Ofenib 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. 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

Treatment of pediatric patients with nintedanib is not authorized.

This medication should not be used in patients with allergies to the active ingredient or any of the components. Pregnant or breastfeeding women should not take this medication. It is not safe to administer this drug to patients with moderate to severe liver dysfunction. Caution is needed in patients with gastrointestinal disorders such as diarrhea, nausea, or vomiting. Patients with bleeding tendencies or those taking anticoagulants in high doses should use this medication cautiously. Special precautions should be taken when prescribing this drug to patients with a history of thromboembolism or gastrointestinal perforation. The dosage of this medication should be adjusted, as it may affect wound healing before and after surgery. Patients with hypertension should have their blood pressure monitored frequently, as it may rise during treatment. Patients with conditions affecting cardiac electrical activity should use this medication with caution. This drug may commonly cause side effects such as diarrhea, nausea, vomiting, abdominal pain, loss of appetite, weight loss, and elevation of liver enzymes. If severe diarrhea occurs, adequate fluid intake and antidiarrheal medication are necessary to prevent dehydration, and dose adjustments or discontinuation of the medication may be required. Liver function abnormalities may occur, so regular liver function tests should be conducted before starting treatment and during the first 3 months. Renal function disturbances may occur, and careful monitoring of kidney status during administration is necessary. The risk of bleeding may increase, so patients with bleeding tendencies should consult healthcare professionals before using this medication. Regular blood pressure measurement is necessary, as blood pressure may rise. This medication may interact with other drugs, so patients must inform healthcare professionals about all medications they are taking. It is recommended to take this medication right after meals, and smoking may reduce its effectiveness, so quitting smoking is encouraged. Women of childbearing potential should avoid pregnancy while taking this medication and must have pregnancy tests before and during treatment. It is safe for breastfeeding women to temporarily stop breastfeeding while taking this medication. There are no specific antidotes for overdose; therefore, immediate contact with a medical institution is necessary for appropriate actions. Keep out of reach of children and be careful not to crush the tablets or transfer them to another container.

Diarrhea, nausea, vomiting, abdominal pain, loss of 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 ulcer, fatigue, fever, back pain, dizziness, rash, pruritus, renal failure, aneurysm, arterial dissection, reversible posterior encephalopathy syndrome, irritable bowel syndrome, stomatitis, dyspepsia, gastrointestinal disorders, asthenia, cough, cystitis, nephrotic syndrome, thrombotic microangiopathy (TMA), fatal liver damage, wound healing impairment, gastrointestinal perforation, ischemic colitis

This medication should be stored in a tightly sealed container to prevent air or moisture from entering, and it is safe to store it at room temperature between 1 to 30 degrees Celsius. Proper storage will maintain the drug's effectiveness and prevent degradation.

Appearance

Brown oval film-coated tablet

Package unit

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