Taceba 150 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 started. Take 150mg once daily at least 1 hour before a meal or at least 2 hours after a meal. Treatment with this medicine may continue until disease progression or unacceptable toxicity occurs. There are no data on the benefit of treatment after disease progression. 2. Pancreatic cancer In combination with gemcitabine, take 100mg once daily at least 1 hour before a meal or at least 2 hours after a meal. Treatment with this medicine may continue 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. Interrupt or temporarily discontinue this medicine in patients with dehydration and 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. If a dose reduction is needed, reduce the dose by 50mg. Consider a 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 the CYP3A4 inducer rifampicin 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, while monitoring the patient's 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 300mg as second-line therapy after chemotherapy did not improve efficacy compared with the recommended dose of 150mg.

This medicine is used to treat certain cancers such as non-small cell lung cancer and pancreatic cancer. When taking this medication, severe side effects may occur in the lungs, so if symptoms such as shortness of breath, cough, or fever suddenly develop or worsen, the medication should be stopped immediately, and a doctor should be consulted. There is also a risk of heart problems, so caution is needed in case of chest pain or discomfort. Cerebrovascular accidents or abnormal reactions in the blood may occur rarely, so if sudden unusual physical symptoms appear, they should be reported to medical personnel. Diarrhea, dehydration, electrolyte imbalance, and decreased kidney function may occur, so if diarrhea is severe or persistent, appropriate treatment should be sought, and the medication may need to be discontinued. This drug can affect liver function; therefore, regular check-ups are needed if liver disease is present or if liver function test results are abnormal, and the medication should be discontinued if liver function significantly deteriorates. Severe gastrointestinal issues such as gastrointestinal perforation may rarely arise, so immediate medical attention is required if abdominal pain or unusual symptoms occur during use. If severe rash or blisters develop on the skin, the medication should be stopped, and medical personnel should be consulted. If inflammation, pain, or blurred vision occur in the eyes, an ophthalmologist should be informed immediately, and in severe cases, medication may need to be stopped. This medicine is not administered to patients with certain genetic disorders or those allergic to its components. Patients with poor liver or kidney function should be particularly careful when using this medication, and dose adjustments may be necessary. Regular liver function and blood tests should be conducted during treatment, and any abnormal symptoms should be immediately reported to medical personnel. Smoking may reduce the effectiveness of this drug, so it is advisable to stop smoking during treatment. This medicine may interact with other drugs, so consultation with medical personnel is necessary, especially when taking medications metabolized in the liver or drugs that reduce stomach acid. Women who are pregnant or may become pregnant must use contraception during treatment, as it may pose risks to the fetus, and it should not be used during pregnancy as a principle. Breastfeeding women should avoid breastfeeding while taking this medication, as it may pose risks to the newborn. Safety for children has not been established, and the elderly can use this medication without special dose adjustments. In the case of overdose, severe diarrhea, rash, liver dysfunction, etc., may occur; therefore, if overdose is suspected, the medication should be stopped immediately, and the hospital should be visited. This medication should be kept out of reach of children, and it is safer not to transfer it to another container. During treatment, it is advisable to use protective clothing or sunscreen to protect the skin from sunlight.

Interstitial lung disease-like symptoms, pneumonia, radiation pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obstructive bronchiolitis, pulmonary fibrosis, acute respiratory distress syndrome, pulmonary infiltrate, alveolitis, dyspnea, cough, fever, myocardial infarction, ischemia, cerebrovascular accident, microvascular hemolytic anemia accompanied by thrombocytopenia, diarrhea, dehydration, electrolyte imbalance, renal failure, hepatitis, acute hepatitis, hepatic failure, gastrointestinal perforation, vesicular and desquamative skin disorders, Stevens-Johnson syndrome, toxic epidermal necrolysis, corneal perforation, corneal ulcer, abnormal eyelash growth, dry conjunctivitis, keratitis, rash, appetite loss, fatigue, nausea, infection, vomiting, stomatitis, pruritus, dry skin, conjunctivitis, dry conjunctivitis, abdominal pain, ALT elevation, AST elevation, bilirubin elevation, weight loss, edema, fever, constipation, bone pain, muscle pain, depression, dyspepsia, dizziness, headache, insomnia, alopecia, anxiety, neuropathy, distension, stiffness, deep vein thrombosis, syncope, arrhythmia, intestinal pigmentation, pancreatitis, thrombocytopenia, thrombotic adverse reactions, abnormal liver function, gastrointestinal bleeding, hematemesis, melena, black stool, eyelash entrapment, excessive growth and hypertrophy, hepatitis, acute hepatitis, acute renal failure, nosebleeds, acne, folliculitis, skin fissures, hyperpigmentation, paronychia, hirsutism, brittle and wobbly nails, pneumonia, disease progression, respiratory dysfunction, systemic weakness, hemoptysis, fever, sepsis, pulmonary embolism, mucositis, sputum, neutropenia, thrombocytopenia, weakness, anemia, pain, insomnia, uveitis, intestinal emphysema, rhabdomyolysis

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. Moreover, when storing the medication, it is important to maintain a temperature between 1 and 30 degrees Celsius (34 and 86 degrees Fahrenheit). This helps preserve the medication's effectiveness for a longer time.

Appearance

White to light yellow round film-coated tablet

Package unit

30 tablets (10 tablets/PTP packaging x 3)