Elosetac Tablet 100 mg (Erlotinib Hydrochloride)

Adult dose

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 when administered after disease progression. 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. Dose adjustment: In patients with acute onset of new or worsening pulmonary symptoms, such as dyspnea, cough, or fever, treatment with this medicine should be interrupted 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. Interrupt or temporarily withhold treatment in patients with dehydration at risk of renal failure, severe bullous or exfoliative skin disorders, or acute/worsening ocular disorders. Diarrhea can usually 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 adverse reactions as well. When dose reduction is necessary, reduce the dose in 50mg increments. If severe adverse reactions occur in patients receiving concomitant strong CYP3A4 inhibitors, such as atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin (TAO), voriconazole, or grapefruit juice, dose reduction should be considered. Administration of the CYP3A4 inducer rifampicin before this medicine may reduce the AUC of this medicine by about 2/3. Therefore, consider using an alternative medicine without CYP3A4-inducing effects. If no alternative is available, consider doses above 150mg for non-small cell lung cancer or above 100mg for pancreatic cancer, while monitoring patient safety and confirming 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. These medicines should be avoided if possible. This medicine is eliminated by hepatic metabolism and biliary excretion. Therefore, caution is required 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 a 300mg dose as second-line therapy after chemotherapy did not improve efficacy compared with the recommended dose of 150mg.

This drug can cause serious toxicity to the lungs. Rarely, symptoms similar to lung diseases may occur in patients with lung cancer or pancreatic cancer, potentially leading to death; thus, if new or worsening symptoms such as shortness of breath, cough, or fever appear, the medication should be stopped immediately and a physician's evaluation should be sought. It may affect the heart and brain, increasing the risk of myocardial infarction or cerebrovascular accidents, so special caution is necessary for patients with a history of cardiovascular diseases. Blood disorders such as thrombocytopenia and hemolytic anemia may occur, necessitating regular monitoring of blood status. Gastrointestinal and renal-related side effects, such as diarrhea, dehydration, electrolyte imbalances, and renal failure, may arise, and if diarrhea is severe or persistent, healthcare personnel should be notified immediately, especially if the patient has pre-existing kidney disease. It can affect liver function, leading to hepatitis, hepatic failure, etc., so patients with liver dysfunction should undergo regular liver function tests. Gastrointestinal perforation may rarely occur; therefore, patients with a history of digestive diseases should be cautious while taking this medication and stop it immediately if symptoms arise. Serious side effects may also occur in the skin and eyes, requiring immediate consultation with a doctor if severe rashes, blisters, conjunctivitis, or corneal ulcers appear. Patients with allergic reactions to this drug or those with specific genetic disorders such as lactose intolerance should not take this medication. Patients with diminished liver or kidney function should exercise particular caution while taking this drug, and dosage adjustment may be necessary. Women who are pregnant or may become pregnant must use contraception during treatment with this drug, and breastfeeding individuals should preferably avoid taking it. The safety and efficacy of this medication in children have not been established, thus it should not be used in pediatric patients. Older adults can use it without special dosage adjustments, but their health status should be closely monitored. In cases of overdose, severe side effects such as diarrhea, rash, and liver function abnormalities may occur, so care must be taken not to exceed the prescribed dose. This drug may interact with other medications, especially those metabolized by the liver, as well as proton pump inhibitors, antibiotics, and antifungal medications, so it is advisable to consult a physician or pharmacist if taking such drugs concurrently. Smoking can reduce the effectiveness of this drug; thus, smoking cessation is recommended during treatment. This medication should be stored out of reach of children and should not be transferred to other containers for safety.

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, liver failure, gastrointestinal perforation, vesiculobullous 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, pruritus, dry skin, conjunctivitis, dry conjunctivitis, abdominal pain, thrombocytopenia, deep vein thrombosis, edema, fever, constipation, bone pain, stomatitis, myalgia, depression, dyspepsia, dizziness, headache, insomnia, alopecia, anxiety, neuropathy, bloating, stiffness, thrombocytopenia, anemia, systemic weakness, mucositis, acne, neutropenia, pulmonary embolism, liver abscess, melena, hemoptysis, pain, sputum, sepsis, pneumonia, pulmonary embolism, uveitis, pneumatosis intestinalis, bleeding, hematemesis, passage of blood in stool, colitis, eyelash entrainment, excessive growth, hypertrophy, paronychia, hirsutism, brittle and loose nails, rhabdomyolysis

Store this medication in a tightly sealed container to prevent exposure to air or moisture. Additionally, avoid storing it in excessively hot or cold areas and keep it at room temperature between 1°C and 30°C.

Appearance

White to light yellow round film-coated tablet

Package unit

30 tablets (10 tablets/PTP x 3)