FASENRA® (benralizumab) for Severe Eosinophilic Asthma | For HCPs

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 or for the relief of acute bronchospasm or status asthmaticus.

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[#1 PRESCRIBED RESPIRATORY BIOLOGIC for eosinophilic asthma*1]

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

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

FOR PATIENTS WITH SEVERE EOSINOPHILIC ASTHMA, YOU CAN REDUCE 2:

EOSINOPHILS EXACERBATIONS ORAL STEROIDS

results may vary

 

MOVE FORWARD WITH FASENRA

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.

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.

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

Please read full Prescribing Information, including Patient Information.

Please read full Prescribing Information, including Patient Information.

You may report side effects related to AstraZeneca products.

IMPORTANT SAFETY INFORMATION

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References

Reference

1. Data on File, US-68618, AZPLP. 2. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; February 2021.

1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; February 2021. 2. 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-acting ß2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2115-2127. 3. FitzGerald JM, Bleecker ER, Nair P, et al; CALIMA study investigators. 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(10056):2128-2141. 4. Korn S, Bourdin A, Chupp G, et al. Integrated safety and efficacy among patients receiving benralizumab for up to 5 years. J Allergy Clin Immunol Pract. 2021;9(12):4381-4392.e4.

1. Pham TH, Damera G, Newbold P, Ranade K. Reductions in eosinophil biomarkers by benralizumab in patients with asthma. Respir Med. 2016;111:21-29. 2. Brusselle GG, Maes T, Bracke KR. Eosinophils in the spotlight: eosinophilic airway inflammation in nonallergic asthma. Nat Med. 2013;19(8):977-979. 3. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; February 2021. 4. Data on File, REF-28001, AZPLP. 5. Laviolette M, Gossage DL, Gauvreau G, et al. Effects of benralizumab on airway eosinophils in asthmatic patients with sputum eosinophilia. J Allergy Clin Immunol. 2013;132(5):1086-1096.e5.

1. Data on File, REF-51332, AZPLP. 2. 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-acting ß2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2115-2127. 3. Skolnik NS, Carnahan SP. Primary care of asthma: new options for severe eosinophilic asthma. Curr Med Res Opin. 2019;35(7):1309-1318. 4. 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.

1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; February 2021. 2. 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-acting ß2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2115-2127. 3. FitzGerald JM, Bleecker ER, Nair P, et al; CALIMA study investigators. 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(10056):2128-2141.

1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; February 2021. 2. Nair P, Wenzel S, Rabe KF, et al. Oral glucocorticoid–sparing effect of benralizumab in severe asthma. N Engl J Med. 2017;376(25):2448-2458. 3. Menzies-Gow A, Corren J, Bel EH, et al. Corticosteroid tapering with benralizumab treatment for eosinophilic asthma: PONENTE trial. ERJ Open Res. 2019;5(3):00009-2019. 4. Menzies-Gow A, Gurnell M, Heaney L, et al. Oral corticosteroid elimination via a personalised reduction algorithm in adults with severe, eosinophilic asthma treated with benralizumab (PONENTE): a multicentre, open-label, single-arm study [published correction appears in Lancet Respir Med. 2021;9(12):e114]. Lancet Respir Med. 2022;10(1):47-58. 5. Menzies-Gow A, Gurnell M, Heaney LG, et al. Adrenal function recovery after durable OCS-sparing with benralizumab in the PONENTE study. Eur Respir J. 2022;60(6):2103226.

1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; February 2021. 2. 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-acting ß2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2115-2127. 3. FitzGerald JM, Bleecker ER, Nair P, et al; CALIMA study investigators. 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(10056):2128-2141. 4. Data on File, REF-19697, AZPLP. 5. Data on File, REF-59636, AZPLP. 6. Busse WW, Bleecker ER, FitzGerald JM, et al; BORA study investigators. 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(1):46-59. 7. FitzGerald JM, Bleecker ER, Bourdin A, et al. Two-year integrated efficacy and safety analysis of benralizumab in severe asthma. J Asthma Allergy. 2019;12:401-413.

