Ofeb Soft Capsules 100 mg (Nintedanib Ethanesulfonate)

Adult dose

The recommended adult dose is 150mg twice daily, at 12-hour intervals. Take immediately after a meal. Swallow the capsule whole with water without chewing. Do not open or crush the capsule. A dose of 100mg twice daily is recommended only if the 150mg twice-daily regimen is poorly tolerated. If a dose is missed, take the recommended dose at the next scheduled dosing time. Do not take an extra dose. Do not exceed the recommended daily dose of 300mg. <Dose adjustment> If adverse reactions require management along with symptomatic treatment (see Precautions for Use), the dose may be reduced or treatment temporarily interrupted until the adverse reaction has improved sufficiently to allow treatment to continue. Treatment with this medicine may then be resumed at the recommended dose (150mg twice daily) or the reduced dose (100mg twice daily). If the 100mg twice-daily dose is poorly tolerated, discontinue this medicine. If treatment is temporarily interrupted because aminotransferases (AST or ALT) exceed 3 times the upper limit of normal (ULN) (but are below 5 times ULN), treatment may be resumed at the reduced dose (100mg twice daily) when aminotransferase levels have returned to baseline, and the dose may subsequently be increased to the recommended dose (150mg twice daily) (see Precautions for Use). Discontinue treatment with this medicine if aminotransferases (AST or ALT) exceed 5 times ULN, or exceed 3 times ULN accompanied by signs or symptoms of severe liver injury. <Elderly patients> No differences in safety or efficacy were observed in patients aged 65 years or older compared with patients younger than 65 years. No dose adjustment is required for elderly patients aged 65 years or older. Patients aged 75 years or older may require dose reduction to manage adverse reactions. <Patients with renal impairment> Less than 1% of a single dose of this medicine was excreted through the kidneys. No adjustment of the starting dose is required in patients with mild to moderate renal impairment. The safety, efficacy, and pharmacokinetic properties of this medicine have not been studied in patients with severe renal impairment (creatinine clearance below 30mL/min). <Patients with hepatic impairment> This medicine is eliminated mainly (>90%) via biliary/fecal excretion. Exposure increased in patients with hepatic impairment (Child-Pugh A, Child-Pugh B). In patients with mild hepatic impairment (Child-Pugh A), the recommended dose is 100mg twice daily, at 12-hour intervals; treatment interruption or discontinuation should be considered to manage adverse reactions. Use of this medicine is not recommended in patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment.

Child dose

Nintedanib is not approved for use in pediatric patients.

This medicine should not be used in patients who are allergic to certain components, are pregnant or breastfeeding, and those with severe liver impairment. Care should be taken in patients with gastrointestinal disorders such as diarrhea, nausea, and vomiting, those at high risk of bleeding, patients with thrombosis, those who have recently undergone abdominal surgery, pre- and post-operative patients, patients with hypertension, and those with abnormalities in cardiac electrical activity. During the use of this medicine, gastrointestinal side effects such as diarrhea, nausea, vomiting, abdominal pain, decreased appetite, weight loss, and liver function abnormalities may occur, and medical consultation should be sought if these symptoms arise. In cases of severe diarrhea, hydration and antidiarrheal medication may be necessary, and if symptoms are severe, discontinuation of the medication may be required. Liver function abnormalities may occur; therefore, regular liver function tests should be conducted before and during treatment, and if liver enzyme levels significantly rise, dosage adjustment or discontinuation of the medication may be necessary. It may also impact kidney function, so careful monitoring of kidney status is required. Due to the risk of bleeding, caution should be exercised in patients with bleeding tendencies or those on anticoagulants, and blood pressure should be regularly monitored due to potential elevations. This medicine may increase the risk of thrombosis and gastrointestinal perforation; therefore, patients with related medical history should be particularly cautious and should immediately discontinue use if gastrointestinal perforation is suspected. Pregnant women or those who may become pregnant should ensure effective birth control while using this medicine and inform their physician immediately if pregnancy occurs. Breastfeeding is discouraged as this medication may be passed into breast milk. This medicine may interact with other medications, so consulting a doctor or pharmacist is advisable for patients taking other drugs. It is recommended to take this medication after meals, and smoking may reduce its effectiveness, so cessation is preferable. Caution is required when driving or operating machinery. In the event of overdose, as there are no specific antidotes, immediate medical attention should be sought for appropriate treatment. Finally, keep this medication out of reach of children, do not open or crush capsules, and if the capsule contents come into contact with the skin, wash hands immediately.

Diarrhea, nausea, vomiting, abdominal pain, reduced appetite, weight loss, elevated liver enzymes, pancreatitis, drug-induced liver damage, elevated alanine aminotransferase, elevated aspartate aminotransferase, elevated alkaline phosphatase, elevated gamma-glutamyl transferase, hyperbilirubinemia, hypertension, hemorrhage, 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 disturbances, asthenia, weight loss, cough, cystitis

This medicine should be stored in a tightly sealed container to prevent exposure to air and moisture, preferably at a cool temperature below 25 degrees Celsius. This will help maintain the medication's efficacy for an extended period.

Appearance

This medicine is an oval, opaque light pink gelatin soft capsule containing a viscous suspension of a bright yellow color.

Package unit

60 capsules (10 capsules/PTP x 6 packs)