Exemestane

What is Exemestane?

• Exemestane (Aromasin) is an aromatase inhibitor used as therapy of estrogen receptor positive breast cancer, usually after resection and after failure of tamoxifen.

Exemestane

Exemestane2DACS

What are the uses of this medicine?

Exemestane (Aromasin) is used in women who are postmenopause for the treatment of: Early breast cancer (cancer that has not spread outside the breast) in women who:

• have cancer that needs the female hormone estrogen to grow, and
• have had other treatments for breast cancer, and
• have taken tamoxifen for 2 to 3 years, and
• are switching to Aromasin to complete 5 years in a row of hormonal therapy.

• Advanced breast cancer (cancer that has spread) after treatment with tamoxifen, and it did not work or is no longer working.

How does this medicine work?

• Exemestane (ex" e mes' tane) is an aromatase inhibitor that acts as an antiestrogen and is used to treat postmenopausal women with estrogen receptor positive breast cancer.
• Aromatase is the enzyme responsible for the conversion of testosterone to estrone (E1) and of androstenedione to estradiol (E2).
• Highest levels of aromatase are found in the ovary and placenta, which are the major sources of estrogen in premenopausal women.
• However, aromatase is also found in other tissues, such as liver, kidney, adrenals, brain, muscle and subcutaneous fat where it is also active in producing estrogens, although at low levels. T
• hese tissues are the major source of estrogen in postmenopausal women.
• Inhibitors of aromatase were developed to block the synthesis of estrogen in the peripheral tissues and, thus, as antiestrogen therapy of estrogen receptor positive breast cancer in postmenopausal women.
• Exemestane is a steroidal, specific aromatase inhibitor which has little or no effect on adrenal glucocorticoid or mineralocorticoid synthesis.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to Aromasin or any of the ingredients in Aromasin.

What drug interactions can this medicine cause?

• Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
• Especially tell your doctor if you take medicines that contain estrogen, including other hormone replacement therapy or birth control pills or patches.
• Aromasin should not be taken with medicines that contain estrogen as they could affect how well Aromasin works.

Is this medicine FDA approved?

• Exemestane was approved for use in postmenopausal women with estrogen receptor positive breast cancer in the United States in 1999.

How should this medicine be used?

Recommended dosage:

• The recommended dose of Aromasin in early and advanced breast cancer is one 25 mg tablet once daily after a meal.
• Concomitant use of strong CYP 3A4 inducers decreases exemestane exposure, For patients receiving Aromasin with a strong CYP 3A4 inducer such as rifampicin or phenytoin, the recommended dose of Aromasin is 50 mg once daily after a meal.

Administration:

• Take Aromasin exactly as your doctor tells you.
• Take Aromasin 1 time each day after a meal.
• If you take too much Aromasin, call your doctor right away or go to nearest hospital emergency room.

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

This medicine is available in fallowing doasage form:

• As Tablets: 25 mg

This medicine is available in fallowing brand namesː

• Aromasin

What side effects can this medication cause?

The most common side effects of Aromasin in women with early breast cancer include:

• hot flashes
• headache
• feeling tired
• trouble sleeping
• joint pain
• increased sweating

The most common side effects of Aromasin in women with advanced breast cancer include:

• hot flashes
• increased sweating
• nausea
• increased appetite
• feeling tired

Aromasin may cause serious side effects, including:

• Bone loss

What special precautions should I follow?

• Reductions in bone mineral density (BMD) over time are seen with exemestane use. Monitor patients for bone mineral density loss and treat as appropriate.
• Routine assessment of 25-hydroxy vitamin D levels prior to the start of aromatase inhibitor treatment should be performed.
• Aromasin should not be coadministered with systemic estrogen-containing agents as these could interfere with its pharmacologic action.
• Aromasin is not indicated for the treatment of breast cancer in premenopausal women.
• Based on findings from animal studies and its mechanism of action, Aromasin can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Aromasin and for 1 month after the last dose.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• leucocytosis
• Convulsions

Management of overdosage:

• There is no specific antidote to overdosage and treatment must be symptomatic.
• General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated.

Can this medicine be used in pregnancy?

• Based on findings in animal studies and its mechanism of action, Aromasin can cause fetal harm when administered to a pregnant woman.

Can this medicine be used in children?

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

What are the active and inactive ingredients in this medicine?

• Active ingredient: exemestane
• Inactive ingredients: mannitol, crospovidone, polysorbate 80, hypromellose, colloidal silicon dioxide, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, simethicone, polyethylene glycol 6000, sucrose, magnesium carbonate, titanium dioxide, methylparaben, and polyvinyl alcohol.

Who manufactures and distributes this medicine?

• Packager: Pharmacia & Upjohn Company LLC

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

• Store Aromasin at room temperature 68°F to 77°F (20°C to 25°C).
• Keep Aromasin and all medicines out of the reach of children.

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• Dailymed label info on Exemestane
• FDA Exemestane

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