Product Details
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Generic name: Gefitinib tablets
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[Pharmacological Actions]
Gefitinib is a selective epidermal growth factor receptor (R) tyrosine kinase inhibitor, which is usually expressed on the epithelium. source of solid tumors.
[Safety] Gefitinib is generally well tolerated. Most adverse events were mild and did not require treatment. Adverse events reported by more than % of subjects were rash (.%), pruritus (.%), and diarrhea (.%). The severity and frequency of adverse events observed were consistent with those observed in other clinical studies.
[Indications]
This product is suitable for the treatment of locally advanced or metastatic non-small cell lung cancer () that has previously received chemotherapy. Previous chemotherapy treatments mainly referred to platinum and docetaxel treatments.
The efficacy of patients with locally advanced or metastatic non-small cell lung cancer who have failed chemotherapy is established based on objective response rate indicators. There are no controlled studies showing improvement in disease-related symptoms and prolonged survival. period clinical benefit. The existing data on the use of this product in the second-line treatment of non-small cell lung cancer are only based on uncontrolled clinical studies and need to be further confirmed by well-designed controlled clinical trials.
For the first-line treatment of non-small cell lung cancer, the results of two large randomized controlled clinical trials showed that platinum-based doublet chemotherapy regimens combined with this product did not show any benefit. Therefore, Gemfil Tinib is not suitable for this treatment.
[Usage and Dosage]
The recommended adult dose of this product is (tablets), once a day, orally, on an empty stomach or with food.
If you have difficulty swallowing, disperse the tablet in half a glass of drinking water (non-carbonated drinks). No other liquids should be used. Throw the tablet into water without crushing, stir until completely dispersed (it will take about a minute), and drink the liquid immediately. Rinse the cup with half a cup of water and drink. The solution may also be administered via a nasogastric tube.
There is no need to adjust the dosage due to the following conditions: age, weight, gender, race, renal function, moderate to severe liver function impairment caused by liver metastasis.
Dose adjustment: When patients experience intolerable diarrhea or skin adverse reactions, they can be resolved by temporarily suspending treatment (up to a few days), and then resuming the daily dose.
【Overdose】
There is no specific treatment for overdose of this product, and the possible symptoms of overdose are not yet known. In phase 1 clinical trials, in a small number of patients taking the daily dose, increased frequency and severity of some adverse reactions were observed, mainly diarrhea and rash. Adverse reactions caused by drug overdose should be treated symptomatically, especially severe diarrhea should be given appropriate treatment.
Specifications: * tablets/box [Storage/Validity Period]: & Save as follows. Valid for months.
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