Epidanib Tablets 150 mg (Nintedanib Esylate)

Adult dosage

The recommended adult dose is 150mg twice daily, at 12-hour intervals. Take immediately after a meal. Swallow the whole dose with water; do not chew or crush it. A dose of 100mg twice daily is recommended only when the 150mg twice-daily regimen is not well tolerated. Treatment with this drug should be initiated by a physician experienced in diagnosing and treating the condition for which this drug is indicated. Liver function and pregnancy tests should be performed at the start of treatment. If a dose is missed, take the recommended dose at the next scheduled dosing time. Do not take an additional dose. Do not exceed the recommended daily dose of 300mg. <Dose adjustment> If management of adverse reactions (see Precautions for Use) is required alongside symptomatic treatment, the dose may be reduced or treatment temporarily interrupted until the adverse reaction has improved to a level that allows treatment to continue. Treatment with this drug may then be resumed at the recommended dose (150mg per dose, twice daily) or the reduced dose (100mg per dose, twice daily). If the 100mg twice-daily dose is not well tolerated, treatment with this drug should be discontinued. If treatment was temporarily interrupted because aminotransferases (AST or ALT) exceeded 3 times (but were less than 5 times) the upper limit of normal (ULN), treatment may be resumed at the reduced dose (100mg per dose, twice daily) once aminotransferases have returned to baseline, and the dose may subsequently be increased to the recommended dose (150mg per dose, twice daily) (see Precautions for Use). Discontinue treatment with this drug if aminotransferases (AST or ALT) exceed 5 times the ULN, or exceed 3 times the ULN with signs or symptoms of severe liver injury. <Elderly patients> No differences in safety or efficacy were observed in patients aged 65 years and older compared with patients younger than 65 years. No dose adjustment is required for elderly patients aged 65 years and older. Patients aged 75 years and older may require a dose reduction to manage adverse reactions. <Patients with renal impairment> Less than 1% of a single dose of this drug was excreted through the kidneys. No starting dose adjustment is required in patients with mild to moderate renal impairment. Safety, efficacy, and pharmacokinetic properties have not been studied in patients with severe renal impairment (creatinine clearance below 30mL/min). <Patients with hepatic impairment> This drug is eliminated mainly (>90%) via biliary/fecal excretion. Exposure was increased in patients with hepatic impairment (Child Pugh A, Child Pugh B). For patients with mild hepatic impairment (Child Pugh A), the recommended dose of this drug is 100mg per dose twice daily, at 12-hour intervals; treatment interruption or discontinuation should be considered to manage adverse reactions. Use of this drug is not recommended in patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment.

Children's dosage

Treatment of pediatric patients with nintedanib is not authorized.

This medicine should not be used in patients who have a hypersensitivity to the active ingredient or any of the components. Pregnant or breastfeeding women should not take this medicine. This medicine should be avoided in patients with moderate to severe liver dysfunction. Patients with gastrointestinal disorders, especially diarrhea, nausea, or vomiting, should use this medicine with caution and may require dosage adjustments if symptoms are severe. Patients at risk of bleeding or taking high doses of anticoagulants should be cautious when using this medicine. Patients with a history of arterial or venous thromboembolism should also use this medicine with caution. Administration should be cautious in patients who have recently undergone abdominal surgery or are at risk of gastrointestinal perforation, as it may affect wound healing before and after surgery. Patients with hypertension should regularly monitor their blood pressure, as this medicine may cause an increase. Caution is required when administering this medicine to patients with a prolonged QT interval. This medicine may commonly cause side effects such as diarrhea, nausea, vomiting, abdominal pain, decreased appetite, weight loss, and elevated liver enzymes, so consultation with a healthcare provider is necessary if any symptoms occur. Regular liver function tests are required if abnormalities are found, and the medication should be discontinued in cases of severe liver damage. Kidney function abnormalities have been reported, so patients with impaired renal function should be closely monitored. This medicine may increase the risk of bleeding, hence should be used with caution in patients with a high bleeding risk. Patients at high risk for cardiovascular diseases should undergo thorough evaluation before use, and those with a history of myocardial infarction or stroke are advised to avoid this medicine. This medicine poses risks of gastrointestinal perforation and ischemic colitis; thus, special precautions are necessary for patients with a history of gastrointestinal diseases. It is important to maintain adequate hydration to prevent dehydration during treatment with this medicine, and dosage adjustments may be necessary if diarrhea is severe. Women of childbearing potential should avoid pregnancy while taking this medicine and should perform pregnancy tests before and during use. Breastfeeding women are advised to discontinue breastfeeding while taking this medicine. This medicine may interact with other drugs, particularly potent P-gp inhibitors or inducers; therefore, consultation with a healthcare provider is necessary when concomitantly using other medications. Smoking may reduce the effectiveness of this medicine, so quitting smoking is recommended. This medicine is best taken immediately after meals, and caution is needed when driving or operating machinery. There is no specific antidote for overdose; therefore, appropriate measures should be taken according to symptoms, and it should be stored out of reach of children.

Diarrhea, nausea, vomiting, abdominal pain, decreased appetite, weight loss, elevated liver enzymes, pancreatitis, drug-induced liver damage, elevated alanine aminotransferase (ALT), elevated aspartate aminotransferase (AST), elevated alkaline phosphatase (ALKP), elevated gamma-glutamyl transferase (GGT), hyperbilirubinemia, hypertension, bleeding, thrombocytopenia, hair loss, headache, proteinuria, skin ulcers, fatigue, fever, back pain, dizziness, rash, itching, renal failure, aneurysm, arterial dissection, reversible posterior leukoencephalopathy syndrome, irritable bowel syndrome, stomatitis, dyspepsia, gastrointestinal disorders, asthenia, cough, cystitis, nephrotic syndrome, thrombotic microangiopathy (TMA)

This medicine should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 degree Celsius and 30 degrees Celsius.

Appearance

Brown oval film-coated tablet

Package unit

60 tablets/box [10 tablets/PTP x 6]