Quninta Soft Capsules 150mg (Nintedanib Esilate)

Adult dose

The recommended adult dose is 150mg twice daily, 12 hours apart. 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 not well tolerated. Treatment with this medicine should be initiated by a physician experienced in diagnosing and treating conditions related to its indications. Liver function tests and a pregnancy test should be performed before starting treatment. If a dose is missed, take the recommended dose at the next scheduled time. Do not take an additional dose. Do not exceed the recommended daily dose of 300mg. <Dose adjustment> If management of an adverse reaction (see Precautions for Use) is needed along with symptomatic treatment, the dose may be reduced or treatment temporarily interrupted until the adverse reaction is sufficiently alleviated to allow treatment to continue. Treatment 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 not well tolerated, treatment with this medicine should be discontinued. If treatment was temporarily interrupted because an aminotransferase (AST or ALT) level exceeded 3 times the upper limit of normal (ULN) (but was 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 an aminotransferase (AST or ALT) level exceeds 5 times ULN, or exceeds 3 times ULN and there are 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 necessary 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 starting dose adjustment is necessary 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. <Patients with hepatic impairment> This medicine is eliminated primarily (>90%) through 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 is 100mg twice daily, 12 hours apart; 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 drug should not be used in patients with allergies to peanuts or legumes or in those with hypersensitivity to the ingredients of this drug. Women who are pregnant or breastfeeding should not take this drug. It should not be administered to patients with moderate or severe liver function impairment, and caution is needed in patients with liver disorders. Patients with gastrointestinal disturbances such as diarrhea, nausea, or vomiting should use this drug cautiously, and if these symptoms worsen, dosage adjustment or discontinuation may be necessary. Patients with a tendency to bleed or those taking high doses of anticoagulants should be cautious when using this drug as the risk of bleeding may increase. Patients with arterial or venous thromboembolism should also use caution when taking this drug. Patients who have recently undergone abdominal surgery or have a history of gastrointestinal perforation must consult their doctor before taking this drug. Care should be taken when using this drug around the time of surgery as it may affect wound healing. Patients with hypertension should monitor their blood pressure regularly as blood pressure increases may occur during treatment with this drug. Patients with a prolonged QT interval should exercise caution when using this drug. During treatment with this drug, gastrointestinal symptoms such as diarrhea, nausea, vomiting, and abdominal pain may commonly occur, and if symptoms persist, consultation with a physician is advised. Regular liver function tests should be conducted at the start of treatment and during the initial stages as liver abnormalities may occur. If liver enzyme levels increase significantly, treatment may need to be interrupted or the dosage adjusted. Kidney function should be monitored periodically, as complications may arise. This drug may increase the risk of bleeding, necessitating careful assessment before administration in patients with high bleeding risk. Due to elevated blood pressure and vascular disease risks, patients with a history of hypertension or aneurysms should exercise particular caution. Patients with recent myocardial infarction or stroke history must consult their physician before using this drug. This drug may increase the risk of gastrointestinal perforation and ischemic colitis; hence, patients with a history of previous gastrointestinal surgeries or ulcers should be cautious. Kidney-related adverse reactions such as nephrotic syndrome or thrombotic microangiopathy may occur, and symptoms should be reported to medical staff immediately. Reversible posterior leukoencephalopathy syndrome may occur during treatment with this drug, and immediate cessation of the medication and consultation with a healthcare provider are warranted if symptoms like headache, visual disturbances, or seizures develop. This medication can interfere with wound healing, so it should be stopped or used cautiously around the time of surgery. Use during pregnancy may be harmful to the fetus, necessitating that women of childbearing age avoid pregnancy while taking this drug and employ effective contraception before and after administration. Breastfeeding women are advised to discontinue nursing when taking this drug. It is advisable to take this drug after meals, and smoking may reduce the drug's effectiveness, so cessation before and after taking this drug is recommended. There are no specific antidotes for overdose, so in case of an overdose, patients should seek appropriate medical treatment immediately. Keep out of reach of children, do not open or crush the capsules, and if the capsule contents come into contact with skin, wash hands thoroughly immediately. Caution is necessary when driving or operating machinery, as these activities may require careful attention.

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 ulcer, fatigue, fever, back pain, dizziness, rash, itching, renal failure, aneurysm, arterial dissection, reversible posterior leukoencephalopathy syndrome, irritable bowel syndrome, stomatitis, dyspepsia, gastrointestinal disorders, weakness, weight loss, cough, cystitis

This drug should be stored in a tightly closed container to protect it from air or moisture. Additionally, it is important to maintain a temperature between 1 to 30 degrees Celsius when storing the medication, to ensure its efficacy and safety.

Appearance

Opaque brown gellatin soft capsule containing a viscous yellow suspension

Package unit

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