Teva Elotinib Tablet 100mg (Elotinib Hydrochloride)

Adult dose

1. Non-small cell lung cancer Take 150mg of this medicine 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 treatment is given after disease progression. 2. Pancreatic cancer In combination with gemcitabine, take 100mg of this medicine 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. 3. Dose adjustment 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 reactions as well. If dose reduction is necessary, reduce the dose in 50mg increments. Consider dose reduction 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. If rifampicin, a CYP3A4 inducer, 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 medicine is available, consider administering more than 150mg for non-small cell lung cancer or more than 100mg for pancreatic cancer, and monitor the patient's safety to confirm tolerability. If the dose of this medicine has been increased, reduce its dose when rifampicin or another inducer is discontinued. 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 inflammation or damage to the lungs; therefore, if new or worsening symptoms such as shortness of breath, cough, or fever occur, the medication should be discontinued immediately and a doctor's consultation is advised. Patients with heart problems or abnormalities in blood circulation should be cautious as there is a risk of myocardial infarction or cerebrovascular accidents. Diarrhea, dehydration, electrolyte imbalance, and renal function deterioration may occur, and immediate treatment should be sought if severe diarrhea persists, and medication should be stopped if necessary. Patients with liver function issues are at higher risk of liver damage and should undergo regular liver function tests, and if abnormalities are detected, they should stop taking the drug. Gastrointestinal perforation or bleeding may rarely occur; therefore, immediate consultation with healthcare professionals should be sought if abdominal pain or bleeding is observed. If severe rashes or blisters appear on the skin, the medication should be discontinued, and medical attention should be sought. If there is inflammation, pain, or blurred vision in the eyes, an eye specialist should be consulted immediately. This drug should not be administered to patients with certain genetic problems or lactose intolerance, and caution should be exercised when administering to patients with impaired liver or kidney function. Women who are pregnant or capable of becoming pregnant must use contraception during treatment, and breastfeeding should be avoided for at least 2 weeks. There may be interactions with other drugs, so especially when taking medications that act on the liver or drugs that reduce stomach acid, consultation with a doctor or pharmacist is necessary. Smoking may reduce the effectiveness of this drug, so it is recommended to quit smoking during treatment. In case of overdose, serious side effects such as diarrhea, rashes, and abnormalities in liver function may occur, so if suspected, immediately discontinue use and seek appropriate treatment. This medication should be stored out of reach of children, and transferring it to another container may pose a risk of accidents or quality degradation.

Interstitial lung disease-like symptoms, pneumonia, radiation pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obstructive bronchiolitis, pulmonary fibrosis, acute respiratory distress syndrome, pulmonary infiltrates, dyspnea, cough, fever, myocardial infarction, 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, appetite loss, fatigue, nausea, infection, vomiting, stomatitis, pruritus, dry skin, conjunctivitis, dry conjunctivitis, abdominal pain, thrombocytopenia, deep vein thrombosis, edema, fever, constipation, bone pain, myalgia, depression, dyspepsia, dizziness, headache, insomnia, alopecia, anxiety, neuropathy, distension, rigidity, hematological abnormalities, bleeding, epistaxis, acne, folliculitis, skin fissures, hyperpigmentation, paronychia, hirsutism, changes in eyelashes/eyebrows, splitting and brittleness of nails, pneumonia, worsening of disease, respiratory failure, general weakness, hemoptysis, fever, sepsis, pulmonary embolism, mucositis, general weakness, dyspepsia, thrombocytopenia, asthenia, anemia, liver abscess, melena, deep vein thrombosis, syncope, arrhythmia, intestinal metaplasia, pancreatitis, microangiopathic hemolytic anemia associated with thrombocytopenia, cerebral hemorrhage, renal failure, uveitis, bowel emphysema, elevated liver transaminases, elevated INR, bleeding, rhabdomyolysis, statin-induced myopathy

This drug can be sensitive to air or moisture, so it should be stored in a sealed container. It is important to maintain a temperature between 15 and 30 degrees Celsius, which is room temperature, not too high or too low.

Appearance

White or almost white round film-coated tablets

Package unit

30 tablets (10 tablets/PTPX3)