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ADVERSE EVENT PROFILE

Adverse event profile comparable to placebo was observed in 3 clinical trials1

Adverse Effect Comparison Table Adverse Effect Comparison Table

*Pharyngitis was defined as follows: pharyngitis, pharyngitis bacterial, viral pharyngitis, and pharyngitis streptococcal.

Hypersensitivity reactions were defined as follows: urticaria, urticaria papular, and rash.

Please see full study descriptions for SIROCCO, CALIMA, and ZONDA.

ADVERSE EVENT PROFILE: BORA

In BORA, FASENRA given for an additional 56 weeks showed a similar adverse event profile to that observed in SIROCCO and CALIMA2

2 Years Icon

In BORA, the primary endpoint was to assess the safety and tolerability of the 2 dosing regimens of FASENRA. Patients who received FASENRA during SIROCCO and CALIMA continued to receive their randomized dose. Patients who received placebo were re-randomized to receive 1 of 2 dosages of FASENRA at the beginning of BORA.2

Injection site reactions

Injection site reactions Injection site reactions

Overall, treatment-emergent anti-drug antibody response developed in 13% of patients treated with FASENRA at the recommended dosing regimen during the 48- to 56-week treatment period. A total of 12% of patients treated with FASENRA developed neutralizing antibodies. Anti-benralizumab antibodies were associated with increased clearance of benralizumab and increased blood eosinophil levels in patients with high anti-drug antibody titers compared to antibody-negative patients. No evidence of an association of anti-drug antibodies with efficacy or safety was observed.1

Please see full study descriptions for SIROCCO, CALIMA, ZONDA, and BORA.

INDICATION

FASENRA is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.

  • FASENRA is not indicated for treatment of other eosinophilic conditions
  • FASENRA is not indicated for the relief of acute bronchospasm or status asthmaticus

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Known hypersensitivity to benralizumab or excipients.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions

Hypersensitivity reactions (eg, anaphylaxis, angioedema, urticaria, rash) have occurred after administration of FASENRA. These reactions generally occur within hours of administration, but in some instances have a delayed onset (ie, days). Discontinue in the event of a hypersensitivity reaction.

Acute Asthma Symptoms or Deteriorating Disease

FASENRA should not be used to treat acute asthma symptoms, acute exacerbations, or acute bronchospasm.

Reduction of Corticosteroid Dosage

Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with FASENRA. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Parasitic (Helminth) Infection

It is unknown if FASENRA will influence a patient’s response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with FASENRA. If patients become infected while receiving FASENRA and do not respond to anti-helminth treatment, discontinue FASENRA until infection resolves.

INDICATION

FASENRA is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.

  • FASENRA is not indicated for treatment of other eosinophilic conditions
  • FASENRA is not indicated for the relief of acute bronchospasm or status asthmaticus

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥ 5%) include headache and pharyngitis.

Injection site reactions (eg, pain, erythema, pruritus, papule) occurred at a rate of 2.2% in patients treated with FASENRA compared with 1.9% in patients treated with placebo.

USE IN SPECIFIC POPULATIONS

A pregnancy exposure registry monitors pregnancy outcomes in women exposed to FASENRA during pregnancy. To enroll call 1-877-311-8972 or visit www.mothertobaby.org/fasenra.

The data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk. Monoclonal antibodies such as benralizumab are transported across the placenta during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy.

Please read full Prescribing Information, including Patient Information.

You may report side effects related to AstraZeneca products by clicking here.

References: 1. FASENRA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; October 2019. 2. Bleecker ER, FitzGerald JM, Chanez P, et al. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting ß2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388:2115-2127. 3. FitzGerald JM, Bleecker ER, Nair P, et al. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016;388:2128-2141. 4. FitzGerald JM, Bleecker ER, Bourdin A, et al. Two-year integrated efficacy and safety analysis of benralizumab SIROCCO, CALIMA, ZONDA, and BORA trials in severe asthma. Presented at: the American Thoracic Society (ATS) International Conference; May 17-22, 2019; Dallas, TX. 5. Busse WW, Bleecker ER, FitzGerald JM, et al. Long-term safety and efficacy of benralizumab in patients with severe, uncontrolled asthma: 1-year results from the BORA phase 3 extension trial. Lancet Respir Med. 2019;7:46-59. 6. Data on File, REF-51332, AZPLP. 7. Pham TH, Damera G, Newbold P, Ranade K. Reductions in eosinophil biomarkers by benralizumab in patients with asthma. Respir Med. 2016;111:21-29. 8. Data on File, REF-28001, AZPLP.

