Everolimus Tablet 10 mg (Everolimus)

Adult dose

This medicine is taken once daily at the same time each day, either consistently with food or consistently on an empty stomach. Swallow this medicine whole with a glass of water; do not chew or crush it. If you have difficulty swallowing the medicine, place it in water (approximately 30 mL) and stir well until it is completely dispersed (approximately 7 minutes), then drink it immediately. After drinking, rinse the cup with the same amount of water and drink all of the water to ensure that you have taken the full dose of the medicine. 1. Breast cancer, neuroendocrine tumors, renal cell carcinoma, and renal angiomyolipoma associated with tuberous sclerosis complex (TSC) Adult patients The recommended dose of this medicine is 10 mg orally once daily. 2. Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) The dose is individualized based on body surface area (Body Surface Area; BSA, m2) using the DuBois formula. (W; body weight (kg), H; height (cm)) BSA = (W0.425 x H0.725) x 0.007184 Starting dose and trough blood concentration The recommended starting dose of this medicine for patients with SEGA associated with TSC is 4.5 mg/m2. (Administer the nearest dose (n) tablets.) The dose may be adjusted to the total dose by combining this medicine with other strengths of this medicine. The dose should be titrated to achieve a trough blood concentration of 5-15 ng/mL. The dose should be titrated in increments of 2.5 mg to achieve the trough blood concentration for optimal clinical response. When titrating the dose, consider efficacy, safety, concomitant medications, and the current trough blood concentration. Dose titration can be calculated using a simple proportional equation: New everolimus dose = current dose x (target concentration/current concentration) For example, if a patient whose steady-state concentration is 4 ng/mL based on their current BSA is receiving a dose of 2.5 mg, the new everolimus dose to achieve a trough concentration of at least 5 ng/mL (e.g. 8 ng/mL) is 5 mg (an increase of 2.5 mg from the current daily dose). The trough blood concentration should be assessed within 1-2 weeks after a dose change. If the adjusted dose is not a multiple of 2.5 mg, administer the nearest dose. Dose monitoring The whole blood concentration of everolimus should be assessed approximately 1-2 weeks after starting treatment or changing the dose. Assess SEGA volume approximately 3 months after starting treatment with this medicine, and adjust the dose based on changes in SEGA volume, the corresponding trough blood concentration, and tolerability. Once a stable dose has been achieved, trough blood concentrations should be monitored every 3-6 months in patients whose body surface area has changed, and every 6-12 months in patients whose body surface area is stable. 3. Dose adjustment In the event of severe or intolerable adverse drug reactions, a temporary dose reduction or interruption of treatment may be necessary. If dose reduction is required, approximately 50% of the previously administered dose is recommended. If reducing the dose to below the lowest dose of one tablet of this medicine, consider administration every 2 days. Elderly patients (65 years or older) No dose adjustment is required for elderly patients. Patients with renal impairment No dose adjustment is required for patients with renal impairment. Patients with hepatic impairment Breast cancer, neuroendocrine tumors, renal cell carcinoma, and renal angiomyolipoma associated with tuberous sclerosis complex (TSC): Mild hepatic impairment (Child-Pugh A): The recommended dose is 7.5mg daily. If not tolerated, the dose may be reduced to 5mg. Moderate hepatic impairment (Child-Pugh B): The recommended dose is 5mg daily. If not tolerated, the dose may be reduced to 2.5mg. Severe hepatic impairment (Child-Pugh C): Administration is not recommended. Administer only if the therapeutic benefit outweighs the risk, and do not exceed 2.5mg daily. The dose should be adjusted if the patient's hepatic status (Child-Pugh) changes during treatment. Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) Patients 18 years or older Mild hepatic impairment (Child-Pugh A): The recommended dose is 75% of the dose calculated based on BSA. (Administer the nearest dose (1 tablet).) Moderate hepatic impairment (Child-Pugh B): The recommended dose is 50% of the dose calculated based on BSA. (Administer the nearest dose (1 tablet).) Severe hepatic impairment (Child-Pugh C): Administration is not recommended. The whole blood trough concentration of everolimus should be measured 1 - 2 weeks after starting treatment or after a change in hepatic status (Child-Pugh). The dose should be titrated to achieve a trough concentration of 5-15ng/mL. The dose should be adjusted if the patient's hepatic status (Child-Pugh) changes during treatment.

Child dose

Breast cancer, neuroendocrine tumors, renal cell carcinoma, and renal angiomyolipoma associated with tuberous sclerosis complex (TSC): The safety and efficacy of this medicine have not been established in pediatric patients under 18 years of age. Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC): In pediatric patients 1 year of age and older, the recommended dose of this medicine is the same as for adult patients. This medicine has not been studied in patients under 1 year of age with SEGA associated with TSC or in patients under 18 years of age with SEGA associated with TSC and hepatic impairment; therefore, its use is not recommended. Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) Patients under 18 years of age This medicine is not recommended for patients under 18 years of age with SEGA associated with TSC and hepatic impairment.

