Medication info
Zepatier 250 mg (Gepotitnib)

Zepatier 250 mg (Gepotitnib)

Prescription medicationTabletOral
Ingredient · strength
Gefitinib›250mg / 1 tablet
Manufacturer / importer
Hanmi Pharmaceutical Co., Ltd.
Appearance
Brown round film-coated tablet
Packaging
14 tablets/box [7 tablets/PTPX2]
Approval status
Active

MFDS item code 201503147 · Approved 2015.05.26 · Insurance code 643507210

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: Administer 1 tablet orally once daily. This medicine may be taken with or without food at approximately the same time each day. Swallow this medicine whole with water, or, if the whole tablet cannot be swallowed, it may be administered dispersed in water (non-carbonated water). Do not use other beverages. Without crushing the tablet, place it in half a glass of drinking water and stir occasionally until the tablet disperses (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

Manufacturer
Hanmi Pharmaceutical Co., Ltd.

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 locally advanced or metastatic non-small cell lung cancer patients with an EGFR TK active mutation. It is effective in inhibiting the growth of lung cancer cells with the mutation, thereby slowing or halting the progression of cancer. This helps in relieving symptoms and improving the quality of life of patients.

How to take

Adult dose

Adults: Administer 1 tablet orally once daily. This medicine may be taken with or without food at approximately the same time each day. Swallow this medicine whole with water, or, if the whole tablet cannot be swallowed, it may be administered dispersed in water (non-carbonated water). Do not use other beverages. Without crushing the tablet, place it in half a glass of drinking water and stir occasionally until the tablet disperses (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, and patients must be fully informed about the drug's effects and side effects—especially the risk of serious lung diseases such as respiratory distress and interstitial lung disease—before administration. Interstitial lung disease can occur rarely in patients taking this medication, and initial symptoms may include shortness of breath, cough, and fever. If these symptoms occur, the drug should be discontinued immediately, and medical attention should be sought. Since this drug is mainly metabolized in the liver, special caution is required when used by patients with poor liver function, and regular liver function tests are recommended. Additionally, patients with a history of serious lung disease or poor health status should be administered this drug carefully. Women who are breastfeeding or are allergic to any components of this drug should not use it. Common side effects during treatment may include diarrhea, skin rash, and vomiting, and if these symptoms are severe, consultation with medical personnel is necessary. This drug may interact with other medications, so caution is needed when taken with drugs metabolized by the liver, drugs that control stomach acid, or anticoagulants like warfarin. Women who are pregnant or may become pregnant must consult a doctor before taking this medication and should avoid pregnancy while on this drug. This medication is not used for children or teenagers, and while older adults do not require special dose adjustments, careful observation is necessary. If a dose is missed, take it as soon as possible, but if the next dose is close, skip the missed dose and do not double the dose. Finally, this medication should not be taken in its packaging, and it must be taken out before administration. It should be stored in a safe place out of reach of children.

Side effects

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

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, and it is best stored at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Brown round film-coated tablet

Package unit

14 tablets/box [7 tablets/PTPX2]

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.

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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.