Irepinon Tablet (Gefitinib)

Adult dose

Adults: Administer 1 tablet orally once daily. This medicine may be taken with food or without regard to food at approximately the same time each day. This medicine may be swallowed whole with water or, if the whole tablet cannot be swallowed, administered after dispersing it in water (non-carbonated water). Do not use any other beverage. Place the tablet in half a glass of drinking water without crushing it, stir occasionally until the tablet disperses (up to 20 minutes), and 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.

This medication is used for the treatment of lung cancer, and patients should be adequately informed about the efficacy and safety of the medication, as well as any abnormal symptoms such as dyspnea, prior to administration. In particular, serious side effects related to interstitial lung disease may occur, so during treatment, symptoms such as shortness of breath, cough, and fever should be carefully monitored. If such symptoms arise, administration should be immediately stopped and appropriate treatment should be sought. Additionally, patients with acute lung injury or interstitial pneumonia must consult with healthcare providers before using this medication, and patients in poor health require even more caution. This medication should only be administered by a physician with extensive experience in cancer therapy in a medical facility capable of managing emergencies. Patients with hypersensitivity or those who are breastfeeding, as well as patients with certain hereditary lactose metabolism disorders, should not use this medication. Patients with impaired liver function or severe renal impairment should use this medication with caution and undergo regular liver function tests during administration. Various side effects such as diarrhea, skin rash, vomiting, and stomatitis may occur upon taking this medication, with most appearing within the first month of treatment and being temporary. Although interstitial lung disease is rare, it can be fatal, requiring special precautions. If treatment effects are not seen or if side effects are severe, consideration should be given to discontinuing treatment. If there is pain or abnormal symptoms in the eyes, immediate consultation with a physician is necessary, and this medication may affect gastric acid change, so it should be taken with consideration of gastric conditions. Pregnant women should make careful decisions regarding the use of this medication due to associated risks, and breastfeeding women should avoid taking this medication. There are no indications for children and adolescents, so it should not be used in these populations. No dosage adjustment is necessary for elderly patients, but careful monitoring is advised due to possible physical decline. There is no specific antidote in the event of an overdose of this medication, and appropriate treatment should be administered based on symptoms. Finally, this medication may cause esophageal injury if consumed while still packaged, so it must be removed from its packaging before consumption and stored out of reach of children.

Shortness of breath, interstitial lung disease, diarrhea, skin reactions (rash, acne, dry skin, pruritus), loss of appetite, conjunctivitis, blepharitis, dry eyes, keratitis, corneal abrasion, epistaxis, hematuria, vomiting, nausea, stomatitis, dehydration, dry mouth, pancreatitis, gastrointestinal perforation, elevated ALT, elevated AST, increased total bilirubin, hepatitis, pustular rash, nails abnormalities, hair loss, angioedema, urticaria, palmar-plantar erythrodysesthesia syndrome, blisters, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, cutaneous vasculitis, increased serum creatinine, proteinuria, cystitis, hemorrhagic cystitis, asthenia, fever, rash, itching, nail disease, dry skin, folliculitis, pigmentation disorders, urticaria, skin thickening, skin peeling, loss of appetite, nausea, constipation, abdominal pain, dyspepsia, oral ulcers, abdominal discomfort, dysphagia, heartburn, gastrointestinal disorders, mucositis, epigastric discomfort, gastritis, shortness of breath, pneumonia, cough, increased sputum, pharyngitis, upper respiratory infection, nosebleed, pleural effusion, asthenia, pain, weakness, fatigue, syncope, influenza-like illness, hepatic dysfunction, sensory disturbances, 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, shingles, conjunctivitis, visual impairment, dry mouth, tinnitus

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

Brown round film-coated tablets

Package unit

30 tablets (10 tablets/PTP x 3)