This drug can cause a serious lung condition called non-infectious pneumonia, so if symptoms such as difficulty breathing or cough occur, you must inform your doctor immediately. It can suppress immune function, making infections easier to catch, so infection status should be checked before administration, and treatment should be sought immediately if any infection symptoms appear. Hypersensitivity reactions can occur, and if symptoms such as difficulty breathing or skin rash develop, immediate medical attention is needed. Oral ulcers or inflammation can develop frequently, so it is important to receive appropriate treatment if symptoms of stomatitis appear. It may affect kidney function, so regular kidney function tests should be conducted, and immediate consultation with a physician is essential if symptoms of renal failure occur. Regular blood tests should be performed to monitor for abnormalities in blood sugar, blood lipids, and blood cell counts. There are numerous interactions with other medications, especially caution is needed when used concomitantly with certain antifungals or antibiotics, calcium channel blockers, etc., and you must inform your doctor of any medications currently being taken. Administration of this drug is not recommended for patients with severely impaired liver function, so liver function status must be checked. During treatment, live vaccines should be avoided, and if vaccinations are required, they should be planned before treatment starts. Women who are pregnant or planning to become pregnant should avoid taking this drug and should use effective contraception during treatment. Breastfeeding women should discontinue breastfeeding during the period of taking this drug and for some time afterward. There are no specific antidotes for overdose, so symptomatic supportive treatment should be provided. Keep the medicine in its original container and store it out of reach of children; it is safer not to transfer it to another container. Healing from surgical wounds may be delayed; therefore, it is necessary to consult with a doctor if there are surgical plans.

Non-infectious pneumonia, hypoxia, pleural effusion, cough, dyspnea, pneumonia, bacterial infection, aspergillosis, candidiasis, pneumocystis pneumonia, viral infection, hypersensitivity reaction, anaphylaxis, flushing, chest pain, vascular edema, stomatitis, oral ulcer, oral mucositis, renal failure, increased serum creatinine, proteinuria, hyperglycemia, hypercholesterolemia, hypertriglyceridemia, hypophosphatemia, diabetes, insomnia, taste disturbance, headache, congestive heart failure, bleeding, hypertension, deep vein thrombosis, epistaxis, hemoptysis, pulmonary embolism, acute respiratory distress syndrome, diarrhea, nausea, vomiting, dry mouth, abdominal pain, oral pain, dyspepsia, dysphagia, rash, pruritus, dry skin, nail disorder, acne, erythema, hand-foot syndrome, angioedema, arthralgia, proteinuria, increased daytime urination, acute kidney failure, menstrual irregularities, amenorrhea, fatigue, weakness, peripheral edema, fever, mucosal inflammation, non-cardiac chest pain, wound healing deficiency, weight loss, increased aspartate aminotransferase, increased alanine aminotransferase, increased blood creatinine, nasopharyngitis, upper respiratory tract infection, urinary tract infection, sinusitis, pharyngitis, otitis media, cellulitis, streptococcal pharyngitis, viral gastroenteritis, gingivitis, herpes zoster, sepsis, viral bronchitis, pancytopenia, pure red cell aplasia, decreased appetite, hyperlipidemia, hypokalemia, dehydration, aggressiveness, hypersensitivity, loss of taste, lymphedema, rhabdomyolysis, menorrhagia, ovarian cyst, vaginal bleeding, delayed menstruation, increased blood lactate dehydrogenase, increased blood luteinizing hormone, increased blood follicle-stimulating hormone, cheilitis, skin lesions, sensory abnormalities, sensory reduction, urticaria, dizziness, skin hyperpigmentation, skin toxicity, hypothyroidism, worsening health, seizures, hyperuricemia, myalgia, eyelid edema, paralysis, peripheral neuropathy, epigastric discomfort, decreased glomerular filtration rate, blurred vision, heart failure, facial edema, otitis externa, communication disorders, generalized edema, rhinitis, chapped lips, pulmonary edema, decreased blood sodium, decreased blood albumin, increased blood creatine, sputum disorders, leg pain, hypercalcemia, hyponatremia, leukocytosis, melena, ocular hemorrhage

This drug is sensitive to moisture and light, so it should be stored in a tightly sealed container. It is advisable to maintain storage temperatures between 1 to 30 degrees Celsius. This will help preserve the drug's efficacy and safety for a longer period.

Appearance

White to pale yellow oblong tablet

Package unit

30 tablets/box [(10 tablets/PTP×3)]