Formulation and specifications: Injection: 100mg (4ml)/bottle
Indications:
1. Pabrolizumab in combination with axitinib is indicated for the first-line treatment of advanced renal clear cell carcinoma.
2. For the treatment of advanced uroepithelial carcinoma with disease progression after platinum-containing chemotherapy.
Key points for rational drug use:
1. The indication for first-line treatment with pablizumab in combination with axitinib in advanced renal clear cell carcinoma is based on the results of the global phase III KEYNOTE-426 clinical study. Pabrolizumab was administered via intravenous injection at a fixed dose of 200 mg every 3 weeks for at least 30 minutes and axitinib 5 mg orally twice daily (some patients underwent dose titration). The indication for first-line treatment with pablizumab for advanced uroepithelial carcinoma intolerant to platinum-based chemotherapy is based on the results of the phase II single-arm clinical study KEYNOTE-052, a combination regimen that has been approved by the U.S. FDA but is not yet approved by the State Drug Administration and may be considered with adequate communication with patients. The second-line indication for pablizumab in advanced uroepithelial carcinoma is based on the results of the global phase III clinical study KEYNOTE-045, which has been approved by the U.S. FDA, but has not yet been approved by the State Drug Administration, and may be considered under full communication with patients.
2. For advanced renal clear cell carcinoma that has failed previous targeted therapy, pablizumab in combination with axitinib may also be considered for second or third line therapy.
3. Systemic glucocorticoids or immunosuppressive agents should be avoided prior to the use of this product because they may affect the pharmacodynamic activity and efficacy of this product. However, systemic glucocorticoids or other immunosuppressive agents may be used to treat immune-mediated adverse reactions after administration of this product has been initiated.
4. Depending on the safety and tolerability of individual patients, dosing may need to be suspended or discontinued, and no dose increases or decreases are recommended.
5. Judge the relevance of the drug based on adverse reactions. If grade 4 or recurrent grade 3 occurs, consider adverse reactions associated with pabrolizumab, and if grade 2 or 3 adverse reactions persist despite therapeutic adjustment, pabrolizumab should be permanently discontinued. For details on the specific use of axitinib, see the section on axitinib.
6. No overall differences in safety or efficacy were observed between elderly patients (≥65 years) and younger patients (<65 years) that would require adjustment in this population. No dose adjustment was required in patients with mild to moderate renal impairment and limited data are available for patients with severe renal impairment.
7. No dose adjustment is required in patients with mild hepatic impairment, and no studies have been conducted with this product in patients with moderate to severe hepatic impairment.
8. Pabrolizumab may cause immune-related adverse reactions. Because adverse reactions may occur during pablizumab therapy or at any time after pablizumab therapy has been discontinued, patient monitoring should be continued.
9. For suspected immune-related adverse reactions, adequate evaluation should be performed to confirm the etiology or to exclude other etiologies. Depending on the severity of the adverse reaction, suspend pablizumab therapy and administer glucocorticoid or non-glucocorticoid immunosuppressive therapy. Perform multidisciplinary treatment with relevant field disciplines if necessary.
10. Do not reintroduce treatment with pabrolizumab while the patient is receiving immunosuppressive doses of glucocorticosteroids or other immunosuppressive therapy.