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Enhertu (fam-trastuzumab deruxtecan-nxki)
fam-trastuzumab deruxtecan
Black Box Warnings .
Interstitial Lung Dz
incl. fatal cases have occurred; monitor for new or worsening respiratory s/sx incl. cough, dyspnea, fever; permanently D/C tx if Grade 2 or higher interstitial lung dz or pneumonitis occurs; advise pts of risk and to immediately report any sx
Embryo-Fetal Toxicity
exposure during pregnancy can result in embryo-fetal harm; advise pts of risks and need for effective contraception
Adult Dosing .
Dosage forms: INJ
Special Note
- [formulation clarification]
- Info: nonproprietary name = fam-trastuzumab deruxtecan-nxki; not interchangeable w/ ado-trastuzumab emtansine or other trastuzumab-containing products
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses, premeds, and dosing incl. toxicity-related dose adjustments
breast CA, unresectable or metastatic
- [HER2-positive dz]
- Dose: 5.4 mg/kg/dose IV x1 on day 1 of 21-day cycle; Info: for pts who have received a prior anti-HER2-based regimen
- [HER2-low dz]
- Dose: 5.4 mg/kg/dose IV x1 on day 1 of 21-day cycle; Info: for pts w/ IHC1+ or IHC2+/ISH-negative dz who have received prior tx
- [hormone receptor-positive HER2-low dz]
- Dose: 5.4 mg/kg/dose IV x1 on day 1 of 21-day cycle; Info: for pts w/ IHC1+ or IHC2+/ISH-negative dz who have progressed on prior endocrine-based tx
- [hormone receptor-positive HER2-ultralow dz]
- Dose: 5.4 mg/kg/dose IV x1 on day 1 of 21-day cycle; Info: for pts w/ IHC0 w/ membrane staining dz who have progressed on prior endocrine-based tx
HER2-mutant non-small cell lung CA, unresectable or metastatic
- [5.4 mg/kg/dose IV x1 on day 1 of 21-day cycle]
- Info: for pts w/ activating HER2 (ERBB2) mutations who have received prior tx
HER2-positive gastric CA, locally advanced or metastatic
- [6.4 mg/kg/dose IV x1 on day 1 of 21-day cycle]
- Info: for pts w/ gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen
HER2-positive solid tumors, unresectable or metastatic
- [5.4 mg/kg/dose IV x1 on day 1 of 21-day cycle]
- Info: for pts w/ IHC3+ dz who have received prior tx and have no alternative tx options
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin 1.1-3x ULN or AST >ULN: no adjustment; bilirubin >3x ULN: not defined
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.