Epidanib 100 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. 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. 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. 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. 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). 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

Nintedanib is not approved for the treatment of pediatric patients.

This drug should not be used in patients with allergies to the active ingredient or its components. Women who are pregnant or breastfeeding should not take this medication. Patients with moderate to severe liver dysfunction should also avoid this medication. Patients with gastrointestinal disorders such as diarrhea, nausea, or vomiting should use this drug with caution, and dosage adjustments may be necessary if symptoms are severe. Patients with a tendency to bleed or those taking anticoagulants should be cautious when taking this medication. Patients with a history of thrombosis or high blood pressure should consult a doctor before taking this medication. This drug may be risky for patients with gastrointestinal perforations or recent abdominal surgeries, requiring caution. Before and after surgery, the use of this drug should be temporarily discontinued or carefully considered, as it may affect wound healing. Regular liver function tests are necessary during treatment, and if liver enzyme levels rise, the medication should be discontinued or the dosage adjusted. Patients with reduced kidney function should be monitored closely, and dosage adjustments may be necessary. If diarrhea symptoms are severe, immediate rehydration and antidiarrheal medication should be taken, and treatment should be discontinued if symptoms persist. This medication may raise blood pressure, so regular monitoring is important. Some patients may experience side effects such as headaches, hair loss, fatigue, fever, dizziness, rashes, itching, coughing, cystitis, and hypersensitivity. Women of childbearing potential must use effective contraception while taking this medication, and discontinue use immediately if pregnancy occurs. Women who are breastfeeding should discontinue nursing if taking this medication, as it is safer. This medication may interact with other drugs, so patients should inform healthcare providers of any other medications they are taking. It is advisable to take this medication after meals, and quitting smoking is recommended as smoking may reduce its efficacy. There is no specific antidote for overdose, so immediate consultation with a healthcare provider is necessary. This drug should be kept out of reach of children, and care should be taken to avoid crushing the pill or direct contact with its contents.

Diarrhea, nausea, vomiting, abdominal pain, decreased appetite, weight loss, elevated liver enzymes, pancreatitis, drug-induced liver injury, 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 ulcer, fatigue, fever, back pain, dizziness, rash, itching, renal failure, aneurysm, arterial dissection, reversible posterior leukoencephalopathy syndrome, irritable bowel syndrome, stomatitis, dyspepsia, gastrointestinal disorder, asthenia, nephrotic syndrome, thrombotic microangiopathy (TMA), fatal liver injury, impaired wound healing, gastrointestinal perforation, ischemic colitis, nephrotic syndrome, headache, hypertension, visual impairment, seizures, lethargy, confusion, visual and neurological disorders

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, it is safe to store at room temperature, avoiding extremes of heat or cold, between 1 to 30 degrees Celsius.

Appearance

Light brown oval film-coated tablet

Package unit

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