Formulation and specifications: Injection: 100mg (10ml)/bottle
Indications: Treatment of hepatocellular carcinoma that has undergone at least one systemic therapy.
Key points for rational drug use:
1. Baseline assessment should be done before treatment 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. This indication is a conditional approval based on objective remission rates and overall survival results from a Phase II clinical trial. Full approval for this indication will be contingent upon ongoing confirmatory randomized controlled clinical trials demonstrating a significant clinical benefit of this treatment versus standard of care.
4. Atypical reactions may be observed. If patients have stable or persistent clinical symptoms, even if there is preliminary 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.
5. Baseline testing including thyroid function and cardiac enzymes is recommended prior to treatment and regular follow-up during treatment for early detection of immune-related adverse reactions. It is also important to note that immune-related adverse reactions may also occur after the end of treatment. For suspected immune-related adverse reactions, adequate evaluation should be performed to confirm the etiology or 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. Severe cases or those with doubtful diagnosis may be consulted by an immune adverse reaction MDT consisting of gastroenterology, rheumatology, dermatology, respiratory medicine, oncology, etc.
6. There is no study data for patients with moderate to severe hepatic impairment, and it is not recommended for patients with moderate to severe hepatic impairment. Patients with mild hepatic impairment should use this product with caution under the guidance of a physician and without dose adjustment if needed.
7. No study data are available for patients with severe renal impairment; use in patients with severe renal impairment is not recommended. This product should be used with caution under medical supervision in patients with mild to moderate renal impairment and no dose adjustment is necessary if used.
8. 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.
9. 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.