Important Safety Info | AROMASIN® (exemestane tablets) | Safety Info

IMPORTANT SAFETY INFORMATION

Do not take AROMASIN if you are allergic to AROMASIN or to anything in it. The active ingredient is exemestane.

Let your doctor know if you are taking or applying any medication that has estrogen in it including hormone replacement therapy or birth control pills or patches, or if you are taking any other medicines including over-the counter medicines, herbal supplements, and vitamins as they can affect how well AROMASIN works.

If you become pregnant while taking AROMASIN, talk to your doctor immediately to learn about the potential risks to the baby. Taking AROMASIN during pregnancy or within 1 month of becoming pregnant can harm your unborn baby. Use effective birth control (contraceptive) during treatment with AROMASIN and for 1 month after your last dose of AROMASIN.

A serious side effect of AROMASIN is bone loss over time that may increase your risk of bone fractures and weak and brittle bones (osteoporosis). The health of your bones should be carefully monitored by your doctor for any bone loss before and during treatment with AROMASIN. Any bone loss should be treated appropriately.

Before starting to take AROMASIN, have your blood levels checked for Vitamin D deficiency. This is a common condition in women with early breast cancer and should be treated with Vitamin D supplements.

A small number of women had chest pain, heart failure or stroke while taking AROMASIN.

Tell your doctor if you 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 1 month after your last dose of AROMASIN.

Common side effects of AROMASIN in women with early breast cancer were:

  • hot flushes
  • increased sweating
  • trouble sleeping
  • feeling tired
  • joint pain, headache

Common side effects of AROMASIN in women with advanced breast cancer were:

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

Before you take AROMASIN, tell your doctor about all of your medical conditions, including if you have liver or kidney problems.

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

INDICATION

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

Please see Full Prescribing Information and Patient Information.

 

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