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< dd ,) dd dh / dd < dd dd dh , ddThe efficacy of this product in patients with locally advanced or metastatic non-small cell lung cancer who have previously received chemotherapy is based on large-scale placebo-controlled clinical trials. It was established based on the survival advantage of the Asian subgroup (note: the trial did not show improvement in disease-related symptoms and prolonged survival in the overall population) and the survival data of uncontrolled clinical trials in China. The results of two large randomized controlled clinical trials showed that gefitinib combined with platinum-containing chemotherapy regimens showed no clinical benefit in the first-line treatment of locally advanced or metastatic patients, so such combination regimens are not recommended. < dd ,) dd dh / dd < dd dd dh , dd Usage and dosage: < dd dd dh , dd The recommended dosage of this product is m (tablets), taken orally once a day, on an empty stomach or with food. If you have difficulty swallowing, disperse the tablet in half a glass of drinking water (non-carbonated beverage). 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 can also be given through a nasogastric tube. There is no need to adjust the dosage based on 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 suspending treatment for a short period of time (up to a few days), and then resume the dose of m per day (see adverse reactions). Use in children There is currently no data on the safety and efficacy of this product in children or adolescent patients, so its use is not recommended. < dd ,) dd dh / dd < dd dd dh , dd dosage form: < dd dd dh , dd tablet < dd ,) dd dh / dd < dd dd dh , dd adverse reactions: < dd dd dh , dd is the most common ( Adverse drug reactions (with an incidence rate of more than %) are diarrhea and skin reactions (including rash, acne, dry skin and itching), which are generally seen within the first month after taking the drug and are usually reversible. Approximately % of patients experienced serious adverse drug reactions (standard or grade). Approximately % of patients discontinued treatment. Adverse events occurring in each body system are arranged in descending order of frequency (common: % common: % and % rare: .% and % rare: .% and .% extremely rare: .%). Based on data from clinical studies, expanded access/compassionate use, and post-marketing use conducted globally, the overall estimated reporting rate of interstitial lung disease outside Japan is approximately .% and in Japan approximately % . In a double-blind phase 1 clinical study, this product plus best supportive care (B) was compared with placebo plus B in patients who had received one or two previous chemotherapy regimens and had failed to respond to the most recent treatment. In patients with locally advanced disease or intolerance, the incidence of interstitial lung disease-type events was similar in the overall population, approximately % in both treatment groups. The vast majority of reported interstitial lung disease-type events have been in Eastern populations, and the incidence of interstitial lung disease was similar in Oriental patients who received this product or placebo, approximately % and %, respectively. One interstitial lung disease-type event resulted in death in a patient who received placebo. In Japanese post-marketing drug surveillance studies (patients), the reported incidence of interstitial lung disease-type events in patients treated with this product was .%.
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