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IMPORTANT SAFETY INFORMATION

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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.

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

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

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References: 1. FASENRATM (benralizumab) [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 β2-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. Data on file, REF-19697, AZPLP. 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.

References: 1. FASENRATM (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; November 2017. 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.

ICS=inhaled corticosteroids; LABA=long-acting β2-agonists; OCS=oral corticosteroids; SOC=standard of care.

*The pharmacodynamic response (blood eosinophil depletion) following repeat subcutaneous (SC) dosing was evaluated in asthma patients in a 12-week phase 2 trial. Patients received 1 of 3 doses of benralizumab [25 mg (n=6), 100 mg (n=6) or 200 mg (n=6) SC] or placebo (n=6) every 4 weeks for a total of 3 doses. Twenty-four hours post dosing, all benralizumab dosage groups demonstrated complete or near complete depletion of median blood eosinophil levels, which was maintained throughout the dosing period.1-3

At baseline of the phase 3 extension trial, in patients with baseline eosinophil ≥300 cells/μL in Trials 1 and 2 who continued on FASENRA every 8 weeks (n=339), the median eosinophil level was 0 cells/μL, which was maintained through Week 56.4,5

The effect of treatment on sputum eosinophil was evaluated in a sub-study of Trial 3. Patients were randomized to receive benralizumab 30 mg SC every 4 weeks (Q4W), every 8 weeks (Q8W; first 3 doses Q4W) or placebo Q4W. In a combined analysis of the benralizumab 30 mg Q4W and Q8W groups, median sputum eosinophil were depleted for patients treated with benralizumab from 4.90% (n=18) at baseline to 0.0% (n=16) at Week 12, and 0.15% (n=8) at Week 28. For patients who received placebo, median sputum eosinophil counts increased from 4.90% (n=8) at baseline to 17.55% (n=4) at Week 12, and 12.15% (n=4) at Week 28. Results are descriptive only.6

References: 1. FASENRATM (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; November 2017. 2. Pham TH, Damera G, Newbold P, Ranade K. Reductions in eosinophil biomarkers by benralizumab in patients with asthma. Respir Med. 2016 Feb;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.

NHANES=National Health and Nutrition Examination Survey.

*Data from the 2005 to 2006 annual survey of a nationally representative sample of a noninstitutionalized United States population in patients with asthma (aged 18-64 years) identified based on the participants’ self-report. Eosinophilic asthma was defined as a blood eosinophil cutoff point of ≥150 cells/μL. Of the 310 adult patients, 69% had a blood eosinophil level ≥150 cells/μL.1

References: 1. 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. 2. de Groot JC, ten Brinke A, Bel EH. Management of the patient with eosinophilic asthma: a new era begins. ERJ Open Res. 2015;1:1-11. 3. de Groot JC, Storm H, Amelink M, et al. Clinical profile of patients with adult-onset eosinophilic asthma. ERJ Open Res. 2016;2(2):1-8. 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.

GINA=Global Initiative for Asthma.

In Trials 1 and 2, FASENRA and placebo were administered plus standard of care (SOC), which is defined as high-dose (Trial 1) to medium- to high-dose (Trial 2) ICS/LABA (inhaled corticosteroids/long-acting β2-agonist) with or without other controllers, including systemic steroids. In Trial 3, FASENRA and placebo were administered in addition to daily OCS (7.5 to 40 mg) plus SOC, which is defined as high-dose ICS/LABA with or without other controllers.1

While 2 dosing regimens were studied in all 4 trials, the recommended dosing regimen is FASENRA administered every 4 weeks for the first 3 doses, then every 8 weeks thereafter.1

*A clinically significant exacerbation was defined as worsening of asthma requiring use of steroids for at least 3 days, and/or emergency department visits requiring use of steroids and/or hospitalization. For patients on maintenance OCS, an exacerbation was defined as a temporary increase in stable oral/systemic corticosteroids for at least 3 days or a single depo-injectable dose of corticosteroids.1

