Everolimus 5 mg Tablet

Adult dose

Take this medicine once daily at the same time each day, consistently either with food or on an empty stomach. The recommended dose for breast cancer, neuroendocrine tumors, renal cell carcinoma, and renal angiomyolipoma associated with tuberous sclerosis complex is 10 mg orally once daily. For subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex, the dose is individualized based on body surface area. The starting dose is 4.5 mg/m2, and the dose is increased in increments of 2.5 mg to achieve a trough blood concentration of 5-15 ng/mL. Dose titration should take into account efficacy, safety, concomitant medications, and trough blood concentration. Blood concentration should be assessed approximately 1-2 weeks after starting treatment or changing the dose. Dose adjustment is required in patients with hepatic impairment ranging from mild to severe; administration is not recommended in patients with severe hepatic impairment.

Child dose

For subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex, the recommended dose of this medicine in pediatric patients 1 year of age and older is the same as for adult patients. Use is not recommended in pediatric patients under 1 year of age or in those under 18 years of age with hepatic impairment. For breast cancer, neuroendocrine tumors, renal cell carcinoma, and renal angiomyolipoma associated with tuberous sclerosis complex, safety and efficacy have not been established in children under 18 years of age. Use is not recommended in patients under 18 years of age with hepatic impairment.

This drug may cause a lung disease called non-infectious pneumonia; therefore, if symptoms such as shortness of breath, cough, or hypoxemia occur, you should inform your doctor immediately. As this drug suppresses immunity, there is an increased risk of infections. If there are symptoms of infection, prompt treatment is necessary, and in some cases, the use of the drug may need to be discontinued. Allergic reactions may occur while taking this medication; thus, if symptoms such as shortness of breath, flushing, chest pain, etc. arise, you should inform medical staff immediately. Stomatitis, which is inflammation or ulcers in the mouth, can commonly occur; it is advisable to maintain oral hygiene and avoid products containing irritating ingredients. There is a risk of decreased kidney function, so regular kidney function tests should be performed, and management should be done according to the doctor’s instructions. You should undergo regular laboratory tests to check for abnormalities in blood glucose, blood lipids, and blood counts. As this drug may interact with other medications, especially when used with certain antifungals, calcium channel blockers, or antibiotics, it is important to consult a doctor and monitor carefully. Patients with severely impaired liver function should not take this medication, and those with liver disease should take it at the discretion of their physician. During the course of this medication, live vaccinations should be avoided, and close contact with individuals who received live vaccinations should be done with caution. When used in conjunction with specific blood pressure medications, serious side effects such as angioedema may occur, so caution is warranted. Wound healing may be impaired before and after surgery; therefore, if there is a surgery planned, you should inform your doctor in advance and manage accordingly. If you have hypersensitivity to this drug or specific genetic conditions like lactose intolerance, do not take this medication. Women who are pregnant or may become pregnant should not take this medication and must use effective contraception while on treatment. Breastfeeding women should avoid breastfeeding while taking this medication and for a certain period afterward. In case of overdose, as there is no specific antidote, general supportive care should be initiated, and immediate medical attention should be sought. This medication should be kept out of reach of children and stored in its original container for safety.

This medication should be stored in a tightly closed container to prevent air and moisture exposure. The storage temperature should be maintained between 1 degree and 30 degrees and should be kept in a cool place away from direct sunlight.

Appearance

White to pale yellow rectangular tablets

Package unit

30 tablets/box [(10 tablets/PTP×3)]