PracticeUpdate Conference Series: ERS 2018

*FASENRA significantly reduced annual exacerbation rate by 51% and 28% vs placebo (p<0.0001, p=0.0188; SIROCCO and CALIMA trials) 1,2 POWER TO REDUCE EXACERBATIONS IN SEVERE EOS INOPHI L IC ASTHMA *

75 % REDUCTION IN MEDIAN OCS DOSE from baseline with FASENRA vs 25% with placebo (p<0.001; week 28; ZONDA study) 3

8 DOSING † WEEKLY † after three doses 4-weekly 4

FASENRA is indicated as add-on therapy in patients aged 12 years and over with severe eosinophilic asthma (blood eosinophil count ≥300 cells/μL or ≥150 cells/μL if on oral corticosteroid treatment) 4

References: 1. Bleecker ER, et al. Lancet 2016;388(10056):2115–27. 2. FitzGerald JM, et al. Lancet 2016;388(10056):2128–41. 3. Nair P, et al. N Engl J Med 2017;376(25):2448–58. 4. Fasenra (benralizumab) Product Information. April 2018. FASENRA ® is a registered trademark of the AstraZeneca group of companies. Registered user AstraZeneca Pty Ltd. ABN 54 009 682 311. 66 Talavera Road, Macquarie Park, NSW 2113. www.astrazeneca.com.au. For Medical Information enquiries: 1800 805 342 or medinfo.australia@astrazeneca.com.To report an adverse event: 1800 805 342 or via https://aereporting.astrazeneca. com. AU-4639 ASTR0072/EMBC Date of preparation: July 2018 FASENRA ® (benralizumab) 30 mg in 1 mL, prefilled syringe for subcutaneous injection. THERAPEUTIC INDICATION: Fasenra is indicated as an add-on therapy in patients aged 12 years and over with severe eosinophilic asthma (blood eosinophil count ≥ 300 cells/µL or ≥ 150 cells/µL if on oral corticosteroid treatment). DOSE AND METHOD OF ADMINISTRATION: Fasenra should be prescribed by a healthcare professional in consultation with a specialist physician experienced in the diagnosis and treatment of severe asthma. Treatment with high-dose ICS and LABA should be optimised prior to commencement of treatment with Fasenra. The recommended dose is 30 mg of Fasenra by subcutaneous injection every 4 weeks for the first 3 doses, and then every 8 weeks thereafter. Fasenra should be administered by a healthcare professional, and is not for self-administration by the patient. CONTRAINDICATIONS: Hypersensitivity to benralizumab or any of its excipients. PRECAUTIONS: Fasenra should not be used to treat acute asthma exacerbations. Reduction in OCS dose, if appropriate, should be gradual and performed under the supervision of a physician. Abrupt discontinuation of OCS after initiation of Fasenra therapy is not recommended. Hypersensitivity reactions (eg urticaria, urticaria papular, rash) have occurred following administration of Fasenra. These reactions generally occur within hours of administration, but in some instances have a delayed onset (ie days). In the event of a hypersensitivity reaction, Fasenra should be discontinued. Parasitic (helminth) infections: treat patients with pre-existing helminth infections before initiating therapy with Fasenra. If patients become infected while receiving treatment with Fasenra and do not respond to antihelminth treatment, discontinue treatment with Fasenra until infection resolves. Children under 12; pregnancy (category B1); lactation. ADVERSE EFFECTS: Common ( ≥ 3% frequency): headache, pharyngitis, arthralgia, cough; Less common ( ≤ 3% frequency): hypersensitivity reactions, pyrexia, injection site reactions. See full PI for details. Date of first inclusion in the ARTG: 2 April 2018. Date of most recent amendment: 2 April 2018. BEFORE PRESCRIBING PLEASE REVIEW FULL PRODUCT INFORMATION AVAILABLE ON REQUEST FROM ASTRAZENECA ON 1800 805 342 OR www.astrazeneca.com.au/PI PBS Information: This product is not listed on the PBS.