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Treatment Name: Fulvestrant (Faslodex®)

Fulvestrant (Faslodex®) is a Treatment Regimen for Breast Cancer - metastatic

​How does fulvestrant work?
It is designed to block estrogen receptors on the surface of breast cancer cells. In patients with Estrogen Receptor positive (ER+) disease, estrogen binds to these receptors and tells the breast cancer cells to grow and divide. Fulvestrant blocks this signal and helps stop the breast cancer cells from growing.

Goals of therapy:
Fulvestrant is commonly given to slow the progression of breast cancer and decrease symptoms. Fulvestrant is not commonly given with the goal of cure.

Schedule

  • Fulvestrant intramuscular (I.M.) injection once weekly for 3 weeks, then once monthly thereafter

Fulvestrant is usually given in an outpatient infusion center or a doctor’s clinic, allowing the person to go home afterwards. Fulvestrant is given until the drug no longer works or until unacceptable sideeffects are experienced.

Click here for common starting dose.

Side Effects

In a multi-drug regimen, each medication has unique side effects. When these medicines are given together, drug-related side effects reported in clinical studies give the best estimate of what to expect. In clinical studies, the most commonly reported side effects with fulvestrant are shown here. Side effects sometimes have percentage ranges [example: 8 –13% for hot flashes] because they differed between clinical studies.

  • Bone pain (14%)
  • Nausea (11%)
  • Joint pain (10 - 19%)
  • Constipation (10%)
  • Vomiting (9%)
  • Trouble breathing (9%)
  • Hot flashes (8 - 13%)
  • Injection site pain/reactions (6 - 14%)
  • Increased sweating (4%)
  • Urinary tract infection (2 - 4%)
  • Weight gain (1%)

On average, 2 - 3% of patients in the clinical studies discontinued fulvestrant due to unacceptable side effects.

Side effect videos Side Effect Videos
PainPainNausea and VomitingNausea and VomitingConstipationConstipation

Monitoring

How often is monitoring needed?
Labs (blood tests) may be checked every one to three months. Labs may include: Complete Blood Count (CBC), and Comprehensive Metabolic Panel (CMP).

How often is imaging needed?
Imaging may be checked before treatment and every two to six months during treatment. Imaging may include: bone scans, magnetic resonance imaging (MRI), and computerized tomography (CT) scans.

How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue fulvestrant as planned, or delay or switch therapy.

ChemoExperts Tips

  • Only a certain amount of fluid can be given by intramuscular (I.M.) injection at one time. Because of this, the total dose of fulvestrant must be given as two separate injections on the same day. Each injection will be given slowly over 1 to 2 minutes, one in each buttock
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • Clinical trials may exist for breast cancer. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering study medications

Patient Assistance & Co-payment Coverage

Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for Fulvestrant (Faslodex®), we have provided links that may help.

Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for Fulvestrant (Faslodex®). Depending upon your income, they may be able to help cover the cost of:

  • Fulvestrant

For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.

  • If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.

Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as Fulvestrant (Faslodex®) and are the best source to help you understand drug cost.

  • Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.

Emotional Wellness

What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.

Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.

Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.

Learn more about pursuing emotional wellness while receiving treatment with Fulvestrant (Faslodex®)

Individual Drug Label Information

Fulvestrant (Faslodex®)

  • Fulvestrant is a intramuscular (I.M.) injection 
  • Dosage adjustments may be required for decreased liver function
  • Should only be given to post-menopausal women
  • Can cause fetal harm when given to pregnant women.  Women of childbearing age should be advised not to become pregnant
General Fulvestrant (Faslodex) Side Effects
  • One of the most common side effects reported are hot flashes. Talk to your doctor about ways to minimize and treat hot flashes. Do not take any medicines, herbs, or natural supplements without speaking with your doctor or pharmacist first
  • Injection site pain
  • Headache
  • Bone and join pain
  • Weakness
  • Nausea/Vomiting
  • Constipation or diarrhea
  • Fatigue
  • Shortness of breath
  • Click on the "See DailyMed package insert" below for complete reported side effects and possible drug interactions

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaFatigue Fatigue ConstipationConstipationPainPain

See DailyMed package insert.

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References

1. Robertson JFR, Llombart-Cussac A, Rolski J, et al. Activity of Fulvestrant 500 mg Versus Anastrozole 1 mg As First-Line Treatment for Advanced Breast Cancer: Results From the FIRST Study. J Clin Oncol 2009;27(27):4530-4535.

2. Di Leo A, Jerusalem G, Petruzelka L, et al. Results of the CONFIRM Phase III Trial Comparing Fulvestrant 250 mg With Fulvestrant 500 mg in Postmenopausal Women With Estrogen Receptor–Positive Advanced Breast Cancer. J Clin Oncol 2010;28(30):4594-4600.

Created: January 27, 2016 Updated: September 24, 2018

What is Breast Cancer - metastatic?

What is Metastatic Breast Cancer?
A disease of the milk-producing glands known as lobules, milk ducts, or other cells found in the breast. Metastatic breast cancer is one that has moved from the breast to other areas of the body, which may include the brain, liver, or bone. Breast cancer is one of the most common types of cancers in women, but may rarely affect men as well. Known causes of breast cancer include genetic causes, such as the BRCA mutation, or obesity. The effectiveness of the treatment may depend upon the stage at diagnosis.

Types of metastatic breast cancer:
1. Hormone-receptor positive or negative (60 - 65% of patients)

  • Estrogen Receptor positive (ER)+ or negative (ER)-
  • Progestin Receptor positive (PR)+ or negative (PR)-

2. Hormone Epidermal growth factor Receptor-2 (HER-2) positive or negative (20 - 25% of patients)

  • HER-2 +
  • HER-2 -

3. Triple Negative (15 - 18% of patients)

  • ER- and PR- and (HER-2)-
NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.

Clinical Studies

If you are interested in reading the clinical trials results, please click on references below:

1. Robertson JFR, Llombart-Cussac A, Rolski J, et al. Activity of Fulvestrant 500 mg Versus Anastrozole 1 mg As First-Line Treatment for Advanced Breast Cancer: Results From the FIRST Study. J Clin Oncol 2009;27(27):4530-4535.

2. Di Leo A, Jerusalem G, Petruzelka L, et al. Results of the CONFIRM Phase III Trial Comparing Fulvestrant 250 mg With Fulvestrant 500 mg in Postmenopausal Women With Estrogen Receptor–Positive Advanced Breast Cancer. J Clin Oncol 2010;28(30):4594-4600.

Common Starting Dose

Fulvestrant 500 mg intramuscular (I.M.) injection weekly for 3 weeks, then monthly thereafter. The injection is two separate 250 mg syringes.

What is a CBC?

A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.

Common uses:
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium

What does Cure mean?

The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.

Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.