Transcription of NUCALA (mepolizumab) for injection NUCALA (mepolizumab ...
1 1 HIGHLIGHTS OF PRESCRIBING information These highlights do not include all the information needed to use NUCALA safely and effectively. See full prescribing information for NUCALA . NUCALA (mepolizumab) for injection , for subcutaneous use NUCALA (mepolizumab) injection , for subcutaneous use Initial Approval: 2015 ----------------------------- RECENT MAJOR CHANGES --------------------------- Indications and Usage, Maintenance Treatment of Chronic Rhinosinusitis with Nasal Polyps ( ) 7/2021 Dosage and Administration, Chronic Rhinosinusitis with Nasal Polyps ( ) 7/2021 Dosage and Administration, Preparation and Administration of NUCALA injection Prefilled Autoinjector and Prefilled Syringes ( )
2 1/2022 ----------------------------- INDICATIONS AND USAGE ---------------------------- NUCALA is an interleukin-5 (IL-5) antagonist monoclonal antibody (IgG1 kappa) indicated for: Add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype. ( ) Add-on maintenance treatment of adult patients 18 years and older with chronic rhinosinusitis with nasal polyps (CRSwNP). ( ) The treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
3 ( ) The treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for 6 months without an identifiable non-hematologic secondary cause. ( ) Limitations of use: Not for relief of acute bronchospasm or status asthmaticus. ( ) ------------------------- DOSAGE AND ADMINISTRATION ----------------------- Severe asthma in patients aged 12 years and older: 100 mg administered subcutaneously once every 4 weeks. ( ) Severe asthma in patients aged 6 to 11 years: 40 mg administered subcutaneously once every 4 weeks.
4 ( ) CRSwNP: 100 mg administered subcutaneously once every 4 weeks. ( ) EGPA: 300 mg as 3 separate 100-mg injections administered subcutaneously once every 4 weeks. ( ) HES: 300 mg as 3 separate 100-mg injections administered subcutaneously once every 4 weeks. ( ) ---------------------- DOSAGE FORMS AND STRENGTHS---------------------- For injection : 100 mg of lyophilized powder in a single-dose vial for reconstitution. (3) injection : 100 mg/mL, single-dose prefilled autoinjector or single-dose prefilled syringe.
5 (3) injection : 40 mL, single-dose prefilled syringe. (3) ------------------------------- CONTRAINDICATIONS ------------------------------ History of hypersensitivity to mepolizumab or excipients in the formulation. (4) ------------------------ WARNINGS AND PRECAUTIONS ----------------------- Hypersensitivity reactions ( , anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred after administration of NUCALA . Discontinue NUCALA in the event of a hypersensitivity reaction. ( ) Do not use to treat acute bronchospasm or status asthmaticus.
6 ( ) Herpes zoster infections have occurred in patients receiving NUCALA . Consider vaccination if medically appropriate. ( ) Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with NUCALA . Decrease corticosteroids gradually, if appropriate. ( ) Treat patients with pre-existing helminth infections before therapy with NUCALA . If patients become infected while receiving treatment with NUCALA and do not respond to anti-helminth treatment, discontinue NUCALA until parasitic infection resolves.
7 ( ) ------------------------------- ADVERSE REACTIONS ------------------------------ Most common adverse reactions (incidence 5%): Asthma: Headache, injection site reaction, back pain, and fatigue. ( ) CRSwNP: Oropharyngeal pain and arthralgia. ( ) EGPA and HES: Most common adverse reactions are similar to asthma. ( , ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or See 17 for PATIENT COUNSELING information and FDA-approved patient labeling.
8 Revised: 1/2022 _____ FULL PRESCRIBING information : CONTENTS* 1 INDICATIONS AND USAGE Maintenance Treatment of Severe Asthma Maintenance Treatment of Chronic Rhinosinusitis with Nasal Polyps Eosinophilic Granulomatosis with Polyangiitis Hypereosinophilic Syndrome 2 DOSAGE AND ADMINISTRATION Severe Asthma Chronic Rhinosinusitis with Nasal Polyps Eosinophilic Granulomatosis with Polyangiitis Hypereosinophilic Syndrome Preparation and Administration of NUCALA for injection Vial Preparation and Administration of NUCALA injection Prefilled
9 Autoinjector and Prefilled Syringe 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions Acute Asthma Symptoms or Deteriorating Disease Opportunistic Infections: Herpes Zoster Reduction of Corticosteroid Dosage Parasitic (Helminth) Infection 6 ADVERSE REACTIONS Clinical Trials Experience in Severe Asthma Clinical Trials Experience in Chronic Rhinosinusitis with Nasal Polyps Clinical Trials Experience in Eosinophilic Granulomatosis with Polyangiitis Clinical Trials Experience in Hypereosinophilic Syndrome Immunogenicity Postmarketing Experience 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS Pregnancy Lactation Pediatric Use Geriatric Use 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY Mechanism of Action
10 Pharmacodynamics Pharmacokinetics 13 NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES Severe Asthma Chronic Rhinosinusitis with Nasal Polyps Eosinophilic Granulomatosis with Polyangiitis Hypereosinophilic Syndrome 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING information *Sections or subsections omitted from the full prescribing information are not listed. _____ 2 FULL PRESCRIBING information 1 INDICATIONS AND USAGE Maintenance Treatment of Severe Asthma NUCALA is indicated for the add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype [see Use in Specific Populations ( ), Clinical Studies ( )].
