Erloseta Tablet 150 mg (Erlotinib Hydrochloride)

Adult dose

1. Non-small cell lung cancer This medication is taken at a dose of 150mg once daily, at least 1 hour before or at least 2 hours after a meal. Treatment may continue until disease progression or unacceptable toxicity occurs. 2. Pancreatic cancer In combination with gemcitabine, this medication is taken at a dose of 100mg once daily, at least 1 hour before or at least 2 hours after a meal. Treatment may continue until disease progression or unacceptable toxicity occurs. 3. Dose adjustment 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, the dose should also be reduced or treatment temporarily interrupted. If dose reduction is required, reduce the dose in 50mg increments. Dose reduction should be considered if severe adverse reactions occur in patients receiving this medication concomitantly with strong 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 medication, the AUC of this medication may decrease by approximately 2/3. Therefore, consider using an alternative medication 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 patient safety to confirm tolerability. If the dose of this medication has been increased, reduce it when rifampicin or another inducer is discontinued. If severe adverse reactions occur, consider reducing the dose or discontinuing this medication. Smoking appears to reduce exposure to this medication by approximately 50-60%. In current smokers with non-small cell lung cancer, the maximum tolerated dose of this medication is 300mg. In patients who continue to smoke, administering a dose of 300mg as second-line therapy after chemotherapy did not improve efficacy compared with the recommended dose of 150mg.

This medication may affect the lungs and can rarely cause inflammation or damage, resulting in symptoms such as difficulty breathing, cough, and fever. If such symptoms occur, discontinue the medication immediately and consult a doctor. It may cause heart problems, posing a risk of serious conditions such as myocardial infarction or cerebrovascular accidents. Therefore, patients with heart disease should use it cautiously. Blood irregularities such as thrombocytopenia or hemolytic anemia may occur, so any related symptoms should be reported immediately. Symptoms such as diarrhea, dehydration, electrolyte imbalance, and renal failure may arise, hence if diarrhea is severe or persists, the medication should be discontinued, and appropriate treatment should be sought. It may affect liver function, leading to hepatitis or liver failure, so patients with liver disease or suspected liver dysfunction should undergo regular liver function tests. Gastrointestinal perforations may rarely occur, and patients with a history of gastrointestinal disease or taking specific medications should be extra cautious. Skin vesicular or desquamative eruptions may seldom occur, and if severe skin abnormalities arise, the medication should be stopped immediately. It may also affect eye health, potentially causing inflammation or corneal ulcers, so any abnormal eye symptoms should prompt immediate consultation with an ophthalmologist. Patients with hypersensitivity to this drug or certain genetic disorders such as lactose intolerance should not take it. Patients with compromised liver or kidney function should use this medication cautiously, and dose adjustments may be necessary if required. Smoking during treatment can reduce the effectiveness of the medication, so quitting smoking is advisable. Women who are pregnant or likely to become pregnant should avoid pregnancy during treatment with this medication, and it is also advisable to avoid taking it while breastfeeding. During treatment, common side effects such as diarrhea, rash, loss of appetite, nausea, vomiting may occur, so if symptoms become severe, consulting a doctor is advised. In case of overdose, serious side effects can occur, so adherence to recommended dosages is essential, and medical personnel should be notified immediately if in doubt. This medication must be kept out of reach of children, and it is recommended not to transfer it to other containers.

Interstitial lung disease-like symptoms, pneumonia, radiation pneumonitis, hypersensitivity pneumonia, interstitial pneumonia, obstructive bronchiolitis, pulmonary fibrosis, acute respiratory distress syndrome, pulmonary infiltrate, 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, pruritus, dry skin, conjunctivitis, dry conjunctivitis, abdominal pain, thrombosis when used in combination with platinum-based drugs, deep vein thrombosis, edema, fever, constipation, bone pain, myalgia, depression, dyspepsia, dizziness, headache, insomnia, alopecia, anxiety, neuropathy, bloating, stiffness, hematological abnormalities, syncope, arrhythmia, intestinal pigmentation, pancreatitis, thrombocytopenia, cerebral hemorrhage, pulmonary hemorrhage, nasal bleeding, acne, folliculitis, fissured skin, hyperpigmentation, paronychia, hirsutism, changes in eyelashes/brows, nail fragility and shaking, pneumonia, systemic weakness, hemoptysis, sepsis, pulmonary embolism, mucositis, neutropenia, anemia, malaise, fever, liver abscess, melena, uveitis, intestinal emphysema, increased INR, bleeding, rhabdomyolysis

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained at room temperature between 1 and 30 degrees Celsius. Proper storage will help preserve the drug's effectiveness for a long time.

Appearance

White to light yellow round film-coated tablet

Package unit

30 tablets (10 tablets/PTP x 3)