Year8
[Drug name]: Generic name: Gefitinib tablets
English name: b, r, Z
< ..
%
Anorexia, mild or moderate (or grade).
Oral mucositis, mostly mild (grade).
Dehydration secondary to diarrhea, nausea, vomiting, or anorexia.
Liver function abnormalities mainly include asymptomatic mild or moderate elevation of transaminase (or grade).
Nail toxicity.
Hair loss
Fatigue, mostly mild (grade)
Conjunctivitis and blepharitis, mostly mild (grade).
(&%)
Digestive system:
Skin and appendages:
Diarrhea is mainly mild (grade), rarely moderate (grade), and severe diarrhea accompanied by dehydration (grade) has been reported occasionally. Nausea, mainly mild (grade).
Skin reactions are mainly mild or moderate (or grade) multivesicular rash, sometimes accompanied by dry and itchy skin on the basis of erythema.
(&.-&%)
Blood and Lymph:
Ophthalmology:
Respiratory:
Increased international normal values (R) and/or bleeding events have occurred in some patients taking warfarin
Corneal erosion, reversible, sometimes with abnormal eyelash growth.
Interstitial lung disease is often severe (-) grade, and fatal cases have been reported.
(&.-&.%)
Digestive system:
Pancreatitis.
(&. %)
Skin and Appendages:
Allergic reactions, including angioedema and urticaria.
Toxic epidermal necrolysis and erythema multiforme have only been reported in individual cases
*In clinical trials worldwide In studies and post-marketing use (Japan only), the overall incidence of interstitial lung disease in approximately 0.0% of patients treated with gefitinib was approximately .% (including .0% of patients outside Japan) and approximately .% in Japan. % (approximately patients). (Interstitial pneumonia usually manifests about one or two months after taking the medicine. If symptoms of coughing and chest tightness suddenly worsen while taking the medicine, please stop taking the medicine immediately and contact us or your attending doctor. The occurrence of interstitial pneumonia in my country The rate is very low, and there is generally no need to worry too much, but this possibility cannot be ruled out.)
[Contraindications]
People who are known to have severe hypersensitivity to this active substance or any excipient of this product .
[Precautions]
Patients receiving gefitinib may occasionally develop acute interstitial lung disease, and some patients may die as a result (see the 'Possible adverse reactions' section). Mortality is increased in patients with concomitant congenital pulmonary fibrosis/interstitial pneumonia/pneumoconiosis/radiation pneumonitis/drug-induced pneumonitis. If the patient's respiratory symptoms such as shortness of breath, cough and fever worsen, treatment should be interrupted and the cause should be identified in time. When interstitial lung disease is confirmed, gefitinib should be discontinued and the patient treated accordingly.
Asymptomatic elevations in hepatic transaminases have been observed (see 'Possible Adverse Reactions' section). Therefore, it is recommended to check liver function regularly. It can be used with caution in patients with mild to moderate elevations of hepatic transaminases. If liver function impairment is severe, discontinuation of the drug should be considered.
Substances that induce activity may increase the metabolism of gefitinib and decrease its plasma concentration. Therefore, concomitant use with inducers (eg phenytoin, carbamazepine, rifampicin, barbiturates) may reduce efficacy (see 'Drug Interactions' section).
Increases in international normal values (R, ) and/or bleeding events have been reported in some patients taking warfarin (see 'Possible Adverse Reactions' section). Patients taking warfarin should be regularly monitored for changes in prothrombin time or R.
Drugs that cause sustained increases in gastric values may reduce the plasma concentration of gefitinib and thus reduce its efficacy (see
'Drug Interactions' and 'Pharmacokinetic Properties' sections).
Patients should be cautioned to seek immediate medical attention if the following conditions worsen:
& Any eye symptoms
& Severe or persistent diarrhea, nausea, vomiting, or anorexia
These symptoms should be treated as clinically necessary Treat (see 'Possible Adverse Reactions' section).
See also the sections 'Pregnancy and breastfeeding' and 'Effects on the ability to drive and operate machinery'.
Effects on the ability to drive and operate machines
During treatment, symptoms of fatigue may occur, and these patients should be reminded when driving or operating machines.
[Drugs for Pregnant and Lactating Women]
There is currently no data for use in pregnant or lactating women. Reproductive toxicity has been observed in animal experiments. Gefitinib and some of its metabolites were also detected in the milk of rabbits in animal experiments (see section 'Preclinical safety information relevant to prescribers').
During treatment, women of childbearing age should be advised to avoid pregnancy and nursing mothers should be advised to stop breastfeeding.
【Drug Interactions】
In vitro tests have confirmed that gefitinib is metabolized.
When gefitinib was co-administered with rifampicin (a known strong inducer), the mean % reduction in gefitinib (see 'Warnings and Precautions' section) in healthy volunteers Among patients who combined gefitinib with rz (an inhibitor), the mean increase in gefitinib was %. Since adverse drug reactions are related to dose and duration of action, this result may have clinical significance. Concomitant use with drugs that can cause sustained gastric reflux can reduce the average dose of gefitinib by % (see 'Warnings and Precautions' and 'Pharmacokinetic Properties' sections)
[Drug Overdose]
There is no specific treatment for gefitinib overdose, and specific signs of overdose are not known. In phase 1 clinical trials, a small number of patients received daily doses. An increase in the frequency and severity of some adverse reactions was observed, mainly rash and diarrhea. Adverse reactions caused by overdose should be treated symptomatically, especially severe diarrhea should be given appropriate treatment.
【Specification】/piece.
[Storage] Below ℃, store in the original packaging (just keep it in a cool place indoors)
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