ERSA (gefitinib tablets), the indication is that this product is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) that has received prior chemotherapy. Previous chemotherapy is mainly platinum and doxorubicin therapy. The efficacy of this product in patients with locally advanced or metastatic non-small cell lung cancer who have received prior chemotherapy was established based on survival benefits in a prespecified Asian subgroup of a large placebo-controlled clinical trial (note: improved disease-related symptoms and prolonged survival were not shown in the overall population of this trial) and survival data from a non-controlled clinical trial in China. Results from two large randomized controlled clinical trials suggest that gefitinib in combination with platinum-containing chemotherapy regimens did not show clinical benefit in the first-line treatment of locally advanced or metastatic NSCLC, so such combination regimens are not recommended.
Drug name: Erythroxel
Drug type: Prescription drugs
Classification of use: Other antineoplastic drugs
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Ingredients
Chemical name: N-(3-chloro-4-fluorophenyl)-7-methoxy-6-(3-morpholinopropoxy)quinazolin-4-amine
Chemical structure formula.
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Molecular formula: C22H24ClFN4O3
Molecular weight: 446.90
Characteristic
Brown, round, film-coated tablets; one side is printed with “IRESSA 250”.
Indications
This product is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) that has received prior chemotherapy. Previous chemotherapy is mainly platinum and doxorubicin therapy.
The efficacy of this product in patients with locally advanced or metastatic non-small cell lung cancer who have received prior chemotherapy was established based on survival benefits in a prespecified Asian subgroup of a large placebo-controlled clinical trial (note: improved disease-related symptoms and prolonged survival were not shown in the overall population of this trial) and survival data from a non-controlled clinical trial in China.
Results from two large randomized controlled clinical trials suggest that gefitinib in combination with platinum-containing chemotherapy regimens did not show clinical benefit in the first-line treatment of locally advanced or metastatic NSCLC, so such combination regimens are not recommended.
Specification
0.25 g.
Dosage
The recommended dose of this product is 250 mg (1 tablet) once a day orally, on an empty stomach or with food.
If there is difficulty swallowing, the tablet may be dispersed in half a glass of drinking water (non-carbonated beverage). No other liquids should be used. Drop the tablet into the water without crushing it, stir until it is completely dispersed (about 10 minutes), and drink the solution immediately. Rinse the glass with half a glass of water and drink. The solution may also be given through a nasogastric tube.
No dose adjustment is necessary for age, weight, sex, race, renal function, moderate to severe hepatic impairment due to liver metastases.
Dose adjustment: When patients experience intolerable diarrhea or skin reactions, this may be resolved by a short-term suspension (up to 14 days) followed by resumption of the 250 mg daily dose (see ADVERSE REACTIONS).
Use in Children
No information is available on the safety and efficacy of this product for use in pediatric or adolescent patients; therefore, its use is not recommended.