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=_b>宋体, , - # b b>Common name: < . #>Gefitinib tablets Songti, , - # b b>Function and Indications: #>This product is suitable for the treatment of locally advanced or metastatic patients who have previously received chemotherapy Non-small cell lung cancer (). Previous chemotherapy treatments mainly referred to platinum and docetaxel treatments.
The efficacy of this product for patients with locally advanced or metastatic non-small cell lung cancer who have previously received chemotherapy is based on the preset survival advantage of the Asian subgroup in a large-scale placebo-controlled clinical trial (Note: The overall population of this trial (has not been shown to improve disease-related symptoms and extend survival) 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. Song Dynasty, , - # b b>Usage and dosage: #>The recommended dosage of this product is (tablet), 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 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 may also be administered via 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 temporarily suspending treatment (up to a few days), and then resuming the daily dose (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. Song Dynasty, , - # b b>Dosage form: #>Tablet Song Dynasty, , - # b b>Adverse reactions: #>The most common (incidence rate is more than %) adverse drug reactions ( ) are diarrhea and skin reactions (including rash, acne, Dry skin and itching), which usually occurs within the first month after taking the drug and is usually reversible. Approximately % of patients experienced serious adverse drug reactions (standard or grade). Approximately % of patients discontinued treatment due to R.
Adverse events occurring in each body system are arranged in descending order by 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 is approximately %.
In a double-blind phase 1 clinical study, this product plus best supportive care (B) was compared with placebo plus B for patients who had received one or two chemotherapy regimens in the past and had failed to respond to the most recent treatment or In intolerant locally advanced patients, 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 .%.
宋体, , - -
宋体, , - # b b>Ingredients: #>Gefitinib. Song Dynasty, , - # b b>Characteristics: #>Brown, round, with &R & printed on one side of the film-coated tablet. Song Dynasty, , - # b b>Usage for pregnant and lactating women: #>Use during pregnancy
There is currently no data on the use of this product for pregnant women. When maternally toxic doses of gefitinib were administered during organogenesis, an increased incidence of osteogenesis imperfecta was observed in rats and a decrease in fetal weight was observed in rabbits. No malformations were observed in rats, except in rabbits at doses that produced severe maternal toxicity. Women of childbearing potential should be advised to avoid pregnancy during treatment with this product.
Use during lactation
During the period of treatment with this product, nursing mothers should be advised to stop breastfeeding.
There is currently no information on the use of this product in lactating women. It is not known whether gefitinib or its metabolites are excreted into human milk, but when oral administration of gefitinib (. Metabolites are widely secreted into breast milk.
Give it to rats during pregnancy and delivery, - # b b>Children's medication: #>There is currently no data on the safety and efficacy of this product in children or adolescent patients, so its use is not recommended.