Lenvima Capsule 10 mg (Lenvatinib Mesylate)

Adult dose

Treatment with this drug should be initiated and supervised by a physician experienced and knowledgeable in cancer therapy. Treatment should continue until the patient no longer derives clinical benefit or develops unacceptable toxicity. Take this drug orally once daily at the same time each day, with or without food. If a dose is missed at the scheduled time and less than 12 hours remain until the next day's dose, skip the missed dose. Do not take a double dose the next day. Caregivers should not open the capsules to avoid repeated exposure to the contents of the capsule. The capsule may be swallowed whole or dissolved in a small cup. To dissolve it in liquid, place the capsule in one tablespoon of water for at least 10 minutes without crushing or breaking it, and stir for at least 3 minutes. After drinking the suspension, add one tablespoon of water to the cup, swirl it several times to rinse, and drink the rinse. Differentiated thyroid cancer: The recommended dose of this drug in adults is 24mg once daily. The daily dose may be adjusted as needed to manage adverse reactions (see section “2) Dose adjustment” below). Take this drug orally at the same time each day, with or without food. Hepatocellular carcinoma: The recommended dose of this drug is based on body weight. - Patients weighing 60kg or more: 12mg - Patients weighing less than 60kg: 8mg Continue administration of this drug once daily until disease progression or unacceptable toxicity occurs. There is no clinical evidence supporting the use of a 10mg dose in hepatocellular carcinoma. Endometrial cancer: The recommended dose of this drug is 20mg orally once daily until disease progression or unacceptable toxicity occurs. Pembrolizumab is administered in combination as an intravenous infusion of 200mg over 30 minutes every 3 weeks. Refer to the prescribing information for pembrolizumab for its recommended dosage. Renal cell carcinoma: The recommended dose of this drug is 20mg orally once daily in combination with pembrolizumab 200mg administered as an intravenous infusion over 30 minutes every 3 weeks. The combination treatment should continue until disease progression or unacceptable toxicity occurs, or for a maximum of 2 years. After 2 years of combination therapy, this drug may be administered as a single agent until disease progression or unacceptable toxicity occurs. Refer to the prescribing information for pembrolizumab for its recommended dosage. Temporary interruption, dose adjustment, or discontinuation of this drug may be necessary to manage adverse reactions. Mild to moderate adverse reactions (e.g., Grade 1 or 2) are generally not a reason to interrupt treatment with this drug, unless they are intolerable to the patient despite appropriate management. For severe adverse reactions (e.g., Grade 3) or intolerable adverse reactions, temporarily interrupt treatment with this drug until symptoms resolve or improve, reduce the dose as shown in Tables 1 and 2, and then resume treatment. Before reducing the dose of this drug or temporarily interrupting treatment, optimal medical management of nausea, vomiting, and diarrhea should be initiated. Gastrointestinal toxicity should be actively managed to reduce the risk of developing renal impairment or renal failure (see Precautions for Use 4. General Precautions 4) Renal Impairment and Renal Failure). Grade 3 hypertension: Temporarily interrupt treatment for persistent Grade 3 hypertension despite appropriate antihypertensive treatment; resume treatment at a reduced dose if hypertension is controlled to Grade 2 or lower. Grade 4: Permanently discontinue. Grade 3 cardiac dysfunction: Temporarily interrupt treatment until improvement to Grade 0-1 or baseline; resume treatment at a reduced dose or discontinue treatment depending on the severity and persistence of the adverse reaction. Grade 4: Permanently discontinue. Arterial thrombotic events, all grades: Permanently discontinue. Grade 3 or 4 hepatotoxicity: Temporarily interrupt treatment until improvement to Grade 0-1 or baseline; resume treatment at a reduced dose or discontinue treatment depending on the severity and persistence of hepatotoxicity; permanently discontinue for hepatic failure. Grade 3 or 4 renal failure or renal impairment: Temporarily interrupt treatment until improvement to Grade 0-1 or baseline; resume treatment at a reduced dose or discontinue treatment depending on the severity and persistence of renal impairment. Proteinuria ≥2g/24 hours: Temporarily interrupt treatment until it decreases to ≤2g/24 hours; resume treatment at a reduced dose; permanently discontinue for nephrotic syndrome. Gastrointestinal perforation, all grades: Permanently discontinue. Grade 3 or 4 fistula formation: Permanently discontinue. QT prolongation >500 ms or an increase of >60 ms from baseline: Temporarily interrupt treatment until improvement to ≤480 ms or baseline; resume treatment at a reduced dose. Reversible posterior leukoencephalopathy syndrome (RPLS), all grades: Temporarily interrupt treatment until complete recovery; resume treatment at a reduced dose or discontinue treatment depending on the severity and persistence of neurologic symptoms. Other adverse reactions: Persistent or intolerable Grade 2-3 adverse reactions, Grade 4 laboratory abnormalities: Temporarily interrupt treatment until improvement to Grade 0-1 or baseline; resume treatment at a reduced