Abiraterone Acetate Tablets — Medical Description

Therapeutic Category: Antineoplastic Agent | Androgen Biosynthesis Inhibitor

Active Ingredient: Abiraterone acetate

Dosage Form: Oral tablets

Medical Description

Abiraterone acetate is an oral anticancer medication used in the treatment of specific types of advanced prostate cancer. It belongs to a class of medicines known as androgen biosynthesis inhibitors, which work by reducing the production of androgens, including testosterone, that can stimulate prostate cancer cell growth.

Abiraterone acetate inhibits the CYP17 enzyme (17α-hydroxylase/C17,20-lyase), which plays a key role in androgen production in the testes, adrenal glands, and prostate tumor tissue. By suppressing androgen synthesis, it helps slow the growth and progression of hormone-sensitive prostate cancer cells.

It is used in combination with a corticosteroid, usually prednisone, for indicated forms of metastatic prostate cancer. Treatment is prescribed and monitored by an oncology specialist.

Indications and Potential Benefits

Abiraterone acetate, in combination with the appropriate corticosteroid, is indicated for the treatment of:

• Metastatic castration-resistant prostate cancer (mCRPC): Prostate cancer that has spread to other parts of the body and progresses despite testosterone-lowering treatment.
• Metastatic high-risk castration-sensitive prostate cancer (mCSPC): High-risk prostate cancer that has spread beyond the prostate and remains responsive to androgen-deprivation therapy.

Potential clinical benefits include:

• Suppression of androgen production that supports prostate cancer growth.
• Delayed disease progression in appropriately selected patients.
• Improved disease control when used as part of an appropriate oncology treatment regimen.

The specific indication depends on the patient's disease status, treatment history, and the applicable product labeling.

Mechanism of Action

Abiraterone acetate is converted in the body to abiraterone, which selectively inhibits the CYP17A1 enzyme. This enzyme is essential for androgen biosynthesis.

By inhibiting CYP17A1, abiraterone reduces androgen production from several sources, including the adrenal glands and prostate tumor tissue. This decreases the hormonal stimulation that supports prostate cancer cell survival and proliferation.

CYP17 inhibition can also increase mineralocorticoid levels, potentially causing hypertension, fluid retention, and hypokalemia. This is why corticosteroid co-treatment and regular clinical monitoring are important.

Dosage and Administration

• Usual adult dose: 1,000 mg orally once daily, according to the prescribed regimen.
• Administration: Take on an empty stomach with water. Do not eat for at least 2 hours before or 1 hour after taking the tablets.
• Swallow tablets whole. Do not crush, chew, or split them.
• Combination therapy: Take the prescribed corticosteroid, generally prednisone, according to the specific cancer indication and physician's instructions.
• Patients generally continue androgen-deprivation therapy with a gonadotropin-releasing hormone (GnRH) analogue unless they have undergone bilateral orchiectomy.

The dose and corticosteroid regimen may differ according to the indication, formulation, liver function, and local product information. Never adjust or discontinue treatment without the treating oncologist's advice.

Possible Side Effects

Common or clinically important adverse effects may include:

• Fatigue and weakness.
• Joint pain and muscle discomfort.
• Hot flushes.
• Nausea, vomiting, or diarrhea.
• Hypertension.
• Peripheral edema and fluid retention.
• Hypokalemia (low blood potassium).
• Increased liver enzyme levels.

Serious risks requiring medical attention:

• Liver injury or severe hepatic toxicity.
• Heart-related complications, including arrhythmias or worsening heart failure.
• Adrenal insufficiency, particularly during infection, surgery, or interruption of corticosteroid treatment.
• Severe hypertension, marked fluid retention, or significant electrolyte disturbances.

Seek urgent medical attention for yellowing of the skin or eyes, severe abdominal pain, fainting, chest pain, breathing difficulties, or a rapid or irregular heartbeat.

Warnings and Precautions

• Liver function: Liver enzymes and bilirubin should be checked before treatment and monitored regularly during therapy.
• Blood pressure and electrolytes: Monitor blood pressure, serum potassium, and signs of fluid retention.
• Cardiovascular disease: Use caution in patients with heart failure, recent myocardial infarction, cardiovascular disease, or arrhythmias.
• Diabetes: Blood glucose monitoring may be necessary, particularly in patients receiving certain concomitant medicines.
• Drug interactions: Inform the healthcare professional about all prescription medicines, over-the-counter products, and herbal supplements.
• Pregnancy exposure: Abiraterone may harm a developing fetus. Women who are pregnant or may become pregnant should not handle broken, crushed, or damaged tablets without appropriate protective measures.
• Corticosteroid therapy: Do not stop prednisone or another prescribed corticosteroid abruptly without medical guidance.

Abiraterone acetate is not intended for use in women or children.

Storage

• Store according to the manufacturer's package instructions.
• Keep in the original packaging when required to protect the medicine from moisture.
• Keep out of the reach and sight of children.
• Do not use after the expiry date printed on the package.

References

The following trusted, non-commercial or official medical sources support this description:

1. National Cancer Institute (NCI) — Abiraterone Acetate: indications and cancer treatment information. Read NCI drug information.
2. U.S. National Library of Medicine — MedlinePlus — Abiraterone: administration, precautions, and patient information. Read MedlinePlus drug information.
3. DailyMed, U.S. National Library of Medicine — Official prescribing information for abiraterone acetate tablets, including indications, dosage, contraindications, and warnings. Read prescribing information.

Patient Disclaimer

This information is intended for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Abiraterone acetate is a prescription anticancer medicine that must be used under the supervision of a qualified oncologist. Treatment decisions, dosage adjustments, and monitoring should be individualized according to the patient's condition and the approved product information. Always consult your healthcare professional before starting, changing, or stopping any medication.