Opilled 150 mg (Nintedanib Esylate)

Adult dose

The recommended dose for adults is 150mg per dose, 2 times daily at 12-hour intervals. Take immediately after meals. Swallow the tablet whole with water; do not chew it. Do not crush the tablet. A dose of 100mg per dose, 2 times daily is recommended only if the 150mg per dose, 2 times 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 needed along with treatment of symptoms, the dose may be reduced or treatment temporarily interrupted until the adverse reaction has resolved to a level that allows treatment to continue. Treatment with this product may then be resumed at the recommended dose (150mg per dose, 2 times daily) or the reduced dose (100mg per dose, 2 times daily). If the 100mg per dose, 2 times daily regimen is not well tolerated, discontinue this product. If treatment was temporarily interrupted because aminotransferases (AST or ALT) exceeded 3 times the upper limit of normal (ULN) (but were less than 5 times the ULN), treatment may be resumed at the reduced dose (100mg per dose, 2 times daily) when aminotransferases return to baseline levels, and the dose may subsequently be increased to the recommended dose (150mg per dose, 2 times daily) (see Precautions for Use). Discontinue treatment with this product 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 65 years of age and older compared with patients younger than 65 years. No dose adjustment is required for older adults 65 years of age and older. Patients 75 years of age and older may require dose reduction to manage adverse reactions. Less than 1% of a single dose of this product 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 product have not been studied in patients with severe renal impairment (creatinine clearance less than 30mL/min). This product is eliminated mainly (>90%) through biliary/fecal excretion. Exposure was 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 per dose, 2 times daily at 12-hour intervals; treatment interruption or discontinuation should be considered to manage adverse reactions. Administration of this product is not recommended in patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment.

Child dose

Treatment with nintedanib is not approved for pediatric patients.

This medication should not be used by individuals who are allergic to the active ingredient or any of its components. Women who are pregnant or breastfeeding should not take this medication. It should not be administered to patients with moderate to severe liver dysfunction. Patients with gastrointestinal disorders, including diarrhea, nausea, and vomiting, should use this medication with caution, and dosage may need to be reduced or discontinued if symptoms are severe. Patients with a tendency to bleed or those taking anticoagulants at maximum dosage should exercise caution when using this medication. Patients with thromboembolism or those who have recently undergone abdominal surgery should use this medication cautiously. The use of this medication should be considered carefully around the time of surgery, as it may affect wound healing. In hypertensive patients, this medication may cause an increase in blood pressure, and blood pressure should be monitored regularly. Patients with conditions that may affect heart rhythm should take caution when taking this medication. Common side effects during treatment may include diarrhea, nausea, vomiting, abdominal pain, loss of appetite, weight loss, and increased liver enzymes. Liver function tests should be conducted before starting treatment, at the beginning of therapy, and regularly thereafter to detect liver damage early. It may also affect kidney function, so renal function status should be monitored periodically. This medication increases the risk of bleeding, so patients with a bleeding tendency must consult healthcare providers. Smoking may reduce the effectiveness of this medication, so it is advisable to quit smoking before taking it. Women of childbearing potential should avoid pregnancy while taking this medication and should take pregnancy tests both before and during use. Breastfeeding women should discontinue nursing while taking this medication. In case of overdose, there is no specific antidote; immediately inform healthcare providers and receive appropriate treatment. This medication should be kept out of reach of children and should not be crushed or transferred to other containers.

Diarrhea, nausea, vomiting, abdominal pain, loss of appetite, weight loss, increased liver enzymes, pancreatitis, drug-induced liver injury, elevated alanine aminotransferase, elevated aspartate aminotransferase, elevated alkaline phosphatase, elevated gamma-glutamyl transferase, hyperbilirubinemia, hypertension, bleeding, thrombocytopenia, hair loss, headache, proteinuria, skin ulcers, fatigue, fever, back pain, dizziness, rash, itching, renal failure, aneurysm, arterial dissection, reversible posterior leukoencephalopathy syndrome, irritable bowel syndrome, stomatitis, dyspepsia, gastrointestinal disorders, weakness, cough, cystitis, nephrotic syndrome, thrombotic microangiopathy, impaired wound healing

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance

Pink round film-coated tablet

Package unit

Bottle - 60 tablets/bottle