Formulation and Specifications: Tablets: 2.5mg, 5mg, 10mg
Indications: Adult patients with inoperable, locally advanced or metastatic, well-differentiated, progressive nonfunctional neuroendocrine tumors of gastrointestinal or pulmonary origin.
Key Points for Rational Use:
1. The recommended dose of this product is 10 mg, administered orally once daily at the same time of day.
2. The tablet should be delivered whole with a glass of water and should not be chewed or crushed. For patients who are unable to swallow the tablet, place the tablet in a glass of water (approximately 30 ml) before administration and stir gently until completely dissolved (approximately 7 minutes) and take immediately. Wash the glass of water with the same volume of water and take the entire wash solution to ensure that the full dose has been taken.
3. Treatment should be continued as long as clinical benefit exists or until intolerable toxic reactions occur.
4. No clinical studies of this product have been conducted in patients with renal impairment. It is not expected that renal impairment will affect drug exposure and dose adjustment of everolimus is not recommended in patients with renal impairment.
5. This product is immunosuppressive and pre-existing invasive fungal infections should be thoroughly treated prior to initiating treatment with this product.
6. It is contraindicated in patients with hypersensitivity to the active ingredient, other rapamycin derivatives, or any of the excipients in this product. Manifestations of allergic reactions that have been observed in patients using everolimus and other rapamycin derivatives include, but are not limited to: hypersensitivity, dyspnea, flushing, chest pain, or angioedema (e.g., airway or tongue swelling with or without respiratory insufficiency).
7. Stomatitis includes oral ulcers and oral mucositis. In clinical trials, the incidence was 44% to 86%, and grade 3 to 4 stomatitis was reported in 4% to 9% of patients. The majority of stomatitis occurred within the first 8 weeks of treatment. If stomatitis occurs, topical treatment is recommended.
8. Avoid the combination of potent CYP3A4 inhibitors and inducers and P-glycoprotein inhibitors. The combination of intermediate-acting CYP3A4 and/or P-glycoprotein inhibitors should reduce the dose of everolimus by approximately 50%; patients with subventricular giant cell astrocytoma requiring a strong CYP3A4 inducer may require an increase in the dose of this product at the start of therapy to achieve a trough concentration of 5 to 15 ng/ml. double the daily dose of this product and assess tolerability. Evaluate everolimus trough concentrations approximately 2 weeks after dose doubling. Adjust the dose further by increases of 1 to 4 mg as necessary to maintain trough concentrations.