Enzadec Soft Capsule 40 mg (Enzalutamide)

Adult dose

The recommended dose of this medicine is 160mg once daily (four 40mg capsules). 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. This medicine should be taken at approximately the same time each day. If you miss a dose of this medicine, take it as soon as possible when 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. Patients who develop Grade 3 or higher toxicity or intolerable adverse reactions should stop taking 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 who take this medicine should also receive androgen deprivation therapy. Patients with high-risk, biochemically recurrent, hormone-sensitive non-metastatic prostate cancer may be treated with this medicine in combination with androgen deprivation therapy or with this medicine alone. Patients treated with this medicine alone or in combination with androgen deprivation therapy may temporarily discontinue treatment after 36 weeks of treatment 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 previously underwent radical prostatectomy, or to 5.0 ng/mL or higher in patients who previously received radical radiotherapy. Concomitant administration with strong CYP2C8 inhibitors Concomitant administration with strong CYP2C8 inhibitors should be avoided if possible. If concomitant administration with a strong CYP2C8 inhibitor is necessary, reduce the daily dose of this medicine to 80mg. When concomitant administration with the strong CYP2C8 inhibitor is discontinued, return the dose of this medicine to the dose used before administration of the strong CYP2C8 inhibitor.

This drug may induce seizures; if seizures occur during treatment, administration should be stopped immediately. Rarely, a neurological disorder called reversible posterior leukoencephalopathy syndrome (PRES) may occur, which can present with headaches, seizures, and visual disturbances, necessitating immediate consultation with medical personnel if symptoms arise. Allergic reactions may cause swelling of the face, tongue, lips, and pharynx or rashes; if these symptoms appear, discontinue the drug and seek medical attention. Due to the large size of the capsules, it is important to swallow them whole with plenty of water. Women who are pregnant or breastfeeding should not take this drug. If taking other medications, especially those that inhibit or induce specific enzymes, consult a physician first. Common side effects include fatigue, facial flushing, nausea, loss of appetite, hypertension, diarrhea, falls, fractures, asthenia, neutropenia, anxiety, hallucinations, headaches, cognitive impairment, taste disturbances, restless legs syndrome, facial flushing, dry skin, itching, rashes, gynecomastia, nipple pain, breast tenderness, decreased platelet count, sweating, hives, nail discoloration, nail loss, alopecia, dermatitis, anemia, nosebleeds, nasal obstruction, and wet cough. Patients with a history of heart problems or seizures must exercise caution and seek immediate treatment if any abnormal symptoms arise. Patients with slightly impaired kidney or liver function can take it without dose adjustments, but caution is advised for those with severe impairment due to lack of sufficient information. This drug can be harmful to the fetus, so women of reproductive age should not take it, and male patients should use effective contraception if there is a possibility of their partner becoming pregnant. Safety and efficacy in children have not been established; however, elderly patients can take it without special dose adjustments. In case of overdose, discontinue the drug immediately and seek treatment according to medical personnel's instructions, as the risk of seizures may increase.

Seizures, reversible posterior leukoencephalopathy syndrome (PRES), facial swelling, tongue swelling, lip swelling, pharyngeal swelling, rash, dysphagia, fatigue, facial flushing, nausea, decreased appetite, hypertension, diarrhea, falls, fractures, weakness, myocardial ischemia, anxiety, hallucinations, headache, cognitive impairment, taste disturbance, restless legs syndrome, dry skin, itching, severe skin reaction, gynecomastia, nipple pain, breast tenderness, dry skin, sweating, urticaria, discoloration of nails, nail loss, alopecia, dermatitis, neutropenia, anemia, dyspnea, epistaxis, nasal obstruction, moist cough, constipation, dizziness, peripheral neuropathy, sensory disturbance, drowsiness, loss of taste, pericardial effusion, congestive heart failure, palpitations, dyspepsia, abdominal pain, abdominal discomfort, abnormal stool, upper abdominal pain, abdominal cramps, gastrointestinal pain, dry mouth, gum pain, insomnia, sleep disorder, mood disorder, tinnitus, muscle weakness, lumbar spinal canal stenosis, low back pain, arthralgia, muscle cramps, limb pain, flank pain, neck pain, hyperkalemia, decreased food intake, hyperlipidemia, breast pain, vertebral compression fracture, hematuria, dysuria, malignant neoplasm progression, decreased platelet count, increased prostate-specific antigen, abnormal liver function tests, increased alanine aminotransferase, increased blood glucose, peripheral edema, fever, chest pain, death, sense of heat, strange feeling

This drug should be stored in a tightly sealed container protected from air and moisture, at a temperature maintaining room temperature between 1°C and 30°C. Proper temperature and container conditions must be maintained to ensure the drug's effectiveness.

Appearance

An opaque white to off-white oblong soft capsule containing a clear colorless to pale yellow liquid

Package unit

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