Formulation and specifications: Injection: 100mg (4ml)/bottle
Indications:
1. Locally advanced or metastatic esophageal squamous cell carcinoma assessed by the State Drug Administration-approved assay with a combined PD-L1 positive score (CPS) ≥10 and failure of previous first-line systemic therapy.
2. First-line treatment of patients with unresectable or metastatic high microsatellite instability (MSI-H) or mismatch repair gene-deficient (dMMR) colorectal cancer (CRC) with wild-type KRAS, NRAS and BRAF genes.
Key points for rational drug use:
1. The approved dose of pabrolizumab, based on the results of the KEYNOTE-181 and KEYNOTE-177 studies, is 200 mg every 3 weeks or 400 mg every 6 weeks, administered by intravenous infusion over at least 30 minutes each.
2. Pabrolizumab therapy should be continued as long as clinical benefit is observed until the patient is intolerant and an atypical response is likely to be observed. If the patient is clinically stable, continued treatment with this product may be considered until disease progression is confirmed, even if the possibility of disease progression is considered, based on the judgment of overall clinical benefit.
3. 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.
4. The occurrence of grade 4 or recurrent grade 3 adverse reactions and the persistence of grade 2 or 3 adverse reactions despite therapeutic modifications should result in permanent discontinuation of pabrolizumab. In the event of any severe, recurrent immune-related adverse reactions and any life-threatening immune-related adverse reactions, pabolizumab therapy must be permanently discontinued.
5. No dose adjustment is required in elderly patients (≥65 years). No dose adjustment is required in patients with mild to moderate renal impairment; limited data are available for patients with severe renal impairment. 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.
6. Systemic glucocorticoids or other immunosuppressive agents should be avoided prior to administration 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. Treatment with pabrolizumab should not be resumed while the patient is receiving immunosuppressive doses of glucocorticosteroids or other immunosuppressive agents.
7. Pabrolizumab may cause immune-related adverse reactions, and 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. Because adverse reactions may occur during pablizumab therapy or at any time after pablizumab therapy is discontinued, patient monitoring should be continued (at least until 5 months after the last dose).
8. 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, pabrolizumab should be temporarily discontinued and glucocorticoid therapy applied. When immune-related adverse reactions improve to ≤ grade 1, gradual dose reduction to discontinuation is required. Based on limited clinical study data, other systemic immunosuppressive agents may be considered in the event of immune-related adverse reactions that cannot be controlled by glucocorticoids. If adverse reactions remain at ≤ grade 1 and the glucocorticoid dose has been reduced to ≤ 10 mg prednisone per day or equivalent, pabrolizumab therapy may be restarted within 12 weeks of the last pabrolizumab dose. Severe cases or those with doubtful diagnosis can be consulted by the MDT of immune adverse reactions composed of gastroenterology, rheumatology, dermatology, respiratory medicine and oncology.