Biology:Efbemalenograstim alfa
From HandWiki
Short description: Medication
| Clinical data | |
|---|---|
| Trade names | Ryzneuta |
| Other names | F-627, efbemalenograstim alfa-vuxw, benegrastim |
| AHFS/Drugs.com | Ryzneuta |
| License data | |
| Routes of administration | Subcutaneous |
| Drug class | Immunological agent |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| UNII | |
| KEGG | |
Efbemalenograstim alfa, sold under the brand name Ryzneuta, is a medication used to decrease the incidence of infection in chemotherapy-induced neutropenia.[1] It is a leukocyte growth factor.[1] It is given by subcutaneous injection.[1]
It was approved for medical use in China in May 2023,[2] and the United States in November 2023.[1] [3]
Medical uses
Efbemalenograstim alfa is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adults with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.[4]
References
- ↑ 1.0 1.1 1.2 1.3 1.4 "Ryzneuta- efbemalenograstim alfa-vuxw injection". 23 November 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9a481ffa-3caa-4c24-a07b-5aac16653f51.
- ↑ 2.0 2.1 "Efbemalenograstim Alfa: First Approval". Drugs 83 (12): 1125–1130. August 2023. doi:10.1007/s40265-023-01911-7. PMID 37368138. https://figshare.com/articles/online_resource/Efbemalenograstim_Alfa_First_Approval/23499267. Retrieved 18 November 2023.
- ↑ "Novel Drug Approvals for 2023". 17 November 2023. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023.
- ↑ "Ryzneuta (efbemalenograstim alfa-vuxw) injection". Biologics license application (BLA) approval letter. Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration. 16 November 2023. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761134Orig1s000ltr.pdf.
This article incorporates text from this source, which is in the public domain.
External links
- "Efbemalenograstim alfa (Code C102854)". 25 September 2023. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C102854.
- Clinical trial number NCT02872103 for "Placebo-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy" at ClinicalTrials.gov
- Clinical trial number NCT03252431 for "Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy" at ClinicalTrials.gov
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