Advanced Breast Cancer: Learn about treatment options.

Faslodex

Pronunciation

Generic Name: fulvestrant (ful-VES-trant)
Brand Name: Faslodex

Faslodex is used for:

Treating certain types of advanced breast cancer in women after menopause who have not responded well to other medicines (eg, antiestrogen drugs) or therapy. It may also be used for other conditions as determined by your doctor.

Faslodex is an estrogen receptor antagonist. It works by blocking estrogen from tumors that need estrogen to grow.

Do NOT use Faslodex if:

  • you are allergic to any ingredient in Faslodex

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using Faslodex:

Some medical conditions may interact with Faslodex. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have liver or kidney problems or low blood platelet levels (thrombocytopenia), or bleeding or clotting problems
  • if you have weak bones or have had a recent broken bone, or if you or a family member has a history of thinning of the bones (osteoporosis)

Some MEDICINES MAY INTERACT with Faslodex. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Anticoagulants (eg, heparin, warfarin) because the risk of bleeding may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Faslodex may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Faslodex:

Use Faslodex as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Faslodex. Talk to your pharmacist if you have questions about this information.
  • Faslodex is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Faslodex at home, a health care provider will teach you how to use it. Be sure you understand how to use Faslodex. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Do not use Faslodex if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of Faslodex, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Faslodex.

Important safety information:

  • Faslodex may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Faslodex with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Avoid becoming pregnant while you are using Faslodex. Talk to your doctor about how to prevent pregnancy while using Faslodex.
  • Lab tests, including liver function, may be performed while you use Faslodex. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Faslodex should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Faslodex may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor immediately. It is not known if Faslodex is found in breast milk. Do not breast-feed while taking Faslodex.

Possible side effects of Faslodex:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back, bone, joint, muscle, or pelvic pain; constipation; cough; diarrhea; dizziness; headache; hot flushes; loss of appetite; mild pain at the injection site; mild sore throat; mild stomach pain; mild pain in the hands or feet; nausea; tiredness; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); anxiety; burning, numbness, or tingling; calf or leg pain, redness, swelling, or tenderness; chest pain; depression; fever, chills, or persistent sore throat; frequent or painful urination; persistent vaginal bleeding; shortness of breath; swelling of the hands, ankles, or feet; symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, severe stomach pain, yellowing of the skin or eyes); unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Faslodex:

Store Faslodex in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C), in the original carton. Do not freeze. Keep Faslodex out of the reach of children and away from pets.

General information:

  • If you have any questions about Faslodex, please talk with your doctor, pharmacist, or other health care provider.
  • Faslodex is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Faslodex or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Faslodex. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Faslodex. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Faslodex.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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