Reslizumab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized (from rat) |
| Target | IL-5 |
| Clinical data | |
| Trade names | Cinqair, Cinqaero |
| AHFS/Drugs.com | Monograph |
| License data |
|
| Routes of administration | Intravenous |
| ATC code | |
| Legal status | |
| Legal status | |
| Pharmacokinetic data | |
| Metabolism | Proteolysis |
| Elimination half-life | ~24 days |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
|
| UNII | |
| KEGG | |
| (what is this?) (verify) | |
Reslizumab, sold under the brand names Cinqair and Cinqaero, is a humanized monoclonal antibody against human interleukin-5 (IL-5).[4] Reslizumab binds specifically to IL-5, a key cytokine responsible for the differentiation, maturation, recruitment and activation of human eosinophils. By binding to human IL-5, it blocks its biological function; consequently survival and activity of eosinophils are reduced. The benefits with reslizumab are its ability to reduce the exacerbation rate and improve lung function and asthma-related quality of life in patients with severe eosinophilic asthma (with blood eosinophil count ≥ 400 cells/μL) and with at least one previous asthma exacerbation in the preceding year. The most common side effects are increased blood creatine phosphokinase, myalgia and anaphylactic reactions.[5]
In March 2016, the US Food and Drug Administration (FDA) approved reslizumab (Cinqair) for use with other asthma medicines for the maintenance treatment of severe asthma in people aged 18 years and older.[6] It is approved for people who have a history of severe asthma attacks (exacerbations) despite receiving their current asthma medicines.[6]
In June 2016, the European Medicines Agency recommended the granting of a marketing authorisation for reslizumab (Cinqaero) intended as add-on treatment in adults with severe eosinophilic asthma.[5]
Reslizumab is supplied as a refrigerated, sterile, single-use, preservative-free solution for intravenous infusion. The reslizumab solution is a slightly hazy/opalescent, slightly yellow liquid and is supplied as 100 mg in a 10 mL glass vial. Each single-use vial of reslizumab is formulated as 10 mg/mL reslizumab in an aqueous solution containing 2.45 mg/mL sodium acetate trihydrate, 0.12 mg/mL glacial acetic acid, and 70 mg/mL sucrose, with a pH of 5.5.[7]
- ^ "Prescription medicines: registration of new chemical entities in Australia, 2017". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 9 April 2023.
- ^ "Prescription medicines and biologicals: TGA annual summary 2017". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 31 March 2024.
- ^ "Health Canada New Drug Authorizations: 2016 Highlights". Health Canada. 14 March 2017. Retrieved 7 April 2024.
- ^ Walsh GM (June 2009). "Reslizumab, a humanized anti-IL-5 mAb for the treatment of eosinophil-mediated inflammatory conditions". Current Opinion in Molecular Therapeutics. 11 (3): 329–36. PMID 19479666.
- ^ a b "Cinqaero : reslizumab" (PDF). European Medicines Agency (EMA). Archived from the original (PDF) on 2016-09-08. Retrieved 2016-11-22.
- ^ a b "FDA approves Cinqair to treat severe asthma". U.S. Food and Drug Administration (FDA) (Press release). 23 March 2016. Archived from the original on September 10, 2019. This article incorporates text from this source, which is in the public domain.
- ^ "PULMONARY-ALLERGY DRUGS ADVISORY COMMITTEE (PADAC) MEETING" (PDF). U.S. Food and Drug Administration (FDA). Archived from the original (PDF) on March 28, 2016. Retrieved 2016-11-22.