaby.org/fasenra. 2 randomized, double-blind, parallel-group,because of asthma. Key secondary endpoints wereLABA therapyOCS and/or other asthma controllers. systemic corticosteroid therapy. placebo-controlled, multicenter studies comparingprebronchodilator FEV 1and total asthma symptomThe primary endpoint was safety and tolerability WARNINGS AND PRECAUTIONS The data on pregnancy exposure from the clinicalFASENRA 30 mg SC Q4W for the first 3 doses, thenscore at Week 48 (SIROCCO) and Week 56 (CALIMA) inmeasured by rates of AEs and SAEs.Hypersensitivity Reactions Parasitic (Helminth) Infection trials are insufficient to inform on drug-associatedQ8W thereafter; benralizumab 30 mg SC Q4W; andthe same population.Hypersensitivity reactions (eg, anaphylaxis,It is unknown if FASENRA will influence a patientsrisk. Monoclonal antibodies such as benralizumabplacebo SC. A total of 1204 (SIROCCO) and 1306Study limitations: Patients who did not angioedema, urticaria, rash) have occurred afterresponse against helminth infections. Treatare transported across the placenta during the(CALIMA) patients aged 12-75 years old with severeMELTEMI (Open-Label Safetyexperience benefits with their asthma treatment administration of FASENRA. These reactions generallypatients with pre-existing helminth infectionsthird trimester of pregnancy; therefore, potentialasthma uncontrolled on high-dose ICS (SIROCCO)Extension Trial) 5 may have been more likely to discontinue the study occur within hours of administration, but in somebefore initiating therapy with FASENRA. If patientseffects on a fetus are likely to be greater duringand medium- to high-dose ICS (CALIMA) plus LABAAn open-label, Phase 3 extension study thatvs those who did experience benefits and, similarly, become infected while receiving FASENRA andthe third trimester of pregnancy. patients who experienced certain SAEs in predecessor instances have a delayed onset (ie, days). Discontinuewith or without additional controllers were included.enrolled patients who were previously enrolled instudies were not eligible to enter MELTEMI, both of in the event of a hypersensitivity reaction. do not respond to anti-helminth treatment,INDICATION Patients had a history of 2 exacerbations requiringa predecessor clinical trialSIROCCO, CALIMA, orwhich could contribute to selection bias.discontinue FASENRA until infection resolves. systemic corticosteroids or temporary increase inZONDAand enrolled in BORA for 16 weeks and Acute Asthma Symptoms orFASENRA is indicated for the add-onusual dosing in the previous year. Patients were40 weeks and then transitioned to MELTEMI. InAE, adverse event; bEOS, blood eosinophils; FEV 1 , Deteriorating Disease ADVERSE REACTIONS maintenance treatment of patients with severepredecessor studies, patients received placebo orforced expiratory volume in 1 second; HD-ICS, stratified by geography, age, and blood eosinophil FASENRA should not be used to treat acuteThe most common adverse reactions (incidenceasthma aged 12 years and older, and with ancounts (300 cells/L and 300 cells/L). TheFASENRA 30 mg SC, either Q4W or Q8W (first 3 doseshigh-dosage inhaled corticosteroids; ICS, inhaled asthma symptoms, acute exacerbations, or acute 5%) include headache and pharyngitis. eosinophilic phenotype. primary endpoint was annual exacerbation rateQ4W); in BORA, patients receiving placebo werecorticosteroid; LABA, long-acting beta agonist; OCS, bronchospasm. Injection site reactions (eg, pain, erythema, pruritus,FASENRA is not indicated for treatment ofratio vs placebo in patients with blood eosinophilrandomized to FASENRA Q4W or Q8W and continuedoral corticosteroid; Q4W, every 4 weeks; Q8W, every 8 Reduction of Corticosteroid Dosage papule) occurred at a rate of 2.2% in patientsother eosinophilic conditions counts of 300 cells/L on high-dose ICS and LABA.on the same treatment in MELTEMI until FASENRAweeks; SAE, severe adverse event; SC, subcutaneous.Do not discontinue systemic or inhaledtreated with FASENRA compared with 1.9% inFASENRA is not indicated for the relief ofExacerbations were defined as a worsening ofwas commercially available in their local market. corticosteroids abruptly upon initiation of therapypatients treated with placebo. acute bronchospasm or status asthmaticus asthma that led to use of systemic corticosteroidsIn MELTEMI, patients received either with FASENRA. Reductions in corticosteroid dose, for 3 days, temporary increase in a stable OCSFASENRA 30 mg SC Q4W or FASENRA if appropriate, should be gradual and performedUSE IN SPECIFIC POPULATIONS Please see Brief Summary ofbackground dose for 3 days, emergency/urgent30 mg SC Q8W. Patients enrolled in under the direct supervision of a physician.A pregnancy exposure registry monitors pregnancyfull Prescribing Information on adjacent page. You are encouraged to report the negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.References: 1. Data on File, US-60239, AstraZeneca Pharmaceuticals LP.2. FASENRA (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; FebruaryThis product information is intended for US healthcare professionals only.2021. 3. Bleecker ER, FitzGerald JM, Chanez P, et al; SIROCCO study investigators. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting2 -agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2115-2127. 4. FitzGerald JM, Bleecker ER, Nair P, et al; CALIMA study investigators. Benralizumab, an anti-interleukin-5 receptormonoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2128-2141. 5.Korn S, Bourdin A, Chupp G, et al. Integrated safetyFASENRA and FASENRA Pen are registered trademarks of the AstraZeneca group of companies. Nucala is a registered trademark of the GSK group of companies.and efficacy among patients receiving benralizumab for up to 5 years. J Allergy Clin Immunol Pract. 2021;9(12):4381-4392.e4.6. FitzGerald JM, Bleecker ER, Bourdin A, et al. Two-yearDupixent is a registered trademark of Sanofi and Regeneron Pharmaceuticals, Inc.integrated efficacy and safety analysis of benralizumab in severe asthma.Asthma Allergy. 2019;12:401-413.7.Data on File, REF-28001 AZPLP.2022AstraZeneca. All rights reserved. US-68979 Last Updated 11/22US-68979_US-51016 Fasenra US Medicine.indd 1 12/5/22 1:53 PM'