Datopotamab Deruxtecan (Datroway) is a novel Trop2-targeted antibody-drug conjugate (ADC) indicated for the treatment of HR-positive, HER2-negative breast cancer. Despite its favorable efficacy, potential side effects and medication precautions must be watched for during administration.
What Are the Side Effects of Datopotamab Deruxtecan (Datroway)?
Gastrointestinal Reactions
Nausea (56%).
Vomiting (24%).
Constipation (34%).
Diarrhea (11%).
Hematological Abnormalities
Leukopenia (41%).
Lymphopenia (36%).
Hemoglobin decrease (35%).
Neutropenia (30%).
Ocular Issues
Dry eyes (27%).
Keratitis (24%).
Conjunctivitis, etc.
Skin and Hair Reactions
Alopecia (38%).
Rash (19%).
Systemic Symptoms
Fatigue (44%).
Decreased appetite (16%).
Severe Side Effects of Datopotamab Deruxtecan (Datroway) That Require Vigilance
Interstitial Lung Disease/Pneumonitis (ILD)
Risk: The incidence is approximately 4.2%, of which 0.5% are grade 3–4 cases, and 0.3% may be fatal.
Symptoms: Cough, dyspnea, fever, and a feeling of chest tightness.
Management: Once ILD is suspected, the drug must be discontinued immediately, and glucocorticoid therapy (e.g., prednisone ≥1 mg/kg/day) should be initiated.
Permanent discontinuation of the drug is required for confirmed grade 2 or higher ILD.
Ocular Adverse Reactions
Risk: 51% of patients experience ocular issues, including keratitis (24%) and dry eyes (27%); severe cases may lead to decreased visual acuity.
Use preservative-free artificial tears at least 4 times daily.
Avoid wearing contact lenses.
When symptoms occur, an ophthalmology consultation is necessary; temporary suspension or dose reduction of the drug may be required if needed.
Oral Mucositis
Risk: Occurs in 59% of patients, with 7% being grade 3–4 cases.
Prevention: Use steroid-containing mouthwash (e.g., dexamethasone oral solution) and hold ice chips in the mouth during infusion.
Management: Severe cases require temporary suspension of treatment or dose adjustment.
Embryo-Fetal Toxicity
Risk: The drug may cause fetal malformations; patients of childbearing age must use strict contraception.
Females: Use contraception during treatment and for 7 months after the last dose.
Males: Use contraception during treatment and for 4 months after the last dose.
Precautions for Administration of Datopotamab Deruxtecan (Datroway)
Pre-Administration Assessment
Baseline Examinations: Include pulmonary function tests and ophthalmic examinations (visual acuity, slit-lamp examination, intraocular pressure, etc.).
Contraindications: There are no absolute contraindications, but the drug should be used with caution in patients with active ILD or severe corneal diseases.
Administration and Monitoring
Infusion Requirements: For intravenous infusion only; intravenous push or rapid administration is prohibited.
The first infusion should take 90 minutes; for patients who tolerate subsequent infusions well, the duration can be shortened to 30 minutes.
Pretreatment: Administer antihistamines, antipyretics, and antiemetics (e.g., 5-HT3 antagonists) before infusion.
Monitoring Frequency: Evaluate complete blood count, liver function, and renal function in each treatment cycle; perform immediate reexaminations if respiratory or ocular symptoms occur.
Special Populations
Patients with Hepatic/Renal Impairment: No dose adjustment is required for patients with mild to moderate impairment; data on patients with severe impairment are insufficient, so caution is advised.
Elderly Patients: The incidence of severe adverse reactions is higher in patients aged ≥65 years, so enhanced monitoring is needed.

