Datroway (datopotamab deruxtecan) is a newly approved Trop-2-targeted antibody-drug conjugate in 2025, demonstrating significant efficacy in the treatment of unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer in patients who have previously received endocrine therapy and chemotherapy.

What Are the Precautions for Using Datroway (Datopotamab Deruxtecan)?

Indications

Datroway is indicated for adult patients with unresectable or metastatic HR-positive, HER2-negative breast cancer who have received endocrine therapy and chemotherapy for unresectable or metastatic disease.

Before clinical use, strictly compare the patient’s pathological characteristics and treatment history to ensure compliance with indication criteria.

Medication in Special Populations

Pregnant women should undergo a rigorous risk assessment before use, as the drug may cross the placental barrier and cause embryotoxicity.

Women of childbearing age must use effective contraception for at least 7 months before initiating treatment, during treatment, and after the last dose.

Male patients must use contraception for at least 4 months during treatment and after the last dose.

Lactating women should discontinue breastfeeding and avoid nursing during treatment and for 1 month after the last dose.

The safety of Datroway in pediatric patients has not been established, while no dosage adjustment is required for elderly patients.

Pre-Administration Prophylaxis Requirements

Standard prophylaxis must be administered 30-60 minutes before each infusion.

Use preservative-free lubricating eye drops at least four times daily to prevent ocular reactions.

Use steroid-containing mouthwash four times daily to prevent oral mucositis.

Administer diphenhydramine 25-50mg intravenously or orally to prevent allergic reactions.

Administer acetaminophen 650-1000mg intravenously or orally to control fever.

Use 5-HT3 serotonin receptor antagonists to prevent nausea and vomiting.

Individualized Infusion Regimen Implementation

The first infusion should last 90 minutes; patients must be monitored for at least 1 hour during and after the infusion.

If well-tolerated, the second and subsequent infusions can be shortened to 30 minutes, with the monitoring period adjusted to 30 minutes accordingly.

Medication Monitoring for Datroway (Datopotamab Deruxtecan)

Dynamic Monitoring of Laboratory Indicators

Hematological indicators: Leukopenia (41%), lymphopenia (36%), hemoglobin decrease (35%), neutropenia (30%).

Biochemical indicators: Hypocalcemia (39%), increased ALT (24%), increased AST (23%), increased alkaline phosphatase (23%).

Regular Assessment of Organ Function

Renal function monitoring: The incidence of interstitial lung disease (ILD) may be increased in patients with mild to moderate renal impairment.

Hepatic function monitoring: Exposure to DXd (deruxtecan) is increased by 2.4-fold in patients with moderate hepatic impairment, requiring enhanced monitoring.