Fam-Trastuzumab Deruxtecan-nxki
Class: Antineoplastic Agents
Chemical Name: Glycinamide, N-[6-(2,5-dihydro-2,5-dioxo-1H-pyrrol-1-yl)-1-oxohexyl]glycylglycyl-l-phenylalanyl-N-[[2-[[(1S,9S)-9-ethyl-5-fluoro-2,3,9,10,13,15-hexahydro-9-hydroxy-4-methyl-10,13-dioxo-1H,12H-benzo[de]pyrano[3¢,4¢:6,7]indolizino[1,2-b]quinolin-1-yl]amino]-2-oxoethoxy]methyl], disulfide with humanized monoclonal antibody k-chain, anti-(human ERBB2 [epidermal growth factor receptor 2, receptor tyrosine-protein kinase erbB-2, EGFR2, HER2, HER-2, p185c-erbB2, NEU, CD340]), immunoglobulin G1-k dimer
CAS Number: 1826843-81-5
Brands: Enhertu
Warning
- Interstitial Lung Disease (ILD)
Serious, sometimes fatal, ILD, including pneumonitis, reported.
Monitor for new or worsening respiratory symptoms indicative of ILD (e.g., dyspnea, cough, fever).
If ILD occurs, temporary interruption, dosage reduction, or permanent discontinuance of therapy may be necessary. (See Dosage Modification for Toxicity under Dosage and Administration and also see ILD under Cautions.)
- Embryofetal Toxicity
Risk of embryofetal death or birth defects.
Inform patients of risk to the fetus.
Advise women of childbearing potential to use effective contraception during therapy and for at least 7 months after the last dose. Advise men who are partners of such women to use effective contraception during therapy and for at least 4 months after the last dose. (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
Introduction
Antineoplastic agent; an anti-human epidermal growth factor receptor type 2 (anti-HER2) antibody-drug conjugate consisting of a humanized IgG1 monoclonal antibody (trastuzumab) covalently linked to a type I DNA topoisomerase inhibitor DXd (an exatecan derivative).
Uses for Fam-Trastuzumab Deruxtecan-nxki
Breast Cancer
Treatment of unresectable or metastatic breast cancer in patients whose tumors overexpress the HER2 protein and who have received at least 2 prior anti-HER2-based regimens for metastatic disease.
Efficacy determined based on objective response rate and duration of response; clinical benefit not established. Continued approval may be contingent on verification and description of clinical benefit in confirmatory studies.
Fam-Trastuzumab Deruxtecan-nxki Dosage and Administration
General
Do not substitute fam-trastuzumab deruxtecan-nxki (Enhertu) for or use with trastuzumab (Herceptin) or ado-trastuzumab emtansine (Kadcyla). Exercise extra care to ensure accuracy of preparation and administration of fam-trastuzumab deruxtecan-nxki.
Consult specialized references for procedures for proper handling and disposal of antineoplastic agents.
If infusion-related reactions occur, slow or interrupt IV infusion. If severe infusion-related reactions occur, permanently discontinue drug.
