Datopotamab Deruxtecan (Datroway) is a Trop-2-targeted antibody-drug conjugate (ADC) indicated for the treatment of unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.
Precautions for Administration of Datopotamab Deruxtecan (Datroway)
Administration Method
Intravenous Infusion Specifications: For intravenous infusion only; intravenous push or rapid injection is prohibited.
The first infusion should take 90 minutes; after the patient tolerates it, subsequent infusions can be shortened to 30 minutes.
A 0.2-micron filter must be used during infusion, and sodium chloride injection should be avoided.
Pretreatment
Infusion Reaction Prophylaxis: Administer antihistamines (e.g., diphenhydramine) and antipyretic analgesics (e.g., paracetamol) 30–60 minutes before infusion.
Ocular Care: Use preservative-free lubricating eye drops (at least 4 times daily); avoid wearing contact lenses during treatment.
Oral Care: Use dexamethasone-containing mouthwash (4 times daily); hold ice chips in the mouth during infusion to reduce the risk of oral mucositis.
Dosage Adjustment and Contraindications
Individualized Dosage: The recommended dosage is 6 mg/kg (maximum 540 mg), administered once every 3 weeks.
Dose reduction should be performed in grades according to the severity of adverse reactions (first reduction to 4 mg/kg, second reduction to 3 mg/kg); permanent discontinuation is required for patients who cannot tolerate the drug.
Contraindicated Populations: There are no absolute contraindications, but the drug should be used with caution in patients with severe hepatic or renal impairment.
The drug is contraindicated in pregnant women; patients of childbearing age must use effective contraceptive measures.
Administration in Special Populations
Pregnancy and Lactation: The drug has embryo-fetal toxicity. Female patients must use contraception for 7 months after the last dose, and male patients must use contraception for 4 months after the last dose.
The drug is contraindicated during lactation.
Elderly Patients and Those with Hepatic/Renal Impairment: Patients aged ≥65 years have a higher incidence of adverse events and require close monitoring.
No dosage adjustment is needed for patients with mild to moderate hepatic or renal impairment, but there is insufficient data to support use in patients with severe impairment.
Medication Monitoring for Datopotamab Deruxtecan (Datroway)
Monitoring of Key Adverse Reactions
Interstitial Lung Disease (ILD)/Pneumonitis: Monitor for symptoms such as cough and dyspnea; discontinue the drug immediately in suspected cases and administer glucocorticoids.
Ocular Toxicity: 51% of patients experience dry eyes, keratitis, etc. Ophthalmic examinations (including visual acuity and intraocular pressure) are required before treatment and annually during treatment.
Oral Mucositis: The incidence is 59%. Strengthen oral care; dose reduction or discontinuation is required in severe cases.
Laboratory and Imaging Monitoring
Hematological Indicators: Regularly test white blood cells, lymphocytes, hemoglobin, and neutrophils (a decrease occurs in ≥20% of patients).
Liver Function: Monitor alanine transaminase (ALT), aspartate transaminase (AST), and alkaline phosphatase (an increase occurs in 24% of patients).
Imaging Evaluation: Assess tumor progression via CT/MRI every 6–8 weeks, with particular attention to the lungs for early detection of ILD.
Long-Term Follow-Up and Patient Education
Symptom Documentation: Instruct patients to record abnormal symptoms such as palpitations, vision changes, and oral ulcers.
Regular Follow-Up Visits: Even if symptoms resolve, tolerance should still be evaluated every 3 weeks, and monitoring should continue for several months after drug discontinuation.
