Formulation and specifications: Injection: 100mg (10ml)/bottle
Indications: Treatment of relapsed or refractory classic Hodgkin’s lymphoma after at least second-line systemic chemotherapy.
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. 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. 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.
4. For suspected immune-related adverse reactions, adequate evaluation should be performed to confirm the etiology or to 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.
5. No study data are available for patients with moderate to severe hepatic impairment, and use is not recommended for patients with moderate to severe hepatic impairment. This product should be used with caution under medical supervision in patients with mild hepatic impairment, and no dose adjustment is necessary for use.
6. 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.
7. 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.
8. Systemic glucocorticoids and other immunosuppressive agents should be avoided prior to initiating treatment with this product because of the potential for interference with its pharmacodynamic activity. However, systemic glucocorticoids and other immunosuppressive agents may be used after initiation of treatment for immune-related adverse reactions.
9. Other: monotherapy for relapsed refractory extranodal NK/T-cell lymphoma (Phase II clinical study data only). Monotherapy for relapsed refractory peripheral T-cell lymphoma (Phase II clinical study data only).