Qunint Tablet 150 milligrams (Nintedanib Esylate)

Adult dose

The recommended dose for adults is 150mg twice daily at 12-hour intervals. Take immediately after a meal. Swallow the tablet whole with water without chewing. Do not crush the tablet. A dose of 100mg twice daily is recommended only if the regimen of 150mg twice daily 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 an adverse reaction requires management in addition to symptomatic treatment (see Precautions for Use), the dose may be reduced or treatment temporarily interrupted until the adverse reaction has improved to a level that allows treatment to continue. Treatment may then be resumed at the recommended dose (150mg twice daily) or the reduced dose (100mg twice daily). If the dose of 100mg twice daily is not well tolerated, treatment with this medicine should be discontinued. If treatment has been temporarily interrupted because aminotransferases (AST or ALT) exceeded 3 times the upper limit of normal (ULN) but were less than 5 times ULN, treatment may be resumed at the reduced dose (100mg twice daily) once 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 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 in elderly patients aged 65 years and older. Patients aged 75 years and 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 in patients with severe renal impairment (creatinine clearance less than 30mL/min) have not been studied. This medicine 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 twice daily at 12-hour intervals, and 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

Treatment of pediatric patients with nintedanib is not authorized.

This medication should not be used in patients who are allergic to the active ingredient or any of the components, pregnant women, breastfeeding women, and patients with moderate to severe liver dysfunction. Patients with gastrointestinal disturbances, a tendency to bleed, or a history of thrombosis, those who have recently undergone abdominal surgery or are perioperative, patients with hypertension, and those with prolonged QT interval should use this medication with caution. Diarrhea, nausea, vomiting, abdominal pain, decreased appetite, weight loss, and elevated liver enzymes may frequently occur upon taking this medication, so any unusual symptoms should be reported to a healthcare professional immediately. Due to the risk of liver function impairment, regular liver function tests should be conducted before starting treatment and during the first three months; dosage adjustments or cessation of administration may be necessary if liver values significantly rise. It may also affect kidney function, so patients with poor kidney function should be closely monitored and dosage adjustments made if necessary. Due to an increased risk of bleeding, patients with a tendency to bleed or those taking anticoagulants should use this medication cautiously. Patients with hypertension or a history of aneurysms or arterial dissection should evaluate risks carefully before administration of this medication. Pregnant women should avoid this medication as it may be harmful to the fetus, and fertile women must use effective contraception during treatment. Breastfeeding women are advised to discontinue breastfeeding while taking this medication. It is recommended to take this medication after meals, and smoking may reduce the effect of the medication, so quitting smoking is advisable. In case of overdose, there is no specific antidote, and prompt medical attention should be sought for appropriate treatment. This medication should be stored out of reach of children, should not be crushed, and hands should be washed thoroughly in case of direct contact with the medication.

Diarrhea, nausea, vomiting, abdominal pain, loss of 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, bleeding, thrombocytopenia, hair loss, headache, proteinuria, skin ulcers, fatigue, fever, back pain, dizziness, rash, itching, renal failure, aneurysm, arterial dissection, reversible posterior encephalopathy syndrome, irritable bowel syndrome, stomatitis, dyspepsia, gastrointestinal disorders, asthenia, cough, cystitis, nephrotic syndrome, thrombotic microangiopathy, impaired wound healing, ischemic colitis

Store this medication in a tightly sealed container to prevent air or moisture from entering. It is advisable to maintain storage temperatures between 1 and 30 degrees Celsius at room temperature. This will help keep the medication effective and safe for a long time.

Appearance

Red oval film-coated tablets

Package unit

60 tablets/box [10 tablets/PTP × 6]