AROMASIN® Medication Guide

(exemestane)

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Bone Effects

Advise patients that AROMASIN lowers the level of estrogen in the body. This may lead to reduction in bone mineral density (BMD) over time. The lower the BMD, the greater the risk of osteoporosis and fracture [see Warnings and Precautions (5.1)].

Other Estrogen-Containing Agents

Advise patients that they should not take estrogen-containing agents while they are taking AROMASIN as these could interfere with its pharmacologic action [see Warnings and Precautions (5.3)].

Use in Premenopausal Women

Advise patients that AROMASIN is not for use for the treatment of breast cancer in premenopausal women [see Warnings and Precautions (5.5)].

Embryo-Fetal Toxicity

Advise pregnant women and females of reproductive potential that exposure during pregnancy or within 1 month prior to conception can result in fetal harm. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.6) and Use in Specific Populations (8.1)].

Advise females of reproductive potential to use effective contraception while taking AROMASIN and for 1 month after the last dose [see Use in Specific Populations (8.3)].

Lactation

Advise women not to breastfeed during treatment with AROMASIN and for 1 month after the last dose [see Use in Specific Populations (8.2)].

Patient Information
AROMASIN (ah ROME ah sin)
(exemestane) tablets
This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 11/2021

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:
    • 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.

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.
    • Females who are able to become pregnant should have a pregnancy test within 7 days before starting treatment with AROMASIN.
    • 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.
  • 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
  • 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

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-0399-9.0

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

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Health Professional Information

Medication Guide

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Bone Effects

Advise patients that AROMASIN lowers the level of estrogen in the body. This may lead to reduction in bone mineral density (BMD) over time. The lower the BMD, the greater the risk of osteoporosis and fracture [see Warnings and Precautions (5.1)].

Other Estrogen-Containing Agents

Advise patients that they should not take estrogen-containing agents while they are taking AROMASIN as these could interfere with its pharmacologic action [see Warnings and Precautions (5.3)].

Use in Premenopausal Women

Advise patients that AROMASIN is not for use for the treatment of breast cancer in premenopausal women [see Warnings and Precautions (5.5)].

Embryo-Fetal Toxicity

Advise pregnant women and females of reproductive potential that exposure during pregnancy or within 1 month prior to conception can result in fetal harm. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.6) and Use in Specific Populations (8.1)].

Advise females of reproductive potential to use effective contraception while taking AROMASIN and for 1 month after the last dose [see Use in Specific Populations (8.3)].

Lactation

Advise women not to breastfeed during treatment with AROMASIN and for 1 month after the last dose [see Use in Specific Populations (8.2)].

Patient Information
AROMASIN (ah ROME ah sin)
(exemestane) tablets
This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 11/2021

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:
    • 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.

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.
    • Females who are able to become pregnant should have a pregnancy test within 7 days before starting treatment with AROMASIN.
    • 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.
  • 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
  • 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

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.

Logo

LAB-0399-9.0

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

Health Professional Information

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