Qunitar Soft Capsule 100mg (Nintedanib Esylate)

Adult dose

The recommended dose for adults 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. 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 an adverse reaction (see Precautions for Use) is needed along with symptomatic treatment, the dose may be reduced or treatment may be temporarily interrupted until the adverse reaction is reduced to a level that allows treatment to continue. Treatment with this drug 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, discontinue this drug. If treatment was temporarily interrupted because aminotransferases (AST or ALT) exceeded 3 times the upper limit of normal (ULN) (but were below 5 times the ULN), treatment may be resumed at the reduced dose (100mg twice daily) when aminotransferases return to baseline, and may subsequently be increased to the recommended dose (150mg twice daily) (see Precautions for Use). Discontinue treatment with this drug 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 aged 65 years or older compared with patients younger than 65 years. No dose adjustment is necessary in elderly patients aged 65 years or older. Dose reduction may be needed to manage adverse reactions in patients aged 75 years or older. Less than 1% of this drug was excreted in the urine after a single dose. No adjustment of the starting dose is necessary in patients with mild to moderate renal impairment. Safety, efficacy, and pharmacokinetic properties have not been studied in patients with severe renal impairment (creatinine clearance below 30mL/min). This drug is eliminated primarily (>90%) through 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, 12 hours apart, and interruption or discontinuation of treatment should be considered to manage adverse reactions. Use of this drug 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 approved.

This medication should not be administered to patients who are allergic to peanuts or legumes or have hypersensitivity to any component of this medicine. Women who are pregnant or breastfeeding should not take this medication. Caution is required when administering this drug to patients with moderate to severe hepatic impairment, and liver function should be monitored frequently. Patients with gastrointestinal disorders such as diarrhea, nausea, or vomiting may experience exacerbation of these symptoms while taking this medication, requiring caution. Patients with bleeding tendencies or those taking high doses of anticoagulants may have an increased risk of bleeding, and caution is advised. Patients with arterial or venous thromboembolic disease should be cautious as this medication may increase the risk of thrombotic issues. Patients who have recently undergone abdominal surgery or have a history of gastrointestinal perforation should consult a physician before taking this medication. The administration may need to be temporarily suspended or adjusted around the time of surgery, as it may interfere with wound healing. Patients with hypertension should regularly monitor their blood pressure as this medication may raise blood pressure. Patients with prolonged QT interval related to cardiac electrical activity should exercise caution, as this medication may increase the risk of cardiac arrhythmias. Diarrhea is the most commonly reported side effect, and if severe, may require hydration and antidiarrheal medications; dose adjustments or discontinuation may be necessary in some cases. Nausea and vomiting are also common side effects, and if persistent, dosage adjustment should be considered along with supportive care. Regular monitoring of liver function tests is necessary, and if liver enzyme levels rise significantly, the dosage should be reduced or the medication discontinued. Renal impairment has been reported, and kidney status should be observed periodically; if abnormalities occur, dosage adjustment or discontinuation should be considered. Since bleeding risk may increase, patients should seek medical advice immediately if bleeding symptoms appear. Patients with a history of hypertension or aneurysm should evaluate risks thoroughly before treatment. Patients at high risk for cardiovascular disease should be cautious as there is a possibility of cardiovascular issues such as myocardial infarction occurring with this medication. The risk of gastrointestinal perforation may be increased, so patients with a history of recent abdominal surgery, peptic ulcers, or diverticulitis should consult their physician prior to administration. This medication may be associated with thrombotic microangiopathy, and if related symptoms occur, administration should be discontinued immediately and evaluation should take place. Reversible posterior leukoencephalopathy syndrome has been reported rarely, and if related symptoms occur, discontinue this medication. This medication may interfere with wound healing, so timing around surgical procedures should be determined carefully. Patients should regularly monitor their blood pressure while taking this medication and report any unusual signs to healthcare professionals immediately. This medication may prolong the QT interval, so patients with cardiac issues should be cautious. Patients with severe allergic reactions should particularly verify their allergy status concerning peanuts or legumes and take care. Caution is also advised when driving or operating machinery, as there is insufficient study on the impact on these activities. This medication can interact with certain drugs, so it's important to inform healthcare professionals about other medications being taken. It is recommended to take this medication after meals, and smoking may reduce its effectiveness, so quitting is advised. Women who are pregnant or planning to become pregnant should avoid taking this medication; if pregnancy occurs during treatment, immediate cessation and consultation with a healthcare professional are necessary. Women who are breastfeeding should discontinue breastfeeding when taking this medication for safety. There is no specific antidote for overdose, and appropriate treatment and medication discontinuation should be based on symptoms. Store out of reach of children, do not open or crush capsules, and wash hands immediately if contents come in contact.

Diarrhea, nausea, vomiting, abdominal pain, decreased appetite, weight loss, elevated liver enzymes, pancreatitis, drug-induced liver damage, alanine aminotransferase (ALT) elevation, aspartate aminotransferase (AST) elevation, alkaline phosphatase (ALKP) elevation, gamma-glutamyltransferase (GGT) elevation, hyperbilirubinemia, hypertension, bleeding, thrombocytopenia, hair loss, headache, proteinuria, skin ulcers, fatigue, fever, back pain, dizziness, rash, pruritus, renal failure, aneurysm, arterial dissection, reversible posterior leukoencephalopathy syndrome, weight loss, cough, irritable bowel syndrome, stomatitis, dyspepsia, gastrointestinal disturbances, asthenia

This medication should be stored in a sealed container to protect it from air and moisture and should ideally be kept at a temperature between 1 and 30 degrees Celsius. Maintaining appropriate temperature and environment will help preserve the medication's effectiveness for a longer period.

Appearance

Oblong opaque light pink soft gelatin capsule containing a bright yellow viscous suspension

Package unit

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