Consumer medicine information

1. Why am I using EXEMESTANE-WGR?

EXEMESTANE-WGR contains the active ingredient exemestane. EXEMESTANE-WGR is used to treat breast cancer in women who no longer have their menstrual periods, either naturally due to their age (after menopause) or because they have had their ovaries surgically removed.
EXEMESTANE-WGR is also used to reduce the risk of recurrence or spreading of the breast cancer. It is also used when the cancer has not responded or has returned after treatment with another medicine or medicines.
For more information, see Section 1. Why am I using EXEMESTANE-WGR? in the full CMI.

2. What should I know before I use EXEMESTANE-WGR?

Do not use if you have ever had an allergic reaction to exemestane 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 use EXEMESTANE-WGR? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with EXEMESTANE-WGR 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 use EXEMESTANE-WGR?

• The recommended dose is one 25 mg tablet taken once daily after meals, however, follow all directions given to you by your doctor or pharmacist carefully as they may differ from the information contained in this leaflet.

• Your doctor or pharmacist will tell you how long to take EXEMESTANE-WGR.

5. What should I know while using EXEMESTANE-WGR?

6. Are there any side effects?

More common side effects may include headache, nausea, constipation or diarrhoea, tiredness or difficulty sleeping. More serious side effects include swelling in legs or feet, abnormal bleeding, skin changes or infections.
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.

Notes

Distributed by Wagner Pharmaceuticals Pty Ltd

1 Name of Medicine

Exemestane.

2 Qualitative and Quantitative Composition

Each tablet contains 25 mg exemestane, as the active ingredient.
For the full list of excipients see Section 6.1 List of Excipients.

3 Pharmaceutical Form

White to off-white, circular, biconvex tablets coated with sugar.

4 Clinical Particulars

4.9 Overdose

Clinical trials have been conducted with exemestane given up to 800 mg in a single dose to healthy female volunteers and up to 600 mg daily to postmenopausal women with advanced breast cancer. These dosages were well tolerated. The single dose of exemestane that could result in life threatening symptoms is not known.
There is no specific antidote to overdosage and treatment should be symptomatic. General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated. Consider administration of activated charcoal in the event of a potentially toxic ingestion. Activated charcoal is most effective when administered within one hour of ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via nasogastric tube once the airway is protected. Haemodialysis is not expected to significantly enhance the clearance of exemestane due to extensive protein binding.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Exemestane was not mutagenic in bacteria (Ames test), in V79 Chinese hamster cells nor did it cause DNA damage in rat hepatocytes. Although exemestane was clastogenic in lymphocytes in vitro, it was not clastogenic in two in vivo studies.
Carcinogenicity. A two year carcinogenicity study in mice at doses of exemestane 50, 150 and 450 mg/kg/day (gavage) resulted in an increased incidence of hepatocellular adenomas and/or carcinomas at doses > 50 mg/kg/day in males and > 150 mg/kg/day in females. Exposures (plasma AUC) at these doses were 4 and 37 times, respectively, exposure in patients at the recommended dose. However, statistical significance was only reached at the high dose exposures (approximately 34 (male) and 75 (female) fold the AUC in patients). An increased incidence of renal tubular adenomas was observed in male mice at the high dose of 450 mg/kg/day.
A carcinogenicity study was conducted in rats at doses of 30, 100 and 315 mg/kg/day (gavage) for 92 weeks in males and two years in females. No evidence of carcinogenic activity up to the highest dose tested (315 mg/kg/day) was observed. At the highest dose, plasma AUC_{0 to 24 hour} levels in male and female rats were 19 and 31-fold higher than those measured in the postmenopausal cancer patients receiving the recommended clinical dose.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Exemestane is a white or yellowish white powder, which is freely soluble in N,N-dimethylformamide, soluble in methanol and practically insoluble in water. Due to the very low solubility in water, the drug is micronised.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSEXEMES.gif Chemical name: 6-methylenandrosta-1,4-diene-3,17-dione.
Molecular formula: C₂₀H₂₄O₂.
Molecular weight: 296.4.
CAS number. 107868-30-4.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

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