Medication info
Iressa (Gefitinib)

Iressa (Gefitinib)

Prescription medicationTabletOral
Ingredient · strength
Gefitinib›250mg / 1 tablet
Manufacturer / importer
AstraZeneca Korea
Appearance
Brown round film-coated tablet
Packaging
30 tablets (10 tablets/PTPX3)
Approval status
Active

MFDS item code 200307971 · Approved 2003.06.14 · Insurance code 650700460

Summary

Main use
Treatment of locally advanced or metastatic non-small cell lung cancer with activating EGFR TK mutations
Who takes it
Adults
Adult dose
Adults: Take 1 tablet orally once daily. This medicine may be taken with or without food at approximately the same time each day. Swallow the tablet whole with water, or, if unable to swallow the whole tablet, it may be dispersed in water (non-carbonated water) before administration. Do not use any other beverage. Without crushing the tablet, place it in half a glass of drinking water and stir occasionally until dispersed (up to 20 minutes), then drink immediately once dispersion is complete. Rinse the glass with half a glass of water and drink. The dispersion may also be administered through a nasogastric or gastrostomy tube.

Ingredients

Importer
AstraZeneca Korea

Efficacy & effects

Treatment of locally advanced or metastatic non-small cell lung cancer with activating EGFR TK mutations

  • Locally advanced non-small cell lung cancer
  • metastatic non-small cell lung cancer
View approved original text

This medication is used for the treatment of patients with locally advanced or metastatic non-small cell lung cancer with EGFR TK activating mutations.

How to take

Adult dose

Adults: Take 1 tablet orally once daily. This medicine may be taken with or without food at approximately the same time each day. Swallow the tablet whole with water, or, if unable to swallow the whole tablet, it may be dispersed in water (non-carbonated water) before administration. Do not use any other beverage. Without crushing the tablet, place it in half a glass of drinking water and stir occasionally until dispersed (up to 20 minutes), then drink immediately once dispersion is complete. Rinse the glass with half a glass of water and drink. The dispersion may also be administered through a nasogastric or gastrostomy tube.

Precautions

This medication is used for the treatment of non-small cell lung cancer. Patients must be adequately informed about the effects and safety of this drug, as well as the early atypical symptoms such as respiratory distress, before administration. In particular, interstitial lung disease, which is a serious lung condition, may occur. Therefore, if symptoms such as shortness of breath, cough, or fever appear, administration should be stopped immediately and medical evaluation should be sought. Caution should be taken when administering this drug to patients with compromised liver function or severely impaired renal function, and regular liver function tests are important. This drug may commonly cause side effects such as skin rashes, diarrhea, and vomiting, and if symptoms worsen, consultation with medical personnel is advised. Pregnant or breastfeeding women should not use this drug, and those planning to become pregnant should consult a physician. This drug is metabolized by specific enzymes, so interactions may occur if taken with other medications; it is essential to inform the physician about any medications currently being taken. Additionally, this drug is not indicated for use in children and adolescents. No special dose adjustments are necessary for elderly patients, but careful observation is recommended considering potential physical decline. If a dose is missed, do not take it if it is less than 12 hours before the next scheduled dose, and be sure not to take double doses all at once. Finally, this medication should not be swallowed in its packaging, but taken out of the package to prevent esophageal damage.

Side effects

Shortness of breath, interstitial lung disease, cough, fever, diarrhea, skin reactions (rash, acne, dry skin, pruritus), loss of appetite, conjunctivitis, blepharitis, dry eyes, keratitis, corneal erosion, epistaxis, hematuria, vomiting, nausea, stomatitis, dehydration, dry mouth, pancreatitis, gastrointestinal perforation, increased ALT, increased AST, increased total bilirubin, hepatitis, pustular rash, nail abnormalities, hair loss, angioedema, urticaria, palmoplantar erythema syndrome, blisters, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, skin vasculitis, increased serum creatinine, proteinuria, cystitis, hemorrhagic cystitis, myasthenia, fever, asymptomatic increase in serum creatinine, pneumonia, increased sputum, pharyngitis, upper respiratory infection, nosebleed, pleural effusion, pain, weakness, fatigue, syncope, influenza-like illness, sensory abnormalities, headache, dizziness, neuropathy, seizures, cognitive impairment, low back pain, arthralgia, hemoptysis, gum bleeding, petechiae, cerebral infarction, peripheral edema, generalized edema, insomnia, pyuria, anemia, neutropenia, chest pain, herpes zoster, visual disturbances, tinnitus

Not everyone experiences these, and they can vary from person to person.

Storage

This medicine may be sensitive to air or moisture, so it must be stored in a tightly sealed container. A storage temperature between 1 and 30 degrees Celsius is recommended. This helps maintain the efficacy of the medication over time.

Appearance and packaging

Appearance

Brown round film-coated tablet

Package unit

30 tablets (10 tablets/PTPX3)

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.