Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Mepolizumab
Drug ID BADD_D01389
Description Eosinophils are involved in inflammatory immune responses, and prolonged hypereosinophilia (typically defined as absolute eosinophil levels of 1500/mm3 or more) is associated with a spectrum of diseases, including severe asthma, eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome (HES). The pathogenesis of eosinophilia is complex, but IL-5 is recognized as a key cytokine involved in the differentiation, recruitment, activation, and prolonged survival of eosinophils in peripheral tissue. Activated eosinophils further stimulate an inflammatory response and also induce tissue lesions and promote fibrosis, all of which contribute to the multifactorial symptomatology of hypereosinophilic diseases.[A221048, A221053, A221058, A221063, A221068, L16518] Mepolizumab is a fully-humanized recombinant IgG1 kappa monoclonal antibody directed against IL-5 produced in Chinese hamster ovary cells. Mepolizumab was first approved by the FDA on November 4, 2015, as an add-on therapy for severe asthma and marketed under the brand name Nucala by GlaxoSmithKline. This indication was subsequently expanded to cover EGPA on December 12, 2017, and HES on September 25, 2020.[L16518]
Indications and Usage Mepolizumab is an anti-IL-5 IgG1 kappa monoclonal antibody indicated as an add-on maintenance treatment in patients aged six years and older with severe eosinophilic asthma and as a treatment in adult patients for eosinophilic granulomatosis with polyangiitis (EGPA). Mepolizumab is also indicated for the treatment of hypereosinophilic syndrome (HES) in patients aged 12 and older in whom eosinophilia is present for at least six months without an identifiable non-hematologic secondary cause.[L16518]
Marketing Status approved; investigational
ATC Code R03DX09
DrugBank ID DB06612
KEGG ID D04923
MeSH ID C434107
PubChem ID Not Available
TTD Drug ID D03MTN
NDC Product Code 58437-004; 58437-009; 0173-0881; 49401-012; 0173-0892; 0173-0904
UNII 90Z2UF0E52
Synonyms mepolizumab | Bosatria | SB-240563 | SB240563 | Nucala
Chemical Information
Molecular Formula Not Available
CAS Registry Number 196078-29-2
SMILES Not Available
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Asthenia08.01.01.001---
Back pain15.03.04.005--
Bronchitis11.01.09.001; 22.07.01.001--
Burning sensation08.01.09.029; 17.02.06.001---
Cystitis11.01.14.001; 20.03.02.002--
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Dyspnoea02.11.05.003; 22.02.01.004--
Ear infection04.03.01.006; 11.01.05.001---
Eczema23.03.04.006--
Erythema23.03.06.001---
Fatigue08.01.01.002--
Flushing08.01.03.025; 23.06.05.003; 24.03.01.002--
Gastroenteritis07.19.03.001; 11.01.07.004---
Headache17.14.01.001--
Influenza11.05.03.001; 22.07.02.001---
Injection site reaction08.02.03.014; 12.07.03.015--
Lower respiratory tract infection11.01.09.002; 22.07.01.002---
Muscle spasms15.05.03.004--
Musculoskeletal pain15.03.04.007--
Myalgia15.05.02.001--
Nasal congestion22.04.04.001--
Nasopharyngitis11.01.13.002; 22.07.03.002---
Nausea07.01.07.001--
Pain08.01.08.004--
Pharyngitis07.05.07.004; 11.01.13.003; 22.07.03.004--
Pruritus23.03.12.001--
Pyrexia08.05.02.003--
Rash23.03.13.001---
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