AdultPediatricDosage Forms & Strengths injection, lyophilized powder for reconstitution 100mg/vial injection, solution 100mg/mL Available as single-dose prefilled autoinjector or syringe Severe Asthma Indicated for add-on maintenance treatment of severe asthma in patients with an eosinophilic phenotype 100 mg SC q4wk Eosinophilic Granulomatosis with Polyangiitis (Churg-Strauss Syndrome) Indicated for adults with eosinophilic granulomatosis with polyangiitis (EGPA) 300 mg SC q4wk (ie, as 3 separate 100-mg SC injections) Hypereosinophilic Syndrome Indicated for adults with hypereosinophilic syndrome (HES) for 6 months without an identifiable nonhematologic secondary cause 300 mg SC q4wk (ie, as 3 separate 100-mg SC injections) Chronic Rhinosinusitis with Nasal Polyps Indicated for add-on maintenance treatment of chronic rhinosinusitis with nasal polys (CRSwNP) in adults with inadequate response to nasal corticosteroids 100 mg SC q4wk Dosage Modifications Renal impairment No dosage adjustment provided in the manufacturer's labeling; dosage adjustment may not be necessary; drug is not renally eliminated Hepatic impairment No dosage adjustment provided in the manufacturer's labeling; dosage adjustment may not be necessary; drug is degraded by proteolytic enzymes, which are not restricted to hepatic tissue Dosing Considerations Limitations of use Not for relief of acute bronchospasm or status asthmaticus Dosage Forms & Strengths injection, lyophilized powder for reconstitution 100mg/vial injection, solution 100mg/mL; single-dose prefilled autoinjector or syringe 40mg/0.4mL; single-dose prefilled syringe Severe Asthma Indicated for add-on maintenance treatment of severe asthma in patients aged ≥6 years with an eosinophilic phenotype <6 years: Safety and efficacy not established 6-11 years: 40 mg SC q4wk ≥12 years: 100 mg SC q4wk Hypereosinophilic Syndrome Indicated for adults and pediatric patients aged ≥12 years with hypereosinophilic syndrome (HES) for 6 months without an identifiable nonhematologic secondary cause 300 mg SC q4wk (ie, as 3 separate 100-mg SC injections) Dosage Modifications Renal impairment No dosage adjustment provided in the manufacturer's labeling; dosage adjustment may not be necessary; drug is not renally eliminated Hepatic impairment No dosage adjustment provided in the manufacturer's labeling; dosage adjustment may not be necessary; drug is degraded by proteolytic enzymes, which are not restricted to hepatic tissue Dosing Considerations Limitations of use Not for relief of acute bronchospasm or status asthmaticus Not for treatment of other eosinophilic conditions >10% Asthma Headache (19%) EGPA Injection site reactions (15%) 1-10% Asthma Injection site reactions (8%) Back pain (5%) Fatigue (5%) Influenza (3%) Urinary tract infection (3%) Upper abdominal pain (3%) Pruritus (3%) Eczema (3%) Muscle spasms (3%) Abdominal pain (≥3%) Allergic rhinitis (≥3%) Asthenia (≥3%) Bronchitis (≥3%) Cystitis (≥3%) Dizziness (≥3%) Dyspnea (≥3%) Ear infection (≥3%) Gastroenteritis (≥3%) Lower respiratory tract infection (≥3%) Musculoskeletal pain (≥3%) Nasal congestion (≥3%) Nasopharyngitis (≥3%) Toothache (≥3%) Viral infection (≥3%) Viral respiratory tract infection (≥3%) Systemic nonallergic reactions (2%) Systemic allergic/hypersensitivity reactions (1%) CRSwNP Oropharyngeal pain (8%) Arthralgia (6%) Upper abdominal pain (3%) Diarrhea (3%) Nasal dryness (3%) Rash (3%) Injection site reactions (2%) EGPA Systemic allergic/hypersensitivity reactions (4%) Systemic nonallergic reactions (1%) HES Injection site reaction (7%) Other systemic reactions (ie, multifocal skin reaction) (2%) <1% CRSwNP Hypersensitivity reactions (<1%) Postmarketing Reports Hypersensitivity reactions, including anaphylaxis Contraindications Hypersensitivity Cautions Hypersensitivity reactions (eg, angioedema, bronchospasm, hypotension, urticaria, rash) reported; these reactions generally occur within hours of administration, but in some instances can have a delayed onset (ie, days); discontinue drug in the event of a hypersensitivity reaction Not for treatment of acute asthma symptoms or acute exacerbations; do not use to treat acute bronchospasm or status asthmaticus; instruct patients to seek immediate medical advice if their asthma remains uncontrolled or worsens after initiating mepolizumab In clinical trials, 2 serious adverse reactions of herpes zoster occurred during treatment compared with none in placebo; consider varicella vaccination if medically appropriate before initiating treatment Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation mepolizumab; 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 Eosinophils may be involved in the immunological response to some helminth infections; patients with known parasitic infections were excluded from participation in clinical trials; treat patients with preexisting helminth infection before initiating mepolizumab; if helminth infection occurs while receiving mepolizumab that does not respond to treatment, discontinue mepolizumab until the infection resolves Pregnancy Data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk Monoclonal antibodies, such as mepolizumab, are transported across the placenta in a linear fashion as pregnancy progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimesters of pregnancy Pregnancy exposure registry Healthcare