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Datroway (datopotamab deruxtecan-dlnk)
datopotamab deruxtecan
Adult Dosing .
Dosage forms: INJ
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses, premeds, concomitant meds, and dosing including toxicity-related dose adjustments; for patients >90 kg, cap wt at 90 kg for dose calculations
EGFR-mutated non-small cell lung CA, locally advanced or metastatic
- [6 mg/kg/dose IV q3wk]
- Max: 540 mg/dose; Info: for patients with previously treated disease
hormone receptor-positive HER2-negative breast CA, unresectable or metastatic
- [6 mg/kg/dose IV q3wk]
- Max: 540 mg/dose; Info: for patients with previously treated disease
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin 1.1-1.5x ULN or AST >ULN: no adjustment; bilirubin >1.5x ULN: not defined, caution advised
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- avoid: breastfeeding during tx and x1mo after D/C
- caution: corneal disease, significant
- caution: patients of childbearing potential
- caution: male patients of reproductive potential
- caution: patients 65 yo and older
- caution: renal impairment
- caution: bilirubin >1.5x ULN
Drug Interactions .
Overview
datopotamab deruxtecan
Trop-2-directed antibody; topoisomerase inhibitor
-
None
No significant interactions known or found for this drug. Caution always advised with multiple medications.
Adverse Reactions .
Serious Reactions
- interstitial lung disease
- pneumonitis
- pulmonary embolism
- ocular toxicity
- stomatitis
- infection
- acute kidney injury
- hemiparesis
- anemia
Common Reactions
- stomatitis
- nausea
- fatigue
- alopecia
- constipation
- dry eyes
- vomiting
- keratitis
- rash
- COVID-19
- appetite decr.
- cough
- diarrhea
- abdominal pain
- infusion reaction
- interstitial lung disease
- pneumonitis
- headache
- pruritus
- xeroderma
- xerostomia
- conjunctivitis
- blepharitis
- meibomian gland dysfunction
- blurred vision
- lacrimation incr.
- photophobia
- visual impairment
- skin hyperpigmentation
- madarosis
- leukocytes decr.
- calcium decr.
- lymphocytes decr.
- Hgb decr.
- neutrophils decr.
- ALT or AST incr.
- alk phos incr.
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; ophthalmic exam, including visual acuity, slit lamp exam, intraocular pressure, fundoscopy, at tx start, annually during tx, at tx D/C, and as clinically indicated; signs/symptoms of infusion reaction during and for at least 1h after 1st 2 infusions, then during and for at least 30min after subsequent infusions; signs/symptoms of interstitial lung disease
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human or animal data available; possible risk of fetal harm based on drug's mechanism of action
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective contraception during tx and x7mo after D/C in patients of childbearing potential and during tx and x4mo after D/C in male patients
Lactation
Clinical Summary
avoid breastfeeding during tx and x1mo after D/C; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for datopotamab deruxtecan: catabolism; CYP450: unknown; Info: active drug deruxtecan (CYP3A4 substrate)
Excretion: for datopotamab deruxtecan: unknown; Half-life: 4.8 days (datopotamab deruxtecan), 5.5 days (deruxtecan)
Subclass: Immunotherapy, Antibody-Drug Conjugates ; Immunotherapy, TROP-2 Inhibitors ; Mitosis Inhibitors, Topoisomerase I Inhibitors
Mechanism of Action
for datopotamab deruxtecan: antibody-drug conjugate binds to trophoblast cell-surface antigen 2 (TROP-2) expressing cells, releases active drug deruxtecan intracellularly, which binds to topoisomerase I-DNA complexes, causing DNA damage and apoptosis
Formulary .
No Formulary Selected
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