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datroway datopotamab deruxtecan-dlnk injection 100mg per vial per box

Description

 Indication & Scope

Datroway® is a prescription TROP2-directed antibody-drug conjugate (ADC) indicated for the treatment of adult patients with unresectable or metastatic hormone receptor-positive (HR-positive), HER2-negative breast cancer who have previously received endocrine therapy and at least one line of chemotherapy in the advanced setting.

  • Mechanism: Datopotamab deruxtecan-dlnk is a TROP2-directed antibody-drug conjugate composed of a humanized anti-TROP2 monoclonal antibody, a cleavable linker, and a topoisomerase I inhibitor payload (DXd). Following TROP2 binding and internalization, DXd is released intracellularly to induce DNA damage, inhibit tumor cell proliferation, trigger apoptosis, and produce a bystander antitumor effect.
  • Drug class: TROP2-directed antibody-drug conjugate (ADC).
  • Clinical use: Treatment of unresectable or metastatic HR-positive/HER2-negative breast cancer after prior endocrine therapy and chemotherapy.
Specification
Generic Name Datopotamab deruxtecan-dlnk for Injection
Brand Name Datroway®
Ingredient Datopotamab deruxtecan-dlnk
Dosage Form Injection
Package 100 mg/vial/box
Conditions Treated Unresectable or metastatic hormone receptor-positive (HR-positive), HER2-negative breast cancer after prior endocrine therapy and chemotherapy
Taboos Hypersensitivity to datopotamab deruxtecan-dlnk or any component of the product
Place of origin Germany
Prescription type Prescription Drug (Rx)
Storage Conditions Store refrigerated at 2–8°C, protected from light. Do not freeze.
Manufacturer Daiichi Sankyo Europe GmbH
Registration Authority National Medical Products Administration (NMPA), China
Approval number SJ20250021
Date of Revision 2025
Shelf Life 48 months

How to use ?

Recommended Dose: The recommended dose is 6 mg/kg administered by intravenous infusion once every 3 weeks (Q3W) until disease progression or unacceptable toxicity.The maximum dosage for patients weighing ≥90 kg is 540 mg.

 

Time: The initial infusion should be administered over approximately 90 minutes. If well tolerated, subsequent infusions may be administered over 30 minutes.

 

Instructions for use: Reconstitute and dilute before intravenous infusion according to the approved prescribing information. Datopotamab deruxtecan-dlnk should be administered by intravenous infusion only and should not be administered as an intravenous push or bolus. Monitor patients for infusion-related reactions during and after administration. Regular monitoring of complete blood counts, pulmonary symptoms, and ocular symptoms is recommended during treatment. Dose interruption, dose reduction, or permanent discontinuation may be required depending on the severity of adverse reactions, including interstitial lung disease/pneumonitis, hematologic toxicity, stomatitis, and other treatment-related toxicities.

 

Interaction: No formal clinical drug interaction studies have been conducted with datopotamab deruxtecan-dlnk. The antibody-drug conjugate is primarily eliminated through intracellular catabolism, and clinically significant CYP450-mediated interactions are not expected. Caution should be exercised when used concomitantly with drugs that may increase the risk of overlapping toxicities.

 

Side effects: Common adverse reactions include stomatitis, nausea, alopecia, fatigue, decreased appetite, anemia, neutropenia, lymphopenia, diarrhea, and vomiting. Serious adverse reactions may include interstitial lung disease/pneumonitis, severe infections, hematologic toxicities, and infusion-related reactions. Ocular toxicity may occur and appropriate monitoring and management should be considered.

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

Certificate of Analysis

GMP Certificate

Commercial Invoice

Packing List & CPP

Cold Chain Logistics

Customs Documentation

Scientific and regulatory sources

1.WHO References
2.NMPA
3.FDA
4.EMA

FAQ

What is Datroway® used for?

Datroway® (Datopotamab deruxtecan-dlnk) is used for the treatment of adults with unresectable or metastatic hormone receptor-positive (HR-positive), HER2-negative breast cancer who have previously received endocrine therapy and chemotherapy.

How does Datopotamab deruxtecan-dlnk work?

Datopotamab deruxtecan-dlnk is a TROP2-directed antibody-drug conjugate (ADC). It binds to TROP2-expressing tumor cells, is internalized, and releases the DXd topoisomerase I inhibitor payload to induce DNA damage and tumor cell death.

How is Datroway® administered?

Datroway® is administered by intravenous infusion at a recommended dose of 6 mg/kg once every 3 weeks (Q3W) until disease progression or unacceptable toxicity.

What are the common side effects of Datroway®?

Common adverse reactions include stomatitis, nausea, alopecia, fatigue, decreased appetite, anemia, neutropenia, lymphopenia, diarrhea, and vomiting. Serious risks include interstitial lung disease/pneumonitis and infusion-related reactions.

Datroway® | Datopotamab Deruxtecan-Dlnk | Breast Cancer | DengYueRX

INN: Datopotamab deruxtecan-dlnk
Indications: Unresectable or metastatic HR+/HER2- breast cancer
Dosage Form: Injection
Strength: 100 mg/Vial

Low MOQ

WHO-GMP

Worldwide Delivery

Compliance and Regulatory Documents

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