Formulation and Specifications: Capsules: 50 mg
Indications: Non-pancreatic-derived neuroendocrine tumors of good differentiation (Gl, G2) of localized late stage or metastatic, progressive stage that are not surgically resectable.
Key points for rational drug use:
1. Based on the SANET-ep study, the recommended dose is 300 mg/dose once daily, taken continuously (every 4 weeks as a treatment cycle). It can be taken with a low-fat meal (500 kcal, ~20% fat) or orally on an empty stomach, and needs to be swallowed whole.
2. Adjust the dosing according to the safety and tolerability of the individual patient during the course of dosing, including suspension, dose reduction or permanent discontinuation of the product.
3. After suspension, if adverse reactions return to ≤ grade 1 within 4 weeks, dose adjustment is recommended under medical supervision: first dose adjustment to 250mg per day; second dose adjustment to 200mg per day; if still not tolerated, 200mg once daily for 3 weeks or permanent discontinuation may be considered.
4. There is no data on the effect on patients with hepatic or renal impairment. Patients with mild renal impairment do not need to adjust the starting dose; patients with moderate to severe renal impairment should use this product with caution under medical supervision; patients with mild to moderate hepatic impairment should use this product with caution under medical supervision and monitor liver function closely; patients with severe hepatic impairment are prohibited.
5. Contraindicated in patients with severe active bleeding, active peptic ulcer, unhealed gastrointestinal perforation or gastrointestinal fistula. Contraindicated during pregnancy and lactation.
6. There are no clinical data on the use of this product in pediatric or adolescent patients under 18 years of age, and its use is not recommended. It is recommended that elderly patients (≥65 years of age) should use this product with caution under medical supervision and without adjustment of the starting dose.
7. Common adverse reactions must be noted during administration, including proteinuria, hypertension, elevated blood bilirubin, diarrhea, decreased blood albumin, elevated blood triglycerides, elevated AST/ALT, elevated blood thyroid stimulating hormone, abdominal pain, fatigue/weakness, elevated blood uric acid, bleeding, and skeletal muscle pain.
8. Combined use of CYP3A4/5 inhibitors, inducers or substrates should be avoided or used with caution.