Class: Hormonal therapy

Generic Name: Fulvestrant (FULL-ve-strent)
Trade Name: Faslodex®

For which conditions is this drug approved? Fulvestrant is approved for the treatment of advanced, hormone-positive breast cancer that has progressed or recurred following previous therapy with the anti-estrogen agent tamoxifen in postmenopausal women. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.

What is the mechanism of action? Fulvestrant produces its anti-cancer effects by binding to estrogen receptors in a cell so that estrogen cannot. Estrogen is a female hormone that produces growth stimulatory effects on a significant portion of breast cancer cells.  By binding to estrogen receptors, fulvestrant inhibits the growth stimulatory effects that estrogen would normally produce. In addition, fulvestrant causes the estrogen receptors to degrade, leaving fewer receptors for estrogen to bind.

How is fulvestrant typically given (administered)? Fulvestrant is given as an injection into a muscle (intramuscular), and the dose depends on several factors, including the condition being treated, the size of the patient, the particular regimen being used, and the overall health of the patient. Fulvestrant is often just administered once per month.

How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while being treated with fulvestrant. Physical examinations, scans and other measures to assess side effects and response to therapy may be performed. Patients will usually be monitored for blood clots, as this is rare but potentially serious side effect of treatment with fulvestrant. Patients should notify their healthcare provider if they have pain, swelling or redness in one extremity but not the other, chest pain, or difficulty breathing.

What are the most commonly occurring side effects of treatment with fulvestrant?

• Diarrhea
• Nausea and vomiting
• Constipation
• Generalized weakness
• Hot flashes
• Headache
• Abdominal pain
• Bone pain
• Back pain
• Sore throat
• Mild pain or swelling at site of injection

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
• Eat small meals frequently to help alleviate nausea.
• Patients who experience hot flashes may wish to wear light clothing, stay in a cool environment, and place cool cloths on their body or head to relieve their symptoms.

Are there any special precautions patients should be aware of before starting treatment?

• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.

When should patients notify their physician?

• Chest pain
• Difficulty breathing
• Swelling, pain, redness in only one extremity
• Excessive vaginal discharge or vaginal bleeding
• Persistent or severe nausea or vomiting
• Persistent or severe diarrhea or constipation
• Severe pain

What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Copyright © 2010 CancerConnect Last updated 07/10.

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