Formulation and specifications: Injection: 40mg (4ml)/bottle, 100mg (10ml)/bottle
Indications: This product in combination with Ipilimumab is indicated for the first-line treatment of patients with advanced renal cell carcinoma with an International Merger Database for Metastatic Renal Cell Carcinoma (IMDC) score of intermediate to high risk.
Key points for rational drug use:
1. The first-line treatment of nabritumomab in combination with ibritumomab in advanced renal cell carcinoma with an IMDC score of intermediate-high risk is based on the CheckMate214 study. The treatment was approved by the US FDA and the European Medicines Agency, and the recommended clinical dose is nabritumomab 3 mg/kg for at least 60 minutes each time + epilimumab 1 mg/kg for at least 30 minutes each time every 3 weeks, followed by a change to nabritumomab 3 mg/kg every 2 weeks for at least 60 minutes each time after 4 consecutive doses. However, this indication has not been approved by the State Drug Administration and may be considered with adequate communication with the patient.
2. The IMDC score includes: anemia (below the lower limit of normal), elevated neutrophils (above the upper limit of normal), elevated platelets (above the upper limit of normal), KPS score <80, first-line treatment <1 year from diagnosis, and hypercalcemia. Each item was scored as 1. A total score of 0 was classified as low risk, 1 to 2 as intermediate risk, and ≥3 as high risk.
3. Because some patients may experience pseudoprogression (transient tumor enlargement or appearance of new small lesions during the first months of treatment, followed by tumor shrinkage or even disappearance) with immunotherapy, treatment with nabumetinumab in combination with epirimizumab or nabumetinumab monotherapy should be continued until definite disease progression or intolerable toxicity occurs, as long as clinical benefit is observed. If the patient is clinically stable, continued treatment with this product may be considered until disease progression is confirmed, even if there is preliminary evidence of disease progression, based on the judgment of overall clinical benefit.
4. Dosing may be suspended or discontinued depending on the safety and tolerability of the individual patient. Dose increases or decreases are not recommended.
5. The relevance to the drugs nabumetinumab and epirimizumab is judged on the basis of adverse reactions. If grade 4 or recurrent grade 3 occurs and grade 2 or 3 adverse reactions persist despite therapeutic modifications, the possible drug that triggered the adverse reaction should be fully analyzed and permanent discontinuation of dual antibodies or nabumetinumab or ibritumomab may be required.
6. Limited data are available for elderly patients, and no dose adjustment is required for patients with mild to moderate renal impairment. Limited data are available for patients with severe renal impairment.
7. No dose adjustment is required in patients with mild hepatic impairment. There are no relevant studies of this product in patients with moderate to severe hepatic impairment.
8. Navulizumab ± Ipilimumab can cause immune-related adverse reactions. Because adverse reactions may occur during immunotherapy or at any time after immunotherapy has been discontinued, patient monitoring should be ongoing.
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 nabumab therapy and administer glucocorticoid or non-glucocorticoid immunosuppressive therapy. Provide multidisciplinary care with relevant field disciplines as necessary.
10. Do not reintroduce treatment with nabumetinumab while the patient is receiving immunosuppressive doses of glucocorticoids or other immunosuppressive therapy.