Tasewon Tablet 100mg (Erlotinib Hydrochloride)

Adult dose

1. Non-small cell lung cancer Take 150mg once daily at least 1 hour before or at least 2 hours after a meal. This medicine 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, take 100mg once daily at least 1 hour before or at least 2 hours after a meal. This medicine may be continued until disease progression or unacceptable toxicity occurs. 3. Dose adjustment In patients with acute onset of new or worsening pulmonary symptoms such as dyspnea, cough, or fever, discontinue this medicine until the diagnostic evaluation is complete. If interstitial lung disease is diagnosed, discontinue this medicine and provide appropriate treatment as needed. Discontinue this medicine in patients with hepatic failure or gastrointestinal perforation. Withhold or temporarily interrupt treatment in patients with dehydration who are at risk of renal failure, patients with severe bullous or exfoliative skin disorders, or patients with acute or worsening ocular disorders. Diarrhea can usually be treated with loperamide. In patients with severe diarrhea that does not respond to loperamide or is accompanied by dehydration, reduce the dose or temporarily interrupt treatment. Reduce the dose or temporarily interrupt treatment in patients with severe skin reactions as well. If dose reduction is necessary, reduce the dose by 50mg. Consider dose reduction if severe adverse reactions occur in patients receiving concomitant potent CYP3A4 inhibitors such as atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin (TAO), voriconazole, or grapefruit juice. If rifampicin, a CYP3A4 inducer, is administered before this medicine, the AUC of this medicine may decrease by approximately 2/3. Therefore, consider using an alternative medicine that does not induce CYP3A4. If no alternative is available, consider administering more than 150mg for non-small cell lung cancer or more than 100mg for pancreatic cancer, and monitor patient safety to confirm tolerability. If the dose of this medicine has been increased, reduce it when rifampicin or another inducer is discontinued. Other CYP3A4 inducers include rifabutin, rifapentine, phenytoin, carbamazepine, phenobarbital, and St.John's Wort. Avoid these medicines 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 drug can cause serious side effects in the lungs, and therefore patients with lung issues or those suffering from lung or pancreatic cancer should be cautious. If sudden symptoms such as shortness of breath, cough, or fever occur, discontinue medication immediately and notify a doctor. As there could be heart-related problems, patients with symptoms of myocardial infarction or stroke must consult a doctor before taking this medication. Symptoms like diarrhea, dehydration, electrolyte imbalance, and renal function decline may occur; such symptoms should be reported to healthcare professionals if they persist or worsen. Patients with liver function issues should undergo frequent liver function tests when taking this medication, and may need to discontinue use if liver damage is severe. Due to risks like gastrointestinal perforation, patients with a history of gastrointestinal diseases should exercise special caution. If severe rashes or blisters occur on the skin, stop taking the medication immediately and consult healthcare professionals. If inflammation, pain, or blurred vision occurs in the eyes, seek ophthalmic specialists immediately and consider stopping this medication. Patients with allergies to this drug or specific genetic issues such as lactose intolerance should avoid use. Patients with liver or kidney dysfunction must use this medication cautiously; dose adjustments may be necessary if required. Women who are pregnant or may become pregnant must practice contraception while on this medication, and nursing mothers should avoid taking it. Special caution is required when prescribing this drug to children or elderly patients, although dose adjustments may not always be necessary for the elderly. There may be interactions with other medications, so patients should inform their doctor or pharmacist about any other current medications. Particularly, caution is needed when taking this drug with medications metabolized by the liver or with medications that reduce stomach acid. In cases of overdose, severe side effects such as diarrhea, rash, or liver dysfunction can occur, so consult healthcare professionals immediately if suspected. This medication should be kept out of reach of children and it is safer not to transfer it to other containers.

Symptoms similar to interstitial lung disease, pneumonia, radiation pneumonia, hypersensitivity pneumonia, interstitial pneumonia, obstructive bronchitis, pulmonary fibrosis, acute respiratory distress syndrome, pulmonary infiltrate, dyspnea, cough, fever, myocardial infarction, ischemia, cerebrovascular accident, microangiopathic hemolytic anemia accompanied by 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, thrombocytopenia, edema, fever, constipation, bone pain, stomatitis, myalgia, depression, dyspepsia, dizziness, headache, insomnia, alopecia, anxiety, neuropathy, bloating, stiffness, deep vein thrombosis, syncope, arrhythmia, intestinal pulmonary disease, pancreatitis, thrombocytopenia, cerebral hemorrhage, pulmonary hemorrhage, nasal hemorrhage, acne, folliculitis, skin fissures, hyperpigmentation, paronychia, alopecia, hirsutism, changes in eyelashes/eyebrows, splitting and brittleness of nails, pneumonia, disease exacerbation, respiratory failure, systemic weakness, hemoptysis, sepsis, pulmonary embolism, mucositis, sputum, liver dysfunction, uveitis, intestinal emphysema, increased hepatic transaminases, bleeding, rhabdomyolysis, statin-induced myopathy

This medication may be sensitive to air or moisture, so it should be stored in a sealed container. Additionally, avoid extremely hot or cold places, and it is best stored at a temperature between 1°C and 30°C, which is room temperature.

Appearance

white to yellowish round film-coated tablet

Package unit

30 tablets (10 tablets/PTP packaging x 3)