Lapatinib 100 mg Tablet (Lapatinib Mesylate)

Adult dose

1. Non-small cell lung cancer When this medicine is administered as first-line treatment for locally advanced or metastatic non-small cell lung cancer, EGFR mutation status should be assessed before starting treatment. This medicine is taken at a dose of 150mg once daily at least 1 hour before or at least 2 hours after a meal. Treatment may be continued until disease progression or unacceptable toxicity occurs. There are no data on benefit from treatment after disease progression. 2. Pancreatic cancer In combination with gemcitabine, this medicine is taken at a dose of 100mg once daily at least 1 hour before or at least 2 hours after a meal. Treatment may be continued until disease progression or unacceptable toxicity occurs. 3. Dosage adjustment In patients who develop an acute onset of new or worsening pulmonary symptoms, such as dyspnea, cough, or fever, treatment with this medicine should be withheld until the diagnostic evaluation is complete. If interstitial lung disease is diagnosed, discontinue this medicine and administer appropriate treatment as needed. Discontinue this medicine in patients with hepatic failure or gastrointestinal perforation. Withhold or interrupt treatment in patients with dehydration at risk of renal failure, severe bullous or exfoliative skin disorders, or acute/worsening ocular disorders. Diarrhea can generally be treated with loperamide. Reduce the dose or temporarily interrupt treatment in patients with severe diarrhea that does not respond to loperamide or is accompanied by dehydration. Reduce the dose or temporarily interrupt treatment in patients with severe skin reactions as well. When dose reduction is required, reduce the dose by 50mg. Consider dose reduction if severe adverse reactions occur in patients receiving this medicine concomitantly with strong CYP3A4 inhibitors such as atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin (TAO), voriconazole, or grapefruit juice. If the CYP3A4 inducer rifampicin is administered before this medicine, the AUC of this medicine may be reduced by approximately 2/3. Therefore, consider using an alternative medicine that does not induce CYP3A4. If an alternative medicine is not available, for non-small cell lung cancer consider administering more than 150mg, and for pancreatic cancer consider administering more than 100mg; monitor patient safety and confirm tolerability. If the dose of this medicine has been increased, reduce its dose when rifampicin or another inducer is discontinued. Other CYP3A4 inducers include rifabutin, rifapentine, phenytoin, carbamazepine, phenobarbital, and St.John's Wort. These medicines should be avoided if possible. This medicine is eliminated by hepatic metabolism and biliary excretion. Therefore, use caution when administering it to patients with hepatic impairment. If severe adverse reactions occur, consider reducing the dose or discontinuing this medicine. Smoking appears to reduce exposure to this medicine by approximately 50-60%. The maximum tolerated dose of this medicine in current smokers with non-small cell lung cancer is 300mg. In patients who continue to smoke, administration of 300mg as second-line therapy after chemotherapy did not improve efficacy compared with the recommended dose of 150mg.

This medication can cause serious inflammation or damage to the lungs, and can rarely lead to fatal lung diseases in patients with lung cancer or pancreatic cancer. If symptoms related to the lungs such as shortness of breath, cough, or fever occur, discontinue the medication immediately and seek a doctor's diagnosis. There may also be potential heart problems, so caution should be exercised regarding symptoms of chest pain or myocardial infarction. Due to the risk of cerebrovascular accidents, sudden headaches, dizziness, or paralysis on one side of the body should lead to immediate hospital visit. Serious anemia related to decreased platelets in the blood may occur, so be aware of symptoms such as bleeding or easy bruising. Severe diarrhea or vomiting can lead to dehydration and electrolyte imbalance, requiring adequate fluid intake and appropriate treatment. Patients with poor liver function should have regular liver function tests as taking this medication may worsen liver damage. If abdominal pain or discomfort increases during treatment, consult a doctor immediately due to the risk of gastrointestinal perforation. If severe rashes or blisters develop on the skin, stop the medication and seek a doctor's care. If there is inflammation or pain in the eyes, or blurred vision occurs, notify an ophthalmologist immediately, and discontinue the medication if corneal ulceration is diagnosed. Patients allergic to this medication or those with specific genetic disorders such as lactose intolerance should not take it. Caution is advised when using this medication in patients with impaired liver or kidney function, especially in cases of hepatic impairment, where dose adjustment or discontinuation may be required. Common symptoms that may arise during treatment include rash, diarrhea, loss of appetite, fatigue, nausea, vomiting, so if symptoms worsen, consult a physician. This medication may interact with other drugs; caution is especially needed when taken with drugs that inhibit or induce liver enzymes. Smoking may reduce the effectiveness of this medication, so it is advisable to quit smoking during treatment. Women who are pregnant or may become pregnant must use contraception during treatment, and nursing mothers should avoid breastfeeding. Safety in children has not been established, so this medication should not be administered to children. The elderly can use this medication without special dose adjustments, but should consult with healthcare professionals depending on their health status. In the case of overdose, serious side effects such as diarrhea, rash, and liver function abnormalities may occur, necessitating immediate contact with a healthcare institution. This medication should be kept out of the reach of children and it is safe not to transfer it to another container. If any abnormal symptoms occur during treatment, inform the healthcare staff immediately, and it is important to confirm health status through regular examinations.

Interstitial lung disease-like symptoms, pneumonia, radiation pneumonia, hypersensitivity pneumonia, interstitial pneumonia, obstructive bronchiolitis, pulmonary fibrosis, acute respiratory distress syndrome, pulmonary infiltration, dyspnea, cough, fever, myocardial infarction, cerebrovascular accident, microangiopathic hemolytic anemia with thrombocytopenia, diarrhea, dehydration, electrolyte imbalance, renal failure, hepatitis, acute hepatitis, hepatic failure, gastrointestinal perforation, vesicular and exfoliative skin disorders, Stevens-Johnson syndrome, toxic epidermal necrolysis, corneal perforation, corneal ulcer, abnormal eyelash growth, dry conjunctivitis, keratitis, rash, loss of appetite, fatigue, nausea, infection, vomiting, stomatitis, itching, dry skin, conjunctivitis, dry conjunctivitis, abdominal pain, elevated bilirubin, elevated ALT, elevated AST, weight loss, edema, fever, constipation, bone pain, myalgia, depression, dyspepsia, dizziness, headache, insomnia, hair loss, anxiety, neuropathy, distension, stiffness, deep vein thrombosis, syncope, arrhythmia, intestinal pneumonitis, pancreatitis, thrombocytopenia, hemolytic anemia, abnormal liver function, gastrointestinal bleeding, hematemesis, hematochezia, melena, eyelash ingrowth, excessive eyelash growth, hypertrophy, hepatitis, acute hepatitis, hypokalemia, acute renal failure, epistaxis, acne, folliculitis, skin fissures, hyperpigmentation, paronychia, hirsutism, nail brittleness, nail shaking, pneumonia, disease exacerbation, respiratory function impairment, general weakness, hemoptysis, sepsis, pulmonary embolism, mucositis, sputum, thrombocytopenia, asthenia, anemia, pain, neutropenia, deep vein thrombosis, increased bilirubin, liver abscess, melena, neutropenia, thrombocytopenia, anemia, rhabdomyolysis, statin-induced myopathy, uveitis, intestinal emphysema

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture, and kept at a temperature between 1 degree and 30 degrees Celsius at room temperature. Following these storage guidelines will maintain the medication’s effectiveness and safety.

Appearance

White to yellowish round film-coated tablets

Package unit

30 tablets (10 tablets/PTP*3)