Enzalutamide Soft Gelatin Capsule 40mg (Enzalutamide)

Adult dose

The recommended dose of this medicine is 160mg (four 40mg capsules) once daily. This medicine may be taken with or without food. Swallow the capsules whole with plenty of water; do not chew or dissolve them, or open the capsules. 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 an entire day, resume taking the daily dose the next day. Do not take more than the prescribed daily dose. For patients who experience 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 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. Patients treated with this medicine alone or in combination with androgen deprivation therapy may temporarily interrupt treatment after 36 weeks if prostate-specific antigen (PSA) reaches an undetectable level (less than 0.2 ng/mL). Treatment should be resumed when PSA increases to 2.0 ng/mL or higher in patients who have previously undergone radical prostatectomy, or to 5.0 ng/mL or higher in patients who have previously received definitive radiotherapy. Concomitant use with strong CYP2C8 inhibitors Concomitant use 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 starting the strong CYP2C8 inhibitor.

This drug can cause seizures; therefore, if seizures occur during treatment, the medication should be stopped immediately. Rarely, a neurological disorder called reversible posterior leukoencephalopathy syndrome (PRES) may occur, which includes symptoms such as seizures, headaches, confusion, and visual disturbances; if these symptoms appear, immediate medical attention is required. Hypersensitivity reactions may occur with swelling of the face, tongue, lips, or throat, or rash; if such symptoms occur, stop taking the medication and seek medical treatment. The capsule size may be large and difficult to swallow, so it is important to take the capsule whole with sufficient water. Women who are allergic to this drug or its components, are pregnant or potentially pregnant, or are breastfeeding should not take this medication. There may be interactions with other drugs, so it is essential to inform your doctor or pharmacist if you are taking medications that inhibit specific enzymes. During treatment with this drug, side effects such as fatigue, facial flushing, nausea, reduced appetite, hypertension, diarrhea, falls, and fractures may occur, so caution is advised. Care should be taken when driving or operating machinery as there may be a decrease in memory or concentration. Patients with impaired kidney or liver function can take this medication without special dosage adjustments, but they should follow the doctor's instructions according to their condition. Pregnant women or nursing mothers should not use this drug, and male patients should use effective contraception during treatment and for three months after treatment ends. This drug should not be used in children, as safety and efficacy have not been established. In case of overdose, treatment should be stopped immediately due to the risk of seizures, and appropriate medical treatment should be provided as directed by health professionals. This drug should be kept out of reach of children, and the capsules should not be dissolved or opened; women who are pregnant or of childbearing age should avoid handling this drug directly.

Seizures, headache, confusion, blindness, visual and neurological disturbances, facial swelling, tongue swelling, lip swelling, pharyngeal swelling, rash, dysphagia, fatigue, facial flushing, nausea, reduced appetite, hypertension, diarrhea, falls, fractures, weakness, myocardial ischemia, anxiety, hallucinations, cognitive impairment, taste disturbances, restless legs syndrome, reversible posterior leukoencephalopathy syndrome, dry skin, itching, severe skin reactions, gynecomastia, nipple pain, breast tenderness, pericardial effusion, congestive heart failure, palpitations, indigestion, abdominal pain, abdominal discomfort, abnormal stools, upper abdominal pain, diarrhea, gastrointestinal pain, dry mouth, gum pain, insomnia, sleep disturbances, mood disorders, tinnitus, muscle weakness, lumbar spinal stenosis, lower back pain, arthralgia, muscle cramps, limb pain, flank pain, neck pain, decreased platelet count, anemia, dyspnea, nasal bleeding, nasal obstruction, wet cough, hyperhidrosis, urticaria, nail discoloration, nail loss, alopecia, dermatitis, hematuria, dysuria, peripheral edema, fever, chest pain, heat sensation, strange feeling, death

This drug should be stored in a tightly closed container to protect it from air and moisture, preferably at room temperature between 1°C and 30°C. Storing it in this manner can help maintain the drug's efficacy safely.

Appearance

White to off-white opaque oblong soft gelatin capsule containing a colorless to pale yellow transparent liquid

Package unit

112 capsules/box [4 capsules/PTP x 28]