datroway datopotamab deruxtecan for injection breast cancer 100mg

Description

Indication & Scope

Datroway® Datopotamab Deruxtecan for Injection treats adult patients with unresectable or metastatic triple-negative breast cancer and HR-positive HER2-negative metastatic breast cancer who have received prior systemic endocrine therapy and chemotherapy for metastatic lesions.

Mechanism: This TROP2-directed antibody-drug conjugate (ADC) consists of an anti-TROP2 monoclonal antibody, cleavable linker and topoisomerase I inhibitor payload. It selectively binds TROP2 overexpressed on breast tumor cells, internalizes and releases cytotoxic payload to trigger tumor DNA damage and cell death, with bystander anti-tumor activity against surrounding tumor tissue.
Drug class: Antibody-drug conjugate (ADC); targeted anti-neoplastic injectable.
Clinical use: First-line and second-line systemic therapy for metastatic TROP2-positive breast cancer; improves objective response rate and prolongs progression-free survival for patients with limited treatment options.

Specification

Generic Name	Datopotamab Deruxtecan for Injection
Brand Name	Datroway
Ingredient	Datopotamab Deruxtecan
Dosage Form	Injection
Package	100mg*1 vial/box
Conditions Treated	Unresectable or metastatic triple-negative breast cancer; HR-positive, HER2-negative metastatic breast cancer
Taboos	Severe hypersensitivity to datopotamab deruxtecan, monoclonal antibody excipients or camptothecin derivatives; patients with active grade ≥3 ocular inflammatory disease
Place of origin	Kantstrasse 2, 33790 Halle/Westfalen, Germany
Prescription type	Prescription-only
Storage Conditions	Unreconstituted vials refrigerated at 2°C–8°C, protected from light. Reconstituted diluted infusion solution must be used within 24 hours if refrigerated, or 4 hours at room temperature. Do not freeze
Manufacturer	Baxter Oncology GmbH
Registration Authority	National Medical Products Administration (NMPA), China
Approval number	SJ20250021
Approval Date	Aug 19, 2025
Shelf Life	30 months

How to use ?

Recommended Dose: 6 mg per kilogram of body weight, maximum single dose 540 mg for patients weighing ≥90 kg.

Time: Intravenous infusion administered once every 21 days (3-week treatment cycle), until disease progression or intolerable toxicity occurs.

Instructions for use: Reconstitute lyophilized powder with sterile water for injection, further dilute in 0.9% sodium chloride solution before slow IV infusion over 60 minutes. Premedicate with anti-emetics to prevent stomatitis and nausea; conduct regular ophthalmic monitoring.

Interaction: Concurrent use of chemotherapy agents with ocular toxicity increases keratitis risk; strong CYP3A4 inhibitors raise payload exposure and amplify myelosuppression side effects.

Side effects:

1. Common reactions: stomatitis, nausea, fatigue, alopecia, neutropenia, decreased calcium, dry eye.

2. Severe adverse events: severe neutropenia, interstitial lung disease, grade 3+ keratitis, severe diarrhea.

Important Notice

This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indicatiaon, and regional regulatory requirements.

Packaging & Shipping

Packaging

Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.

Shipping Methods

Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.

Export Support