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Brand Name: Faslodex®
Active Ingredient:   fulvestrant
Strength(s): 50 mg/ml (available in one 250 mg or two 125 mg pre-filled syringes)
Dosage Form(s):   Intramuscular Injection
Company Name:    AstraZeneca Pharmaceuticals LP
Availability:         Prescription only
*Date Approved by the FDA:   April 25, 2002
*Approval by FDA does not mean that the drug is available for consumers at this time.

What is Faslodex used for?

FASLODEX is used to treat hormone receptor positive breast cancer in postmenopausal women whose disease has spread after treatment with antiestrogens, primarily tamoxifen. Postmenopausal women are women who have gone through the "change of life", and are no longer having menstrual cycles. 

How does Faslodex work?

Many breast cancer tumors have hormone receptors, which are stimulated by estrogen and cause the tumors to grow. Faslodex and Tamoxifen are antiestrogens, which may block the action of estrogen on cancer cells, and may cause some breast cancer tumors to shrink.

Who should not use Faslodex?

Do not use Faslodex if you: 

  • have not been treated with Tamoxifen or another antiestrogen medicine first 
  • are pregnant. Faslodex may cause birth defects or miscarriage 
  • are allergic to Faslodex or to any of the ingredients in Faslodex 

What should I tell my health care provider?

Tell your health care provider if you: 

  • are still having menstrual periods 
  • are pregnant, are planning to become pregnant or are breast-feeding 
  • have or had liver problems 
  • bleed easily 
  • are taking anticoagulants (blood thinners) 
  • have a low level of platelets in your blood 

Tell your health care provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may affect how Faslodex works or Faslodex may affect how your other medicines work.

What are some possible side effects of Faslodex? (This list is NOT a complete list of side effects reported with Faslodex. Your health care provider can discuss with you a more complete list of side effects.)

Side effects of Faslodex include: 

  • nausea 
  • weakness 
  • pain 
  • hot flashes 
  • sore throat 
  • bone pain 
  • headache 
  • shortness of breath 
  • back pain 
  • vomiting 
  • constipation 
  • diarrhea 
  • stomach pain 
  • pain, redness and swelling at the injection site
  • cough 
  • pelvic pain 
  • loss of appetite 
  • swelling of the extremities (arms and legs) 
  • rash 
  • chest pain 
  • flu symptoms 
  • dizziness 
  • trouble sleeping 
  • fever 
  • increased skin sensations (including numbness, tingling, burning, prickling) 
  • urinary tract infection 
  • depression 
  • anxiety 
  • sweating 

For more detailed information about Faslodex, ask your health care provider or pharmacist.    Link to Faslodex's approved labeling, full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions, and contraindications

Posted: 11/22/02


Back to Drug Side Effects

source: FDA

last update: December 2004

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