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 indicated for add-on maintenance treatment of severe eosinophilic asthma, as identified by blood eosinophils greater than or equal to 150 cells/μl at initiation of treatment or blood eosinophils greater than or equal to 300 cells/μl in the past 12 months, in patients aged 12 years and older. Mepolizumab has been shown to reduce exacerbations of asthma in patients with an exacerbation history
Marketing Status Prescription
ATC Code R03DX09
DrugBank ID DB06612
KEGG ID D04923
MeSH ID C434107
PubChem ID Not Available
TTD Drug ID D03MTN
NDC Product Code 49401-012; 0173-0881; 58437-009; 58437-004; 0173-0904; 0173-0892
Synonyms mepolizumab | Bosatria | SB-240563 | SB240563 | Nucala
Chemical Information
Molecular Formula Not Available
CAS Registry Number 196078-29-2
SMILES Not Available
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
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--Not Available
Back pain15.03.04.005--
Bronchitis22.07.01.001; 11.01.09.001--
Burning sensation17.02.06.001; 08.01.09.029--Not Available
Cystitis11.01.14.001; 20.03.02.002--
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Dyspnoea22.02.01.004; 02.01.03.002--
Ear infection11.01.05.001; 04.03.01.006--Not Available
Eczema23.03.04.006--
Erythema23.03.06.001--Not Available
Fatigue08.01.01.002--
Flushing24.03.01.002; 23.06.05.003; 08.01.03.025--
Gastroenteritis11.01.07.004; 07.19.03.001--Not Available
Headache17.14.01.001--
Influenza22.07.02.001; 11.05.03.001--Not Available
Injection site reaction12.07.03.015; 08.02.03.014--
Lower respiratory tract infection22.07.01.002; 11.01.09.002--Not Available
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--Not Available
Nausea07.01.07.001--
Pain08.01.08.004--
Pharyngitis22.07.03.004; 11.01.13.003; 07.05.07.004--
Pruritus23.03.12.001--
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
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