Indication:
Aromasin® (exemestane) lowers estrogen levels in postmenopausal women, which may slow the growth of certain types of breast tumors that need estrogen to grow in the body.
Aromasin® is used to treat breast cancer in postmenopausal women. It is often given to women whose cancer has progressed even after surgery, radiation, or other cancer medications have been tried without success.
Aromasin® may also be used for purposes not listed in this medication guide.
Contraindications:
Aromasin® is contraindicated in patients with a known hypersensitivity to the drug or to any of the excipients.
Administration:
The recommended dose of Aromasin® in early and advanced breast cancer is one 25 mg tablet once daily after a meal.
- adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to Aromasin® for completion of a total of five consecutive years of adjuvant hormonal therapy.
- the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy.
Precautions:
In patients with early breast cancer, the incidence of hematological abnormalities of Common Toxicity Criteria (CTC) grade ≥1 was lower in the exemestane treatment group, compared with tamoxifen. Incidence of CTC grade 3 or 4 abnormalities was low (approximately 0.1%) in both treatment groups. Approximately 20% of patients receiving exemestane in clinical studies in advanced breast cancer experienced CTC grade 3 or 4 lymphocytopenia. Of these patients, 89% had a pre-existing lower grade lymphopenia. Forty percent of patients either recovered or improved to a lesser severity while on treatment. Patients did not have a significant increase in viral infections, and no opportunistic infections were observed. Elevations of serum levels of AST, ALT, alkaline phosphatase, and gamma glutamyl transferase >5 times the upper value of the normal range (i.e., ≥ CTC grade 3) have been rarely reported in patients treated for advanced breast cancer but appear mostly attributable to the underlying presence of liver and/or bone metastases. In the comparative study in advanced breast cancer patients, CTC grade 3 or 4 elevation of gamma glutamyl transferase without documented evidence of liver metastasis was reported in 2.7% of patients treated with Aromasin® and in 1.8% of patients treated with megestrol acetate.
In patients with early breast cancer, elevations in bilirubin, alkaline phosphatase, and creatinine were more common in those receiving exemestane than either tamoxifen or placebo. Treatment-emergent bilirubin elevations (any CTC grade) occurred in 5.3% of exemestane patients and 0.8% of tamoxifen patients on the Intergroup Exemestane Study (IES), and in 6.9% of exemestane treated patients vs. 0% of placebo treated patients in the 027 study. CTC grade 3–4 increases in bilirubin occurred in 0.9% of exemestane treated patients compared to 0.1% of tamoxifen treated patients. Alkaline phosphatase elevations of any CTC grade occurred in 15.0% of exemestane treated patients on the IES compared to 2.6% of tamoxifen treated patients, and in 13.7% of exemestane treated patients compared to 6.9% of placebo treated patients in study 027. Creatinine elevations occurred in 5.8% of exemestane treated patients and 4.3% of tamoxifen treated patients on the IES and in 5.5% of exemestane treated patients and 0% of placebo treated patients in study 027.
Side effects:
Get emergency medical help if you have any signs of an allergic reaction to Aromasin®: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- new or unusual bone pain;
- swelling in your hands or feet;
- feeling short of breath, even with mild exertion;
- chest pain, sudden numbness or weakness, sudden headache, confusion, problems with vision, speech or balance.
Common Aromasin® side effects may include:
- hot flashes;
- headache, tired feeling;
- joint pain;
- nausea, increased appetite;
- sleep problems (insomnia); or
- increased sweating.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
Overdosage:
In case, an overdose with Aromasin happened seek emergency help.