Instructions for Tevimbra (Tislelizumab-jsgr)

1. Name:Tislelizumab-jsgr

Product name: Tevimbra

2. Indications:

Tevimbra (Tislelizumab-jsgr) is indicated as a single agent for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) who have received prior systemic chemotherapy without a PD-(L)1 inhibitor.

3. Usage and dosage:

1. Recommended dose:The recommended dose of Tevimbra is 200mg, administered intravenously every 3 weeks until disease progression or unacceptable toxicity occurs. Give the first infusion within 60 minutes. If tolerated, subsequent infusions can be given within 30 minutes.

2. Dose adjustment: It is not recommended to reduce the dose ofTevimbra. In general, Tevimbra should be withheld for serious (Grade 3) immune-mediated adverse reactions. Tevimbra should be permanently discontinued for life-threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune-mediated reactions requiring systemic immunosuppressive therapy, or failure to reduce the corticosteroid dose to 10 mg or less prednisone equivalents per day within 12 weeks of initiating steroids.

4. Adverse reactions:

In clinical studies of Tevimbra in the treatment of esophageal squamous cell carcinoma, the most common (≥20%) adverse reactions (including laboratory abnormalities) include increased blood sugar, decreased hemoglobin, decreased lymphocytes, decreased sodium, decreased albumin, increased alkaline phosphatase, and anemia. Blood loss, fatigue, increased aspartate aminotransferase (AST), musculoskeletal pain, weight loss, increased alanine aminotransferase (ALT), and cough; post-marketing adverse events such as skin and subcutaneous tissue disorders, including Stevens-Johnson syndrome and toxic epidermal necrolysis (including fatal cases).

5. Supply and storage:

Tevimbra injection is a clear to slightly opalescent, colorless to slightly yellow solution in a carton containing a 100 mg/10 mL (10 mg/mL) single-dose vial; store in the original carton in a refrigerator at 2°C to 8°C (36°F to 46°F) to avoid light. Do not freeze. Don't shake.

6. Special groups:

Based on its mechanism of action, Tevimbra use by pregnant women can cause harm to the fetus. Therefore, it is recommended that women of childbearing potential use effective contraception during treatment with Tevimbra and for 4 months after the last dose of Tevimbra; women are advised not to breastfeed during treatment and for 4 months after the last dose of Tevimbra.

7. Mechanism of action:

The PD-1 ligands PD-L1 and PD-L2 bind to the PD-1 receptor found on T cells and inhibit T cell proliferation and cytokine production. Upregulation of PD-1 ligand occurs in some tumors, and signaling through this pathway may contribute to suppression of active T cell immune surveillance of tumors. Tislelizumab-jsgr, the main component of Tevimbra, releases PD-1 pathway-mediated suppression of immune responses, including anti-tumor immune responses, by binding PD-1 and blocking its interaction with PD-L1 and PD-L2. Tislelizumab-jsgr reduces tumor growth in xenograft models and human PD-1 transgenic mouse models.

Reference: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08ef1e3e-496f-4b0b-94ee-fbba3cc1985a##