Formulation and specifications: Injection: 100mg (10ml)/bottle
Indications:
1. Sindilizumab in combination with pemetrexed and platinum-based chemotherapy for the treatment of EGFR mutation-negative and ALK-negative advanced or recurrent non-squamous cell NSCLC without systemic therapy.
2. Sindilizumab in combination with gemcitabine and platinum-based chemotherapy for the first-line treatment of non-surgically resectable advanced or recurrent squamous cell NSCLC.
Key points for rational drug use:
1. This product is administered by intravenous infusion. The recommended dose of intravenous infusion is 200 mg, administered every 3 weeks until disease progression or intolerable toxicity develops. The duration of intravenous infusion should be within 30 to 60 minutes. The drug should not be administered by intravenous push or single rapid intravenous injection.
2. It is possible that atypical reactions may be observed. If patients have stable or persistent clinical symptoms, even with preliminary imaging evidence of disease progression, continued treatment with this product may be considered until disease progression is confirmed based on a judgment of overall clinical benefit.
3. Depending on the safety and tolerability of individual patients, dosing may need to be suspended or permanently discontinued. Dose increases or decreases are not recommended.
4. No dose adjustment is required in patients with mild to moderate hepatic impairment and in patients with mild to moderate renal impairment. There are no data from independent studies in patients with severe hepatic impairment or severe renal impairment. This product should be used with caution under medical supervision in patients with severe hepatic impairment or severe renal impairment, and no dose adjustment is necessary if used.
5. No safety and efficacy data are available in children and adolescents under 18 years of age. No significant differences in safety have been shown in older (≥65 years) versus younger patients. Use with caution under the supervision of a physician is recommended and no dose adjustment is necessary for use.
6. Treatment with this product is not recommended during pregnancy. Lactating women are advised to stop breastfeeding during treatment with this product and for at least 5 months after the last dose.
Systemic glucocorticoids and other immunosuppressive agents should be avoided prior to initiating treatment with this product, but may be used after initiating treatment with this product if necessary to treat immune-related adverse reactions.