Description
Indication & Scope
Sacituzumab Govitecan for Injection (Trodelvy®) is a Trop-2 targeted antibody-drug conjugate (ADC). The humanized anti-Trop-2 antibody selectively binds Trop-2 overexpressed on breast tumor cells, releases SN-38 (topoisomerase I inhibitor) intracellularly to induce DNA damage and tumor cell apoptosis.
- Mechanism
Trop-2 targeted antibody-drug conjugate (ADC) - Drug class
Prescription ADC targeted anticancer biotherapy - Clinical use
Metastatic triple-negative breast cancer, HR+/HER2-negative metastatic breast cancer
| Generic Name | Sacituzumab Govitecan for Injection |
| Brand Name | Trodelvy® |
| Ingredient | Sacituzumab Govitecan |
| Dosage Form | Injection |
| Package | 180mg/vial |
| Conditions Treated | Adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC), who have received at least 2 prior systemic therapies (at least one for metastatic disease); Adult patients with unresectable locally advanced/metastatic HR-positive, HER2-negative breast cancer, previously treated with endocrine therapy plus ≥2 systemic regimens for metastatic disease. |
| Taboos | Severe hypersensitivity to sacituzumab govitecan or any excipients |
| Place of origin | Latina, Italy |
| Priscription Type | Prescription Drug |
| Storage Conditions | Store at 2°C–8°C, protected from light. Do not freeze or shake violently. |
| Manufacturer | BSP Pharmaceuticals S.p.A. |
| Registration Authority | National Medical Products Administration (NMPA) |
| Approval number | SJ20220015 |
| Approval Date | June 07, 2022 |
| Shelf Life | 36 months |
How to use ?
Recommended Dose: Standard dose: 10 mg/kg, administered on Day 1 and Day 8 of a 21-day cycle. Treatment continues until disease progression or intolerable toxicity.
Time: Initial infusion: Administer intravenously over 3 hours. If no severe infusion reaction occurs, subsequent infusions can be completed over 1–2 hours. Observe patients for at least 30 minutes after infusion ends.
Interaction: Do not substitute or co-administer with irinotecan or SN-38-containing agents. Strong CYP3A4 inhibitors may increase SN-38 exposure. Prophylactic antiemetics are recommended before infusion.
Side effects: Boxed warnings: Severe neutropenia, severe diarrhea. Common adverse reactions: Neutropenia, nausea, diarrhea, fatigue, alopecia, anemia, constipation, vomiting, decreased appetite, dyspnea, abdominal pain. Grade 3/4 main toxicities: Neutropenia, leukopenia, diarrhea, anemia.
Important Notice
This product shall only be used for post-exposure rabies prophylaxis by professional medical staff. It must be applied combined with rabies vaccine and injected via wound infiltration plus intramuscular routes as specified. Do not administer intravenously or alter the dosage at will. Hypersensitivity monitoring is required throughout the whole injection process.
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 pre-medication is recommended before sacituzumab govitecan infusion?
Prophylactic antiemetics are suggested to prevent nausea and vomiting during treatment.
What solvent is used to flush the infusion line after administration?
0.9% normal saline shall be used to flush the pipeline after infusion.
Why can this ADC not be combined with irinotecan?
Both sacituzumab govitecan and irinotecan contain SN-38, and combined use will increase toxic risk.
What should we do if grade 4 neutropenia occurs during treatment?
Interrupt administration and conduct full supportive treatment until blood cells recover, followed by dose reduction for subsequent cycles.
Trodelvy® | Sacituzumab Govitecan for Injection | Breast Cancer | DengYueRX
INN: Sacituzumab Govitecan
Indications: Breast Cancer
Dosage Form: Injection
Strength: 180mg/Vial
Original price was: $2,117.65.$1,800.00Current price is: $1,800.00.
