Formulation and specifications: Injection: 40mg (4ml)/bottle, 100mg (10ml)/bottle
Indications.
1. Combination chemotherapy with fluorouracil and platinum-containing agents is indicated for first-line treatment of patients with advanced or metastatic gastric cancer, cancer of the gastroesophageal junction, or adenocarcinoma of the esophagus.
2. Patients with advanced or recurrent gastric or gastroesophageal junction adenocarcinoma who have received two or more prior systemic treatment regimens.
Key points for rational drug use:
1. The recommended dose for monotherapy is 3 mg/kg or 240 mg fixed dose every 2 weeks by 30-minute intravenous infusion. The recommended dose for combination chemotherapy containing fluorouracil and platinum drugs is 360 mg every 3 weeks by intravenous infusion over 30 minutes or 240 mg of this product every 2 weeks by intravenous infusion over 30 minutes. The maximum duration of treatment is 24 months.
2. Navulizumab 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 has stable or persistently decreasing clinical symptoms, even if the possibility of disease progression is considered, continued treatment with this product may be considered based on the judgment of overall clinical benefit until disease progression is confirmed.
3. Depending on the safety and tolerability of the individual patient, dosing may be suspended or discontinued, and no dose increase or decrease is recommended.
4. The occurrence of grade 4 or recurrent grade 3 adverse reactions, persistence of grade 2 or 3 adverse reactions despite therapeutic adjustment, occurrence of grade 3 immune-associated pneumonia, hepatitis, or myocarditis should result in permanent discontinuation of nabumetinumab. 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.
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 to moderate hepatic impairment; no studies of this product have been performed in patients with severe hepatic impairment; use with caution in patients with severe hepatic impairment (total bilirubin, ALT or AST > 3 times the upper limit of normal).
6. Systemic glucocorticoids or other 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 the administration of this product has been initiated.
7. Navulizumab may cause immune-related adverse reactions. Baseline tests including thyroid function and cardiac enzymes are recommended prior to treatment and regular follow-up during treatment for early detection of immune-related adverse reactions. Because adverse reactions may occur at any time during or after discontinuation of nabumab therapy, patient monitoring should be continued (at least until 5 months after the last dose).
8. For suspected immune-related adverse reactions, an 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 and symptoms improve, the dose needs to be tapered to discontinuation; rapid dose reduction may cause worsening or recurrence of adverse reactions. If glucocorticoids are used but there is still no improvement, non-glucocorticoid immunosuppressive therapy should be added. In severe cases or those with doubtful diagnosis, MDT of immune adverse reactions composed of gastroenterology, rheumatology, dermatology, respiratory medicine, oncology, etc. may be consulted.
9. Navulizumab treatment should not be reintroduced while the patient is receiving immunosuppressive doses of glucocorticoids or other immunosuppressive agents.