Xtandi 40 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 may induce seizures; therefore, if seizures occur during treatment, it should be discontinued immediately. Rarely, neurological conditions such as reversible posterior leukoencephalopathy syndrome can occur, and in such cases, discontinuation of the medication is necessary. If symptoms of hypersensitivity such as swelling of the face, tongue, lips, or pharynx, or rash occur, the medication must be discontinued immediately, and a doctor should be consulted. Due to the size of the tablets, they may be difficult to swallow; therefore, they should be swallowed whole with sufficient water. Patients with hypersensitivity, pregnant or potentially pregnant women, and nursing mothers should not take this medication. Because this drug may interact with certain medications, patients taking other medications must inform their healthcare provider. Common side effects may include fatigue, facial flushing, nausea, decreased appetite, hypertension, diarrhea, falls, fractures, and weakness. Serious side effects such as myocardial ischemia, seizures, and severe skin reactions may also occur; if these symptoms manifest, immediate consultation with a healthcare provider is necessary. Patients with slightly impaired kidney or liver function can take the medication without special dosage adjustments, but safety has not been established for severe cases. This medication may affect the ability to drive or operate machinery, so caution is needed when engaging in these activities. Pregnant or nursing women should not take this medication, and male patients must use effective contraception during and for 3 months after treatment. Safety in children has not been established, while elderly patients can take it without special dosage adjustments. In case of overdose, treatment should be stopped immediately and appropriate supportive care must be administered according to healthcare provider instructions, as the risk of seizures may increase after an overdose. This drug should be stored out of reach of children, and tablets should not be cut, crushed, or chewed but swallowed whole. Pregnant or potential childbearing women and individuals who should not handle this medication must take extra precautions.

Seizures, headache, confusion, blindness, visual and neurological disorders, facial swelling, tongue swelling, lip swelling, pharyngeal swelling, rash, difficulty swallowing, fatigue, facial flushing, nausea, decreased appetite, hypertension, diarrhea, falls, fractures, weakness, myocardial ischemia, anxiety, hallucinations, cognitive impairment, taste disturbances, restless legs syndrome, reversible posterior leukoencephalopathy syndrome, skin dryness, itching, severe skin reactions, gynecomastia, nipple pain, breast tenderness, palpitations, pericardial effusion, congestive heart failure, constipation, dizziness, peripheral neuropathy, sensory disturbance, drowsiness, loss of taste, dyspepsia, abdominal pain, abdominal discomfort, abnormal stools, upper abdominal pain, dysentery, gastrointestinal pain, dry mouth, gum pain, insomnia, sleep disorders, affective disorders, flushing, tinnitus, muscle weakness, lumbar spinal canal stenosis, lower back pain, arthralgia, musculoskeletal pain, muscle cramps, thrombocytopenia, anemia, dyspnea, epistaxis, nasal obstruction, wet cough, hyperhidrosis, urticaria, discoloration of fingernails and toenails, nail loss, alopecia, dermatitis, hematuria, dysuria, death, peripheral edema, fever, chest pain, warmth, strange sensations

This medication may degrade due to air or moisture; therefore, it must be stored in a tightly closed container. The storage temperature should be maintained at room temperature between 1 to 30 degrees Celsius, avoiding extremely hot or cold environments.

Appearance

Yellow round film-coated tablets

Package unit

112 tablets/box [28 tablets/PTP × 4]