b'FASENRA is indicated for the add-on maintenance treatment of patients withHELP PROTECT OUR VETERANS severe asthma aged 12 years and older, and with an eosinophilic phenotype.FASENRA is not indicated for treatment of other eosinophilic conditions or for the relief of acute bronchospasm or status asthmaticus. and Service Men and Women from severe asthma exacerbations leading to OCS overexposureIn the SIROCCO (48 weeks) pivotal trial, a 51% reduction in annual asthma exacerbation rate was observed in patients treated with FASENRA + SOC (n=267) vs placebo + SOC (n=267) (0.74 vs 1.52, P0.0001). 2,3FASENRA(benralizumab)In ZONDA (28 weeks), a 75% median reduction in final OCS dose was observed in OCS-dependent patients treated with FASENRA + SOC (n=73) compared to a 25% reduction with placebo + SOC (n=75) while maintaining asthma control is PREFERRED * on the (P 2,4 In ZONDA, OCS-dependent patients received chronic oral corticosteroid therapy (7.5 to 40 mg daily) for 0.001).6 continuous months directly preceding enrollment. 4VA FORMULARY for Results from PONENTE OCS Reduction Phase: an open-label, single-arm studyof patients ACHIEVED ZERO DAILY OCSsevere eosinophilic asthma 63 % 51 while maintaining asthma control*Preferred is defined as Tier 1, Tier 2, or Tier 3 when Tier 3 is the lowest branded tier.or REDUCED THE DAILY of patients ELIMINATED OCS USEFewest Doses Per Year With Q8W Dosing 2 82 %DOSAGE to 5 mg if adrenal insufficiency prevented further reduction 5Every 8 weeks following the first 3 doses (Q4W)Results observed in patients treated with FASENRA + SOC (N=598) during the OCS reduction phase of the PONENTE study. FASENRA Pen Results are descriptive only; no formal hypotheses were tested. 5FASENRA PenPharmacy Benefit In PONENTE, OCS-dependent patients received chronic oral corticosteroid therapy (prednisone 5 mg/day or equivalent) for at Pharmacy Benefit least 3 months preceding enrollment. 5FASENRA Pre-Filled Syringe Do not abruptly discontinue corticosteroids. Dose reductions, if appropriate, should be gradual and may be associated with FASENRA Pre-Filled Syringe withdrawal symptoms and/or unmask previously controlled conditions.Medical BenefitMedical BenefitRead about OCS Reduction Data at FasenraStudies.comGET THE CRITERIA FOR USE FORM HERE Sustained over at least 4 weeks without worsening of asthma5Daily OCS dosages were reduced by 1 to 5 mg every 1 to 4 weeksdepending on the starting OCS dosage and asthma controluntil a daily dosage of 5 mg was achieved. For patients with baseline OCS 5 mg/day, the median time to achieve 5 mg/day was 4.4 weeks. For those taking 10 mg/day, the median time was 8.4 weeks. The HPA axis function was assessed after reaching Dosing comparisons do not imply comparable efficacy, safety,a stable 5-mg daily OCS dosage for 4 weeks; thereafter, the dosage was titrated downward according to adrenal status.5or FDA-approved indications STUDY DESIGNSSIROCCO (Trial 1) 3 ZONDA (Trial 3) 4 daily OCS (5mg) for 3 months were included. Patients had IMPORTANT SAFETY INFORMATION SIROCCO (48 weeks) was a randomized, double-blind, parallel- A 28-week, randomized, double-blind, parallel-group, placebo- a bEOS count of 150 cells/L at baseline or 300 cells/L in group, placebo-controlled, multicenter study comparingcontrolled, multicenter OCS reduction study comparing thethe previous 12 months for inclusion in the study. The primary CONTRAINDICATIONS be gradual and performed under the directUSE IN SPECIFIC POPULATIONS FASENRA (30 mc SC) Q4W for the first 3 doses, then Q8Wefficacy and safety of FASENRA (30 mg SC) Q4W for the first 3endpoints were percentage of patients who achieved a 100% Known hypersensitivity to benralizumab orsupervision of a physician. Reduction inA pregnancy exposure registry monitorsthereafter; benralizumab (30 mg SC) Q4W; and placebo (SC).doses, then Q8W thereafter; benralizumab (30 mg SC) Q4W; andreduction in daily OCS dosage and percentage of patients who placebo (SC) Q4W. A total of 220 adult (18-75 years old) patientsachieveda 100% dosage reduction or achieved a daily OCS excipients. corticosteroid dose may be associated withpregnancy outcomes in womenA total of 1204patients aged 12-75 years old with severewith severe asthma on high-dose ICS plus LABA and daily OCSdosage 5mg if further reduction was not possible because of asthma uncontrolled on high-dose ICS plus LABA with or WARNINGS AND PRECAUTIONS systemic withdrawal symptoms and/or unmaskexposed to FASENRA during pregnancy.without additional controllers were included. Patients had a(7.5 to 40 mg/day), bEOS counts of 150 cells/L, and a history ofadrenal insufficiency. 1 exacerbation in the previous year were included. The primaryAfter the OCS reduction phase, patients spent approximately Hypersensitivity Reactions conditions previously suppressed by systemicTo enroll call 1-877-311-8972 or visithistory of 2 exacerbations requiring systemic corticosteroidsendpoint was the median percent reduction from baseline in the6 months in the maintenance phase. During this time, they corticosteroid therapy. www.mothertobaby.org/fasenra. or temporary increase in usual dosing in the previous year.final daily OCS dose while maintaining asthma control.continued treatment with 30 mg benralizumab Q8W and Hypersensitivity reactions (eg, anaphylaxis,Patients were stratified by geography, age, and bloodPONENTE (Phase3b Oral angioedema, urticaria, rash) have occurredParasitic (Helminth) Infection The data on pregnancy exposure from the clinicaleosinophil counts (300 cells/L and 300 cells/L). TheCorticosteroid Reduction Trial) 5-7 either continued without OCS treatment or