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Abiraterone Acetate: Brands, Price & Uses in Bangladesh
Abiraterone Acetate is a CYP17 (androgen biosynthesis) inhibitor used, in combination with corticosteroid therapy, for the treatment of prostate cancer in adult men.
About Abiraterone Acetate
Indications of Abiraterone Acetate
Abiraterone Acetate is a CYP17 (androgen biosynthesis) inhibitor used, in combination with corticosteroid therapy, for the treatment of prostate cancer in adult men. It is always used together with ongoing medical or surgical castration (androgen deprivation therapy).
FDA-approved / Established Indications
- Metastatic castration-resistant prostate cancer (mCRPC): Abiraterone Acetate in combination with prednisone (or prednisolone) is indicated for men with mCRPC, including those previously treated with chemotherapy and those who are chemotherapy-naive.
- Metastatic high-risk castration-sensitive prostate cancer (mCSPC): Abiraterone Acetate in combination with prednisone is indicated for men with newly diagnosed, high-risk metastatic castration-sensitive prostate cancer, given together with a GnRH analog (or after bilateral orchiectomy).
Abiraterone Acetate is not indicated for use in women and has no role in the treatment of any condition outside prostate cancer.
Dosage & Administration of Abiraterone Acetate
General Instructions
Abiraterone Acetate tablets must be taken on an empty stomach — at least one hour before or at least two hours after a meal — because food substantially increases absorption and can result in excessive drug exposure. Tablets should be swallowed whole with water and must not be crushed or chewed.
Dosing by Indication
| Indication | Dose of Abiraterone Acetate | Co-administered Corticosteroid | Additional Therapy |
|---|---|---|---|
| Metastatic castration-resistant prostate cancer (mCRPC) | 1,000 mg (e.g., four 250 mg tablets) orally once daily | Prednisone/prednisolone 5 mg twice daily | Continue GnRH analog or prior bilateral orchiectomy |
| Metastatic high-risk castration-sensitive prostate cancer (mCSPC) | 1,000 mg orally once daily | Prednisone/prednisolone 5 mg once daily | Continue GnRH analog or prior bilateral orchiectomy |
Missed Dose
If a dose (or the daily corticosteroid dose) is missed, treatment should resume the next day at the usual dose; patients should not double the dose. Any missed dose should be discussed with the treating physician.
See Use in Special Populations for hepatic-impairment dose adjustments, and Precautions and Warnings for monitoring requirements during treatment.
Side Effects of Abiraterone Acetate
Common side effects of Abiraterone Acetate (occurring in more than 10% of patients) include:
- Fatigue
- Joint swelling or discomfort (arthralgia)
- Edema (fluid retention/swelling of the legs)
- Hot flushes
- Hypertension (high blood pressure)
- Diarrhea and nausea/vomiting
- Urinary tract infection
- Cough and upper respiratory infection
- Headache
Serious Side Effects
- Mineralocorticoid excess: hypertension, hypokalemia (low potassium), and fluid retention, related to the drug's mechanism of action.
- Adrenocortical insufficiency: especially during illness, physical stress, or abrupt discontinuation of the co-administered corticosteroid; symptoms include weakness, dizziness, and low blood pressure.
- Hepatotoxicity: elevations in liver enzymes and bilirubin; rare cases of severe liver injury have been reported.
- Laboratory abnormalities: anemia, elevated alkaline phosphatase, high triglycerides, low lymphocyte count, and high blood sugar.
Patients should promptly report symptoms of these serious effects to their physician; see Precautions and Warnings for monitoring guidance.
Contraindications of Abiraterone Acetate
Abiraterone Acetate is contraindicated in:
- Patients with known hypersensitivity to abiraterone acetate or any component of the formulation.
- Women, particularly those who are pregnant or may become pregnant — Abiraterone Acetate is not indicated for use in females and can cause fetal harm.
- Patients with severe hepatic impairment (Child-Pugh Class C), in whom the drug has not been shown to be safe and should not be used.
Frequently Asked Questions about Abiraterone Acetate
What is Abiraterone Acetate used for?
Abiraterone Acetate is used, together with a corticosteroid (prednisone or prednisolone) and ongoing androgen deprivation therapy, to treat metastatic castration-resistant prostate cancer and metastatic high-risk castration-sensitive prostate cancer in adult men.
Why must Abiraterone Acetate be taken on an empty stomach?
Food significantly increases the absorption of Abiraterone Acetate, which can lead to excessive drug levels in the blood and a higher risk of side effects. It should always be taken at least 1 hour before or 2 hours after eating.
Can Abiraterone Acetate be taken alone, without a corticosteroid?
No. Abiraterone Acetate must be taken together with a corticosteroid such as prednisone/prednisolone, because it increases mineralocorticoid activity that can cause high blood pressure, low potassium, and fluid retention; the corticosteroid helps prevent these effects. The corticosteroid dose should never be stopped abruptly without a doctor's advice, as this can cause adrenal insufficiency.
Can women take Abiraterone Acetate?
No. Abiraterone Acetate is not indicated for use in women and can cause fetal harm if a woman is pregnant. Women who are or may become pregnant should avoid handling the tablets, especially if broken or crushed, without gloves.
What monitoring is needed while taking Abiraterone Acetate?
Regular monitoring of blood pressure, serum potassium, fluid status, and liver function tests (before starting, every two weeks for the first three months, then monthly) is required throughout treatment with Abiraterone Acetate, because of the risks of mineralocorticoid excess, adrenal insufficiency, and liver toxicity.
What should I do if I miss a dose of Abiraterone Acetate?
If a dose of Abiraterone Acetate or the corticosteroid is missed, resume the normal dosing schedule the next day; do not take a double dose. Contact your physician if you miss multiple doses or are unsure what to do.
Disclaimer
The information provided is accurate to the best of our knowledge, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy, and the absence of specific information about a drug should not be taken as an endorsement. We are not responsible for any consequences arising from this information, so please consult a healthcare professional for any concerns or questions.