Ofev Soft Capsule 150 mg (Nintedanib Esylate)

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. 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. 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. 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). 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 medication should not be used by patients who have allergies to peanuts or legumes, or who have hypersensitivity to any of its components. Pregnant or breastfeeding women should not take this medication. It should be used cautiously in patients with moderate to severe liver dysfunction and regular liver function tests should be performed. Caution is also needed for patients with gastrointestinal disorders, bleeding tendencies, thrombosis, or those who have recently undergone abdominal surgery. Symptoms such as diarrhea, nausea, or vomiting may frequently appear; if symptoms are severe, consult a physician to adjust the dose or temporarily discontinue use. Due to the risk of liver damage, liver function tests should be frequently performed before and after starting treatment, and the medication should be discontinued if liver enzyme levels rise significantly. It can also affect kidney function, so kidney status should be checked regularly. There may be an increased risk of bleeding, so patients with a tendency to bleed or those on anticoagulants need to be cautious. Blood pressure may rise, so regular monitoring of blood pressure is essential, and management of blood pressure should be prioritized. Discontinuation or careful consideration of use should be made around the time of surgery, as it may affect wound healing. This medication is best taken after meals, and smoking is advised against due to its potential impact on the medication's efficacy. Women of childbearing potential should use effective contraception to avoid pregnancy while taking this medication, and must inform healthcare providers immediately if they become pregnant. It is safest not to take this medication while breastfeeding. In case of overdose, consult a healthcare provider immediately for appropriate treatment; there is no specific antidote for this medication. This medication should be kept out of reach of children, and capsules should not be opened or crushed; if the contents come into contact with skin, hands should be washed immediately.

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, itching, renal failure, aneurysm, arterial dissection, reversible posterior leukoencephalopathy syndrome, weight loss, cough, cystitis, irritable bowel syndrome, stomatitis, dyspepsia, gastrointestinal disorders, weakness

This medication should be stored in a tightly closed container, protected from air and moisture, and kept in a cool place at a temperature below 25 degrees. Proper storage will help maintain the effectiveness of the medication for a longer period.

Appearance

This medication is an opaque brown oval soft gelatin capsule that contains a viscous suspension of light yellow.

Package unit

60 capsules (10 capsules/PTP x 6 packs)