FDA approvals and indicationsNucala is approved: as an add-on maintenance treatment of severe asthma with an eosinophilic phenotype in adults and children aged 6 years and older. It is not a rescue medicine for acute bronchospasm or status asthmaticus as an add-on maintenance treatment of ...
‡Pharmacy benefit coverage as of January 2024. “Patients” means covered lives for all approved indications across commercial and employer payer types (excluding Managed Medicaid) as calculated by Managed Markets Insight & Technology (MMIT), LLC. ...
In July 2021, the U.S. FDA approved mepolizumab (Nucala; GlaxoSmithKline) as add-on maintenance treatment for adult patients 18 years and older with chronic rhinosinusitis with nasal polyps (CRSwNP) who have had inadequate response to nasal corticosteroids. Mepolizumab is the first anti-IL-5 biol...
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Hypersensitivity Reactions Inform patients that hypersensitivity reactions (e.g., angioedema, bronchospasm, hypotension, urticaria, rash) have occurred after administration of NUCALA. Instruct...
.fda.gov/medwatch. See17forPATIENTCOUNSELINGINFORMATIONandFDA- approvedpatientlabeling. Revised:11/2015 FULLPRESCRIBINGINFORMATION:CONTENTS* 1INDICATIONSANDUSAGE 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage 2.2 Preparation and Administration 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WAR...