Trodelvy Sacituzumab Govitecan for Injection

1. Indications and Usage
Locally Advanced or Metastatic Triple-Negative Breast Cancer (mTNBC):
Indicated for adults with mTNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.
HR-Positive, HER2-Negative Metastatic Breast Cancer:
Indicated for adults with unresectable locally advanced or metastatic HR-positive, HER2-negative breast cancer who have received endocrine-based therapy and at least two prior systemic therapies.
Locally Advanced or Metastatic Urothelial Cancer (la/muVa):
Indicated for adults with la/muVa who have previously been treated with a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy.
2. Dosage and Administration
Route of Administration:
Intravenous Infusion ONLY. Do not administer as an IV push or bolus.
Recommended Dosage:
Dose: 10 mg/kg administered intravenously on Day 1 and Day 8 of each 21-day cycle.
Premedication: Administer antiemetics (e.g., ondansetron) prior to each infusion.
Administration Instructions:
Dilute with 0.9% Sodium Chloride Injection to a concentration of 1.1 mg/mL to 3.4 mg/mL.
Infuse over at least 3 hours for the first dose; subsequent doses may be infused over at least 1 hour if no hypersensitivity occurred.
3. Mechanism of Action
ADC Technology:
Sacituzumab govitecan is an antibody-drug conjugate targeting TROP-2, a cell surface protein expressed in many epithelial tumors.
Payload Release:
Upon binding to TROP-2, the drug is internalized and degraded in lysosomes, releasing the active metabolite SN-38. SN-38 acts as a potent topoisomerase I inhibitor, causing DNA damage and tumor cell apoptosis.
4. Safety and Warnings
Neutropenia:
May cause severe or life-threatening neutropenia. Monitor complete blood counts prior to each dose. Administer G-CSF if necessary.
Diarrhea:
May cause severe or life-threatening diarrhea. Monitor patients for signs of diarrhea and provide supportive care (e.g., loperamide, atropine).
Hypersensitivity Reactions:
Monitor patients during and for 1 hour after infusion.
5. Adverse Reactions
Most Common:
Neutropenia, diarrhea, nausea, fatigue, anemia, vomiting, constipation, rash, alopecia, pyrexia, and decreased appetite.
6. Drug Interactions
UGT1A1 Modulators:
Avoid concomitant use of UGT1A1 inhibitors (e.g., atazanavir) or inducers, as they may increase or decrease SN-38 exposure, respectively.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Sacituzumab Govitecan-hziy.
Storage:
Store in a refrigerator at 2-8°C. Do not freeze or shake. Protect from light.