Extandi Tablet 80 mg (Enzalutamide)

Adult dose

The recommended dose of this medicine is 160mg once daily (four 40mg tablets or two 80mg tablets). This medicine may be taken with or without food. Swallow the tablets whole with plenty of water; do not cut, crush, or chew them. Take this medicine at approximately the same time each day. If you miss a dose, take it as soon as you remember. If you miss a dose for a whole day, resume taking the daily dose of this medicine the next day. Do not take more than the prescribed daily dose. For patients who develop Grade 3 or higher toxicity or intolerable adverse reactions, interrupt treatment with this medicine for 1 week or until symptoms improve to Grade 2 or lower. Once improvement is confirmed, resume treatment at the same dose or at a reduced dose of 120mg or 80mg. Patients with castration-resistant prostate cancer and hormone-sensitive metastatic prostate cancer taking this medicine should also receive androgen deprivation therapy. Patients with high-risk, biochemically recurrent, hormone-sensitive nonmetastatic prostate cancer may be treated with this medicine together with androgen deprivation therapy or with this medicine alone. In patients treated with this medicine alone or in combination with androgen deprivation therapy, treatment may be temporarily interrupted if prostate-specific antigen (PSA) reaches an undetectable level (less than 0.2 ng/mL) after 36 weeks of treatment. Resume treatment if PSA increases to 2.0 ng/mL or higher in patients who previously underwent radical prostatectomy, or to 5.0 ng/mL or higher in patients who previously underwent radical radiotherapy. Concomitant administration with strong CYP2C8 inhibitors Concomitant administration with strong CYP2C8 inhibitors should be avoided whenever possible. If concomitant use with a strong CYP2C8 inhibitor is necessary, reduce the daily dose of this medicine to 80mg. When the strong CYP2C8 inhibitor is discontinued, return the dose of this medicine to the dose used before the strong CYP2C8 inhibitor was started.

This drug can cause seizures, so if seizures occur during use, you must immediately stop taking it. It can rarely cause a neurological condition called reversible posterior leukoencephalopathy syndrome (PRES), which may present various neurological symptoms including seizures, headaches, and visual disturbances. Seek medical attention promptly if symptoms appear. If swelling of the face, tongue, lips, or throat, or any allergic reactions such as rashes occur, stop taking the medication immediately and seek treatment. The tablets may be large and difficult to swallow, so they should be taken whole with plenty of water, and should not be cut or crushed. This medication should not be used by women who are pregnant or may become pregnant, as well as nursing mothers. It may interact with other medications, especially those involving certain enzyme inhibitors or P-gp substrate drugs, so you must consult your doctor if you are taking such medications. Common side effects include fatigue, facial flushing, nausea, loss of appetite, hypertension, diarrhea, falls, and fractures, as well as potentially severe side effects such as myocardial ischemia or seizures. Patients with slightly impaired kidney or liver function can take this medication without special dosage adjustments, but caution is needed in cases of severe renal or hepatic impairment. This medication may affect driving or machinery operation, so be cautious when engaging in these activities. In case of overdose, stop taking the medication immediately and inform your healthcare provider, as there may be an increased risk of seizures. This drug should not be handled or taken by children, pregnant women, women of reproductive age, or nursing mothers, and must be stored out of reach of children.

Seizures, headache, confusion, blindness, visual and neurological disorders, facial swelling, tongue swelling, lip swelling, pharyngeal swelling, rash, decreased appetite, hypertension, diarrhea, falls, fractures, weakness, myocardial ischemia, anxiety, hallucinations, cognitive impairment, taste disorder, restless legs syndrome, reversible posterior leukoencephalopathy syndrome, flushing, nausea, vomiting, xerosis, pruritus, severe skin reactions, gynecomastia, nipple pain, breast tenderness, ischemic heart disease, constipation, dizziness, peripheral neuropathy, paresthesia, drowsiness, loss of taste, pericardial effusion, congestive heart failure, palpitations, dyspepsia, abdominal pain, abdominal discomfort, abnormal stool, epigastric pain, abdominal cramps, gastrointestinal pain, dry mouth, gum pain, insomnia, sleep disorders, mood disorders, hyperkalemia, decreased appetite, hyperlipidemia, breast pain, vertebral compression fracture, hematuria, dysuria, malignant neoplasm progression, thrombocytopenia, prostate-specific antigen increase, abnormal liver function tests, alanine aminotransferase increase, increased blood glucose, anemia, dyspnea, epistaxis, nasal obstruction, wet cough, hyperhidrosis, urticaria, discoloration of nails, nail loss, alopecia, dermatitis, peripheral edema, fever, chest pain, heat sensation, strange feelings

This medication should be stored in a tightly closed container to prevent air or moisture from entering and should be kept at room temperature between 1 degree and 30 degrees Celsius. This way, the effectiveness of the medication can be maintained for a longer period.

Appearance

Yellow oval film-coated tablet

Package unit

56 tablets/box [14 tablets/PTP×4]