Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Reslizumab
Drug ID BADD_D01927
Description Reslizumab is a humanized interleukin-5 (IL-5) antagonist monoclonal antibody (IgG4 kappa) that is produced by recombinant DNA technology in murine myeloma non-secreting 0 (NS0) cells. IL-5 is a pro-inflammatory cytokine that is responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils [FDA Label]. Elevated levels of eosinophils increase the risk for asthma exacerbations, including both allergic forms and nonallergic forms of asthma where eosinophilia is prominent. By targeting the IL-5 and disrupting its signalling pathways, reslizumab aims to inhibit eosinophil maturation and promote programmed cell death [A31578]. Asthma is a chronic respiratory disease that causes inflammation in the lungs with asthma attacks that lead to severe breathing difficulties. Patients often experience persistent or exacerbating symptoms overtime despite conventional first-line therapies available. Inflammation-predominant asthma, which is chatacterized by eosinophilic infiltration of airway mucosa and elevated levels of eosinophils in the blood, sputum and BAL fluid, is associated with an increased risk for recurrent exacerbation and asthma-related hospitalizations [A31579]. In four double-blind, randomized, placebo‑controlled trials in patients with severe asthma on currently available therapies, patients receiving reslizumab had fewer asthma attacks, and a longer time to the first attack compared to patients receiving placebo [FDA Label, A31579]. In addition, a significant improvement in lung function was seen, as measured by the volume of air exhaled by patients in one second [L1133]. Studies demonstrated that reslizumab was not effective in various asthma outcomes in patients without eosinophilia [A31577]. Reslizumab was developed by Teva Pharmaceuticals. Approved by the FDA in March 2016, reslizumab is marketed under the brand name Cinqair for intravenous injection. It is injected once every four weeks via intravenous infusion. Cinqair is indicated as an add-on maintenance therapy for adults with severe asthma with an eosinophilic phenotype. It is approved for patients who have a history of severe asthma attacks (exacerbations) despite receiving their current asthma medicines. Reslizumab is marketed as Cinqaero in Europe.
Indications and Usage Indicated for the add-on maintenance treatment of patients with severe asthma aged 18 years and older with an eosinophilic phenotype.
Marketing Status approved; investigational
ATC Code R03DX08
DrugBank ID DB06602
KEGG ID D08985
MeSH ID C515492
PubChem ID Not Available
TTD Drug ID Not Available
NDC Product Code 59310-610; 67643-0015
UNII 35A26E427H
Synonyms reslizumab | SCH-55700 | SCH55700 | SCH 55700 | CEP-38072 | CEP38072 | Cinqair | DCP-835 | DCP835 | DCP 835
Chemical Information
Molecular Formula Not Available
CAS Registry Number 241473-69-8
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)
Blood creatine phosphokinase increased13.04.01.001--
Dyspnoea02.11.05.003; 22.02.01.004--
Muscle spasms15.05.03.004--
Musculoskeletal pain15.03.04.007--
Myalgia15.05.02.001--
Neck pain15.03.04.009--
Neoplasm malignant16.16.01.001--Not Available
Oxygen saturation decreased13.02.01.004--Not Available
Pain in extremity15.03.04.010--
Urticaria10.01.06.001; 23.04.02.001--
Vomiting07.01.07.003--
Wheezing22.03.01.009--
Muscle fatigue15.05.03.006--Not Available
Musculoskeletal chest pain22.09.01.001; 15.03.04.012--
Oropharyngeal pain22.12.03.016; 07.05.05.004--
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