1. Skolnik NS, Carnahan SP. Primary care of asthma: new options for severe eosinophilic asthma. Curr Med Res Opin. 2019;35(7):1309-1318. 2. Global Initiative for Asthma. 2022 GINA Report, Global Strategy for Asthma Management and Prevention. https://ginasthma.org/gina-report/. Accessed March 23, 2023. 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-acting ß2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2115-2127. 4. 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.

1. Data on File, US-68618, AZPLP. 2. Data on File, US-70054.

1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; February 2021.

1. Maselli DJ, Carstens D, Yang D, et al. Benralizumab is effective in reducing asthma exacerbations: results from the ZEPHYR 2 study. Poster presented at: American College of Allergy, Asthma, and Immunology Meeting 2021; November 4-8, 2021; New Orleans, LA. 2. Carstens D, Maselli DJ, Yang D, et al. Reduction in asthma exacerbations from ZEPHYR 2 – largest RWE study on benralizumab. Poster presented at: AAAAI Annual Meeting 2022; February 25-28, 2022; Phoenix, AZ. 3. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; February 2021. 4. 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-acting ß2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2115-2127.

1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; February 2021. 2. 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-acting ß2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2115-2127. 3. FitzGerald JM, Bleecker ER, Nair P, et al; CALIMA study investigators. 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(10056):2128-2141. 4. Nair P, Wenzel S, Rabe KF, et al. Oral glucocorticoid–sparing effect of benralizumab in severe asthma. N Engl J Med. 2017;376(25):2448-2458. 5. Busse WW, Bleecker ER, FitzGerald JM, et al; BORA study investigators. 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(1):46-59. 6. Korn S, Bourdin A, Chupp G, et al. Integrated safety and efficacy among patients receiving benralizumab for up to 5 years. J Allergy Clin Immunol Pract. 2021;9(12):4381-4392.e4. 7. Menzies-Gow A, Gurnell M, Heaney L, et al. Oral corticosteroid elimination via a personalised reduction algorithm in adults with severe, eosinophilic asthma treated with benralizumab (PONENTE): a multicentre, open-label, single-arm study [published correction appears in Lancet Respir Med. 2021;9(12):e114]. Lancet Respir Med. 2022;10(1):47-58. 8. Menzies-Gow A, Corren J, Bel EH, et al. Corticosteroid tapering with benralizumab treatment for eosinophilic asthma: PONENTE trial. ERJ Open Res. 2019;5(3):00009-2019. 9. Menzies-Gow A, Gurnell M, Heaney LG, et al. Adrenal function recovery after durable OCS sparing with benralizumab in the PONENTE study. Eur Respir J. 2022;60(6):2103226. 10. Maselli DJ, Carstens D, Yang D, et al. Benralizumab is effective in reducing asthma exacerbations: results from the ZEPHYR 2 study. Poster presented at: American College of Allergy, Asthma, and Immunology Meeting 2021; November 4-8, 2021. 11. Carstens D, Maselli DJ, Yang D, et al. Reduction in asthma exacerbations from ZEPHYR 2–largest RWE study on benralizumab. Poster presented at: AAAAI Annual Meeting 2022; February 25-28, 2022; Phoenix, AZ.

1. Korn S, Bourdin A, Chupp G, et al. Integrated safety and efficacy among patients receiving benralizumab for up to 5 years. J Allergy Clin Immunol Pract. 2021;9(12):4381-4392.e4. 2. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; February 2021. 3. Busse WW, Bleecker ER, FitzGerald JM, et al; BORA study investigators. 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(1):46-59. 4. Data on File, REF-153839, AZPLP. 5. ClinicalTrials.gov [Internet]. National Library of Medicine (US). Identifier NCT00783289 ClinicalTrials.gov website. https://clinicaltrials.gov/ct2/show/NCT00783289. Accessed March 23, 2023.

1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; February 2021. 2. Ferguson GT, Cole J, Aurivillius M, et al. Single-use autoinjector functionality and reliability for at-home administration of benralizumab for patients with severe asthma: GRECO trial results. J Asthma Allergy. 2019;12:363-373.

1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; February 2021. 2. 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-acting ß2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2115-2127. 3. FitzGerald JM, Bleecker ER, Nair P, et al; CALIMA study investigators. 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(10056):2128-2141.