The primary analysis population in Trial 1 was 267 for FASENRA + SOC and 267 for the placebo + SOC arm. In Trial 2, the primary analysis population for FASENRA + SOC and placebo + SOC was 239 and 248, respectively.1

Atopic status for the placebo groups in Trials 1, 2, and 3 was 57%, 65%, and 49%, respectively.2-4

§Allergic rhinitis for the placebo groups in Trials 1, 2, and 3 was 54%, 56%, and 40%, respectively.2-4

IIIn a post hoc analysis of Trials 1 and 2, comorbid allergic conditions were determined from medical history and respiratory disease characteristics.7

References: 1. FASENRATM (benralizumab) [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 β2-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. 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. 5. 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. 6. Nair P, Wenzel S, Rabe KF, et al. Protocol for: Oral glucocorticoid–sparing effect of benralizumab in severe asthma. N Engl J Med. 2017;376:2448-2458. 7. Kamboj A, Newbold P, Hirsch I, Zangrilli JG. Characteristics of patients with and without allergic disease from benralizumab phase III severe asthma trials. Presented at the American College of Allergy, Asthma and Immunology Annual Meeting; November 15-19, 2018, Seattle, WA. Poster P106. 8. 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. 9. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2018. http://ginasthma.org/2018-gina-report-global-strategy-for-asthma-management-and-prevention/. Accessed January 16, 2019.

FEV1=forced expiratory volume in 1 second; GINA=Global Initiative for Asthma; ICS=inhaled corticosteroids; IgE=immunoglobulin E; LABA=long-acting β2-agonists; LTRA=leukotriene receptor antagonists; OCS=oral corticosteroids; PRN=as required; SABA=short-acting β2-agonists.

Reference: 1. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2017. http://ginasthma.org/2017-gina-report-global-strategy-for-asthma-management-and-prevention/. Accessed November 30, 2017.

References: 1. 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 β2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388:2115-2127. 2. 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. 3. 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. 4. Pham TH, Damera G, Newbold P, Ranade K. Reductions in eosinophil biomarkers by benralizumab in patients with asthma. Respir Med. 2016;111:21-29. 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.

*Annual exacerbation rate (AER) was defined as the total number of exacerbations multiplied by 365.25, divided by the total duration of follow-up (days) within the treatment group.

References: 1. FASENRATM (benralizumab) [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 β2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388:2115-2127. 3. 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. 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. 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.

FASENRA and placebo were administered plus standard of care (SOC), which is defined as high-dose ICS/LABA (inhaled corticosteroids/long-acting β2-agonist) with or without other controllers, including systemic steroids.1 In the phase 3 extension trial, patients from Trials 1 and 2 were to be maintained on their same dose of ICS/LABA.5

In patients with baseline eosinophils ≥300 cells/μL in Trials 1 and 2 who continued on FASENRA every 8 weeks (n=339). Final pre-bronchodilator FEV1 assessment was at Week 48 (interim analysis for adolescents; n=310 [adults and adolescents]) and at Week 56 (end of treatment for adults; n=291).5

References: 1. FASENRATM (benralizumab) [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 β2-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. Data on File, REF-19697, AZPLP. 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.

References: 1. FASENRATM (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; November 2017. 2. 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. 3. 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. 4. 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 β2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388:2115-2127. 5. 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. 6. Data on File, REF-41246, AZPLP. 7. 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 β2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388:2115-2127. 8. 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. 9. Data on File, REF-19697, AZPLP.

References: 1. FASENRATM (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; November 2017. 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.

*In a US survey study, 47 adult patients with severe asthma and 25 board-certified physicians (ie, pulmonologists and allergists) were interviewed to understand their perceptions of biologic therapies and preferences in relation to biologic therapy attributes in the treatment of severe, uncontrolled asthma. Key attributes included dosing frequency, number of injections per treatment, delivery route, medication administration, and process required for administration.2

References: 1. FASENRATM (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; November 2017. 2. Data on File, REF-39648, AZPLP.