What is FASLODEX?
FASLODEX is a prescription medicine used to treat women with:
- hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer, who have gone through menopause and have not been previously treated with endocrine therapy
- HR-positive advanced breast cancer, who have gone through menopause and whose disease has progressed after endocrine therapy
- HR-positive, HER2-negative advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), in combination with palbociclib in women whose disease has progressed after endocrine therapy
- When FASLODEX is used in combination with palbociclib, please also see the palbociclib Patient Information. It is not known if FASLODEX is safe and effective in children. It is not known if FASLODEX is safe and effective in people with severe liver problems.
Who should not receive FASLODEX?
- Do not receive FASLODEX if you have had an allergic reaction to fulvestrant or any of the ingredients in FASLODEX. See the end of this leaflet for a list of the ingredients in FASLODEX.
- Symptoms of an allergic reaction to FASLODEX may include:
- Itching or hives
- swelling of your face, lips, tongue or throat
- trouble breathing
What should I tell my healthcare provider before receiving FASLODEX?
Before receiving FASLODEX, tell your healthcare provider about all of your medical conditions, including if you:
- have a low level of platelets in your blood or bleed easily.
- have liver problems.
- are pregnant or plan to become pregnant. FASLODEX can harm your unborn baby.
- Females who are able to become pregnant should use effective birth control during treatment with FASLODEX and for one year after the last dose of FASLODEX.
- Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with FASLODEX.
- are breastfeeding or plan to breastfeed. It is not known if FASLODEX passes into your breast milk. Do not breast-feed during your treatment with FASLODEX and for one year after the final dose of FASLODEX. Talk to your healthcare provider about the best way to feed your baby during this time.
- Tell your healthcare provider about all the medicines you take, including prescription and over the counter medicines, vitamins, and herbal supplements. FASLODEX may affect the way other medicines work, and other medicines may affect how FASLODEX works. Especially tell your healthcare provider if you take a blood thinner medicine.
How will I receive FASLODEX?
- Your healthcare provider will give you FASLODEX by injection into the muscle of each buttock.
- Your healthcare provider may change your dose of FASLODEX if needed.
How will I receive FASLODEX?
- FASLODEX may cause injection site related nerve damage. Call your healthcare provider if you develop any of the following symptoms in your legs following a FASLODEX injection:
- numbness
- tingling
- weakness
- Common side effects of FASLODEX include:
- injection site pain
- injection site pain
- nausea
- muscle, joint, and bone pain
- headache
- tiredness
- hot flashes
- vomiting
- loss of appetite
- weakness
- cough
- constipation
- shortness of breath
- increased liver enzymes
- diarrhea
- FASLODEX may cause fertility problems in males and females. Talk to your healthcare provider if you plan to become pregnant. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects with FASLODEX. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of FASLODEX
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about FASLODEX that is written for health professionals.
What are the ingredients in FASLODEX?
- Active ingredient: fulvestrant
- Inactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 20, α,α-trehalose dihydrate, and Water for Injection alcohol, benzyl alcohol, benzyl benzoate, and castor oil
Tell your healthcare provider if you have vomiting, diarrhea, or signs of dehydration that does not go away. FASLODEX may cause fertility problems in males and females, which may affect your ability to have a child.
Talk to your healthcare provider if this is a concern for you. These are not all of the possible side effects of FASLODEX. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Ask your healthcare provider if you do not know.