OfeNIB Tablet 100mg (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. <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 medication should not be administered to patients who are allergic to any of the active ingredients or components. It is also safest not to use it in women who are pregnant or breastfeeding. Caution should be used when administering this drug to patients with moderate to severe liver impairment. Patients with gastrointestinal symptoms such as diarrhea, nausea, or vomiting should exercise caution when taking this medication. Patients with a tendency to bleed or those taking high doses of anticoagulants must consult their physician before starting this medication. Patients with thrombosis or those who have undergone recent surgery should also be cautious when using this drug. The administration should be carefully decided around the time of surgery, as it may affect wound healing. Since blood pressure can increase, patients with hypertension should have their blood pressure checked regularly. Patients with heart-related diseases or prolonged QT intervals should also be cautious when using this medication. Gastrointestinal disturbances such as diarrhea are common during the use of this medication, so if symptoms are severe, they should inform a doctor. Liver function abnormalities may occur, so regular liver function tests should be conducted both before and during treatment. Renal function may also be affected, so it’s important to periodically check kidney status. This drug can interact with other medications, so if the patient is taking other drugs, they should inform their healthcare provider. In particular, caution should be taken with changes in drug concentrations when taken with strong P-gp inhibitors or inducers. It is recommended to take this medication after meals, and smoking may reduce its efficacy, so quitting smoking is advisable. Women who may become pregnant should use effective contraception during treatment to avoid pregnancy. This medication is not recommended for women who are breastfeeding; if necessary, breastfeeding should be discontinued. There is no specific antidote for overdose, so in case of an overdose, seek medical attention immediately. Keep out of reach of children, and it’s safest not to crush the medication or transfer it to another container.

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 ulcer, fatigue, fever, back pain, dizziness, rash, pruritus, renal failure, aneurysm, aortic dissection, reversible posterior leukoencephalopathy syndrome, irritable bowel syndrome, stomatitis, dyspepsia, gastrointestinal disturbance, asthenia, cough, cystitis, nephrotic syndrome, thrombotic microangiopathy (TMA)

This medication must be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain the storage temperature between 1 and 30 degrees Celsius at room temperature.

Appearance

Light brown oval film-coated tablet

Package unit

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