continued with the final dosage they had achieved in the reduction phase. after administration of FASENRA. TheseIt is unknown if FASENRA will influence atrials are insufficient to inform on drug-associatedprimary endpoint was annual exacerbation rate ratio vsAn open-label, single-arm, multicenter, Phase 3b OCS- Investigators could prescribe corticosteroids for exacerbations placebo in patients with blood eosinophil counts of 300reduction study designed to evaluate the efficacy and safety of reactions generally occur within hours ofpatients response against helminth infections.risk. Monoclonal antibodies such as benralizumabcells/L on high-dose ICS and LABA. Exacerbations weretapering chronic OCS use in patients with severe uncontrolledor increase daily dose in cases of decreased asthma control.administration, but in some instances haveTreat patients with pre-existing helminthare transported across the placenta during thedefined as a worsening of asthma that led to use of systemicasthma after initiation of FASENRA. Patients received FASENRAExacerbations were defined as worsening of asthma symptoms a delayed onset (ie, days). Discontinue in theinfections before initiating therapy withthird trimester of pregnancy;therefore, potentialcorticosteroids for 3 days, temporary increase in a stable OCS30 mg SC Q4W for the first 3 doses, then Q8W thereafter.leading to the temporary need for systemic corticosteroids, background dose for 3 days, emergency/urgent care visitThe benralizumab treatment period consisted of a 4-weekemergency department, or urgent care visit because of asthma event of a hypersensitivity reaction. FASENRA. If patients become infected whileeffects on a fetus are likely to begreater duringbecause of asthma that needed systemic corticosteroids, orVisit us online to: that required a systemic corticosteroid bolus, or inpatient induction phase with no OCS adjustments, followed by a Acute Asthma Symptoms orreceiving FASENRA and do not respond to anti- the third trimester of pregnancy. inpatient hospital stay of 24 hours because of asthma. Keyvariable, personalized OCS reduction phase, and a 24-32hospitalization related to asthma.helminth treatment, discontinue FASENRA untilsecondary endpoints were prebronchodilator FEV 1and totalweek maintenance phase. A total of 598 adult (18 yearsIn PONENTE, FASENRA was administered in addition to daily OCS Deteriorating Disease infection resolves. INDICATION asthma symptom score at Week 48 in the same population.Read the latest issue (5 mg) plus SOC, which is defined as high-dose ICS plus LABA.FASENRA should not be used to treat acuteold) patients on high-dose ICS plus LABA for 6 months and FASENRA is indicated for the add-onbEOS, blood eosinophil; HPA, hypothalamic-pituitary-adrenal; ICS, inhaled corticosteroid; LABA, long-acting beta-agonist;OCS, oral corticosteroids; Q4W, every 4 weeks; Q8W, every 8 weeks; asthma symptoms, acute exacerbations, orADVERSE REACTIONS maintenance treatment of patients with severeSC, subcutaneous; SOC, standard of care.Post a comment or read commentsacute bronchospasm. The most common adverse reactions (incidenceasthma aged 12 years and older, and with an Keep up with late-breaking newsReferences: 1. Data on File, US-60239, AstraZeneca Pharmaceuticals LP.2. FASENRA (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Reduction of Corticosteroid Dosage5%) include headache and pharyngitis. eosinophilic phenotype. Pharmaceuticals LP; February 2021. 3. Bleecker ER, FitzGerald JM, Chanez P, et al; SIROCCO study investigators. Efficacy and safety of benralizumab for patients Do not discontinue systemic or inhaledInjection site reactions (eg, pain, erythema,FASENRA is not indicated for treatment of other Receive CME/CE creditswith severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting b 2 -agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2115-2127.4. Nair P, Wenzel S, Rabe KF, et al. Oral glucocorticoidsparing effect of benralizumab in severe asthma. N Engl J Med. 2017;376(25):2448-2458. 5. Menzies-Gow A, Gurnell M, Heaney L, et al. Oral corticosteroid elimination via a personalised reduction corticosteroids abruptly upon initiationpruritus, papule) occurred at a rate of 2.2% ineosinophilic conditionsSign up for the USM e-newsletterU.S. Medicine Directalgorithm in adults with severe, eosinophilic asthma treated with benralizumab (PONENTE): a multicentre, open-label, single-arm study [published correction of therapy with FASENRA. Reductions inpatients treated with FASENRA compared withFASENRA is not indicated for the relief of acuteappears in Lancet Respir Med. 2021;9(12):e114]. Lancet Respir Med. 2022;10(1):47-58. 6. Menzies-Gow A, Corren J, Bel EH, et al. Corticosteroid tapering with corticosteroid dose, if appropriate, should1.9% in patients treated with placebo. bronchospasm or status asthmaticusStart or continue your free subscription to U.S. Medicinebenralizumab treatment for eosinophilic asthma: PONENTE trial. ERJ Open Res. 2019;5(3):00009-2019. 7. Menzies-Gow A, Gurnell M, Heaney LG, et al. Adrenal function recovery after durable oral corticosteroid sparing with benralizumab in the PONENTE study. Eur Respir J. 2022;60(6):2103226. Search the U.S. Medicine archivesYou 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.Please see Brief Summary of full Prescribing Information on adjacent pages. 2023 AstraZeneca. All rights reserved. US-79891 9/23 usmedicine.comFASENRA and FASENRA Pen are registered trademarks of the AstraZeneca group of companies. US-79891_US-51016 Fasenra US Medicine 2024 Directory of Federal Medical Treatment Facilities.indd 1 11/22/23 12:04 PM'