(exemestane)

Prescribing Information
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HIGHLIGHTS OF PRESCRIBING INFORMATION

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use AROMASIN safely and effectively. See full prescribing information for AROMASIN.

AROMASIN® (exemestane) tablets, for oral use
Initial U.S. Approval: 1999

INDICATIONS AND USAGE

AROMASIN is an aromatase inhibitor indicated for:

•
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 (14.1).
•
treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy (14.2).

DOSAGE AND ADMINISTRATION

Recommended Dose: One 25 mg tablet once daily after a meal (2.1).

DOSAGE FORMS AND STRENGTHS

Tablets: 25 mg (3)

CONTRAINDICATIONS

Patients with a known hypersensitivity to the drug or to any of the excipients (4).

WARNINGS AND PRECAUTIONS

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Reductions in bone mineral density (BMD) over time are seen with exemestane use (5.1).
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Routine assessment of 25-hydroxy vitamin D levels prior to the start of aromatase inhibitor treatment should be performed (5.2).
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Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception (5.6, 8.1, 8.3).

ADVERSE REACTIONS

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Early breast cancer: Adverse reactions occurring in ≥10% of patients in any treatment group (AROMASIN vs. tamoxifen) were hot flushes (21% vs. 20%), fatigue (16% vs. 15%), arthralgia (15% vs. 9%), headache (13% vs. 11%), insomnia (12% vs. 9%), and increased sweating (12% vs. 10%). Discontinuation rates due to AEs were similar between AROMASIN and tamoxifen (6% vs. 5%). Incidences of cardiac ischemic events (myocardial infarction, angina, and myocardial ischemia) were AROMASIN 1.6%, tamoxifen 0.6%. Incidence of cardiac failure: AROMASIN 0.4%, tamoxifen 0.3% (6, 6.1).
•
Advanced breast cancer: Most common adverse reactions were mild to moderate and included hot flushes (13% vs. 5%), nausea (9% vs. 5%), fatigue (8% vs. 10%), increased sweating (4% vs. 8%), and increased appetite (3% vs. 6%) for AROMASIN and megestrol acetate, respectively (6, 6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Strong CYP 3A4 inducers: Concomitant use of strong CYP 3A4 inducers decreases exemestane exposure. Increase the AROMASIN dose to 50 mg (2.2, 7).

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed (8.2).

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 12/2024

Medication Guide

MEDICATION GUIDE

Patient Information
AROMASIN® (ah ROME ah sin)
(exemestane) tablets

What is AROMASIN?

AROMASIN is used in women who are past menopause for the treatment of:

•
Early breast cancer (cancer that has not spread outside the breast) in women who:
o
have cancer that needs the female hormone estrogen to grow, and
o
have had other treatments for breast cancer, and
o
have taken tamoxifen for 2 to 3 years, and
o
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.

It is not known if AROMASIN is safe and effective in children.

Do not take AROMASIN if you are allergic to AROMASIN or any of the ingredients in AROMASIN. See the end of this leaflet for a complete list of ingredients in AROMASIN.

Before you take AROMASIN, tell your doctor about all your medical conditions, including if you:

•
are still having menstrual periods (are not past menopause). AROMASIN is only for women who are past menopause.
•
have weak or brittle bones (osteoporosis)
•
are pregnant or plan to become pregnant. Taking AROMASIN during pregnancy or within 1 month of becoming pregnant can harm your unborn baby.
o
Females who are able to become pregnant should have a pregnancy test within 7 days before starting treatment with AROMASIN.
o
Females who are able to become pregnant should use effective birth control (contraceptive) during treatment with AROMASIN and for 1 month after your last dose of AROMASIN. Tell your doctor right away if you become pregnant or think you may be pregnant.
•
are breastfeeding or plan to breastfeed. It is not known if AROMASIN passes into your breast milk. Do not breast-feed during treatment with AROMASIN and for 1 month after your last dose of AROMASIN.
•
Have liver or kidney problems.

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.

How should I take AROMASIN?

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

What are the possible side effects of AROMASIN?

AROMASIN may cause serious side effects, including:

•
Bone loss. AROMASIN decreases the amount of estrogen in your body which may reduce your bone mineral density (BMD) over time. This may increase your risk for bone fractures or weak and brittle bones (osteoporosis). Your doctor may check your bones during treatment with AROMASIN if you have osteoporosis or at risk for osteoporosis.

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

•
hot flashes
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headache
•
feeling tired
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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

Your doctor will do blood tests to check your vitamin D level before starting treatment with AROMASIN.

AROMASIN may cause decreased fertility in males and females. Talk to your doctor if you have concerns about fertility.

These are not all the possible side effects of AROMASIN. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store AROMASIN?

•
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.

General information about the safe and effective use of AROMASIN.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use AROMASIN for a condition for which it was not prescribed. Do not give AROMASIN to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or doctor for information about AROMASIN that is written for health professionals.

What is in AROMASIN?

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.

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LAB-0399-10.0

For more information, go to www.AROMASIN.com or call 1-888-AROMASIN (1-888-276-6274).

This Patient Information has been approved by the U.S. Food and Drug Administration                            Revised: 12/2024

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