Exemestane

Exemestane is used to treat early breast cancer in women who have experienced menopause ('change of life'; end of monthly menstrual periods) and who have already been treated with a medication called tamoxifen (Nolvadex) for 2 to 3 years. This medication is also used to treat breast cancer in women who have experienced menopause whose breast cancer has worsened while they were taking tamoxifen. Exemestane is in a class of medications called aromatase inhibitors. It works by decreasing the amount of estrogen produced by the body. This can slow or stop the growth of some breast tumors that need estrogen to grow.

Exemestane comes as a tablet to take by mouth. It is usually taken once a day after a meal. Take exemestane at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take exemestane exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

You may need to take exemestane for several years or longer. Continue to take exemestane even if you feel well. Do not stop taking exemestane without talking to your doctor.

Contraindications

Hypersensitivity

Women who are or may become pregnant; premenopausal women

Cautions

Uncontrolled hypertension

Do not administer with concomitant estrogens

Routine assessment of 25-hydroxy vitamin D levels prior to the start of aromatase inhibitor treatment should be performed, due to the high prevalence of vitamin D deficiency in women with early breast cancer; women with vitamin D deficiency should receive supplementation with vitamin D

Reductions in bone mineral density (BMD), women with or at risk of osteoporosis should have their BMD formally assessed by bone densitometry at the commencement of treatment

Not indicated for breast cancer in premenopausal women

Advise females of reproductive potential to use effective contraception during treatment and for 1 month after final dose

Based on findings in animals, male and female fertility may be impaired by treatment

• Breast Cancer
• Menopause

Tell your doctor about all the medicines you take. Include prescription and nonprescription medicines, herbal remedies, and vitamins. exemestane and other medicines may affect how each other work.

Be sure to tell your doctor if you take:

• Medicines with estrogen, such as Premarin, other hormone replacement therapy, or birth control pills or patches. Exemestane should not be taken with these medicines as they could affect how well exemestane works.
• Rifadin (rifampin)
• Dilantin (phenytoin), Tegretol (carbamazepine), or Luminal (phenobarbital)
• St. John's wort

Know what medicines you take. Keep a list of them with you. Show it to your doctor or pharmacist each time you get a new prescription.

Tell your doctor if you are pregnant or could be pregnant. Taking exemestane during pregnancy may cause birth defects or miscarriage.

Tell your doctor if you are breastfeeding. Do not breastfeed while you are being treated with exemestane.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose of exemestane in postmenopausal women is 25 mg once daily. The dose your doctor recommends may be higher if you take certain medications.

Storage

Oral

25°C (may be exposed to 15–30°C).1

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal supplements, as well as any concomitant illnesses.1 Importance of not taking estrogenic agents concomitantly.1

• Warn of potential hazard to the fetus in cases of inadvertent exposure of pregnant women to exemestane.1 Advise patients that exemestane is indicated for use only in postmenopausal women.1

• Risk of osteoporosis.1 12 Life-style changes (e.g., weight-bearing exercise, abstinence from smoking, moderation of alcohol consumption) and dietary supplementation with calcium and vitamin D advised.12 13 14 15 Importance of BMD monitoring.1 12 13 15 71 73

• Importance of informing patients of other important precautionary information.1 (See Cautions.)

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 exemestane, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to exemestane 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.

Breast Feeding

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.

Interactions with Medicines

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. When you are taking exemestane, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using exemestane with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Carbamazepine
• Enzalutamide
• Fosphenytoin
• Idelalisib
• Mitotane
• Phenytoin
• Primidone
• Rifabutin
• Rifampin
• Rifapentine
• St John's Wort

Interactions with Food/Tobacco/Alcohol

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 exemestane. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone marrow problems (eg, lymphocytopenia) or
• Bone problems (eg, osteoporosis, broken bones)—Use with caution. May make these conditions worse.

• Aromasin

No adjustment necessary (although the safety of chronic doses in patients with moderate-to-severe renal impairment has not been studied, dosage adjustment does not appear necessary).

Applies to exemestane: oral tablet

Along with its needed effects, exemestane 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 while taking exemestane:

• Cough or hoarseness
• difficult or labored breathing
• fever or chills
• lower back or side pain
• mental depression
• swelling of the hands, ankles, feet, or lower legs
• tightness in the chest

• Chest pain
• difficult, burning, or painful urination
• frequent urge to urinate
• headache
• sore throat
• unexplained broken bones

• Abdominal or stomach pain
• clay-colored stools
• confusion
• dark urine
• decreased urine output
• diarrhea
• difficulty with speaking
• dilated neck veins
• dizziness
• double vision
• inability to move the arms, legs, or facial muscles
• inability to speak
• irregular breathing
• irregular heartbeat
• itching or rash
• loss of appetite
• nausea
• slow speech
• unpleasant breath odor
• unusual tiredness or weakness
• vomiting of blood
• weight gain
• yellow eyes or skin

Some side effects of exemestane 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:

• Anxiety
• constipation
• general feeling of discomfort or illness
• general feeling of tiredness or weakness
• hot flashes
• increased sweating
• pain
• trouble sleeping

• Back pain
• bone pain
• burning, tingling, or prickly sensations
• decreased sense of touch
• increased appetite
• joint pain
• loss of hair
• runny nose
• stomach upset
• weakness, generalized

No adjustment recommended