Medication info
Anamide Soft Capsule 40mg (Enzalutamide)

Anamide Soft Capsule 40mg (Enzalutamide)

Prescription medicationSoft capsuleOral
Ingredient · strength
Enzalutamide›40mg / 1 capsule
Manufacturer / importer
Alvogen Korea Co., Ltd.
Appearance
A white to off-white opaque capsule containing a colorless to slightly yellow transparent liquid.
Packaging
112 capsules/box [4 capsules/PTP x 28]
Approval status
Active

MFDS item code 202500452 · Approved 2025.02.28

Summary

Main use
Treatment of castration-resistant prostate cancer and hormone-sensitive prostate cancer
Who takes it
Adults
Adult dose
The recommended dose of this medication is 160mg once daily (4 capsules of 40mg). This medication 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 medication at approximately the same time each day. If you forget to take this medication, take it as soon as you remember. If you miss a dose for a day, resume the daily dose of this medication the next day. Do not take more than the prescribed daily dose. For patients experiencing Grade 3 or higher toxicity or intolerable adverse reactions, discontinue this medication for 1 week or until symptoms improve to Grade 2 or lower; when 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 medication should also receive androgen deprivation therapy. Patients with high-risk, biochemically recurrent, hormone-sensitive nonmetastatic prostate cancer may be treated with this medication together with androgen deprivation therapy or with this medication alone. Patients treated with this medication alone or in combination with androgen deprivation therapy may temporarily discontinue treatment after 36 weeks of therapy if prostate-specific antigen (PSA) reaches an undetectable level (less than 0.2 ng/mL). Treatment should be resumed 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 received radical radiotherapy. Concomitant administration with a strong CYP2C8 inhibitor Concomitant administration with a strong CYP2C8 inhibitor should be avoided if possible. If concomitant administration with a strong CYP2C8 inhibitor is necessary, reduce the daily dose of this medication to 80mg. When concomitant use with a strong CYP2C8 inhibitor is discontinued, return the dose of this medication to the dose used before the strong CYP2C8 inhibitor was administered.

Ingredients

Importer
Alvogen Korea Co., Ltd.

Efficacy & effects

Treatment of castration-resistant prostate cancer and hormone-sensitive prostate cancer

  • Metastatic castration-resistant prostate cancer
  • metastatic castration-resistant prostate cancer after docetaxel treatment
  • high-risk non-metastatic castration-resistant prostate cancer
  • hormone-sensitive metastatic prostate cancer
  • high-risk hormone-sensitive non-metastatic prostate cancer with biochemical recurrence.
View approved original text

This medication is used in various conditions for patients with metastatic castration-resistant prostate cancer. It is effective for treating asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer and is also applicable to patients previously treated with docetaxel. Additionally, it is used in the treatment of high-risk non-metastatic castration-resistant prostate cancer, and in hormone-sensitive metastatic prostate cancer, it is treated in combination with androgen blockade therapy. It is also utilized for the treatment of high-risk hormone-sensitive non-metastatic prostate cancer patients with biochemical recurrence. Hence, it is widely used in the treatment of various stages of prostate cancer.

How to take

Adult dose

The recommended dose of this medication is 160mg once daily (4 capsules of 40mg). This medication 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 medication at approximately the same time each day. If you forget to take this medication, take it as soon as you remember. If you miss a dose for a day, resume the daily dose of this medication the next day. Do not take more than the prescribed daily dose. For patients experiencing Grade 3 or higher toxicity or intolerable adverse reactions, discontinue this medication for 1 week or until symptoms improve to Grade 2 or lower; when 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 medication should also receive androgen deprivation therapy. Patients with high-risk, biochemically recurrent, hormone-sensitive nonmetastatic prostate cancer may be treated with this medication together with androgen deprivation therapy or with this medication alone. Patients treated with this medication alone or in combination with androgen deprivation therapy may temporarily discontinue treatment after 36 weeks of therapy if prostate-specific antigen (PSA) reaches an undetectable level (less than 0.2 ng/mL). Treatment should be resumed 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 received radical radiotherapy. Concomitant administration with a strong CYP2C8 inhibitor Concomitant administration with a strong CYP2C8 inhibitor should be avoided if possible. If concomitant administration with a strong CYP2C8 inhibitor is necessary, reduce the daily dose of this medication to 80mg. When concomitant use with a strong CYP2C8 inhibitor is discontinued, return the dose of this medication to the dose used before the strong CYP2C8 inhibitor was administered.

Precautions

This medication may cause seizures, so if seizures occur during treatment, it should be discontinued immediately. Rarely, reversible posterior leukoencephalopathy syndrome affecting the brain may occur, so if symptoms such as headache or visual disturbances appear, prompt medical attention should be sought. Allergic reactions that cause swelling of the face, tongue, lips, and throat may occur, so if these symptoms appear, stop taking the medication and visit a clinic immediately. The capsule size may be large, making it difficult to swallow; therefore, it is important to swallow the capsule whole with plenty of water. This medication should not be used by women who are pregnant or nursing, or by those with allergies to this drug or its excipients. Caution is needed when taking other drugs that may interact, particularly those that inhibit or activate specific enzymes. Common side effects include fatigue, facial flushing, nausea, decreased appetite, hypertension, diarrhea, falls, and fractures. Caution should be taken when driving or operating machinery due to side effects like seizures or cognitive impairment. Dosage adjustments may not be required for minor renal or hepatic impairment, but consultation with a healthcare professional is advised for severe impairment. This medication can be harmful to a fetus, so women who are pregnant or may become pregnant should not take it. Nursing women should also refrain from this medication, and male patients should use effective contraception during and for a period after treatment. Safety in pediatric patients has not been established, while elderly patients can use it without special dosage adjustments. In cases of overdose, treatment should be stopped immediately and professional care sought, as there is an increased risk of seizures.

Side effects

Seizures, headache, confusion, blindness, visual and neurological disorders, facial edema, tongue edema, lip edema, pharyngeal edema, rash, dysphagia, 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, dry skin, itching, severe skin reactions, gynecomastia, nipple pain, breast tenderness, constipation, dizziness, peripheral neuropathy, sensory disturbances, somnolence, taste loss, pericardial effusion, congestive heart failure, palpitations, dyspepsia, abdominal pain, abdominal discomfort, abnormal stools, upper abdominal pain, abdominal cramps, gastrointestinal pain, dry mouth, gum pain, insomnia, sleep disorders, mood disorders, tinnitus, muscle weakness, lumbar spinal stenosis, lower back pain, arthralgia, muscle spasms, limb pain, flank pain, cervical pain, decreased platelet count, anemia, dyspnea, epistaxis, nasal obstruction, wet cough, sweating, urticaria, nail discoloration, nail loss, alopecia, dermatitis, hematuria, dysuria, peripheral edema, fever, chest pain, death, feeling of warmth, strange sensations

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is recommended to store it at room temperature, between 1 and 30 degrees Celsius. This helps to maintain the efficacy of the medication over time.

Appearance and packaging

Appearance

A white to off-white opaque capsule containing a colorless to slightly yellow transparent liquid.

Package unit

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

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Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.