Formulation and specification: Injection: 100mg (10ml)/bottle
Indications: This product is indicated for the treatment of relapsed or refractory classic Hodgkin’s lymphoma that has undergone at least second-line systemic chemotherapy.
Key points for rational drug use:
1. A clear diagnosis of classic Hodgkin’s lymphoma must be made prior to drug administration.
2. Baseline evaluation should be done prior to treatment and treatment response and toxicity should be monitored regularly during treatment in accordance with relevant disease guidelines.
3. 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 occurs.
4. 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.
5. 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.
6. No data are available on this product for patients with moderate to severe hepatic impairment. Patients with mild hepatic impairment should use this product with caution and without dose adjustment if needed; it is not recommended for patients with moderate to severe hepatic impairment.
7. 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; it is not recommended for patients with moderate to severe renal impairment.
8. 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.
9. No safety and efficacy data are available for this product in children and adolescents under 18 years of age.
10. 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.
11. The use of this product for treatment during pregnancy is not recommended.
12. 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 therapy for the treatment of immune-related adverse reactions.