Iretinib 250 mg (Gefitinib)

Adult dose

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

Before starting treatment, it is essential to explain the effects and safety of this drug to the patient, as well as any abnormal symptoms such as shortness of breath. Particularly, serious lung diseases such as interstitial lung disease may occur, so symptoms like breathlessness, cough, or fever should be closely monitored during treatment. If these symptoms arise, the medication should be immediately discontinued, and medical consultation should be sought. Additionally, patients with a history of serious lung diseases such as acute lung injury or pneumonia must discuss with their doctor before taking this medication, and greater caution is required if their health condition is poor. This drug should only be used in hospitals equipped to respond to emergency situations by physicians experienced in cancer treatment. It is not administered to individuals allergic to any components of this drug, breastfeeding women, or patients with certain genetic disorders. Patients with poor liver function need to undergo regular liver function tests while on this medication, and extreme caution is necessary for patients with severe liver disorders. Patients with severely impaired kidney function should also use this drug carefully. Common side effects such as diarrhea, skin rash, vomiting, and stomatitis may occur frequently during the first month of treatment, but they are generally manageable and tend to resolve. Serious side effects such as interstitial lung disease have also been reported, so symptoms should be promptly reported to medical personnel. Regular chest X-rays should be conducted during treatment, and pulmonary function tests should be performed as needed. If any abnormal symptoms occur, the administration of the drug should be immediately stopped, and appropriate treatment should be received. If eye discomfort or pain occurs, medication should be discontinued, and an ophthalmologist should be consulted. This medication may be affected by changes in acidity, so caution is necessary when taken with antacids. Caution should also be exercised when driving or operating machinery due to the potential for side effects such as weakness. The safety and efficacy of this drug have not been established when used in conjunction with other chemotherapeutic agents or radiation therapy, so it should be used alone. If a dose is missed, it should be skipped if within 12 hours and taken at the next scheduled time, and never take double the dose at once. This drug is metabolized by specific enzymes, so when taken with drugs affecting enzyme activity, the risk of side effects may increase, and consultation with medical personnel is necessary. Women who are pregnant or may become pregnant must consult a doctor before taking this drug and should avoid pregnancy while on medication; breastfeeding is not recommended. This drug is not used in children or adolescents due to lack of indications. Elderly patients do not require special dosing adjustments, but careful monitoring is advised. There is no specific antidote for overdose, and appropriate treatment should be received according to symptoms, especially in cases of severe diarrhea. This medication should not be taken while in its packaged state and must be removed from its packaging to reduce the risk of esophageal injury. Lastly, it is important to keep this drug out of reach of children and not transfer it to another container.

Dyspnea, interstitial lung disease, acute lung injury, interstitial pneumonia, diarrhea, skin reactions (rash, acne, dry skin, pruritus), loss of appetite, conjunctivitis, blepharitis, dry eyes, keratitis, corneal abrasion, abnormal eyelash growth, nosebleed, hematuria, vomiting, nausea, stomatitis, dehydration, dry mouth, pancreatitis, gastrointestinal perforation, increased ALT, increased AST, increased total bilirubin, hepatitis, pustular rash, nail and skin abnormalities, hair loss, angioedema, urticaria, palmoplantar erythrodysesthesia syndrome, vesicles, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, cutaneous vasculitis, increased serum creatinine, proteinuria, cystitis, hemorrhagic cystitis, asthenia, fever, asymptomatic increase in serum creatinine, fever, asthenia, pain, frailty, fatigue, syncope, influenza-like syndrome, paresthesia, 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, dry mouth, tinnitus, pneumonia, cough, increased sputum, pharyngitis, upper respiratory infection, nosebleed, pleural effusion, constipation, abdominal pain, dyspepsia, oral ulcers, abdominal discomfort, dysphagia, heartburn, gastrointestinal disturbance, mucositis, epigastric discomfort, gastritis, respiratory failure, progression of illness

This drug should be stored in a tightly closed container to protect it from air and moisture. Additionally, it is advisable to keep the drug at room temperature between 1 to 30 degrees Celsius, avoiding places that are too hot or too cold.

Appearance

Brown round film-coated tablet

Package unit

10 tablets/PTP*3