References: 1. FASENRA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; October 2019. 2. Pham TH, Damera G, Newbold P, Ranade K. Reductions in eosinophil biomarkers by benralizumab in patients with asthma. Respir Med. 2016;111:21-29. 3. Data on File, REF-28001, AZPLP. 4. Busse WW, Bleecker ER, FitzGerald JM, et al. Long-term safety and efficacy of benralizumab in patients with severe, uncontrolled asthma: 1-year results from the BORA phase 3 extension trial. Lancet Respir Med. 2019;7:46-59. 5. Busse WW, Bleecker ER, FitzGerald JM, et al. Supplementary Appendix to: Long-term safety and efficacy of benralizumab in patients with severe, uncontrolled asthma: 1-year results from the BORA phase 3 extension trial. Lancet Respir Med. 2019;7:46-59. 6. Nair P, Wenzel S, Rabe KF, et al. Supplementary Appendix to: Oral glucocorticoid–sparing effect of benralizumab in severe asthma. N Engl J Med. 2017;376:2448-2458.

References: 1. Data on File, REF-51332, AZPLP. 2. de Groot JC, Storm H, Amelink M, et al. Clinical profile of patients with adult-onset eosinophilic asthma. ERJ Open Res. 2016;2(2):00100-2015. 3. de Groot JC, ten Brinke A, Bel EH. Management of the patient with eosinophilic asthma: a new era begins. ERJ Open Res. 2015;1:00024-2015. 4. Price DB, Rigazio A, Campbell JD, et al. Blood eosinophil count and prospective annual asthma disease burden: a UK cohort study. Lancet Respir Med. 2015;3:849-858. 5. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2019. https://ginasthma.org/wp-content/uploads/2019-main-report-June-2019-wms.pdf. 6. Skolnik NS, Carnahan SP. Primary care of asthma: new options for severe eosinophilic asthma. Curr Med Res Opin. 2019;35:1309-1318. 7. Tran TN, Zeiger RS, Peters SP, et al. Overlap of atopic, eosinophilic, and TH2-high asthma phenotypes in a general population with current asthma. Ann Allergy Asthma Immunol. 2016;116(1):37-42. 8. Carr TF, Berdnikovs S, Simon H-U, et al. Eosinophilic bioactivities in severe asthma. World Allergy Organ J. 2016;9:21. 9. Ortega H, Llanos J-P, Lafeuille M-H, et al. Effects of systemic corticosteroids on blood eosinophil counts in asthma: real-world data. J Asthma. 2019;56(8):808-815. 10. FASENRA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; October 2019.

References: 1. Data on File, REF-60828, AZPLP. 2. FASENRA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; October 2019. 3. Bleecker ER, FitzGerald JM, Chanez P, et al. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting ß2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388:2115-2127. 4. FitzGerald JM, Bleecker ER, Nair P, et al. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016;388:2128-2141. 5. FitzGerald JM, Bleecker ER, Bourdin A, et al. Two-year integrated efficacy and safety analysis of benralizumab SIROCCO, CALIMA, ZONDA, and BORA trials in severe asthma. Presented at: the American Thoracic Society (ATS) International Conference; May 17-22, 2019; Dallas, TX. 6. Busse WW, Bleecker ER, FitzGerald JM, et al. Long-term safety and efficacy of benralizumab in patients with severe, uncontrolled asthma: 1-year results from the BORA phase 3 extension trial. Lancet Respir Med. 2019;7:46-59. 7. Data on File, REF-19697, AZPLP. 8. Data on File, REF-59636, AZPLP. 9. O’Quinn S, Xu X, Hirsch I. Rescue medication use reduction with benralizumab for patients with severe, uncontrolled eosinophilic asthma. Ann Allergy Asthma Immunol. 2018;121:S18-S21. 10. Bleecker ER, Wechsler M, FitzGerald JM, et al. Baseline patient factors impact on the clinical efficacy of benralizumab for severe asthma. Eur Respir J. 2018;52:1800936. 11. Bleecker ER, FitzGerald JM, Chanez P, et al. Appendix to: Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting ß2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388:2115-2127. 12. FitzGerald JM, Bleecker ER, Nair P, et al. Appendix to: Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016;388:2128-2141. 13. Data on File, REF-19698, AZPLP. 14. Nair P, Wenzel S, Rabe KF, et al. Oral glucocorticoid–sparing effect of benralizumab in severe asthma. N Engl J Med. 2017;376:2448-2458. 15. Nair P, Wenzel S, Rabe KF, et al. Supplementary Appendix to: Oral glucocorticoid–sparing effect of benralizumab in severe asthma. N Engl J Med. 2017;376:2448-2458.

