Formulation and specifications: Tablets: 2.5mg, 5mg, 10mg
Indications:
1. Adult and pediatric patients with subventricular giant cell astrocytoma associated with tuberous sclerosis that requires therapeutic intervention but is not amenable to surgical resection.
2. For the treatment of adult patients with tuberous sclerosis-associated renal vascular smooth muscle lipoma who do not require immediate surgical treatment.
Key points for rational drug use:
1. The recommended dose of this product is 10 mg, administered orally once daily, at the same time each day, with or without food, and should not be chewed or crushed.
2. Missed dose: The missed dose can be made up within 6 hours after the normal time of taking this product, after 6 hours the dose should be skipped and the product should be taken at the normal time the next day. Do not double the dose to make up for the missed dose.
3. Hepatic impairment increases everolimus exposure and dosing adjustments are made as follows: (1) Mild hepatic impairment: The recommended dose is 7.5 mg per day; if not well tolerated, the dose may be reduced to 5 mg per day.(2) Moderate hepatic impairment: The recommended dose is 5 mg per day; if not well tolerated, the dose may be reduced to 2.5 mg per day.(3) Severe hepatic impairment: If the expected benefit is higher than the risk, 2.5mg per day may be used, but this dose should not be exceeded.
4. Common stomatitis, etc., must be noted during dosing; special attention should be paid to the occurrence of interstitial pneumonia, possible creatinine, glucose and lipid abnormalities, and review during dosing.
5. Avoid combination of potent CYP3A4 inducers; if combination is necessary, increase the dose to a maximum of 20 mg per day; if moderate CYP3A4 inhibitors or P-glycoprotein inhibitors are needed, reduce the dose to 2.5 mg per day, or increase to 5 mg per day if tolerated; avoid combination of foods or nutritional supplements that inhibit CYP and P-glycoprotein activity, such as grapefruit juice, etc.
6. Avoid live vaccinations and close contact with people who have received live vaccines during treatment with this product.
7. Pregnant women should be fully informed of the possible hazards to the fetus when taking it.