Product Details
< [Ingredients] Each tablet contains erlotinib (in the form of erlotinib hydrochloride).
【Character】This product is a round, biconvex, white coated tablet with brown && and && printed on one side and blank on the other side.
[Mechanism of action] The anti-tumor mechanism is mainly to inhibit the intracellular phosphorylation of epidermal growth factor (R) tyrosine kinase.
[Indications] It is used as the third-line treatment for locally advanced or metastatic non-small cell lung cancer that has failed two or more chemotherapy regimens.
[Usage and Dosage] It must be used under the guidance of a doctor with experience in using such drugs, and only used in the national oncology drug clinical trial base or tertiary A hospitals. The recommended dose of erlotinib monotherapy for non-small cell lung cancer is /day, taken at least one hour before or one hour after eating. Continue treatment until disease progression or intolerable toxicity occurs. There is no evidence that continuing treatment after progression can benefit patients
[Specification] *Tablets
[Pharmacokinetics] % absorption after oral administration, half-life is about hours, and is mainly eliminated by metabolism. The bioavailability of r after oral administration is approximately %, and peak plasma concentration is reached after several hours. Pharmacokinetic analysis of the patient treated with a single drug r showed that it took - days to reach stable blood concentration. The patient's age, weight, and gender had no significant relationship with the clearance rate of the drug. Smoking can increase the clearance rate of the drug by 5%.
【Contraindications】Contraindicated for those allergic to ingredients.
[Adverse reactions] The most common adverse reactions are rash and diarrhea. The incidence rates of rash and diarrhea are % and % respectively. The median appearance time of rash is days and the median appearance time of diarrhea is days. Adverse reactions with an incidence rate greater than % include: rash, diarrhea, decreased appetite, fatigue, dyspnea, cough, nausea, infection, vomiting, stomatitis, itching, dry skin, conjunctivitis, keratoconjunctivitis, and abdominal pain. Pulmonary Toxicity: There are rare reports of severe interstitial lung disease (), even leading to death, in patients treated with r or other solid tumors. In randomized controlled studies, the incidence rate was .% and was the same in the r treatment and placebo groups. Reported include: pneumonia, interstitial pneumonia, interstitial lung disease, bronchiolitis obliterans, pulmonary fibrosis, acute respiratory stress syndrome, and pulmonary effusion. Symptoms occurred from the day after treatment to more than one month, with a median onset time of days. Most patients often have confounding factors, such as previous chemotherapy/radiation therapy, existing parenchymal lung disease, lung metastasis or lung infection. When there are new and unexplained pulmonary symptoms, such as dyspnea, cough, fever, etc., examination and evaluation are required. Once diagnosed, continued use should be stopped and appropriate treatment should be taken. Hepatotoxicity: r treatment can cause asymptomatic increases in liver transaminase. Therefore, liver function should be reviewed regularly during treatment, including: transaminase, bilirubin, alkaline phosphatase, etc. If liver function damage is severe, the dose should be reduced or the drug should be discontinued. . Liver damage is often temporary or accompanied by liver metastasis. Gastrointestinal bleeding is rarely reported and often occurs in patients taking warfarin at the same time. Therefore, patients taking warfarin or other anticoagulants at the same time should monitor their prothrombin time. Elderly patients: Safety and pharmacokinetics do not differ significantly between young and elderly patients; therefore, no dose adjustment is recommended when used in elderly patients.
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