References: 1. Data on File, REF-60828, AZPLP. 2. FASENRA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; October 2019. 3. Bleecker ER, FitzGerald JM, Chanez P, et al. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting ß2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388:2115-2127. 4. FitzGerald JM, Bleecker ER, Nair P, et al. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016;388:2128-2141. 5. FitzGerald JM, Bleecker ER, Bourdin A, et al. Two-year integrated efficacy and safety analysis of benralizumab SIROCCO, CALIMA, ZONDA, and BORA trials in severe asthma. Presented at: the American Thoracic Society (ATS) International Conference; May 17-22, 2019; Dallas, TX. 6. Busse WW, Bleecker ER, FitzGerald JM, et al. Long-term safety and efficacy of benralizumab in patients with severe, uncontrolled asthma: 1-year results from the BORA phase 3 extension trial. Lancet Respir Med. 2019;7:46-59. 7. Data on File, REF-19697, AZPLP. 8. Data on File, REF-59636, AZPLP. 9. O’Quinn S, Xu X, Hirsch I. Rescue medication use reduction with benralizumab for patients with severe, uncontrolled eosinophilic asthma. Ann Allergy Asthma Immunol. 2018;121:S18-S21. 10. Bleecker ER, Wechsler M, FitzGerald JM, et al. Baseline patient factors impact on the clinical efficacy of benralizumab for severe asthma. Eur Respir J. 2018;52:1800936. 11. Bleecker ER, FitzGerald JM, Chanez P, et al. Appendix to: Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting ß2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388:2115-2127. 12. FitzGerald JM, Bleecker ER, Nair P, et al. Appendix to: Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016;388:2128-2141. 13. Data on File, REF-19698, AZPLP. 14. Nair P, Wenzel S, Rabe KF, et al. Oral glucocorticoid–sparing effect of benralizumab in severe asthma. N Engl J Med. 2017;376:2448-2458. 15. Nair P, Wenzel S, Rabe KF, et al. Supplementary Appendix to: Oral glucocorticoid–sparing effect of benralizumab in severe asthma. N Engl J Med. 2017;376:2448-2458.

References: 1. Data on File, REF-60828, AZPLP. 2. FASENRA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; October 2019. 3. Bleecker ER, FitzGerald JM, Chanez P, et al. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting ß2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388:2115-2127. 4. FitzGerald JM, Bleecker ER, Nair P, et al. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016;388:2128-2141. 5. FitzGerald JM, Bleecker ER, Bourdin A, et al. Two-year integrated efficacy and safety analysis of benralizumab SIROCCO, CALIMA, ZONDA, and BORA trials in severe asthma. Presented at: the American Thoracic Society (ATS) International Conference; May 17-22, 2019; Dallas, TX. 6. Busse WW, Bleecker ER, FitzGerald JM, et al. Long-term safety and efficacy of benralizumab in patients with severe, uncontrolled asthma: 1-year results from the BORA phase 3 extension trial. Lancet Respir Med. 2019;7:46-59. 7. Data on File, REF-19697, AZPLP. 8. Data on File, REF-59636, AZPLP. 9. O’Quinn S, Xu X, Hirsch I. Rescue medication use reduction with benralizumab for patients with severe, uncontrolled eosinophilic asthma. Ann Allergy Asthma Immunol. 2018;121:S18-S21. 10. Bleecker ER, Wechsler M, FitzGerald JM, et al. Baseline patient factors impact on the clinical efficacy of benralizumab for severe asthma. Eur Respir J. 2018;52:1800936. 11. Bleecker ER, FitzGerald JM, Chanez P, et al. Appendix to: Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting ß2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388:2115-2127. 12. FitzGerald JM, Bleecker ER, Nair P, et al. Appendix to: Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016;388:2128-2141. 13. Data on File, REF-19698, AZPLP. 14. Nair P, Wenzel S, Rabe KF, et al. Oral glucocorticoid–sparing effect of benralizumab in severe asthma. N Engl J Med. 2017;376:2448-2458. 15. Nair P, Wenzel S, Rabe KF, et al. Supplementary Appendix to: Oral glucocorticoid–sparing effect of benralizumab in severe asthma. N Engl J Med. 2017;376:2448-2458.

