Erinito Tablet 10 mg (Everolimus)

Adult dose

Take this medicine once daily at the same time each day, consistently either with food or on an empty stomach. Swallow the tablet whole with a glass of water; do not chew or crush it. If you have difficulty swallowing the tablet, 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 rinse water to ensure you take the full dose. 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 (BSA, m2) using the Dubois formula. (W: 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 the treatment of patients with SEGA associated with TSC is 4.5 mg/m2. (Administer the nearest dose (n tablets).) This medicine may be combined with other strengths of this medicine to achieve the total dose. The dose should be titrated to achieve a trough blood concentration of 5-15 ng/mL. Titrate the dose by increasing it in increments of 2.5 mg to achieve a trough blood concentration associated with an 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 proportion: New everolimus dose = current dose x (target concentration/current concentration) For example, if a patient with a steady-state concentration of 4 ng/mL based on the current BSA is taking 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 the change in SEGA volume, the corresponding trough blood concentration, and tolerability. Once a stable dose has been achieved, monitor the trough blood concentration 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 (1) Adverse reactions: If severe or intolerable adverse drug reactions occur, 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 below the lowest dose of one tablet of this medicine, consider administering it every 2 days. If dose reduction is required, the recommended dose is approximately 50% of the previously administered dose. Elderly patients (65 years and older) No dose adjustment is necessary for elderly patients. Patients with renal impairment No dose adjustment is necessary 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 once daily. If not tolerated, the dose may be reduced to 5mg. • Moderate hepatic impairment (Child-Pugh B): The recommended dose is 5mg once 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 once 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) (1) Patients 18 years and 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. If the patient's hepatic status (Child-Pugh) changes during treatment, the dose should be adjusted.

Child dose

Pediatric patients under 18 years of age (breast cancer, neuroendocrine tumors, renal cell carcinoma, and renal angiomyolipoma associated with tuberous sclerosis complex (TSC)): The safety and efficacy of this drug have not been established. Pediatric patients aged 1 year and older with SEGA associated with TSC: The recommended dosage of this drug is the same as that for adult patients. Patients under 1 year of age with SEGA associated with TSC: This drug has not been studied; therefore, its use is not recommended. Patients under 18 years of age with SEGA associated with TSC and hepatic impairment: This drug has not been studied; therefore, its use is not recommended.

This medication suppresses the immune system and may cause pulmonary diseases such as non-infectious pneumonia. If symptoms such as difficulty breathing, cough, or hypoxia occur, notify a physician immediately, and depending on the severity of the symptoms, the drug administration may need to be stopped or the dosage adjusted. Additionally, taking this drug increases the risk of infections from bacteria, fungi, and viruses, so prompt treatment is required if symptoms of infection occur. Allergic reactions can cause anaphylaxis, difficulty breathing, flushing, and chest pain, so immediate assistance from medical personnel is necessary. Oral mucositis may be common, and local treatment may be needed to alleviate sores or ulcers in the mouth; however, avoid products containing irritating ingredients. Kidney function may decline, so kidney function should be monitored regularly through blood tests. Blood sugar and lipid levels may rise, so regular checks of blood sugar and cholesterol levels are essential, and appropriate treatment should be received as necessary. Red blood cells, white blood cells, and platelet counts in the blood may decrease, so complete blood counts should be performed regularly. The possibility of drug interactions exists, especially in combination with CYP3A4 and P-glycoprotein related drugs; some medications should be avoided with this drug. The use of this drug is not recommended in patients with severely impaired liver function. During the use of this medication, avoid vaccinations with live vaccines and close contact with individuals who have received live vaccines. The use during pregnancy may pose risks to the fetus, so women of childbearing age should engage in effective contraception during treatment and for a period afterward. It is advisable not to take this medication while breastfeeding, as it may affect fertility in both men and women. In the event of an overdose, there is no specific antidote; general supportive therapy should be provided to manage symptoms. The medication should be stored in its original container, and kept out of reach of children.

Non-infectious pneumonia, hypoxia, pleural effusion, cough, dyspnea, pneumonia, bacterial infection, aspergillosis, candidiasis, pneumocystis pneumonia, viral infection, reactivation of hepatitis B virus, anaphylaxis, flushing, chest pain, vascular edema, stomatitis, oral ulcers, oral mucositis, acute kidney failure, elevated 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, xerostomia, abdominal pain, oral pain, dyspepsia, dysphagia, rash, pruritus, dry skin, nail (toe) disorders, acne, erythema, hand-foot syndrome, angioedema, arthralgia, renal failure, increased daytime urination, menstrual disorders, amenorrhea, fatigue, weakness, peripheral edema, fever, mucosal inflammation, non-cardiac chest pain, impaired wound healing, weight loss, increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), increased blood creatinine, nasopharyngitis, upper respiratory infection, urinary tract infection, sinusitis, pharyngitis, otitis media, cellulitis, streptococcal pharyngitis, viral gastroenteritis, gingivitis, herpes zoster, sepsis, viral bronchitis, pancytopenia, increased partial thromboplastin time, increased blood lactate dehydrogenase, increased blood luteinizing hormone, increased blood follicle-stimulating hormone, rhabdomyolysis, menorrhagia, ovarian cyst, vaginal bleeding, delayed menstruation, aggressiveness, hypersensitivity, lymphedema, angioedema, thrombocytopenia, neutropenia, leukopenia, lymphopenia, thrombocytopenic syndrome, leukopenic syndrome, decreased calcium in blood, decreased albumin in blood, decreased uric acid in blood, increased blood lactate dehydrogenase, decreased calcium in blood, increased creatinine in blood, decreased sodium in blood, decreased albumin in blood, increased creatinine in blood, decreased calcium in blood, decreased sodium in blood, decreased albumin in blood, increased creatinine in blood

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture. Maintain storage temperatures between 1 to 30 degrees Celsius, and keep it away from direct sunlight in a dark place.

Appearance

White to yellowish oval biconvex tablet

Package unit

30 tablets/box [(5 tablets/PTP*6)]