Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Aromasin

Descriptions


Exemestane is used to treat early and advanced breast cancer in women who have already stopped menstruating (postmenopausal). It is usually used in women who have already received a cancer medication called tamoxifen.

Many breast cancer tumors grow in response to estrogen. Exemestane interferes with the production of estrogen in the body. As a result, the amount of estrogen that the tumor is exposed to is reduced, which will limit the growth of the tumor.

Before you begin treatment with exemestane, you and your doctor should talk about the benefits this medicine will do as well as the risks of using it.

This medicine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, exemestane is used in certain patients with the following medical conditions:

  • Prevention of invasive breast cancer in postmenopausal women at increased risk.

This product is available in the following dosage forms:

  • Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of exemestane in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of exemestane in the elderly.

Pregnancy

Information about this exemestane-oral-route
Pregnancy Category Explanation
All Trimesters X Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bone marrow problems (e.g., lymphocytopenia) or
  • Bone problems (e.g., osteoporosis, broken bones)—Use with caution. May make these conditions worse.
  • Pregnant women or
  • Premenopausal women (have menstrual cycles)—Should not be used in these patients.

Proper Use

Use this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Taking too much may increase the chance of side effects, while taking too little may not improve your condition.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Talk to your doctor if you have any questions.

Do not change the dose or stop using this medicine without checking with your doctor first. When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.

Take your medicine at the same time each day.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For breast cancer in postmenopausal women:
      • Adults—25 milligrams (mg) once a day after a meal.
      • Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects. It is important for women to have regular gynecologic check-ups while taking this medicine.

It is unlikely that a postmenopausal woman may become pregnant. But, you should know that using this medicine while you are pregnant could harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, call your doctor right away.

Exemestane can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, talk to your doctor.

Stop taking this medicine and check with your doctor right away if you start having chest pains or shortness of breath. This medicine may cause heart problems for some people, but this does not occur very often.

Do not take this medicine if you are also using medicines that contain estrogen (e.g., Premarin®), birth control pills or patches, or other medicines used for hormone replacement therapy.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  1. Cough or hoarseness
  2. difficult or labored breathing
  3. fever or chills
  4. increased blood pressure
  5. lower back or side pain
  6. mental depression
  7. shortness of breath
  8. swelling of the hands, ankles, feet, or lower legs
  9. tightness in the chest

Less common

  1. Chest pain
  2. difficult, burning, or painful urination
  3. frequent urge to urinate
  4. headache
  5. sore throat
  6. unexplained broken bones
  7. wheezing

Incidence not known

  1. Abdominal or stomach pain
  2. clay-colored stools
  3. confusion
  4. dark urine
  5. decreased urine output
  6. diarrhea
  7. difficulty with speaking
  8. dilated neck veins
  9. dizziness
  10. double vision
  11. inability to move the arms, legs, or facial muscles
  12. inability to speak
  13. irregular breathing
  14. irregular heartbeat
  15. itching
  16. loss of appetite
  17. nausea
  18. rash
  19. slow speech
  20. unpleasant breath odor
  21. unusual tiredness or weakness
  22. vomiting of blood
  23. weight gain
  24. yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Anxiety
  2. constipation
  3. general feeling of discomfort or illness
  4. general feeling of tiredness or weakness
  5. hot flashes
  6. increased sweating
  7. pain
  8. trouble with sleeping

Less common

  1. Back pain
  2. bone pain
  3. burning, tingling, or prickly sensations
  4. decreased sense of touch
  5. increased appetite
  6. joint pain
  7. loss of hair
  8. runny nose
  9. stomach upset
  10. weakness, generalized

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.