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What Are the Side Effects of Datopotamab Deruxtecan (Datroway)?
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Article source: Seagull Pharmacy
Oct 16, 2025

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.

Note: For internal discussion among medical personnel only. For specific medication, please consult the attending physician. Drug information may change over time. For the latest information, we recommend adding a medical consultant or consulting for free online.
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