Enzalutamide Soft Gelatin Capsule 40 mg (Enzalutamide)

Adult dose

The recommended dose of this medicine is 160mg (4 capsules of 40mg) 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 a whole day, resume taking your daily dose the next day. Do not take more than the prescribed daily dose. In 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 receive concomitant androgen deprivation therapy. Patients with high-risk, biochemically recurrent, hormone-sensitive nonmetastatic 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 interrupt treatment after 36 weeks if prostate-specific antigen (PSA) reaches an undetectable level (less than 0.2 ng/mL). Treatment should be resumed if PSA rises 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 use with strong CYP2C8 inhibitors Concomitant use with strong CYP2C8 inhibitors should be avoided if possible. If concomitant use with a strong CYP2C8 inhibitor is necessary, reduce the daily dose of this medicine to 80mg. When concomitant use with 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 induce seizures, so if a seizure occurs during use, it should be discontinued immediately. Rarely, a neurological disorder called reversible posterior leukoencephalopathy syndrome may occur, and discontinuation is also advised in this case. If symptoms of hypersensitivity such as swelling of the face, tongue, lips, or throat occur, immediate medical attention should be sought. As the capsules are in a form that may be difficult to swallow, they should be taken whole with sufficient water. Those with hypersensitivity to this medication, pregnant women, and nursing mothers should avoid its use. Patients taking other medications, especially those that inhibit or induce certain enzymes, should consult a doctor or pharmacist. Fatigue, facial flushing, nausea, decreased appetite, hypertension, diarrhea, falls, fractures, and other side effects may occur, requiring caution. Patients with heart-related issues or those at risk of seizures need to be more vigilant. Patients with impaired kidney or liver function can take this medication without special dose adjustment, but in cases of severe impairment, a physician should be consulted. Caution is necessary when driving or operating machinery, particularly if there is cognitive decline or fatigue. This medication may be harmful to the fetus, so women of childbearing potential should not take it, and men should ensure effective contraception. Children and the elderly do not require special dose adjustments, but safety has not been adequately established. In cases of overdose, the risk of seizures increases, and immediate medical treatment is necessary. Store this medication out of reach of children, and do not dissolve or open the capsules.

Seizures, headache, confusion, blindness, 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, cognitive impairment, dysgeusia, restless legs syndrome, reversible posterior leukoencephalopathy syndrome, dry skin, itching, severe skin reactions, gynecomastia, nipple pain, breast tenderness, constipation, dizziness, peripheral neuropathy, paresthesia, somnolence, loss of taste, pericardial effusion, congestive heart failure, palpitations, dyspepsia, abdominal pain, abdominal discomfort, abnormal stool, epigastric pain, diarrhea, gastrointestinal pain, dry mouth, gum pain, insomnia, sleep disturbances, mood disorders, tinnitus, muscle weakness, lumbar spinal stenosis, lower back pain, arthralgia, limb pain, flank pain, cervical pain, muscle spasms, spinal compression fractures, hematuria, dysuria, decreased platelet count, generalized edema, fever, chest pain, warmth sensation, strange feeling, sweating, hives, nail discoloration, nail loss, alopecia, dermatitis, anemia, dyspnea, epistaxis, nasal obstruction, wet cough

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is recommended to maintain storage temperatures between 1 and 30 degrees Celsius.

Appearance

Opaque rectangular soft gelatin capsules that are white to off-white containing a colorless to yellowish transparent liquid

Package unit

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