Toripalimab Injection

240 mg (6ml) /vial

80 mg (2ml) / vial

This product must be used under the guidance of a physician experienced in tumor treatment. Recommended dosage: For unresectable or metastatic melanoma that has failed systemic therapy in the past, and for locally advanced or metastatic urothelial carcinoma with platinum-based chemotherapy failure within 12 months of neoadjuvant or adjuvant chemotherapy, or for recurrent/metastatic nasopharyngeal carcinoma that has failed second-line or higher systemic treatment (monotherapy): the recommended dosage is 3 mg/kg, administered via intravenous infusion every 2 weeks, until disease progression or intolerable toxicity occurs. For first-line local recurrence or metastatic nasopharyngeal carcinoma, unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma first-line treatment, and first-line treatment for unresectable locally advanced or metastatic non-squamous non-small cell lung cancer with negative EGFR gene mutation and negative anaplastic lymphoma kinase (ALK): the recommended dosage is a fixed dose of 240 mg, administered via intravenous infusion every 3 weeks, until disease progression or intolerable toxicity occurs. For resectable stage IIIA-IIIB non-small cell lung cancer perioperative treatment: the recommended dosage is a fixed dose of 240 mg, administered via intravenous infusion every 3 weeks, combined with chemotherapy during 3 cycles of neoadjuvant treatment, 1 cycle of adjuvant treatment, then continue with single-agent adjuvant treatment of this product at a fixed dose of 240 mg, intravenous infusion every 3 weeks for a total of 13 cycles or until disease recurrence or intolerable toxicity occurs. When up to 4 cycles of perioperative combined chemotherapy are met, the medication cycle and timing of surgery for perioperative combined chemotherapy can be adjusted according to actual clinical circumstances. When administering Treprilizumab in combination with chemotherapy, Treprilizumab should be administered first. Please also refer to the prescription information for chemotherapy drug administration. Atypical responses have been observed in tumors treated with this product (for instance, temporary enlargement of the tumor or new small lesions may appear in the initial months of treatment, followed by tumor shrinkage). If the patient’s clinical symptoms are stable or continuously improving, even with initial evidence of disease progression, it may be considered to continue treatment with this product based on overall clinical benefit, until disease progression is confirmed.

This manual describes the approximate incidence of adverse reactions judged to be possibly related to Treplizumab observed in clinical trials. Since clinical trials are conducted in different patient populations and under various conditions, the incidence of adverse reactions observed in different clinical trials cannot be directly compared and may not reflect the actual incidence in clinical practice.