Erinit 5 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 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. Treatment with this medicine should be initiated by a physician experienced in the use of anticancer therapy. Treatment should continue for as long as clinical benefit is observed or until unacceptable toxicity occurs. 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; 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 the treatment of patients with SEGA associated with TSC is 4.5 mg/m2. (Administer the nearest dose (n) tablet.) The total dose may be achieved 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 a trough blood concentration that provides 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 proportional equation: New everolimus dose = current dose x (target concentration/current concentration) For example, if a patient has a steady-state concentration of 4 ng/mL based on the current BSA and 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 changed 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 treatment initiation or a dose change. 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, 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 In the event of severe or intolerable adverse drug reactions, 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 the dose is reduced to below the lowest dose of one tablet of this medicine, consider administering it every 2 days. Elderly patients (65 years of age or older) No dose adjustment is required in elderly patients. Patients with renal impairment No dose adjustment is required in 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) Patients 18 years of age 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 drug have not been established in pediatric patients under 18 years of age. Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC): The recommended dose of this drug for pediatric patients aged 1 year or older is the same as that for adult patients. Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC): Use of this drug is not recommended in patients under 1 year of age with TSC-associated SEGA or in patients under 18 years of age with TSC-associated SEGA and hepatic impairment, as these patients have not been studied.

This drug is a derivative of rapamycin and can cause a lung condition called non-infectious pneumonia. Symptoms such as shortness of breath, cough, and hypoxia should be reported to a physician immediately, and treatment may be adjusted or stopped based on these symptoms. This drug may suppress immune function, increasing the risk of infections; thus, prompt treatment is necessary if symptoms of infection occur, and treatment may be discontinued in cases of severe infection. Allergic reactions can occur, so immediate medical attention is required in cases of symptoms such as shortness of breath, skin rashes, or chest pain. Stomatitis may commonly occur, so if oral ulcers or pain develop, it is advisable to avoid alcohol and irritating products and to seek appropriate treatment. It may affect kidney function; therefore, regular kidney function tests should be performed, and any abnormalities should be discussed with a physician. Blood sugar and lipid levels may increase; thus, blood sugar and cholesterol tests should be routinely conducted before and during treatment. Hematologic abnormalities, such as anemia or leukopenia, may also occur, necessitating regular blood tests. This drug may interact with various other medications, so it is crucial to inform a physician or pharmacist if taking other medications, particularly certain antifungal agents or antibiotics. Patients with impaired liver function may experience increased drug exposure, so it is advisable not to administer it to patients with severe liver dysfunction. During treatment, vaccination with live vaccines should be avoided, and vaccine plans should be discussed before treatment starts. Pregnancy should be avoided while taking this drug, and women should use effective contraception during and for some time after treatment. Breastfeeding women should not take this drug, and both men and women may be affected in their reproductive capabilities. In case of overdose, general supportive care should be implemented, and since there are no specific antidotes, caution is required. This drug should be kept out of reach of children and stored in its original container.

non-infectious pneumonia, hypoxia, pleural effusion, cough, dyspnea, pneumonia, bacterial infection, aspergillosis, candidiasis, Pneumocystis pneumonia, viral infection, reactivation of hepatitis B virus, hypersensitivity reaction, anaphylaxis, flushing, chest pain, angioedema, stomatitis, oral ulcer, oral mucositis, acute renal failure, elevated serum creatinine, proteinuria, hyperglycemia, hypercholesterolemia, hypertriglyceridemia, decreased hemoglobin, lymphopenia, neutropenia, thrombocytopenia, anemia, taste disturbance, rash, fatigue, diarrhea, nausea, loss of appetite, anemia, taste disturbance, peripheral edema, asthenia, pruritus, weight loss, epistaxis, headache, dyspnea, bleeding, hypophosphatemia, hypertension, increased aspartate aminotransferase, increased alanine aminotransferase, diabetes mellitus, insomnia, taste abnormalities, congestive heart failure, deep vein thrombosis, hemoptysis, pulmonary embolism, acute respiratory distress syndrome, dry mouth, abdominal pain, oral pain, dyspepsia, dysphagia, dry skin, nail (finger or toe) disorders, acne, erythema, hand-foot syndrome, vascular edema, arthralgia, increased urinary frequency during the day, menstrual irregularities, amenorrhea, fever, mucosal inflammation, non-cardiac chest pain, impaired wound healing, weight loss, increased serum creatinine, rhinitis, upper respiratory infection, vomiting, sinusitis, pharyngitis, fever, amenorrhea, cellulitis, nasopharyngitis, otitis media, streptococcal pharyngitis, viral gastroenteritis, gingivitis, herpes zoster, sepsis, viral bronchitis, pancytopenia, pure red cell aplasia, aggressiveness, hypersensitivity, lymphedema, rhabdomyolysis, menorrhagia, ovarian cyst, vaginal bleeding, menstrual delay, increased serum lactate dehydrogenase, increased serum progesterone, increased serum follicle-stimulating hormone, vascular edema, leg pain, hypercalcemia, hyponatremia, leukocytosis, hypothyroidism, discoloration of stools, ocular hemorrhage, duodenal ulcer bleeding, skin ulcer, hematuria, cheilitis, azotemia, skin lesions, sensory abnormalities, sensory decline, urticaria, dizziness, cutaneous hyperpigmentation, skin toxicity, confusion, hypothyroidism, worsened 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, nasal inflammation, chapped lips, pulmonary edema, decreased serum sodium, decreased serum albumin, increased serum creatinine

This drug should be stored in a tightly sealed container to prevent exposure to air and moisture, and it is recommended to maintain the temperature between 1 degree and 30 degrees Celsius. Additionally, storing it away from direct sunlight in a dark place helps maintain the drug's effectiveness.

Appearance

White to yellowish round, biconvex oval tablet

Package unit

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