

Sacituzumab Govitecan for Injection
Gilead Sciences
Quick Info
Triple negative breast cancer, HR positive, HER2 negative breast cancer
【Ingredients】
Active ingredient: Gosartuzumab
Active ingredient source: Gosartuzumab is an antibody-drug conjugate (ADC) consisting of an antibody targeting trophoblast cell surface antigen-2 (Trop-2) and a topoisomerase inhibitor, including the following three components:
Humanized monoclonal antibody hRS7 IgG1κ (also known as sacituzumab), which can bind to the trophoblast cell surface antigen (Trop-2); Drug SN-38, a topoisomerase inhibitor; A hydrolyzable linker (called CL2A) that connects the humanized monoclonal antibody and SN-38.
The recombinant monoclonal antibody is produced by mammalian cells, while the small molecule components SN-38 and CL2A are produced by chemical synthesis. The average drug/antibody ratio of gosartuzumab is 7-8.
[Properties]
Gosartuzumab for injection is a preservative-free, off-white to pale yellow, sterile lyophilized powder for intravenous infusion.
[Indications]
This product is used for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received at least 2 systemic therapies (at least 1 of which was for metastatic disease).
This indication is conditionally approved based on the objective response rate and duration of response results of a Phase II single-arm clinical trial. Full approval of this indication will depend on whether subsequent confirmatory clinical trials can confirm the clinical benefits of this product.
180 mg/vial
[Usage and Dosage]
Important medication information
Do not replace this product with other drugs containing irinotecan or its active metabolite SN-38, or use it in combination with such drugs.
Recommended dose and administration regimen
The recommended dose of this product is 10 mg/kg, intravenously infused on the 1st and 8th days of each 21-day treatment cycle, and continued until disease progression or unacceptable toxicity occurs. The dose of this product should not exceed 10 mg/kg.
This product can only be administered by intravenous infusion and not by intravenous push.
First infusion: The infusion time should last for 3 hours. Observe the patient for infusion reactions during the infusion and for at least 30 minutes after the end of the infusion (see [Precautions]).
Subsequent infusions: If the previous infusion is tolerable, the infusion time can be 1-2 hours. Observe the patient for infusion reactions during the infusion and for at least 30 minutes after the end of the infusion.
Preventive medication
Preventive medication is recommended before each dose of this product to prevent infusion reactions and chemotherapy-induced nausea and vomiting
(CINV).
Use antipyretics, H1 and H2 blockers for pre-infusion prophylaxis, and glucocorticoids for patients with previous infusion reactions.
Use a two- or three-drug combination [e.g., dexamethasone and a 5-hydroxytryptamine 3 (5-HT3) receptor antagonist
or a neurokinin receptor 1 (NK1 receptor) antagonist, or other drugs as appropriate] for prophylaxis.
[Contraindications]
This product is contraindicated in patients with severe hypersensitivity reactions to this product (see [Precautions]).
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Sacituzumab Govitecan for Injection
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