Registered Kenya · PPB

ABIRON

ABIRETERONE ACETATE

H2018/CTD5713/711ER 250MG GENERIC/BIOSIMILARS

What it does

Abiraterone is a medication used primarily to treat prostate cancer by lowering hormone levels that fuel cancer growth.

Commonly used for: prostate cancer, hormone-sensitive prostate cancer

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
H2018/CTD5713/711ER
Registration date
2019-02-21 00:00:00
Expiry date
-
Status
Registered
Active ingredient
ABIRETERONE ACETATE
Dosage form
250MG
Strength
-
Pack size
120'S
Therapeutic class
GENERIC/BIOSIMILARS
Manufacturer / MAH
Ripple Pharmaceuticals
Country of origin
FOREIGN
Manufacturer location
Swaminarayan Road/ Laxcon Court Mezzanine, Nairobi, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-01-28 20:11:29 · updated 2026-08-03 04:11:41

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About this medicine

Abiraterone is a medication used primarily to treat prostate cancer by lowering hormone levels that fuel cancer growth.

What it treats

  • prostate cancer
  • hormone-sensitive prostate cancer

How it works

It works by reducing the production of testosterone, a hormone that can help some prostate cancers grow.

Who it's for

This medicine is for men with prostate cancer, particularly those whose cancer has spread or returned after other treatments.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: abireterone

Abiraterone is an anti-androgen medication primarily used in the treatment of prostate cancer. It works by inhibiting the production of androgens, such as testosterone, which can stimulate the growth of prostate cancer cells. Abiraterone is typically used in combination with prednisone to enhance its efficacy and manage adrenal effects.

Indications

  • Metastatic castration-resistant prostate cancer
  • Metastatic hormone-sensitive prostate cancer

Dosage

Children: Safety and efficacy in paediatric populations have not been established; refer to specialist guidelines for any consideration.

Adults: Refer to specific prescribing guidelines for adult dosage as it may vary depending on the clinical context and concurrent medications.

Mechanism of action

Abiraterone selectively inhibits the enzyme CYP17A1, which is crucial in the biosynthesis of androgens. By blocking this enzyme, abiraterone reduces the levels of circulating testosterone and other androgens, leading to decreased stimulation of androgen receptors on prostate cancer cells and subsequently inhibiting tumor growth.

Pharmacodynamics

Abiraterone exhibits its pharmacodynamic effects by significantly lowering serum testosterone levels, which contributes to the suppression of androgen-mediated growth in prostate cancer. The use of abiraterone in combination with prednisone helps mitigate the side effects related to adrenal insufficiency that may result from androgen suppression.

Pharmacokinetics

Abiraterone is administered orally and is highly protein-bound, primarily to albumin and alpha-1 acid glycoprotein. It undergoes extensive hepatic metabolism, mainly via CYP2D6 and CYP3A4. The elimination half-life is approximately 12 hours, with the majority of the drug being excreted in the feces. Food can affect the absorption of abiraterone, so it is recommended to take it on an empty stomach.

Contra-indications

  • Hypersensitivity to abiraterone or any of its components
  • Severe hepatic impairment
  • Pregnancy

Adverse effects

  • Hypertension
  • Hypokalemia
  • Liver function abnormalities
  • Fatigue
  • Joint pain
  • Hot flashes
  • Nausea
  • Diarrhea

Interactions

  • CYP17 inhibitors may increase the risk of toxicity
  • CYP3A4 inducers may decrease the effectiveness of abiraterone
  • Corticosteroids may increase the risk of adverse effects

Precautions

  • Monitor blood pressure regularly during treatment
  • Assess liver function before and during treatment
  • Use caution in patients with a history of cardiovascular disease

Pregnancy

Abiraterone is contraindicated in pregnancy due to potential harm to the fetus.

Breast-feeding

It is unknown whether abiraterone is excreted in human milk; breastfeeding is not recommended during treatment.

Storage

Store at room temperature, away from moisture and heat.

Formulations

  • Tablets: 250 mg

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.