providers can enroll patients or encourage patients to enroll themselves by 1-877-311-8972 or www.mothertobaby.org/asthma Clinical considerations In women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate Closely monitor the level of asthma control in pregnant women and treatment adjusted as necessary to maintain optimal control Animal data In a prenatal and postnatal development study, pregnant cynomolgus monkeys received mepolizumab from gestation days 20 to 140 at doses that produced exposures up to ~9 times that achieved with the MRHD (on an AUC basis with maternal IV doses up to 100 mg/kg once every 4 weeks) Mepolizumab did not elicit adverse effects on fetal or neonatal growth (including immune function) up to 9 months after birth Examinations for internal or skeletal malformations were not performed Mepolizumab crossed the placenta in cynomolgus monkeys Concentrations of mepolizumab were ~2.4 times higher in infants than in mothers up to day 178 postpartum Lactation Unknown if distributed in human breast milk However, mepolizumab is a humanized monoclonal antibody (IgG1 kappa), and immunoglobulin G (IgG) is present in human milk in small amounts Present in the milk of cynomolgus monkeys postpartum following dosing during pregnancy; levels in milk were ≤0.5% of maternal serum concentration Consider developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug 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 Humanized IgG1 kappa monoclonal antibody specific for IL-5; binds IL-5, and therefore stops IL-5 from binding to its receptor on the surface of eosinophils Inhibiting IL-5 binding to eosinophils reduces blood, tissue, and sputum eosinophil levels Absorption Bioavailability: 80% Following repeat SC administration once every 4 weeks, there was ~2-fold accumulation at steady-state Distribution Vd: 3.6 L (70-kg adult) Metabolism Degraded by proteolytic enzymes widely distributed in the body and not restricted to hepatic tissue Elimination Half-life: 16-22 days Systemic clearance: 0.28 L/day (70-kg adult) SC Preparation Lyophilized powder for reconstitution Reconstitute each vial with 1.2 mL sterile water for injection (SWI); final concentration of 100 mg/mL Do not mix with other medications Direct stream of SWI vertically onto the center of the lyophilized cake Gently swirl vial for 10 sec with a circular motion at 15-sec intervals until powder dissolves Reconstitution is typically complete within 5 min after the SWI has been added, but it may take additional time If a mechanical reconstitution device (swirler) is used, swirl at 450 rpm for ≤10 min; alternatively, may swirl at 1000 rpm for ≤5 min Visually inspect for particulate matter and clarity before use; solution should be clear to opalescent and colorless to pale yellow or pale brown; small air bubbles are expected and acceptable; discard if particulate matter remains in the solution or if solution appears cloudy or milky Prefilled autoinjector or syringe Remove from refrigerator and allow to sit at room temperature for ~30 min before administration; do not warm in any other way Visually inspect window of autoinjector or syringe for particulate matter or discoloration Solution should be clear-to-opalescent, colorless-to-pale yellow or pale brown in color Do not use if solution appears discolored, cloudy, or has particulate matter Do not use if dropped on a hard surface SC Administration Do NOT shake reconstituted solution; gently swirl to avoid foaming or precipitation For SC use only Administer SC into the upper arm, thigh, or abdomen Use each vial for a single patient; discard any remaining contents 40-mg dose: Remove 0.4 mL of reconstituted solution; administer 0.4 mL (equivalent to 40-mg dose) 40-mg/0.4-mL prefilled syringe is only for use in children aged 6-11 yr and must be administered by the healthcare provider or the patient caregiver 100-mg dose: Remove 1 mL of reconstituted solution; administer 1 mL (equivalent to 100-mg dose) 300-mg dose: Administer as 3 separate 100-mg injections; individual 100-mg injections should be administered at least 5-cm (~2-inches) apart if administered at the same site Missed dose Administer as soon as possible; thereafter, resume dosing on usual day of administration; if next dose is due, then administer as scheduled Storage Lyophilized powder Store below 25ºC (77ºF) Do not freeze Store in the original package to protect from light Reconstituted solution Store below 30ºC (86ºF) BRAND FORM. UNIT PRICE PILL IMAGE Nucala subcutaneous- 100 mg/mL solutionNucala subcutaneous- 100 mg/mL syringeNucala subcutaneous- 100 mg vialNucala subcutaneous- 100 mg/mL syringeCopyright © 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. View explanations for tiers and restrictions Tier Description 1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs. 2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs. 3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs. 4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. NC NOT COVERED – Drugs that are not covered by the plan. Code Definition PA Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription. QL Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered. ST Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription. OR Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription. 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