Tabrecta 200 mg (capmatinib hydrochloride hydrate)

Adult dose

Recommended dosage: The recommended dose of this drug is 400mg twice daily, with or without food. Treatment with this drug should continue for as long as clinical benefit is achieved, based on individual safety and tolerability. Dose modification for adverse drug reactions: The recommended dose reduction schedule for managing adverse drug reactions based on individual safety and tolerability is shown in Table 1. Table 1. Dose reduction schedule for this drug Starting dose: 400 mg twice daily First reduction: 300 mg twice daily Second reduction: 200 mg twice daily If the patient cannot tolerate this drug at 200 mg twice daily, permanently discontinue treatment. Recommendations for dose adjustment of this drug for adverse drug reactions are shown in Table 2. Table 2. Dose adjustment of this drug for the management of adverse drug reactions Interstitial lung disease (ILD)/pneumonitis — treatment-related, all grades: Permanently discontinue Isolated elevation of ALT and/or AST from baseline, without increased total bilirubin Grade 3 (greater than 5.0 times and up to 20.0 times the ULN): Temporarily interrupt this drug until ALT/AST return to the baseline grade. If they return to baseline levels within 7 days, resume this drug at the same dose; otherwise, resume this drug at a reduced dose according to Table 1. Grade 4 (greater than 20.0 times the ULN): Permanently discontinue Combined elevation of ALT and/or AST with increased total bilirubin, without cholestasis or hemolysis Regardless of the patient's baseline grade, total bilirubin greater than 2.0 times the ULN and ALT and/or AST greater than 3.0 times the ULN: Permanently discontinue Isolated increase in total bilirubin from baseline, without increased ALT and/or AST Grade 2 (greater than 1.5 times and up to 3.0 times the ULN): Temporarily interrupt this drug until bilirubin returns to the baseline grade. If it returns to baseline levels within 7 days, resume this drug at the same dose; otherwise, resume this drug at a reduced dose according to Table 1. Grade 3 (greater than 3.0 times and up to 10.0 times the ULN): Temporarily interrupt this drug until bilirubin returns to the baseline grade. If it returns to baseline levels within 7 days, resume this drug at a reduced dose according to Table 1; otherwise, permanently discontinue this drug. Grade 4 (greater than 10.0 times the ULN): Permanently discontinue Increased lipase or amylase Grade 3: Temporarily interrupt this drug until levels return to baseline or Grade 2. If they return to baseline or Grade 2 within 14 days, resume this drug at a reduced dose according to Table 1; otherwise, permanently discontinue this drug. Grade 4: Permanently discontinue Pancreatitis Grade 3 or 4: Permanently discontinue Other adverse drug reactions Grade 2: Maintain the current dose level. If intolerable, consider temporarily interrupting this drug until the reaction resolves, then resume this drug at a reduced dose according to Table 1. Grade 3: Temporarily interrupt this drug until the reaction resolves, then resume this drug at a reduced dose according to Table 1. Grade 4: Permanently discontinue This drug should be administered orally twice daily, with or without food. It should be swallowed whole and must not be broken, chewed, or crushed. If a dose of this drug is missed or vomiting occurs, the patient should not take an additional dose to make up for it and should take the next dose at the scheduled time.

This drug may cause serious lung diseases such as interstitial lung disease or pulmonary inflammation, so if new symptoms such as shortness of breath, cough, or fever occur, immediate medical examination is required. Patients with allergies to the main ingredient or other components should not take this drug. Various side effects such as shortness of breath, pneumonia, vomiting, fatigue, and peripheral edema may occur during treatment, and any unusual symptoms should be reported to medical staff. It may affect liver function, so regular liver function tests should be conducted after starting treatment, and if liver enzyme levels increase, discontinuation or dosage adjustment may be necessary. Pancreatic enzyme levels may increase, so regular pancreatic function tests should also be conducted during treatment. Hypersensitivity reactions may occur, so if symptoms such as fever, rash, or low blood pressure appear, the medication should be discontinued, and medical staff should be consulted. During pregnancy, it may harm the fetus, so women who are pregnant or may become pregnant should avoid this medication, and effective contraception should be used while taking it. While taking this medication, it may cause hypersensitivity to ultraviolet light, so it is advisable to avoid sun exposure and use sunscreen. There may be interactions with other drugs, so caution is needed, especially when taken with strong CYP3A inhibitors or inducers, and acid suppressants. Patients with impaired kidney or liver function can take it without special dosage adjustments, but their condition should be closely monitored. The safety for children or patients under 18 years of age has not been established, so it is advisable not to use it. Elderly patients over 65 years can also take it without special dosage adjustments. In case of overdose, immediately inform medical staff and seek appropriate treatment. This drug should be kept away from moisture and unreachable by children.

• Dyspnea
• pneumonia
• pleural effusion
• worsening of overall health status
• vomiting
• peripheral edema
• lung inflammation
• fatigue
• elevated ALT
• elevated AST

This drug is sensitive to air and moisture, so it should be stored in a tightly sealed container in a cool place below 25 degrees Celsius. By doing so, the effectiveness of the drug can be maintained for a long time.

Appearance

yellow oval film-coated tablet

Package unit

120 tablets/box [12 tablets/PTP x 10]