Datopotamab (Datroway) is a Trop-2-targeted antibody-drug conjugate (ADC). It was approved in the United States in 2025 for the treatment of HR-positive, HER2-negative advanced breast cancer.
How to Use Datopotamab (Datroway)
Dosage Regimen
(1) Standard Dosage: The recommended dosage is 6 mg/kg (with a maximum dosage of 540 mg for patients with a body weight ≥ 90 kg), administered via intravenous infusion once every 3 weeks (a 21-day cycle) until disease progression or the occurrence of intolerable toxicity.
(2) Infusion Requirements: Administration is only allowed via intravenous infusion; intravenous push or rapid injection is prohibited. The first infusion should last for 90 minutes. If well tolerated, subsequent infusions can be shortened to 30 minutes.
Pretreatment and Adjuvant Medication
(1) Prophylaxis for Nausea/Vomiting and Infusion Reactions: 30-60 minutes before each infusion, antihistamines (e.g., diphenhydramine), antipyretics (e.g., paracetamol), and 5-HT3 receptor antagonist antiemetics must be administered.
(2) Ocular Care: Patients should use preservative-free lubricating eye drops at least 4 times a day and avoid wearing contact lenses during treatment.
(3) Oral Care: To prevent oral ulcers, use a mouthwash containing dexamethasone (0.1 mg/mL) 4 times a day. During infusion, it is recommended to hold ice chips in the mouth to reduce the risk of mucositis.
Precautions for Preparation and Infusion
(1) Preparation: The drug must be reconstituted with sterile water for injection to a final concentration of 20 mg/mL, and then diluted in 5% dextrose injection (sodium chloride injection is prohibited).
(2) Stability: Infusion must be completed within 24 hours after reconstitution, and the drug should be stored protected from light.
Dosage Adjustment of Datopotamab (Datroway)
Dosage Adjustment Related to Adverse Reactions
(1) Interstitial Lung Disease (ILD): If suspected ILD occurs, administration must be immediately suspended. For confirmed ILD of grade ≥ 2, permanent discontinuation of the drug is required. After remission of asymptomatic ILD, the original dosage can be maintained or reduced (from 4 mg/kg to 3 mg/kg).
(2) Ocular Toxicity: For non-fusional superficial keratitis, administration can be suspended until remission; for corneal ulcers or severe vision loss, permanent discontinuation is necessary.
(3) Stomatitis: For stomatitis of grade ≥ 2, administration should be suspended and the dosage reduced after recovery; for grade ≥ 3, permanent discontinuation is required.
Management of Other Toxicities
(1) Infusion Reactions: If an infusion reaction occurs for the first time, the infusion rate should be reduced by 50%; if it occurs again, permanent discontinuation is required.
(2) Hematological Toxicity: For neutropenia of grade ≥ 3, administration must be suspended until recovery.
Medication for Special Populations of Datopotamab (Datroway)
Patients with Hepatic or Renal Impairment
(1) Mild Hepatic Impairment (bilirubin ≤ upper limit of normal [ULN] and aspartate transaminase [AST] > ULN): No dosage adjustment is needed.
(2) Moderate to Severe Renal Impairment (creatinine clearance [CrCl] 30-90 mL/min): Close monitoring of adverse reactions is required, especially for patients with an increased risk of ILD.
Elderly Patients
The incidence of grade ≥ 3 adverse reactions is higher in patients aged ≥ 65 years (42% vs. 33%). However, no routine dosage adjustment is necessary, and enhanced monitoring is required.
Pregnancy and Lactation
(1) Pregnancy: The drug has embryo-fetal toxicity. Effective contraceptive measures must be taken during treatment and for 7 months after the last dose (for females) / 4 months after the last dose (for males).
(2) Lactation: Breastfeeding is prohibited during treatment and for 1 month after the last dose.
