Medication info
Abiraterone Tablet 500mg (Abiraterone Acetate (Unrefined))

Abiraterone Tablet 500mg (Abiraterone Acetate (Unrefined))

Prescription medicationTablet경구
Ingredient · strength
Abiraterone Acetate Micronized›500mg / 1 tablet
Manufacturer / importer
한미약품(주)
Appearance
Pink oval film-coated tablet
Packaging
56 tablets/box [14 tablets/PTPX4]
Approval status
Active

MFDS item code 202301839 · Approved 2023.06.14 · Insurance code 643508710

Summary

Main use
Treatment and improvement of prostate cancer (metastatic, hormone-sensitive)
Who takes it
Adults
Adult dose
The recommended dosage for this medication is 1,000mg (2 tablets of 500mg) once daily and it must be taken on an empty stomach. It should be taken at least 2 hours after a meal and no food should be consumed for at least 1 hour after taking it. The tablet should be swallowed whole with water. In cases of liver impairment, the dose is reduced to 500mg (1 tablet) once daily, and it should not be taken with food. Monitoring is required for re-treatment.

Ingredients

Manufacturer
한미약품(주)

Efficacy & effects

Treatment and improvement of prostate cancer (metastatic, hormone-sensitive)

  • Metastatic castration-resistant prostate cancer
  • metastatic castration-resistant prostate cancer after chemotherapy
  • high-risk metastatic hormone-sensitive prostate cancer
View approved original text

This medication is used for the treatment of patients with asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer. It is also effective for the treatment of metastatic castration-resistant prostate cancer patients who have previously received docetaxel chemotherapy. Additionally, it is utilized in the treatment of newly diagnosed, high-risk metastatic hormone-sensitive prostate cancer in combination with androgen blockade therapy. It is important to use this medication together with prednisone. It helps effectively treat prostate cancer through various stages and combinations.

How to take

Adult dose

The recommended dosage for this medication is 1,000mg (2 tablets of 500mg) once daily and it must be taken on an empty stomach. It should be taken at least 2 hours after a meal and no food should be consumed for at least 1 hour after taking it. The tablet should be swallowed whole with water. In cases of liver impairment, the dose is reduced to 500mg (1 tablet) once daily, and it should not be taken with food. Monitoring is required for re-treatment.

Precautions

This medication should not be used in women who are pregnant or may become pregnant. Individuals who have an allergic reaction to this medication should also not take it. It should not be administered to patients receiving radium-223 chloride in combination. Patients with mineralocorticoid excess symptoms such as hypertension, hypokalemia, and fluid retention should be cautious when taking this medication. Blood pressure, serum potassium, and fluid status should be monitored regularly, especially in patients with heart disease. Patients with impaired liver function should frequently undergo liver function tests before and during treatment with this medication, and the use of this medication must be stopped immediately if liver function worsens severely. This medication should not be used in patients with severe liver impairment. Adverse effects of this medication may include hypertension, hypokalemia, fluid retention, edema, urinary tract infection, fatigue, joint swelling/discomfort, constipation, diarrhea, dyspepsia, facial flushing, cough, insomnia, bruising, falls, upper respiratory infection, rhinitis, hematuria, rash, back pain, limb pain, bone pain, flank pain, spinal osteoarthritis, joint swelling, spinal foramen stenosis, weakness, facial swelling, pain, chest pain, chest discomfort, mucosal inflammation, dizziness, headache, and sensory disturbances. Patients with cardiovascular disease or decreased heart function should exercise particular caution when using this medication. This medication should be taken on an empty stomach, as taking it with food may increase absorption and safety and efficacy have not been established. It may interact with other medications, especially those metabolized by the liver; consultation with a doctor or pharmacist is advised when taking other drugs. The safety of this medication has not been established in pregnant or nursing women, and men who are sexually active with women of childbearing age should take precautions to prevent pregnancy, such as using condoms. This medication is not intended for use in children. In the case of overdose, medication should be stopped immediately, and cardiac status and liver function should be monitored in a hospital setting. Store this medication out of reach of children and in its original container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, vision abnormalities, paralysis, significant decrease in urine output.

Mild side effects

  • Hypokalemia
  • hypertension
  • peripheral edema
  • urinary tract infection
  • fatigue
  • joint swelling/discomfort
  • constipation
  • diarrhea
  • dyspepsia
  • facial flushing
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  • cough
  • insomnia
  • bruising
  • falls
  • upper respiratory infection
  • rhinitis
  • hematuria
  • rash
  • back pain
  • limb pain
  • bone pain
  • flank pain
  • spinal osteoarthritis
  • joint swelling
  • spinal foramen stenosis
  • weakness
  • facial swelling
  • pain
  • chest pain
  • chest discomfort
  • mucosal inflammation
  • dizziness
  • headache
  • sensory disturbances.

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

Storage

This medication should be stored in a tightly sealed container, protected from air and light, and it is safe to store at a temperature between 1 to 30 degrees Celsius. Storing this way will help maintain the medication's effectiveness and prevent degradation.

Appearance and packaging

Appearance

Pink oval film-coated tablet

Package unit

56 tablets/box [14 tablets/PTPX4]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

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.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.