Chinese instructions for gosatuzumab for injection (Tudavi)

1. Generic name: gosatuzumab, Sacituzumab govitecan

Product name: TRODELVY, TRODELVY

Other names: Gosatolizumab for injection, Certolizumab, Todavir

2. Who can use gosatuzumab? Indications?

Sacituzumab govitecan (Sacituzumab govitecan) is indicated for the treatment of the following conditions:

1. Breast cancer (BC) cancer:

(1) Triple-negative breast cancer (mTNBC) cancer: Indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who have previously received two or more systemic therapies, at least one of which is for metastatic disease.

(2)Breast cancer with certain mutations: Indicated for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+, or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

2. Locally advanced or metastatic urothelial carcinoma (mUC): Indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received platinum-containing chemotherapy and programmed death receptor -1 (PD-1) or programmed death ligand-1 (PD-L1) inhibitors.

3. What are the side effects of gosatuzumab?

The most common side effects of gosatuzumab are diarrhea, nausea, fatigue, alopecia, constipation, vomiting, and decreased appetite; laboratory abnormalities may include decreased lymphocyte count, increased blood glucose, decreased albumin, decreased creatinine clearance, increased alkaline phosphatase, decreased magnesium, decreased potassium, and decreased sodium.

4. How should gosatuzumab be used?

Gosatuzumab is available as an intravenous infusion only. Do not give this product as an intravenous push or bolus injection. The recommended dose of gosatuzumab is 10 mg/kg administered once weekly as an intravenous infusion on days 1 and 8 of a 21-day treatment cycle. Continue treatment until disease progression or unacceptable toxicity. Do not give gosatuzumab to patients in doses greater than 10 mg/kg.

The patient's first infusion should take more than 3 hours, and the patient should be observed for signs or symptoms of infusion-related reactions during the infusion and for at least 30 minutes after the initial administration; if the previous infusion is tolerated, infuse gosatuzumab within 1-2 hours. Observe the patient during the infusion and for at least30 minutes after the infusion.

5. How to store gosatuzumab?

Gosatuzumab for injection is a sterile, off-white to yellow lyophilized powder for injection, packaged in a single-dose vial. Each gosatuzumab vial is packaged individually in a carton. Store the vial in the original carton in a refrigerator at 2°C to 8°C (36°F to 46°F) to avoid exposure to light prior to reconstitution. Do not freeze.

6. How does gosatuzumab work?

Gosatuzumab is aTrop-2-directed antibody-drug conjugate. Sacituzumab is a humanized antibody that recognizes Trop-2. The small molecule SN-38 is a topoisomerase I inhibitor covalently linked to the antibody through a linker. Pharmacological data indicate that gosatuzumab binds to Trop-2-expressing cancer cells and is internalized via hydrolysis of the linker with subsequent release of SN-38. SN-38 interacts with topoisomerase I and prevents the religation of topoisomerase I-induced single-strand breaks. The resulting DNA damage leads to apoptosis and cell death. Gosatuzumab reduces tumor growth in a mouse xenograft model of triple-negative breast cancer.

7. What will happen if you overdose on gosatuzumab?

Information on the toxicity of gosatuzumab is not readily available. In one clinical trial, gosatuzumab was administered at doses up to 18 mg/kg (approximately 1.8 times the maximum recommended dose of 10 mg/kg). In these patients, a higher incidence of severe neutropenia was observed. Overdose patients are at increased risk for serious adverse reactions, such as neutropenia, diarrhea, hypersensitivity reactions, nausea/vomiting, and other systemic reactions associated with cytotoxic drugs. Take symptomatic support measures.

8. Who cannot use gosatuzumab?

Gosatuzumab is contraindicated in patients with severe allergic reactions toSacituzumab govitecan.