Consumer medicine information

1. Why am I taking Abiraterone Sandoz?

Abiraterone Sandoz contains the active ingredient abiraterone acetate. Abiraterone Sandoz is used to treat prostate cancer that has spread to other parts of the body.
For more information, see Section 1. Why am I taking Abiraterone Sandoz? in the full CMI.

2. What should I know before I take Abiraterone Sandoz?

Do not use if you have ever had an allergic reaction to Abiraterone Sandoz or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I take Abiraterone Sandoz? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Abiraterone Sandoz and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take Abiraterone Sandoz?

• The usual daily dose is four 250 mg tablets, two 500 mg tablets or one 1000 mg tablet taken as a single dose.

• Abiraterone Sandoz must be taken on an empty stomach, at least one hour before or at least two hours after food.

• Swallow the tablet whole with a glass of water and take at about the same time each day.

5. What should I know while taking Abiraterone Sandoz?

6. Are there any side effects?

Common side effects: diarrhoea, fluid in legs and feet, low blood potassium, urinary tract infection, high blood pressure and bone fractures. Serious side effects: blood in urine, chest pain, heart beat disorders, heart failure, rapid heart rate, muscle pains and adrenal gland problems.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Abiraterone acetate.

2 Qualitative and Quantitative Composition

Abiraterone Sandoz tablets contain either 250 mg, 500 mg or 1000 mg of the active ingredient abiraterone acetate.
Excipient(s) with known effect. Lactose monohydrate.
For a full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Abiraterone Sandoz 250 mg are white to off-white, oval-shaped film-coated tablets, debossed with "250" on one side.
Abiraterone Sandoz 500 mg are purple, oval-shaped, film-coated tablets, debossed with "500" on one side.
Abiraterone Sandoz 1000 mg are white to off-white, oval-shaped film-coated tablets, with a break line on one side and plain on the other side.

4 Clinical Particulars

4.9 Overdose

There have been no reports of overdose of abiraterone during clinical studies.
There is no specific antidote. In the event of an overdose, administration of abiraterone should be stopped and general supportive measures undertaken, including monitoring for arrhythmias. Liver function also should be assessed.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Abiraterone acetate and abiraterone were devoid of genotoxic potential in the standard panel of genotoxicity tests including, an in vitro bacterial reverse mutation assay (the Ames test), an in vitro mammalian chromosome aberration test (using human lymphocytes) and an in vivo rat micronucleus assay. Genotoxicity studies have not been conducted with the main human metabolites of abiraterone.
Carcinogenicity. Carcinogenicity studies were not conducted with abiraterone acetate.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSABIACE.gif Chemical name: 3β-Acetoxy-17-(3-pyridyl)-androsta-5,16-diene.
Molecular formula: C₂₆H₃₃NO₂.
Molecular weight: 391.55.
CAS number. 154229-18-2.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/ABISANST.gif