AdultPediatricDosage Forms & Strengths solution for SC injection (single-dose prefilled syringe) 30mg/mL (single-dose prefilled syringe or autoinjector pen) Severe Asthma Add-on maintenance treatment in patients with an eosinophilic phenotype 30 mg SC q4weeks for the first 3 doses, THEN q8weeks thereafter Dosage Modifications Hepatic impairment: IgG monoclonal antibodies are not primarily cleared via hepatic pathway; changes in hepatic function are not expected to influence benralizumab clearance Renal impairment Based on population pharmacokinetic analysis, clearance was comparable with CrCl of 30-80 mL/min and patients with normal renal function Data are limited with CrCl <30 mL/min; however, benralizumab is not cleared renally Dosing Considerations Limitations of use Not indicated for treatment of other eosinophilic conditions Not indicated for relief of acute bronchospasm or status asthmaticus Orphan Designations Hypereosinophilic syndrome Eosinophilic granulomatosis with polyangiitis Eosinophilic esophagitis Sponsor AstraZeneca; P.O. Box 8355; 1800 Concord Pike; Wilmington, Delaware 19803 Dosage Forms & Strengths solution for SC injection (single-dose prefilled syringe) 30mg/mL (single-dose prefilled syringe or autoinjector pen) Severe Asthma Add-on maintenance treatment in patients with an eosinophilic phenotype <12 years: Safety and efficacy not established ≥12 years: 30 mg SC q4weeks for the first 3 doses, THEN q8weeks thereafter Dosage Modifications Hepatic impairment: IgG monoclonal antibodies are not primarily cleared via hepatic pathway; changes in hepatic function are not expected to influence benralizumab clearance Renal impairment Based on population pharmacokinetic analysis, clearance was comparable with CrCl of 30-80 mL/min and patients with normal renal function Data are limited with CrCl <30 mL/min; however, benralizumab is not cleared renally Dosing Considerations Limitations of use Not indicated for treatment of other eosinophilic conditions Not indicated for relief of acute bronchospasm or status asthmaticus 1-10% Headache (8%) Pharyngitis (5%) Pyrexia (3%) Hypersensitivity reactions (3%) Contraindications Hypersensitivity to benralizumab or any of its excipients Cautions Hypersensitivity reactions (eg, anaphylaxis, angioedema, urticaria, rash) reported; these reactions generally occur within hours of administration, but in some instances have a delayed onset (ie, days); discontinue if hypersensitivity occurs Do not discontinue systemic or inhaled corticosteroids abruptly upon initiating benralizumab; corticosteroid dose reductions, if appropriate, should be gradual and performed under the direct supervision of a physician; monitor for systemic withdrawal symptoms and/or unmasking of conditions previously suppressed by systemic corticosteroid therapy Eosinophils may be involved in the immunological response to some helminth infections; unknown if benralizumab influences immunologic response against helminth infections; treat patients with preexisting helminth infections before initiating therapy; if parasitic infection occurs while receiving treatment and does not respond to antihelminth treatment, discontinue benralizumab until infection resolves Avoid use in acute asthma symptoms or acute exacerbations; do not use to treat acute bronchospasm or status asthmaticus Pregnancy No data are available regarding use in pregnant women; a pregnancy exposure registry monitors pregnancy outcomes in women exposed to drug during pregnancy; healthcare providers can enroll patients or encourage patients to enroll themselves by calling 1-877-311-8972 or visiting mothertobaby.org/Fasenra Monoclonal antibodies 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 In women with poorly or moderately controlled asthma, evidence demonstrates an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate; closely monitor in pregnant women and adjust treatment as necessary Lactation No information is available regarding the presence of benralizumab in human or animal milk, and the effects of benralizumab on the breastfed infant and on milk production are not known Humanized monoclonal antibodies and immunoglobulin G are present in human milk in small amounts The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed child or from the underlying maternal conditionPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Interleukin (IL)-5 receptor alpha-directed cytolytic monoclonal antibody (IgG1, kappa); the IL-5 receptor is expressed on the surface of eosinophils and basophils; reduces eosinophils and basophils through antibody-dependent cell-mediated cytotoxicity (ADCC) Absorption Absorption half-life: ~3.5 days Absolute bioavailability: ~59% (no difference between injection sites) Distribution Vd: 3.2 L (central); 2.5 L (peripheral) Metabolism IgG1 monoclonal antibody that is degraded by proteolytic enzymes widely distributed in the body and not restricted to hepatic tissue Elimination Elimination half-life: 15.5 days Systemic clearance: 0.29 L/day SC Preparation Instruct patients regarding SC injection technique and proper disposal of syringe and needles Prior to administration, warm by leaving carton at room temperature for about 30 minutes Once removed from refrigerator, administer within 24 hr or discard into sharps container Visually inspect; solution should appear clear to opalescent, colorless to slightly yellow, and may contain a few translucent or white to off-white particles Do not use if solution is cloudy, discolored, or if it contains large particles or foreign particulate matter SC Administration For subcutaneous use only Administer SC in upper arm if given by care giver or clinician, or in thigh or abdomen by self-injection with autoinjector Discard used syringe into a sharps container Storage All formulations Refrigerate at 2-8°C (36-46°F) Store in the original carton to protect from light Do not freeze Do not shake BRAND FORM. UNIT PRICE PILL IMAGE Fasenra subcutaneous- 30 mg/mL solutionCopyright © 2010 First DataBank, Inc.A Patient Handout is not currently available for this monograph.Print FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. 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