Registered Tanzania · TMDA

BIRATO 250

Aberaterone Acetate 250 mg

TZ 20 H 0210 Tablets 250

What it does

Aberaterone is a medication used to treat prostate cancer by reducing hormone levels that fuel cancer growth.

Commonly used for: prostate cancer, advanced 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.
TZ 20 H 0210
Registration date
2025-05-14
Expiry date
2030-05-13
Status
Registered/Compliant
Active ingredient
Aberaterone Acetate 250 mg
Dosage form
Tablets
Strength
250
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Msn Laboratories
Country of origin
INDIA
Manufacturer location
MSN Corporate, H. No. 2-91/10 & 11 /MSN, Kondapur, Laxmi Cyber City, Whitefields, Gachibowli, Hyderabad, Telangana 500084, India

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:48:40 · updated 2026-09-24 03:00:47

Disclaimer: This information is sourced from Tanzania Medicines and Medical Devices Authority (Tanzania). Always consult a qualified healthcare professional before using any medication.

About this medicine

Aberaterone is a medication used to treat prostate cancer by reducing hormone levels that fuel cancer growth.

What it treats

  • prostate cancer
  • advanced prostate cancer

How it works

It works by blocking the production of androgens, which are hormones that can promote the growth of prostate cancer cells.

Who it's for

This medication is for men who have prostate cancer that has spread or is not responding to other treatments.

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

Clinical monograph: aberaterone

Abiraterone is an oral medication primarily used in the treatment of prostate cancer. It inhibits the production of androgens, including testosterone, which can fuel the growth of prostate cancer cells. Abiraterone is typically used in conjunction with prednisone to manage hormone-sensitive and castration-resistant metastatic prostate cancer.

Indications

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

Dosage

Children: Not indicated for paediatric use.

Adults: Refer to specific prescribing guidelines as doses may vary based on clinical circumstances.

Mechanism of action

Abiraterone acts as a selective irreversible inhibitor of the enzyme CYP17A1, which is crucial for the biosynthesis of androgens. By inhibiting this enzyme, abiraterone effectively decreases the levels of testosterone and other androgens in the body, thereby reducing tumor growth and proliferation driven by these hormones.

Pharmacodynamics

The pharmacodynamic effects of abiraterone include a significant reduction in serum testosterone levels, which is directly correlated with clinical responses in patients with prostate cancer. The lowering of androgen levels helps to slow disease progression and can lead to improvements in symptoms associated with advanced prostate cancer.

Pharmacokinetics

Abiraterone is absorbed well after oral administration, with peak plasma concentrations occurring approximately 2 hours post-dose. It is extensively metabolized in the liver, primarily by CYP3A4, and has a half-life of about 12 hours. The drug is eliminated predominantly through feces, with only a small fraction excreted in urine. Food intake can significantly affect its absorption, thus it is recommended to be taken on an empty stomach.

Contra-indications

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

Adverse effects

  • Hypertension
  • Hypokalemia
  • Fluid retention
  • Liver function abnormalities
  • Fatigue
  • Hot flushes
  • Joint pain
  • Nausea
  • Diarrhea

Interactions

  • CYP2D6 substrates
  • CYP3A4 inhibitors and inducers
  • Anticoagulants (increased risk of bleeding)
  • Corticosteroids (may require adjustment in dosage)

Precautions

  • Monitor blood pressure regularly
  • Periodic liver function tests are recommended
  • Use with caution in patients with cardiovascular disease
  • Caution in patients with a history of adrenal insufficiency

Pregnancy

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

Breast-feeding

It is not known if abiraterone is excreted in human milk. A decision should be made to discontinue breastfeeding or to discontinue the drug.

Storage

Store in a cool, dry place away from light. Keep out of reach of children.

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.