FASENRA is indicated as an add-on maintenance treatment of patients 12 years and older with severe eosinophilic asthma. FASENRA is not indicated for treatment of other eosinophilic conditions, relief of acute bronchospasm or status asthmaticus.

LARGE CLINICAL TRIAL PROGRAM REVEALED A SAFETY PROFILE FOR FASENRA THAT IS COMPARABLE TO PLACEBO1

Adverse reactions that occurred in some patients from Trial 3 after 28 weeks of treatment with FASENRA.

Adverse reactions from Trial 3 with 28 weeks of treatment with FASENRA (n=73) or placebo (n=75) in which the incidence was more common in FASENRA than placebo include headache (8.2% compared to 5.3%, respectively) and pyrexia (2.7% compared to 1.3%, respectively). The frequencies for the remaining adverse reactions with FASENRA were similar to placebo.1

INJECTION SITE REACTIONS

In Trials 1 and 2, injection site reactions with FASENRA were similar to placebo: 2.2% vs 1.9%, respectively.1

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

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

Please see full study descriptions for Trials 1, 2, and 3.

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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

Prescribing Information including Patient Information.

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References: 1. FASENRA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; December 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. Pham TH, Damera G, Newbold P, Ranade K. Reductions in eosinophil biomarkers by benralizumab in patients with asthma. Respir Med. 2016;111:21-29.

*The pharmacodynamic response (blood eosinophil depletion) following repeat 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-hours post dosing, all benralizumab dosage groups demonstrated complete or near complete depletion of blood eosinophil levels, which was maintained throughout the dosing period.1,2

References: 1. FASENRA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; December 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.

*The pharmacodynamic response (blood eosinophil depletion) following repeat 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 blood eosinophil levels, which was maintained throughout the dosing period.1,2

References: 1. FASENRA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; December 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.

GINA=Global Initiative for Asthma; ICS=inhaled corticosteroids; LABA=long-acting β2-agonists; OCS=oral corticosteroids; SOC=standard of care.

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 3 trials, the recommended dosing regimen is FASENRA administered every 4 weeks for the first 3 doses, then every 8 weeks thereafter.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

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

Atopic status for the placebo groups in Trials 1, 2, and 3 was 57%, 65%, and 49%, respectively.2,3,9

References: 1. FASENRA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; December 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. Nucala [package insert]. Research Triangle Park, NC: GlaxoSmithKline LLC; December 2017. 5. Cinqair [package insert]. Frazer, PA: Teva Pharmaceuticals, LLC; May 2016. 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 β2-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. 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. 11. 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 December 5, 2017.

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.

*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. FASENRA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; December 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. Oral glucocorticoid-sparing effect of benralizumab in severe asthma. N Engl J Med. 2017;376:2448-2458.

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

*Statistical significance for FEV1 improvement was established at end of treatment. Week 4 results were descriptive only. FASENRA demonstrated greater improvements in change from baseline in pre-bronchodilator FEV1 compared with placebo at Week 4 (first measured time point after administration of treatment dose) that were maintained through end of treatment.2-4

The analyses of these endpoints were not multiplicity protected. Therefore, P values are reported as nominal. Results are descriptive only.

References: 1. FASENRA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; December 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. Data on File, REF-19697, AZPLP. 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. 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. 6. 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.

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

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

Reference: 1. FASENRA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; December 2017.

Xolair is a registered trademark of Novartis AG; Nucala is a registered trademark of the GSK group of companies; Cinqair is a registered trademark of Teva Pharmaceutical Industries Ltd.

References: 1. FASENRA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; December 2017. 2. Xolair [package insert]. Genentech, Inc. and Novartis Pharmaceuticals Corporation; June 2017. 3. Nucala [package insert]. Research Triangle Park, NC: GlaxoSmithKline LLC; December 2017. 4. Cinqair [package insert]. Frazer, PA: Teva Pharmaceuticals, LLC; May 2016.