Exemestane (Page 7 of 7)

Patient Information

Exemestane Tablets
(ex e mes’ tane) Rx Only

Patient InformationExemestane Tablets

What is exemestane?

Exemestane 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 exemestane 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 exemestane is safe and effective in children.

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

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

are still having menstrual periods (are not past menopause). Exemestane is only for women who are past menopause.
have weak or brittle bones (osteoporosis)
are pregnant or plan to become pregnant. Taking exemestane 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 exemestane.
o
Females who are able to become pregnant should use effective birth control (contraceptive) during treatment with exemestane and for 1 month after your last dose of exemestane. 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 exemestane passes into your breast milk. Do not breast-feed during treatment with exemestane and for 1 month after your last dose of exemestane.
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. Exemestane should not be taken with medicines that contain estrogen as they could affect how well Exemestane works.

How should I take exemestane?

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

What are the possible side effects of exemestane?

Exemestane may cause serious side effects, including:

Bone loss. Exemestane 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 exemestane if you have osteoporosis or at risk for osteoporosis.

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

● hot flashes ● feeling tired ● joint pain

● headache ● trouble sleeping ● increased sweating

The most common side effects of exemestane in women with advanced breast cancer include:

● hot flashes ● nausea ● feeling tired

● increased sweating ● increased appetite

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

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Keep exemestane and all medicines out of the reach of children.

General information about the safe and effective use of exemestane.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use exemestane for a condition for which it was not prescribed. Do not give exemestane to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or doctor or call West-Ward Pharmaceuticals Corp. at 1-800-962-8364 for information about exemestane that is written for health professionals.

What is in exemestane tablets?

Active ingredient: exemestane

Inactive ingredients: magnesium stearate, mannitol, microcrystalline cellulose, Opadry II (white), polysorbate 80, povidone and sodium starch glycolate. Opadry II (white) contains: hypromellose, polyethylene glycol, polydextrose, titanium dioxide and triacetin.

*All trademarks are the property of their respective owners.

This Patient Information has been approved by the U.S. Food and Drug Administration

Distr. by: West-Ward

Pharmaceuticals Corp.

Eatontown, NJ 07724

10003700/08

Revised November 2018

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

fpl-bl-36mg-20tabs-05.jpg
(click image for full-size original)
EXEMESTANE exemestane tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0054-0080
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EXEMESTANE (EXEMESTANE) EXEMESTANE 25 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
MANNITOL
POLYSORBATE 80
SODIUM STARCH GLYCOLATE TYPE A POTATO
POLYETHYLENE GLYCOL 8000
POLYDEXTROSE
TITANIUM DIOXIDE
TRIACETIN
HYPROMELLOSE, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 5mm
Flavor Imprint Code 54571
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0054-0080-13 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077431 04/01/2011
Labeler — West-Ward Pharmaceuticals Corp (080189610)
Establishment
Name Address ID/FEI Operations
West-Ward Columbus Inc. 058839929 MANUFACTURE (0054-0080)

Revised: 11/2018 West-Ward Pharmaceuticals Corp

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