dose. Grade 4 adverse reactions: Permanently discontinue. Differentiated thyroid cancer: First dose reduction, 20mg once daily; second dose reduction, 14mg once daily; third dose reduction, 10mg once daily. Hepatocellular carcinoma, body weight ≥ 60kg: First dose reduction, 8mg once daily; second dose reduction, 4mg once daily; third dose reduction, 4mg every other day. Hepatocellular carcinoma, body weight ＜ 60kg: First dose reduction, 4mg once daily; second dose reduction, 4mg every other day; third dose reduction, discontinue treatment. Endometrial cancer: First dose reduction, 14mg once daily; second dose reduction, 10mg once daily; third dose reduction, 8mg once daily. Renal cell carcinoma: First dose reduction, 14mg once daily; second dose reduction, 10mg once daily; third dose reduction, 8mg once daily. When this drug is administered in combination with pembrolizumab, adjust the dose of one or both drugs as appropriate. Temporarily interrupt, reduce the dose of, or permanently discontinue this drug according to Tables 1 and 2. Refer to the prescribing information for pembrolizumab for additional dose adjustment information. For life-threatening adverse reactions (e.g., Grade 4), permanently discontinue treatment. Laboratory abnormalities that are considered not to be life-threatening are excluded; in such cases, manage them in the same manner as severe adverse reactions (e.g., Grade 3). Tolerability of this drug tended to be reduced in patients aged 75 years or older, Asian patients, patients with comorbidities (such as hypertension, hepatic impairment, and renal impairment), and patients weighing less than 60kg (see Precautions for Use 3. Adverse Reactions 3) Individual Adverse Reactions). Blood pressure should be controlled before treatment with this drug is initiated, and should be monitored regularly during treatment. If necessary, hypertension should be managed as shown in Table 3 (see Precautions for Use 4. General Precautions 1) Hypertension). 140mmHg ≤ systolic blood pressure <160mmHg or 90mmHg ≤ diastolic blood pressure <100mmHg: If the patient is not receiving antihypertensive medication, initiate antihypertensive therapy while continuing this drug; if the patient is receiving antihypertensive medication, increase the dose of the current antihypertensive medication or initiate additional antihypertensive therapy while continuing this drug. Systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg despite appropriate antihypertensive therapy: 1. Withhold this drug. 2. Resume treatment at a dose reduced by one dose level in patients whose systolic blood pressure is ≤150mmHg and diastolic blood pressure is ≤95mmHg and who have been receiving stable antihypertensive therapy for at least 48 hours (see Table 1 in the Dosage and Administration section). If life-threatening consequences occur (malignant hypertension, neurologic deficit, hypertensive crisis): Prompt intervention is required. Discontinue this drug and initiate appropriate medical management. Differentiated thyroid cancer, hepatic impairment: No initial dose adjustment based on hepatic function is required in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment. An initial dose of 14mg daily is recommended for patients with severe (Child-Pugh C) hepatic impairment. Further dose adjustment may be necessary depending on individual tolerability. Hepatocellular carcinoma, hepatic impairment: Dose adjustment is not recommended for patients with mild hepatic impairment. This drug has not been studied in patients with moderate or severe hepatic impairment. Endometrial cancer, hepatic impairment: Dose adjustment is not recommended for patients with mild or moderate (Child-Pugh A or B) hepatic impairment. The recommended dose of this drug in patients with severe (Child-Pugh C) hepatic impairment is 10mg orally once daily. Renal cell carcinoma, hepatic impairment: Dose adjustment is not recommended for patients with mild or moderate (Child-Pugh A or B) hepatic impairment. The recommended dose of this drug in patients with severe (Child-Pugh C) hepatic impairment is 10mg orally once daily. Differentiated thyroid cancer, renal impairment: No initial dose adjustment based on renal function is required in patients with mild or moderate renal impairment. An initial dose of 14mg daily is recommended for patients with severe renal impairment. Further dose adjustment may be necessary depending on individual tolerability. Patients with end-stage renal disease have not been studied, and treatment with this drug is not recommended. Hepatocellular carcinoma, renal impairment: Patients with severe renal impairment and end-stage renal disease have not been studied. Endometrial cancer, renal impairment: Dose adjustment is not recommended for patients with mild or moderate renal impairment. The recommended dose of this drug in patients with severe renal impairment is 10mg orally once daily. Renal cell carcinoma, renal impairment: Dose adjustment is not recommended for patients with mild or moderate renal impairment. The recommended dose of this drug in patients with severe renal impairment (creatinine clearance less than 30mL/min by the Cockcroft-Gault equation) is 10mg orally once daily. No initial dose adjustment based on age is required. Available data in patients aged 75 years or older are limited. No initial dose adjustment based on race is required. Available data in patients of races other than White and Asian are limited.

