"June 3, 2011 -- A drug that battles bone loss may have added benefits for women with estrogen-sensitive breast cancers, significantly reducing the chance that their cancer will return or spread, a new study shows.
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(anastrozole) Tablets for Oral Administration
What is the most important information I should know about ARIMIDEX?
ARIMIDEX may cause serious side effects including:
- heart disease. Women with early breast cancer, who have a history of blockage in their heart arteries (ischemic heart disease) and who take ARIMIDEX, may have an increase in symptoms of decreased blood flow to their heart compared to similar women who take tamoxifen.
Get medical help right away if you have new or worsening chest pain or shortness of breath during treatment with ARIMIDEX.
What is ARIMIDEX?
- treatment of early breast cancer
- after surgery
- in women whose breast cancer is hormone receptor-positive
- the first treatment of breast cancer that has spread to nearby tissue or lymph nodes (locally advanced) or has spread to other parts of the body (metastatic), in women whose breast cancer is hormone receptor-positive or the hormone receptors are not known
- treatment of advanced breast cancer, if the cancer has grown, or the disease has spread after tamoxifen therapy
ARIMIDEX does not work in women with breast cancer who have not gone through menopause (premenopausal women).
Who should not take ARIMIDEX?
Do not take ARIMIDEX if you:
- are pregnant or able to become pregnant. ARIMIDEX may harm your unborn baby. If you become pregnant while taking ARIMIDEX, tell your doctor right away.
- have not gone through menopause (are premenopausal)
- have had a severe allergic reaction to anastrozole or any of the ingredients in ARIMIDEX. See the end of this leaflet for a complete list of ingredients in ARIMIDEX. Symptoms of a severe allergic reaction to ARIMIDEX include: swelling of the face, lips, tongue, or throat, trouble breathing or swallowing, hives and itching.
What should I tell my doctor before taking ARIMIDEX?
Before you take ARIMIDEX, tell your doctor if you:
- have not gone through menopause. Talk to your doctor if you are not sure.
- have or had a heart problem
- have been told you have bone thinning or weakness (osteoporosis)
- have high cholesterol
- have any other medical conditions
- are pregnant or plan to become pregnant. ARIMIDEX may harm your unborn baby. See “Who should not take ARIMIDEX?”
- are breastfeeding or plan to breastfeed. It is not known if ARIMIDEX passes into breast milk. You and your doctor should decide if you will take ARIMIDEX or breastfeed. You should not do both.
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:
- tamoxifen. You should not take ARIMIDEX if you take tamoxifen. Taking ARIMIDEX with tamoxifen may lower the amount of ARIMIDEX in your blood and may cause ARIMIDEX not to work as well.
- Medicines that contain estrogen. ARIMIDEX may not work if taken with any of these medicines:
- hormone replacement therapy
- birth control pills
- estrogen creams
- vaginal rings
- vaginal suppositories
Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
How should I take ARIMIDEX?
- Take ARIMIDEX exactly as your doctor tells you to take it.
- Continue taking ARIMIDEX until your doctor tells you to stop.
- ARIMIDEX can be taken with or without food.
- If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Take your next regularly scheduled dose. Do not take two doses at the same time.
If you take too much ARIMIDEX, call your doctor or go to the nearest hospital emergency room right away.
What are the possible side effects of ARIMIDEX?
ARIMIDEX may cause serious side effects including:
- See “What is the most important information I should know about ARIMIDEX?”
- bone thinning or weakness (osteoporosis). ARIMIDEX lowers estrogen in your body, which may cause your bones to become thinner and weaker. This may increase your risk of fractures, especially of your spine, hip and wrist. Your doctor may order a bone mineral density test
- before you start and during treatment with ARIMIDEX to check you for bone changes.
- increased blood cholesterol (fat in the blood). Your doctor may do blood tests to check your cholesterol while you are taking ARIMIDEX.
- skin reactions. Stop taking ARIMIDEX and call your doctor right away if you get any skin lesions, ulcers, or blisters.
- severe allergic reactions. Get medical help right away if you get:
- swelling of your face, lips, tongue, or throat
- trouble swallowing or breathing
- liver problems. ARIMIDEX can cause
inflammation of your liver and changes in liver function blood tests. Your
doctor may check you for this.
Stop taking ARIMIDEX and call your doctor right away if you have any of these signs or symptoms of a liver problem:
- a general feeling of not being well
- yellowing of your skin or whites of your eyes
- pain on the right side of your stomach-area (abdomen)
Common side effects in women taking ARIMIDEX include:
- hot flashes
- joint aches
- joint pain, stiffness or swelling (arthritis)
- sore throat
- high blood pressure
- nausea and vomiting
- back pain
- sleep problems
- bone pain
- swelling of your legs, ankles, or feet
- increased cough
- shortness of breath
- build up of lymph fluid in the tissues of your affected arm (lymphedema )
ARIMIDEX may also cause you to have tickling, tingling or numbness of your skin.
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of ARIMIDEX. For more information, ask your doctor or pharmacist.
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 ARIMIDEX?
- Store ARIMIDEX at room temperature between 68°F to 77°F (20°C to 25°C).
Keep ARIMIDEX and all medicines out of the reach of children.
General information about the safe and effective use of ARIMIDEX.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not take ARIMIDEX for a condition for which it was not prescribed. Do not give ARIMIDEX to other people, even if they have the same symptoms that you have. It may harm them.
If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about ARIMIDEX that is written for health professionals. For more information call 1-866-992-9276 or go to www.ARIMIDEX.com.
What are the ingredients in ARIMIDEX?
Active ingredient: anastrozole
Inactive ingredients: lactose, magnesium stearate, hydroxypropylmethylcellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide.
Last reviewed on RxList: 5/23/2014
This monograph has been modified to include the generic and brand name in many instances.
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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