Formulation and Specifications: Injection: 40mg (4ml)/vial, 100mg (10ml)/vial
Indications: This product is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma who develop disease progression during or after treatment with platinum-containing regimens and whose tumors are positive for PD-L1 expression (defined as ≥1% of tumor cells expressing PD-L1).
Key points for rational drug use:
1. The recommended dosing regimen for patients with recurrent or metastatic head and neck squamous cell carcinoma who develop disease progression during or after treatment with platinum-containing regimens and whose tumors are positive for PD-L1 expression (defined as ≥1% of tumor cells expressing PD-L1) is 3 mg/kg or 240 mg fixed dose intravenously over 30 minutes every 2 weeks until disease progression or intolerable toxicity occurs. intolerable toxicity. Treatment with this product should be continued as long as clinical benefit is observed until the patient is unable to tolerate it. It is possible that atypical reactions may be observed. If a patient has stable or persistent clinical symptoms, even with preliminary evidence of disease progression, continued treatment with this product may be considered until disease progression is confirmed based on a judgment of overall clinical benefit. 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.
2. Navulizumab can cause immune-related adverse reactions and patient monitoring should be continued (at least until 5 months after the last dose) as adverse reactions may occur during or at any time after discontinuation of navulizumab therapy. 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, nabumetinumab therapy should be suspended and glucocorticoids administered. If glucocorticoid immunosuppressive therapy is used to treat adverse reactions, a taper to discontinuation is required for at least 1 month after symptoms improve. Rapid dose reduction may cause worsening or recurrence of adverse reactions. If there is worsening or no improvement despite the use of glucocorticoids, non-glucocorticoid immunosuppressive therapy should be added. Navulizumab therapy should not be resumed while the patient is receiving immunosuppressive doses of glucocorticosteroids or other immunosuppressive agents. Prophylactic antibiotics should be used to prevent opportunistic infections in patients receiving immunosuppressive therapy. In the event of any severe, recurrent immune-related adverse reactions and any life-threatening immune-related adverse reactions, nabumetinumab therapy must be permanently discontinued.
3. Patients who develop mild to moderate infusion reactions should be closely monitored while receiving nabumetinumab and administered prophylactically according to the treatment guidelines for infusion reactions. In case of severe or life-threatening infusion reactions, nabumab therapy must be stopped and appropriate medication given.
4. It is possible that nabumetumab may be transmitted to the developing fetus via the mother. The use of nabumetumab during pregnancy, in women of childbearing age who are not using effective contraception, is not recommended unless the clinical benefit outweighs the potential risk. Effective contraception should be used for at least 5 months after the last application of nabumetumab. A risk to the newborn/infant cannot be excluded and a decision must be made whether to discontinue breastfeeding or discontinue nabumab therapy after considering the benefits of breastfeeding for the child and the benefits of treatment for the woman.
5. The safety and efficacy of this product in children under 18 years of age have not been established and no dose adjustment is required in the elderly population.
6. No dose adjustment is required in patients with mild to moderate renal impairment. Data in patients with severe renal impairment are limited. No dose adjustment is required in patients with mild to moderate hepatic impairment. No studies have been conducted on this product in patients with severe hepatic impairment.
7. Systemic glucocorticoids and other immunosuppressive agents should be avoided prior to initiation of nabumetinumab therapy at baseline.