References: 1. FASENRA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; November 2017. 2. Bleecker ER, FitzGerald JM, Chanez P, et al. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting ß2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388:2115-2127. 3. FitzGerald JM, Bleecker ER, Nair P, et al. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016;388:2128-2141. 4. FitzGerald JM, Bleecker ER, Menzies-Gow A, et al. Predictors of enhanced response with benralizumab for patients with severe asthma: pooled analysis of the SIROCCO and CALIMA studies. Lancet Respir Med. 2018;6(1):56-64. 5. Bleecker ER, Wechsler M, FitzGerald JM, et al. Baseline patient factors impact on the clinical efficacy of benralizumab for severe asthma. Eur Respir J. 2018;52:1800936. 6. Bleecker ER, FitzGerald JM, Chanez P, et al. Appendix to: Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting ß2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388:2115-2127. 7. FitzGerald JM, Bleecker ER, Nair P, et al. Appendix to: Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016;388:2128-2141. 8. Nair P, Wenzel S, Rabe KF, et al. Oral glucocorticoid–sparing effect of benralizumab in severe asthma. N Engl J Med. 2017;376:2448-2458. 9. Nair P, Wenzel S, Rabe KF, et al. Supplementary Appendix to: Oral glucocorticoid–sparing effect of benralizumab in severe asthma. N Engl J Med. 2017;376:2448-2458. 10. FitzGerald JM, Bleecker ER, Bourdin A, et al. Two-year integrated efficacy and safety analysis of benralizumab SIROCCO, CALIMA, ZONDA, and BORA trials in severe asthma. Presented at: the American Thoracic Society (ATS) International Conference; May 17-22, 2019; Dallas, TX. 11. Busse WW, Bleecker ER, FitzGerald JM, et al. Long-term safety and efficacy of benralizumab in patients with severe, uncontrolled asthma: 1-year results from the BORA phase 3 extension trial. Lancet Respir Med. 2019;7:46-59. 12. Data on File, REF-19697, AZPLP. 13. O’Quinn S, Xu X, Hirsch I. Rescue medication use reduction with benralizumab for patients with severe, uncontrolled eosinophilic asthma. Ann Allergy Asthma Immunol. 2018;121:S18-S21. 14. Data on File, REF-52421, AZPLP.

References: 1. FASENRA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; October 2019. 2. Nucala [package insert]. Research Triangle Park, NC: GlaxoSmithKline LLC; September 2019. 3. Xolair [package insert]. South San Francisco, CA: Genentech Inc; May 2019. 4. Dupixent [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc. and sanofi-aventis U.S. LLC; June 2019. 5. Barker P, Ferguson GT, Cole J, et al. Single-use autoinjector functionality and reliability for at-home benralizumab administration: GRECO trial results. Presented at: the American Academy of Allergy, Asthma and Immunology (AAAAI) Congress; February 22-25, 2019; San Francisco, CA. Poster P289.

References: 1. FASENRA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; October 2019. 2. Busse WW, Bleecker ER, FitzGerald JM, et al. Long-term safety and efficacy of benralizumab in patients with severe, uncontrolled asthma: 1-year results from the BORA phase 3 extension trial. Lancet Respir Med. 2019;7:46-59.