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FASLODEX®
(faz-lo-dex)
(fulvestrant)

Read this Patient Information before you start receiving FASLODEX and before each injection. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or treatment.

What is FASLODEX?

FASLODEX is a prescription medicine used to treat hormone receptor-positive breast cancer in women who have gone through menopause whose disease has spread after treatment with an antiestrogen medicine.

It is not known if FASLODEX is safe and effective in children.

Who should not receive FASLODEX?

You should not receive FASLODEX if you have had an allergic reaction to any of the ingredients in FASLODEX. See the end of this leaflet for a list of the ingredients in FASLODEX.

Symptoms of an allergic reaction to FASLODEX may include:

• itching
• swelling of your face, lips, tongue or throat
• trouble breathing

What should I tell my healthcare provider before taking FASLODEX?

Before you receive FASLODEX, tell your healthcare provider if you:

• have a low level of platelets in your blood or bleed easily.
• have liver problems
• have any other medical conditions
• are pregnant or plan to become pregnant. FASLODEX can harm your unborn baby. Talk to your healthcare provider about how to prevent pregnancy while taking FASLODEX. Tell your healthcare provider right away if you become pregnant or think you are pregnant while receiving FASLODEX.
• are breastfeeding or plan to breastfeed. You and your healthcare provider will decide if you will take FASLODEX or breast feed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. FASLODEX may affect the way other medicines work, and other medicines may affect how FASLODEX works.

Especially tell your healthcare provider if you take a blood thinner medicine.

Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider or pharmacist when you get a new medicine.

How will I receive FASLODEX?

Your healthcare provider will give you the appropriate amount of FASLODEX by injection into the muscle of your buttock.

What are the possible side effects of FASLODEX?

Common side effects of FASLODEX include:

• injection site pain
• nausea
• muscle, joint, and bone pain
• headache
• tiredness
• hot flashes
• vomiting
• loss of appetite
• weakness
• cough
• constipation
• shortness of breath
• increased liver enzymes

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects with FASLODEX. For more information, ask your healthcare provider or pharmacist.

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

You may also report side effects to AstraZeneca at 1-800-2369933.

General Information about FASLODEX.

Certain types of breast cancer require estrogen, a female hormone, to grow. FASLODEX works by blocking the effect of estrogen on certain tumors. This may slow the growth of tumors that are stimulated by estrogen.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. This leaflet summarizes the most important information about FASLODEX. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about FASLODEX that is written for health professionals.

For more information, go to www.FASLODEX.com

What are the ingredients in FASLODEX?

Active ingredient: fulvestrant

Inactive ingredients: alcohol, benzyl alcohol, benzyl benzoate, and castor oil.

Last reviewed on RxList: 6/3/2011
This monograph has been modified to include the generic and brand name in many instances.