Tazeba Tablet 25 mg (Erlotinib Hydrochloride)

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 treatment is initiated. Take 150mg orally once daily at least 1 hour before or at least 2 hours after a meal. Treatment with this medicine may be continued until disease progression or unacceptable toxicity occurs. There are no data on benefit when treatment is continued after disease progression. 2. Pancreatic cancer In combination with gemcitabine, take 100mg orally once daily at least 1 hour before or at least 2 hours after a meal. Treatment with this medicine may be continued until disease progression or unacceptable toxicity occurs. 3. Dose adjustment In patients who develop acute onset of new or worsening pulmonary symptoms, such as dyspnea, cough, or fever, treatment with this medicine should be interrupted until 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 who are 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 who are dehydrated. Reduce the dose or temporarily interrupt treatment in patients with severe skin adverse reactions as well. When dose reduction is necessary, reduce the dose by 50mg at a time. Consider dose reduction if serious 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. Pretreatment with rifampicin, a CYP3A4 inducer, may reduce the AUC of this medicine by approximately 2/3. Therefore, consider using an alternative medicine with no CYP3A4-inducing effect. If no alternative is available, doses above 150mg for non-small cell lung cancer or above 100mg for pancreatic cancer may be considered; in this case, monitor patient safety and 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. These medicines should be avoided if possible. This medicine is eliminated by hepatic metabolism and biliary excretion. Therefore, caution is required when it is administered to patients with hepatic impairment. If serious adverse reactions occur, consider dose reduction or discontinuation. Smoking appears to reduce exposure to this medicine by approximately 50-60%. In current smokers with non-small cell lung cancer, the maximum tolerated dose of this medicine 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 conditions affecting the lungs, so if symptoms such as shortness of breath, cough, or fever occur suddenly or worsen, you must stop taking it immediately and consult a doctor. There is also a risk of heart problems, so if you experience chest pain or discomfort, you should quickly inform medical staff. Blood abnormalities can occur, so if symptoms such as a decrease in platelet count arise, caution is necessary. Diarrhea, dehydration, electrolyte imbalances, and kidney function impairment may occur, so if diarrhea is severe or lasts long, you must consult a doctor immediately. Since liver function problems may arise, patients with liver diseases or abnormal laboratory values for liver function should undergo regular tests, and may need to stop taking the medication if symptoms worsen. Rare side effects such as gastrointestinal perforation may occur, so you should be particularly cautious if experiencing severe abdominal pain or have a history of digestive diseases. If there are severe skin rashes or blisters, you must stop taking the medication immediately and inform medical staff, and if symptoms like inflammation, pain, or blurred vision occur in the eyes, consult an ophthalmologist. You should not take this medication if you have an allergy to it or a specific genetic lactose-related disorder. Patients with poor liver or kidney function should use this medication with caution and may require dosage adjustments. Regular tests for liver function, blood counts, and electrolyte levels should be conducted during the course of treatment, particularly being mindful of interactions with other medications. Women who are pregnant or may become pregnant should avoid becoming pregnant during treatment and should use contraception for a period after treatment as well. Women who are breastfeeding should avoid breastfeeding during the medication period and for at least two weeks after. The safety and efficacy in children have not been established, so it should not be used in children. Elderly patients can use it without special dose adjustments, but caution is needed if adverse reactions occur. In cases of overdose, symptoms such as diarrhea, rash, or liver function abnormalities may appear, so if suspected, stop taking it immediately and visit a hospital. This medication should be kept 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, interstitial lung disease, obstructive bronchiolitis, pulmonary fibrosis, acute respiratory distress syndrome, pulmonary infiltration, alveolitis, dyspnea, cough, fever, myocardial infarction, ischemia, cerebrovascular accident, thrombotic microangiopathy with thrombocytopenia, diarrhea, dehydration, electrolyte imbalance, renal failure, hepatitis, acute hepatitis, liver 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, pruritus, skin dryness, conjunctivitis, dry conjunctivitis, abdominal pain, thrombocytopenia, edema, fever, constipation, bone pain, myalgia, depression, dyspepsia, dizziness, headache, insomnia, alopecia, anxiety, neuropathy, distension, stiffness, deep vein thrombosis, syncope, arrhythmia, intestinal pigmentation, pancreatitis, thrombocytopenia, hemolytic anemia, cerebral hemorrhage, liver dysfunction, gastrointestinal bleeding, hemoptysis, melena, tarry stools, eyelash entrapment, excessive eyelash growth, hypertrophy, hepatitis, acute hepatitis, hypokalemia, acute renal failure, epistaxis, acne, folliculitis, skin fissures, hyperpigmentation, paronychia, hirsutism, eyelash/eyebrow changes, nail brittleness and waviness, pneumonia, systemic weakness, hemoptysis, sepsis, pulmonary embolism, neutropenia, asthenia, anemia, pain, systemic weakness, uveitis, intestinal emphysema

This medication may be sensitive to air or moisture and should be stored in a tightly sealed container. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication for a longer period.

Appearance

White to slightly yellow round film-coated tablet

Package unit

30 tablets (10 tablets/PTP packaging x 3)