Child dose

Children under 2 years: This medicine must not be administered to children under 2 years due to safety concerns identified in animal studies (see Precautions for Use, 11. Other, 1) Nonclinical safety study results). Children aged 2 years to under 18 years: No data are available, and safety and efficacy have not been established.

This drug should not be used in patients with allergic reactions to the active ingredient or excipients, or in breastfeeding patients. It should be administered with caution in patients with a history of hypertension, thromboembolism, brain metastasis, unhealed postoperative wounds, and those with tumor infiltration in major blood vessels. This medication may cause various side effects such as hypertension, diarrhea, decreased appetite, weight loss, fatigue, stomatitis, vomiting, headache, dysphonia, palmar-plantar erythrodysesthesia syndrome, etc. Particularly, hypertension and proteinuria may appear from the initial phase of treatment, thus careful monitoring is required. Blood pressure should be monitored regularly during the use of this medication, and antihypertensive agents should be used appropriately if necessary. Serious side effects such as liver dysfunction, heart failure, arterial thromboembolism, renal failure, proteinuria, gastrointestinal perforation, bleeding, hypothyroidism, etc., may also occur, so regular tests and monitoring are necessary. Women of childbearing potential should use effective contraception during and at least one month after treatment. Wound healing may be delayed during treatment, so the use of this drug should be suspended for a certain period before and after surgery, and symptoms of acute cholecystitis or interstitial lung disease may occur; if abnormal symptoms arise, immediate consultation with healthcare professionals is necessary. Elderly patients, patients with low body weight, liver impairment, or renal impairment should use this drug with increased caution due to a higher risk of side effects.

