Zelcor Capsule 200 mg (Crizotinib)

Adult dose

Adults: Take 250 mg orally twice daily. This drug may be taken with or without food. Swallow the capsule whole. Continue treatment for as long as clinical benefit is observed. If a dose is missed, take it as soon as remembered if 6 hours or more remain until the next dose; if less than 6 hours remain, skip the missed dose. Do not take 2 doses at once to make up for a missed dose. If vomiting occurs after taking a dose, take the next dose at the originally scheduled time. For patients with moderate hepatic impairment [all AST and total bilirubin >1.5 times and ≤3 times the upper limit of normal (ULN)], the recommended dose is 200 mg orally twice daily. For patients with severe hepatic impairment [all AST and total bilirubin >3 times the ULN], administer 250 mg orally once daily. Dose reductions are as follows: • First dose reduction: 200 mg orally twice daily • Second dose reduction: 250 mg orally once daily • If 250 mg once daily is not tolerated, permanently discontinue treatment Grade 3: Temporarily withhold treatment until the adverse reaction recovers to Grade 2 or lower, then resume treatment at the same dose and schedule as before Grade 4: Temporarily withhold treatment until the adverse reaction recovers to Grade 2 or lower, then resume treatment at the next lower dose Grade 3 or 4 ALT or AST elevation accompanied by a total bilirubin increase of Grade 1 or lower: Temporarily withhold treatment until the adverse reaction recovers to Grade 1 or lower or baseline, then resume treatment at the next lower doseb Grade 2, 3, or 4 ALT or AST elevation accompanied by a Grade 2, 3, or 4 total bilirubin increase (in the absence of cholestasis or hemolysis): Permanently discontinue treatment Interstitial lung disease/interstitial pneumonia of any gradec: Permanently discontinue treatment Grade 3 QTc prolongation: Temporarily withhold treatment until the adverse reaction recovers to Grade 1 or lower, then resume treatment at the next lower doseb Grade 4 QTc prolongation: Permanently discontinue treatment Bradycardiad (symptomatic, severe and potentially medically significant, requiring medical intervention): Temporarily withhold treatment until the bradycardia resolves to asymptomatic bradycardia or the heart rate recovers to 60 bpm or higher Assess concomitant medications known to cause bradycardia, as well as antihypertensive medications If a concomitant medication that causes bradycardia is identified and that medication is discontinued or its dose adjusted, resume treatment at the previous dose when the bradycardia resolves to asymptomatic bradycardia or the heart rate recovers to 60 bpm or higher If no concomitant medication that causes bradycardia is identified, or the concomitant medication is not discontinued or its dose is not adjusted, resume treatment at a reduced dose when the bradycardia resolves to asymptomatic bradycardia or the heart rate recovers to 60 bpm or higher Bradycardiad, e (life-threatening, requiring emergency intervention): If no concomitant medication that causes bradycardia is identified, permanently discontinue treatment If a concomitant medication that causes bradycardia is identified and that medication is discontinued or its dose adjusted, resume treatment at 250 mg once daily with frequent monitoring when the bradycardia resolves to asymptomatic bradycardia or the heart rate recovers to 60 bpm or higher Grade 4 eye disorder (loss of vision): In cases of severe vision loss, discontinue this drug b. If the adverse reaction recurs, temporarily withhold treatment until it recovers to Grade 1 or lower, then resume treatment at 250 mg once daily. If a Grade 3 or 4 adverse reaction recurs again, permanently discontinue treatment.

This drug may cause liver damage, so liver function tests must be conducted every two weeks for the first two months after starting treatment. Symptoms of liver dysfunction include fatigue, loss of appetite, nausea, vomiting, abdominal pain, jaundice, and if these symptoms occur, the patient must inform their hospital immediately. Inflammation of the lungs or interstitial lung disease may occur, so if symptoms like difficulty breathing or coughing appear, consult a doctor immediately. As this drug may affect heart electrical activity, regular electrocardiograms should be performed to check for any irregular heartbeats. In particular, since QT interval prolongation may occur, those with congenital QT prolongation syndrome or heart disease should use this drug with caution. If symptoms of heart failure such as shortness of breath, swelling, or sudden weight gain appear, inform medical staff immediately, and dosage adjustments or discontinuation may be necessary. Those allergic to this drug or its excipients should not use it. Patients with poor liver or kidney function must consult a doctor before use, and in cases of severe kidney dysfunction, dosage adjustment is needed. Bradycardia (decreased heart rate) may occur, so caution should be taken when taken with drugs that cause bradycardia, such as beta-blockers, and monitoring heart rate and blood pressure monthly is recommended. Visual disturbances, dizziness, and fatigue may occur while taking this drug, so caution is needed while driving or operating machinery. Women who are pregnant or planning to become pregnant must consult a doctor and ensure appropriate contraception during treatment. If breastfeeding, since this drug may be secreted in breast milk, discuss whether to continue breastfeeding with medical staff. The safety and efficacy of this drug in children have not been established, so it is not recommended for use in pediatric patients. This drug should be kept out of reach of children, and care should be taken not to transfer it to another container.

• Hepatotoxicity
• increased bilirubin
• increased ALT
• increased AST
• increased transaminases
• weakness
• fatigue
• loss of appetite
• nausea
• vomiting

This drug may be sensitive to air and moisture, so it should be stored in a tightly closed container. The storage temperature should be maintained between 15 degrees Celsius and 30 degrees Celsius at room temperature. Storing it in this manner helps maintain the drug's effectiveness and safety for a longer duration.

Appearance

Hard capsule with a reddish upper part and white lower part containing a white or light yellow powder

Package unit

60 capsules (10 capsules/blister x 6)