Global InformationRozanolixizumab information
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Chimeric/humanized hybrid |
| Target | Neonatal Fc receptor (FCGRT) |
| Clinical data | |
| Trade names | Rystiggo |
| Other names | UCB-7665, rozanolixizumab-noli |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a623040 |
| License data |
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| Routes of administration | Subcutaneous |
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| Legal status | |
| Legal status |
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| Identifiers | |
| CAS Number |
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| DrugBank |
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| Chemical and physical data | |
| Formula | C6462H9984N1704O2016S44 |
| Molar mass | 145211.51 g·mol−1 |
Rozanolixizumab, sold under the brand name Rystiggo, is a monoclonal antibody used for the treatment of myasthenia gravis.[1] Rozanolixizumab is a humanized and chimeric monoclonal antibody;[4] and is a neonatal Fc receptor blocker.[1][4]
The most common adverse reactions include headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea.[5]
Rozanolixizumab was approved for medical use in the United States in June 2023.[6][7][8]
- ^ a b c "Rystiggo- rozanolixizumab injection, solution". DailyMed. U.S. National Library of Medicine. 30 June 2023. Archived from the original on 29 August 2023. Retrieved 29 August 2023.
- ^ "Rystiggo EPAR". European Medicines Agency. 22 April 2020. Retrieved 18 March 2024.
- ^ "Rystiggo Product information". Union Register of medicinal products. 8 January 2024. Retrieved 18 March 2024.
- ^ a b World Health Organization (2017). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77". WHO Drug Information. 31 (1). hdl:10665/330984.
- ^ "FDA Roundup: June 27, 2023". U.S. Food and Drug Administration (FDA). 27 June 2023. Archived from the original on 27 June 2023. Retrieved 28 June 2023.
This article incorporates text from this source, which is in the public domain.
- ^ "Novel Drug Approvals for 2023". U.S. Food and Drug Administration (FDA). 28 June 2023. Archived from the original on 21 January 2023. Retrieved 28 June 2023.
- ^ "UCB announces U.S. FDA approval of Rystiggo (rozanolixizumab-noli) for the treatment of adults with generalized myasthenia gravis" (Press release). UCB. 27 June 2023. Archived from the original on 28 June 2023. Retrieved 28 June 2023 – via PR Newswire.
- ^ Hoy SM (November 2023). "Correction to: Rozanolixizumab: First Approval". Drugs. 83 (16): 1569. doi:10.1007/s40265-023-01960-y. PMC 10624700. PMID 37861882.
