Description
Indication & Scope
ShuTaiLai® Trastuzumab Botidotin for Injection treats adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2 targeted therapy regimens.
- Mechanism: HER2-targeted antibody-drug conjugate consisting of humanized trastuzumab monoclonal antibody, cleavable valine-citrulline linker and duostatin-5 microtubule inhibitor payload. The conjugate selectively binds HER2 overexpressed on breast cancer cells, internalizes and releases cytotoxic payload to block tumor cell microtubule assembly and induce mitotic arrest and apoptosis.
- Drug class: Anti-HER2 antibody-drug conjugate; injectable targeted anti-neoplastic drug.
- Clinical use: Second-line and salvage systemic therapy for metastatic HER2-positive breast cancer progressing after trastuzumab and taxane treatment; improves overall survival for metastatic HER2-positive breast cancer populations.
| Generic Name | Trastuzumab Botidotin for Injection |
| Brand Name | ShuTaiLai |
| Ingredient | Trastuzumab Botidotin |
| Dosage Form | Injection |
| Package | 40mg*1 vial/box |
| Conditions Treated | Unresectable or metastatic HER2-positive adult breast cancer |
| Taboos | Severe hypersensitivity to trastuzumab derivatives, ADC linker components or microtubule toxin payloads; patients with untreated severe congestive heart failure |
| Place of origin | China |
| Prescription type | Prescription-only |
| Storage Conditions | Unreconstituted vials refrigerated 2°C–8°C, shielded from light. Diluted infusion solution stable for maximum 24 hours refrigerated. Do not freeze lyophilized powder |
| Manufacturer | KeLunTaiBo Biopharmaceutical Co., Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | S20250056 |
| Approval Date | Oct 14, 2025 |
| Shelf Life | 30 months |
How to use ?
Recommended Dose: 4.0 mg per kilogram body weight for initial cycle infusion; maintain 3.2 mg/kg every 3 weeks for subsequent cycles.
Time: Intravenous infusion administered once every 21 days throughout treatment duration until disease progression or unmanageable toxicity.
Instructions for use: Reconstitute powder with sterile water for injection, dilute in normal saline for slow IV infusion over 90 minutes first cycle, then 30 minutes for subsequent cycles. Monitor cardiac ejection fraction every 3 months during therapy.
Interaction: Concurrent anthracycline chemotherapy increases cardiac dysfunction risk; CYP3A4 inhibitors elevate payload exposure and amplify myelosuppression.
Side effects:
1. Common adverse reactions: fatigue, alopecia, neutropenia, nausea, peripheral neuropathy, elevated liver enzymes.
2. Severe toxicities: severe left ventricular ejection fraction decline, severe neutropenic fever, interstitial lung disease.
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
FAQ
What is the applicable population of Trastuzumab Botidotin for Injection?
It is for adult patients with unresectable or metastatic HER2-positive breast cancer with prior anti-HER2 treatment failure.
What is the maintenance dose of Trastuzumab Botidotin for Injection after the first cycle?
The maintenance dose is 3.2 mg per kilogram of body weight administered every 3 weeks.
What severe cardiac adverse reaction may be caused by Trastuzumab Botidotin for Injection?
It may lead to decreased left ventricular ejection fraction and severe cardiac dysfunction.
What combined medication will increase cardiac toxicity risk when using Trastuzumab Botidotin for Injection?
Concurrent use of anthracycline chemotherapy drugs will significantly increase the risk of cardiac dysfunction.
ShuTaiLai® | Trastuzumab Botidotin for Injection | Breast Cancer | DengYueRX
INN: Trastuzumab Botidotin for Injection
Indications: Breast cancer
Dosage Form: Injection
Strength: 40mg/vial
