fam-trastuzumab deruxtecan-nxki (Enhertu)
Jump to navigation
Jump to search
Indications
- HER2-positive (activating mutation) unresectable or metastatic breast cancer unresponsive to prior chemotherapy
- FDA approves two separate indications for fam-trastuzumab deruxtecan-nxki in HER2-positive early-stage breast cancer[4]
Contraindications
Dosage
- 5.4 mg/kg intravenous every 3 weeks
Adverse effects
- nausea, leukopenia, anemia, neutropenia, lymphopenia, thrombocytopenia
- decreased serum albumin, increased serum AST, increased serum ALT
- increased serum alkaline phosphatase
- fatigue, constipation, anorexia, vomiting, alopecia
Notes
- distinguish from trastuzumab (Herceptin) with different dosage & treatment schedules[3]
More general terms
References
- ↑ FDA Approved drugs. 2022. August 2022 FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for HER2-mutant non-small cell lung cancer. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-fam-trastuzumab-deruxtecan-nxki-her2-mutant-non-small-cell-lung
- ↑ HIGHLIGHTS OF PRESCRIBING INFORMATION Enhertu: fam-trastuzumab deruxtecan-nxki) for injection, for intravenous use https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761139s021lbl.pdf
- ↑ 3.0 3.1 FDA MedWarch. May 6, 2013 Kadcyla (ado-trastuzumab emtansine): Drug Safety Communication
Potential Medication Errors Resulting from Name Confusion. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm350817.htm - ↑ 4.0 4.1 Ingram I Blockbuster Drug Gets Breast Cancer Approvals in Curative Setting. New trastuzumab deruxtecan indications cover neoadjuvant and adjuvant treatment. MedPage Today. May 18, 2026 https://www.medpagetoday.com/hematologyoncology/breastcancer/121320
FDA May 15, 2026 FDA approves two separate indications for fam-trastuzumab deruxtecan-nxki in HER2-positive early-stage breast cancer https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-two-separate-indications-fam-trastuzumab-deruxtecan-nxki-her2-positive-early-stage