Formulation and specifications: Injection: 100mg (10ml)/vial
Indications: Indicated for the treatment of locally advanced or metastatic uroepithelial carcinoma that has failed platinum-containing chemotherapy including neoadjuvant or adjuvant chemotherapy within 12 months of progression with high PD-L1 expression.
Key points for rational drug use:
1. Baseline assessment should be done before treatment, especially PD-L1 expression testing of tumor tissues, and treatment response and toxicity should be monitored regularly during treatment, in accordance with relevant disease guidelines.
2. Administer by intravenous infusion. The recommended dose of intravenous infusion is 200 mg, administered every 3 weeks until disease progression or intolerable toxicity occurs.
3. It is possible that atypical reactions may be observed. If patients have stable or persistent clinical symptoms, even with preliminary evidence of disease progression, continued treatment with this product may be considered based on the judgment of overall clinical benefit until disease progression is confirmed.
4. For suspected immune-related adverse reactions, adequate evaluation should be performed to confirm the etiology or to exclude other etiologies, and dosing may need to be suspended or permanently discontinued depending on the safety and tolerability of the individual patient. Dose increases or reductions are not recommended.
5. No study data are available for patients with severe hepatic or renal impairment, and it is not recommended for patients with moderate to severe hepatic impairment or severe renal impairment. Patients with mild hepatic impairment and mild to moderate renal impairment should be used with caution under medical supervision and without dose adjustment if needed.
6. It is recommended that nursing mothers stop breastfeeding during treatment with this product and for at least 5 months after the last dose. Women of childbearing potential should use effective contraception during treatment with this product and for at least 5 months after the last dose of this product.
7. Systemic glucocorticoids and other immunosuppressive agents should be avoided prior to initiating treatment with this product because of possible interference with its pharmacodynamic activity. However, systemic glucocorticoids and other immunosuppressive agents may be used after initiation of treatment for immune-related adverse reactions.