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Abiraterone Acetate

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What Is Abiraterone acetate ?

Abiraterone acetate tablets are a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC).

What are the uses of this medicine?

Abiraterone acetate is approved to be used with prednisone to treat: Prostate cancer that has metastasized (spread to other parts of the body).

It is used:

  • In patients whose disease is castration resistant (has not responded to treatments that lower testosterone levels). This use is approved for the Zytiga brand name of abiraterone acetate.
  • With methylprednisolone in patients whose disease is castration resistant. This use is approved for the Yonsa brand name of abiraterone acetate.
  • In patients whose disease is high-risk and castration sensitive (has responded to treatments that lower testosterone levels). This use is approved for the Zytiga brand name of abiraterone acetate.

How does this medicine work?

  • Abiraterone is in a class of medications called androgen biosynthesis inhibitors.
  • It works by decreasing the amount of certain hormones in the body.
  • Abiraterone acetate is converted in vivo to abiraterone, an androgen biosynthesis inhibitor, that inhibits 17 α-hydroxylase/C17,20-lyase (CYP17).
  • This enzyme is expressed in testicular, adrenal, and prostatic tumor tissues and is required for androgen biosynthesis.

Who Should Not Use this medicine ?

This medicine cannot be used in:

  • Do not use abiraterone acetate tablets in patients with baseline severe hepatic impairment.

Is this medicine FDA approved?

  • Abiraterone acetate was described in 1995, and approved for medical use in the United States and Europe in 2011.
  • It is on the World Health Organization's List of Essential Medicines, the safest and most effective medicines needed in a health system.
  • The medication is marketed widely throughout the world.

How should this medicine be used?

  • Abiraterone acetate tablets must be taken on an empty stomach, at least one hour before or at least two hours after a meal.
  • The tablets should be swallowed whole with water.
  • Do not crush or chew tablets.

Recommended Dose for Metastatic CRPC

  • The recommended dose of abiraterone acetate tablets is 1,000 mg (four 250 mg tablets) orally once daily with prednisone 5 mg orally twice daily.
  • Patients receiving abiraterone acetate tablets should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.
  • For patients with baseline moderate hepatic impairment , reduce the abiraterone acetate starting dose to 250 mg once daily.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

  • Abiraterone acetate is available as 250 mg tablets, USP are white to off-white, oval, biconvex uncoated tablets.

This medicine is available in fallowing brand names: Zytiga®

What side effects can this medication cause?

Common possible side effects of this medicine include:

Common laboratory abnormalities may inlude:

What special precautions should I follow?

  • Monitor blood pressure, serum potassium and symptoms of fluid retention at least monthly.
  • Monitor for symptoms and signs of adrenocortical insufficiency.
  • Monitor liver function and modify, interrupt, or discontinue abiraterone acetate dosing as recommended.
  • Use of abiraterone acetate plus prednisone/prednisolone in combination with radium Ra 223 dichloride is not recommended.
  • abiraterone acetate can cause fetal harm. Advise males with female partners of reproductive potential to use effective contraception.
  • Monitor blood glucose in patients with diabetes and assess if antidiabetic agent dose modifications are required.

What to do in case of emergency/overdose?

  • Human experience of overdose with abiraterone acetate is limited.
  • There is no specific antidote.
  • In the event of an overdose, stop abiraterone acetate, undertake general supportive measures, including monitoring for arrhythmias and cardiac failure and assess liver function.

Can this medicine be used in pregnancy?

  • The safety and efficacy of abiraterone acetate have not been established in females.
  • Based on its mechanism of action, abiraterone acetate may harm a developing fetus.
  • Women who are pregnant or women who may be pregnant should not handle abiraterone acetate 250 mg uncoated tablets or other abiraterone acetate tablets if broken, crushed, or damaged without protection, e.g., gloves .

Can this medicine be used in children?

  • Safety and effectiveness of abiraterone acetate in pediatric patients have not been established.

What should I know about storage and disposal of this medication?

  • Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) .
  • Keep out of reach of children.

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