Product Details
The third-line treatment indication of Tarceva in India for locally advanced or metastatic non-small cell lung cancer that has failed two or more chemotherapy regimens is based on the results of the aforementioned foreign phase-1 clinical study for Chinese non-small cell lung cancer. The efficacy of second-line treatment needs to be confirmed by further clinical studies. The results of two multi-center placebo-controlled randomized phase III trials in the first-line treatment of locally advanced or metastatic patients showed that platinum-based chemotherapy (carboplatin + paclitaxel or gemcitabine + cisplatin ) Simultaneous use of erlotinib is not clinically relevant and is therefore not recommended for the above situations. [Usage and Dosage] This product must be used under the guidance of a doctor with experience in the use of such drugs, and only in the National Clinical Trial Pharmacology Base or a tertiary A hospital. use. Trade Name: Tarceva Generic Name: Erlotinib Hydrochloride Tablets English Trade Name: English Common Name: r [Ingredients] < Each tablet contains Erlotinib (in the form of Erlotinib Hydrochloride) Tarceva India [Properties] Round, biconvex, white coated tablets. [Mechanism of Action] The anti-tumor mechanism of action is mainly to inhibit the intracellular phosphorylation of epidermal growth factor (R) tyrosine kinase. [Pharmacokinetics] % absorbed after oral administration, half-life is about 1 hour, 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 takes - days to reach stable blood concentration. The patient's age, weight, and gender have no significant relationship with the drug clearance rate. Smoking can increase the drug clearance rate by %. [Indications] For the third-line treatment of locally advanced or metastatic non-small cell lung cancer that has failed two or more chemotherapy regimens. [Contraindications] It is prohibited for those who are allergic to this product and its ingredients. [Usage and Dosage] This product must be used under the guidance of doctors with experience in the use of such drugs, and can only be used in the national tumor 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 patients benefit from continuing treatment after progression. [Dosage Instructions] Whether it takes effect depends on the situation. Some patients will have effects on the same day they take Tarceva, while others will see significant improvement in their condition within a few days. This varies from person to person and is not the same. There are also patients who get results after taking it for a week, but this is extremely rare. The onset of effect of Tarceva is usually within - days. How to test whether Tarceva is effective? First, check the improvement of the patient's symptoms, whether the pain is relieved, whether the spirit is improved, etc. The second is to check with the help of modern technology, that is, imaging, which means to conduct a comparative examination of the lesions after taking Tarceva for a period of time. Whether Tarceva is effective can be clearly seen from the film. Men or patients with phosphorus cancer are less effective when taking Tarceva, but it is not completely ineffective. The reason for this misunderstanding is that Tarceva has always placed too much emphasis on individual characteristics such as women and non-smoking. It gives the impression that Tarceva is not suitable for men. In fact, men taking Tarceva can also have the same effect. When it comes to Tarceva's onset of effect, we have to mention Tarceva's resistance. Tarceva's resistance, like Tarceva's onset of action, varies from person to person. Under normal circumstances, the survival period is another month or a little more, and for some patients, it is normal to develop drug resistance for one month. Some patients even have drug resistance for years, which varies from person to person. Common adverse reactions The most common adverse reactions are rash and diarrhea. The incidence rates of rash and diarrhea are % and % respectively. The median occurrence time of rash is days and the median occurrence 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 few reports suggesting that severe interstitial lung disease () may occur in patients treated with r or other solid tumors, and may even lead to death. 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, use of r should be stopped and appropriate treatment should be taken. [Hepatotoxicity] Tarceva treatment can cause an asymptomatic increase 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 amount of liver function should be reduced. dosage or discontinuation of medication. 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] There is no significant difference in safety and pharmacokinetics between young and elderly patients. Therefore, dose adjustment is not recommended when used in elderly patients. [Precautions] This product must be used under the guidance of doctors with experience in the use of such drugs, and can only be used in the national oncology drug clinical trial base or tertiary A hospitals. Usage and Dosage This product must be used under the guidance of doctors who have experience in using such drugs, and can only be 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 patients benefit from continuing treatment after progression. [Specifications] [Storage] Store at ℃, and it is also acceptable between ℃ and ℃. [Packaging] Blister packaging sheet/box. [New package] Tablets/box [Validity period] months [Imported drug registration certificate number] [Manufacturer] R (z).
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