Formulation and specifications: Injection: 100 mg (10 ml)/vial
Indications: This product is indicated for use in combination with bevacizumab in the first-line treatment of unresectable or metastatic hepatocellular carcinoma that has not received prior systemic therapy.
Key points for rational drug use:
1. Baseline evaluation should be done before treatment and treatment response and toxicity should be monitored regularly during treatment in accordance with relevant disease guidelines.
2. This product is based on the ORIENT-32 clinical study in combination with bevacizumab and is administered 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 until disease progression is confirmed based on the judgment of overall clinical benefit.
4. Baseline tests including thyroid function and cardiac enzymes are recommended prior to treatment and regular follow-up during treatment for early detection of immune-related adverse reactions, while it should be noted that immune-related adverse reactions may also occur after the end of treatment. In the event of immune-related adverse reactions, 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.
5. There is no study data on this product 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 no dose adjustment is required if needed; patients with moderate to severe hepatic impairment are not recommended.
6. There is no study data on this product for patients with moderate to severe renal impairment. Patients with mild renal impairment should use this product with caution under the guidance of a physician, and no dose adjustment is necessary if needed.
7. The most common adverse reactions (≥10%) in patients with Hodgkin’s lymphoma treated with this product include fever, hypothyroidism, weight gain, pneumonia, upper respiratory tract infection, rash, anemia, and cough. The most common grade 3 or higher adverse reactions included weight gain, anemia, infusion reaction, respiratory tract infection, infectious pneumonia, and immune-related pneumonia.
8. No safety and efficacy data are available for this product in children and adolescents under 18 years of age.
9. There are limited data on the use of this product in elderly patients ≥ 65 years of age, and caution is advised under the guidance of a physician; no dose adjustment is necessary if it is needed.
10. The use of this product for treatment during pregnancy is not recommended.
11. 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.