Teva Elotinib Tablet 25mg (Elotinib Hydrochloride)

Adult dose

Non-small cell lung cancer: This medicine is taken once daily at a dose of 150mg, 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 the benefit of treatment after disease progression. Pancreatic cancer: In combination with gemcitabine, this medicine is taken once daily at a dose of 100mg, 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. In patients who develop acute onset of new or worsening pulmonary symptoms, such as dyspnea, cough, or fever, treatment with this medicine should be withheld until diagnostic evaluation is complete. If interstitial lung disease is diagnosed, treatment with this medicine should be discontinued and appropriate treatment administered as necessary. This medicine should be discontinued in patients with hepatic failure or gastrointestinal perforation. Treatment with this medicine should be interrupted or withheld in patients with dehydration who are at risk of renal failure, patients with severe bullous or exfoliative skin disorders, and 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, the dose should be reduced or treatment temporarily interrupted. The dose should also be reduced or treatment temporarily interrupted in patients with severe skin reactions. When dose reduction is required, the dose should be reduced in 50mg increments. Dose reduction should be considered if severe adverse reactions occur in patients receiving this medicine concomitantly with strong CYP3A4 inhibitors such as atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin (TAO), voriconazole, or grapefruit juice. Administration of the CYP3A4 inducer rifampicin before treatment with this medicine may reduce the AUC of this medicine by approximately 2/3. Therefore, use of an alternative medicine without CYP3A4-inducing effects should be considered. If an alternative medicine is not available, doses above 150mg for non-small cell lung cancer or above 100mg for pancreatic cancer may be considered, provided that the patient's safety is monitored and tolerability is confirmed. If the dose of this medicine has been increased, the dose should be reduced when rifampicin or another inducer is discontinued. If severe adverse reactions occur, dose reduction or discontinuation of this medicine should be considered. In patients with non-small cell lung cancer who are current smokers, the maximum tolerated dose of this medicine 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 medication can rarely cause pulmonary toxicity such as interstitial lung disease, which can lead to severe inflammation or damage to the lungs. If new or worsening pulmonary-related symptoms such as shortness of breath, cough, or fever occur during treatment, the medication should be discontinued immediately and a doctor's consultation should be sought. Caution is needed as there may be heart issues, especially symptoms of myocardial infarction or ischemia. There is also a risk of cerebrovascular accidents, so if sudden headaches, dizziness, or paralysis occur, prompt medical attention is necessary. Rare blood disorders that cause a decrease in platelets may occur, so symptoms of easy bleeding or bruising should be monitored. Diarrhea, dehydration, electrolyte imbalance, and renal impairment may occur, so if diarrhea is severe or persists, medical consultation should be obtained. Liver function abnormalities may arise, necessitating regular liver function tests, and if symptoms of hepatitis or liver failure appear, medication should be discontinued. There is a risk of gastrointestinal perforation, so if severe abdominal pain or discomfort occurs, it should be reported to a doctor for treatment. If serious rashes or blisters develop on the skin, medication should be discontinued, and immediate medical care should be sought. If symptoms of eye inflammation or pain, blurred vision, etc., arise, consultation with an ophthalmologist is required, and in severe cases, medication should be discontinued. This medication contains lactose, so patients with lactose intolerance should not take it. Special caution is needed for patients with impaired liver or kidney function. While taking this medication, regular monitoring of liver function, kidney function, and blood tests should be conducted to confirm the absence of abnormalities. This medication may interact with other drugs, so if you are taking other medications, be sure to inform your doctor or pharmacist. Particularly, caution is needed when taken with drugs that affect enzymes that metabolize medications in the liver. Smoking may reduce the effectiveness of this medication, so it is recommended to quit smoking during treatment. Women who are pregnant or may become pregnant must use contraception during treatment and should not take this medication during pregnancy. If breast-feeding, it is advised to avoid breast-feeding for at least 2 weeks after taking this medication. Safety and effectiveness have not been sufficiently confirmed for children or the elderly, so consultation with a doctor is required before use. Overdosage may cause severe diarrhea, rash, liver function abnormalities, etc., so it is essential to adhere to the prescribed dosage and administration guidelines. This medication should be kept out of the reach of children and not transferred to other containers.

Interstitial lung disease-like symptoms, pneumonia, radiation pneumonia, hypersensitivity pneumonia, interstitial pneumonia, obstructive bronchiolitis, pulmonary fibrosis, acute respiratory distress syndrome, pulmonary infiltrates, dyspnea, cough, fever, myocardial infarction, ischemia, cerebrovascular accident, microangiopathic hemolytic anemia associated 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, anorexia, fatigue, nausea, infection, vomiting, stomatitis, pruritus, skin dryness, conjunctivitis, dry conjunctivitis, abdominal pain, thrombocytopenia, deep vein thrombosis, edema, fever, constipation, bone pain, stomatitis, myalgia, depression, dyspepsia, dizziness, headache, insomnia, alopecia, anxiety, neuropathy, distension, rigidity, thrombocytopenia, anemia, generalized weakness, mucositis, acne, neutropenia, pneumonia, pulmonary embolism, sepsis, pulmonary embolism, liver abscess, melena, hemoptysis, pain, sputum, thrombocytopenia, asthenia, anemia, pain, generalized weakness, uveitis, pneumatosis intestinalis, hemorrhage, gastrointestinal bleeding, peptic ulcer bleeding, hematemesis, hematochezia, melena, eyelash ingrowth, excessive eyelash growth, hypertrophy, liver function abnormalities, hypokalemia, acute renal failure, epistaxis, acneiform dermatitis, folliculitis, skin fissures, hyperpigmentation, paronychia, hirsutism, eyelashes/eyebrows changes, nail brittleness and loosening, deep vein thrombosis, syncope, arrhythmia, intestinal color change, pancreatitis, microangiopathic hemolytic anemia associated with thrombocytopenia, cerebral hemorrhage, renal failure, liver function abnormalities, hepatitis, hepatic failure, acute hepatitis, abnormal liver function test results, elevated liver transaminases, elevated bilirubin, hemorrhage, rhabdomyolysis, statin-associated myopathy

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, and it is recommended to keep it at room temperature between 15 and 30 degrees Celsius. Proper storage helps maintain the medication's effectiveness and prevents degradation.

Appearance

White or almost white round film-coated tablets

Package unit

30 tablets (10 tablets/PTPX3)