What is the most important information I should know about fulvestrant?
You should not receive fulvestrant if you are pregnant.
Avoid getting pregnant or breast-feeding a baby for at least 1 year after you stop using this medicine.
What is fulvestrant?
Fulvestrant is an anti-estrogen medication. It works by blocking the actions of estrogen in the body. Certain types of breast cancer use estrogen to grow and multiply in the body.
Fulvestrant is used to treat advanced hormone-related breast cancer in women. Fulvestrant is used for this condition only if your tumor tests negative for a protein called human epidermal growth factor receptor 2 (HER2). HER2 protein can speed the growth of cancer cells.
Fulvestrant may also be used when the cancer has progressed or has spread to other parts of the body after treatment with anti-estrogen medication.
For women who have not gone through menopause, fulvestrant is given together with another medicine called palbociclib to treat advanced HER2-negative breast cancer that has progressed or spread.
Fulvestrant may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before I receive fulvestrant?
You should not receive this medicine if you are allergic to fulvestrant, or if you are pregnant.
To make sure fulvestrant is safe for you, tell your doctor if you have:
- liver disease;
- a bleeding or blood clotting disorder; or
- thrombocytopenia (a low level of platelets in the blood).
Using fulvestrant during pregnancy could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 1 year after your treatment ends. Tell your doctor right away if you become pregnant during this time.
It is not known whether fulvestrant passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
How is fulvestrant given?
Fulvestrant is given as two injections into a muscle of your buttock. Your doctor, nurse, or other healthcare provider will give you this injection.
Each injection must be given slowly, and can take up to 2 minutes to complete.
Fulvestrant is usually given once every 2 weeks at first, and then once a month. Do not miss any scheduled appointments.
When treatment also includes taking palbociclib capsules, you will most likely take your palbociclib dose once daily with food for 21 days in a row, followed by 7 days off the medicine. Follow your doctor's dosing instructions very carefully.
If you are a woman using fulvestrant together with palbociclib, tell your doctor if you are going through menopause (you have symptoms such as irregular menstrual periods, hot flashes, night sweats, or vaginal dryness). You may need to be treated with an additional hormone medication.
This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using fulvestrant.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your fulvestrant injection.
What happens if I overdose?
Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
What should I avoid while receiving fulvestrant?
This medicine can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.
What are the possible side effects of fulvestrant?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
-
signs of nerve damage --numbness, tingling, weakness, or burning pain.
Common side effects may include:
- headache;
- bone pain, joint pain, muscle pain;
- nausea, vomiting, loss of appetite, constipation;
- weakness, feeling tired;
- cough, trouble breathing;
- abnormal liver function tests;
- hot flashes; or
- pain where the medicine was injected.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect fulvestrant?
Tell your doctor about all your current medicines and any you start or stop using, especially:
-
a blood thinner --warfarin, Coumadin, Jantoven.
This list is not complete. Other drugs may interact with fulvestrant, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Where can I get more information?
Your doctor or pharmacist can provide more information about fulvestrant.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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