Urinary tract infection, perineal abscess, thrombocytopenia, leukopenia, neutropenia, lymphopenia, splenic infarction, hypothyroidism, increased serum thyroid-stimulating hormone, hypocalcemia, hypokalemia, weight loss, decreased appetite, dehydration, hypomagnesemia, hypercholesterolemia, tumor lysis syndrome, insomnia, dizziness, headache, taste disturbance, cerebrovascular accident, reversible posterior leukoencephalopathy syndrome, monoparesis, transient cerebral ischemic attack, myocardial infarction, heart failure, prolonged QT interval on electrocardiogram, decreased ejection fraction, bleeding, hypertension, hypotension, aneurysm and arterial dissection, dysarthria, pulmonary embolism, pneumothorax, diarrhea, gastrointestinal and abdominal pain, vomiting, nausea, oral inflammation, oral pain, constipation, dyspepsia, dry mouth, anal perforation, abdominal distension, increased lipase, increased amylase, pancreatitis, increased serum bilirubin, hypoalbuminemia, increased alanine aminotransferase, increased aspartate aminotransferase, liver failure, hepatic encephalopathy, increased serum alkaline phosphatase, liver dysfunction, increased gamma-glutamyltransferase, cholecystitis, hepatocellular damage, hepatitis, red palm syndrome, rash, hair loss, hyperkeratosis, back pain, arthralgia, myalgia, pain in extremities, musculoskeletal pain, osteonecrosis of the jaw, proteinuria, cases of renal failure, kidney disease, increased serum creatinine, increased blood urea nitrogen, nephrotic syndrome, fatigue, weakness, peripheral edema, malaise, impaired wound healing, gastrointestinal fistula, lymph node abscess, folliculitis, urethritis, seizures, sensory impairment, peripheral sensory neuropathy, deterioration of overall health status, generalized edema, peripheral swelling, dermatitis, dry skin, perioral dermatitis, urticaria, dysphagia, gastritis, anal fissure, gingival swelling, flank pain, atelectasis, malignant neoplasm progression, eye discharge, eyelid swelling, orbital edema, delirium, sleep disturbances, frequent menstruation, ureterolithiasis, palpitations, hyperthyroidism, periodontitis, inguinal pain, myocarditis, heart hypertrophy, candidiasis, localized infection, onychomycosis, tinea pedis, acute kidney injury, hematuria, hydronephrosis, urogenital symptoms, urethral pain, autoimmune disorders, tremors, vesicular dermatitis, skin erosion, melanosis, hearing loss, necrotizing pneumonia, sudden death, cardiopulmonary arrest, sepsis, arrhythmia, autoimmune hepatitis, dyspnea, hypertensive crisis, increased blood creatinine, multiple organ dysfunction syndrome, myasthenic syndrome, myocarditis, nephritis, lung inflammation, ruptured aneurysm, subarachnoid hemorrhage, pneumonia, spontaneous bacterial peritonitis, liver abscess, Clostridium difficile infection, hand-foot-and-mouth disease, subcutaneous abscess, soft tissue infection, laryngitis, lung abscess, hyperglycemia, hypoglycemia, hypertriglyceridemia, hypercalcemia, hypermagnesemia, hypophosphatemia, hyponatremia, hypokalemia, hypomagnesemia, hyperkalemia, hypercholesterolemia, hyperbilirubinemia, hyperaminotransferasemia, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury, hepatitis, hepatotoxicity, decreased liver function tests, liver enzyme abnormalities, biliary tract disorders, liver disorders, hepatotoxicity, liver failure, acute hepatitis, hepatorenal syndrome, hepatic encephalopathy, hepatic coma, metabolic encephalopathy, hepatitis, hepatic steatosis, cholestatic liver injury, hepatotoxicity, liver dysfunction, liver damage, increased aminotransferases, hepatic encephalopathy, liver failure, hepatorenal syndrome, hepatitis, acute liver failure, chronic liver failure, hepatocellular injury

This medication should be stored in a tightly closed container to protect it from air or moisture. The appropriate storage temperature is between 1 and 30 degrees Celsius at room temperature, avoiding excessively hot or cold places.

Appearance

A capsule filled with white to off-white granules, with an upper orange part and a lower yellow part.

Package unit

(10 capsules/blister) × 3