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- Important Safety Information
- Approved Uses
- Prescribing Information
IMPORTANT SAFETY INFORMATION
-
You should not receive FASLODEX if you have had an allergic reaction to fulvestrant or any of the ingredients in FASLODEX. Talk to your health care provider if you experience symptoms of an allergic reaction to FASLODEX, which may include itching or hives; swelling of your face, lips, tongue, or throat; and trouble breathing.
- Have a low level of platelets in your blood or bleed easily. Especially tell your health care provider if you take a blood thinner medicine (anticoagulant)
- Have liver problems
- Are pregnant or plan to become pregnant, because FASLODEX can harm your unborn baby. Women who are able to become pregnant should use effective birth control during treatment with FASLODEX and for 1 year after the final dose. Tell your health care provider right away if you become pregnant or think you are pregnant while on FASLODEX
- Are breastfeeding or plan to breastfeed. It is not known if FASLODEX passes into breast milk. Do not breastfeed during treatment with FASLODEX and for 1 year after the final dose. Talk to your health care provider about the best way to feed your baby during this time
Before receiving FASLODEX, tell your health care provider about all of your medical conditions, including if you:
Tell your health care provider about all of 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.
FASLODEX is administered by your health care provider as an injection into the muscle of each buttock. Your health care provider may change your dose of FASLODEX if needed.
FASLODEX may cause injection site–related nerve damage. Call your health care provider if you develop any of the following symptoms in your legs following a FASLODEX injection: numbness, tingling, or weakness.
Common side effects of FASLODEX include injection site pain; nausea; muscle, joint, and bone pain; headache; tiredness; hot flashes; vomiting; loss of appetite; weakness; cough; shortness of breath; constipation; increased liver enzymes; and diarrhea.
Tell your health care provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects with FASLODEX. For more information, ask your health care provider or pharmacist. You may report side effects to the FDA at 1-800-FDA-10881-800-FDA-1088.
Approved Uses for 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 or abemaciclib, in women whose disease has progressed after endocrine therapy
When FASLODEX is used in combination with palbociclib, please also see the palbociclib Patient Information.
When FASLODEX is used in combination with abemaciclib, please also see the abemaciclib Patient Information.
It is not known if FASLODEX is safe and effective in children or in people with severe liver problems.
Please see FASLODEX Prescribing Information with Patient Information (Medication Guide).
You should not receive FASLODEX if you have had an allergic reaction to fulvestrant or any of the ingredients in FASLODEX... Read More
Understanding your FASLODEX treatment
Whether you and your doctor are considering FASLODEX, or you are already receiving FASLODEX, it’s important to understand how your medicine works—and what that means for your advanced breast cancer treatment.
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 IBRANCE® (palbociclib) or VerzenioTM (abemaciclib) in women whose disease has progressed after endocrine therapy
Most breast cancers are HR-positive. FASLODEX can be used in HR -positive breast cancer because it is designed to target the estrogen receptor, which is an HR that is present in this type of breast cancer.
FASLODEX may be an appropriate choice for you whether it is used alone or with either IBRANCE or Verzenio. Talk to your doctor about which option may be best for you.
If you have HR-positive, HER2-negative advanced breast cancer and have not been given endocrine therapy for advanced breast cancer, and have gone through menopause, FASLODEX may be an option for your first hormonal therapy. Based on the results of a clinical study called FALCON, FASLODEX can be used instead of an aromatase inhibitor called anastrozole.
If you have been given endocrine therapy for advanced breast cancer and you have HR-positive, HER2-negative advanced breast cancer, FASLODEX with Verzenio may be a treatment option available to you.
Now, let’s break down some of those terms. Understanding these terms can help you take on more of an active role in your treatment.
HR-positive
Breast cancer can be either HR-positive or HR-negative. HR-positive breast cancer uses proteins and hormones to support the growth or spread of the cancer. HR-negative breast cancer does not use hormones to grow.
HR-positive cancer cells depend on HRs, such as estrogen receptors (see definition below) or progesterone receptors (a different type of receptor), to grow. Your doctor may also use the term estrogen receptor-positive.
Ask your doctor if you are not sure what your HR status is.
HER2-negative
HER2 is a type of specialized receiver that can play a role in cancer growth.
Cancer cells can be either HER2-positive or HER2-negative.
HER2-negative cancer cells may grow more slowly than cells with a high amount of HER2.
Ask your doctor if you are not sure what your HER2 status is.
The estrogen receptor
If you have HR-positive metastatic breast cancer (see definition above), this means that the estrogen receptor—pictured near this text—may play a role in your cancer.
The estrogen receptor, which is the most common type of HR, can cause cancer to grow in several ways, explained below.
FASLODEX can connect with estrogen receptors much like how a baseball connects with a glove: by fitting into a specialized receiver. When FASLODEX fits into the estrogen receptor, it may be able to slow cancer growth by blocking* estrogen receptor activation.
*FASLODEX does not block 100% of estrogen receptors.
Why is the estrogen receptor an important factor in HR-positive metastatic breast cancer?
HR-positive breast cancer relies on proteins and hormones inside your body to grow. The estrogen receptor is one of these proteins. It can cause cancer growth in several ways, such as by:
Connecting with estrogen, which is a hormone that can send signals leading to the spread of cancer.
When FASLODEX connects with the estrogen receptor, the estrogen receptor’s ability to connect with estrogen is reduced.
Sending signals that do not rely on estrogen inside cancer cells.
Breast cancer doesn’t always need estrogen to grow. Sometimes, the estrogen receptor can cause cancer growth without estrogen. FASLODEX works on the estrogen receptor rather than on estrogen.
Participating in the cell cycle, which leads to tumor cell division.
Cancer grows when tumor cells divide and multiply. The estrogen receptor can start this process—but FASLODEX may be able to get in the way of the estrogen receptor.
Learn more about how FASLODEX works
FASLODEX acts in many ways. Below, you can learn more about how FASLODEX works on the estrogen receptor—and what that means for your treatment.
FASLODEX acts on the estrogen receptor
Select an option below to learn more about the impact FASLODEX can have on HR-positive metastatic breast cancer growth. FASLODEX is the only approved hormonal medicine that has been shown to interact with the estrogen receptor in these ways.
Connect with the estrogen receptor 
When FASLODEX connects with estrogen receptors,† those estrogen receptors can react by:
- Losing stability, meaning that they will not work as well
- Changing shape, affecting their ability to bind to estrogen
†As demonstrated in laboratory studies.
FASLODEX impacts the way estrogen receptors work by connecting to them.
Block‡ estrogen receptor activation
Estrogen receptors that are connected to FASLODEX have a reduced ability to activate or communicate with estrogen. Inactive estrogen receptors cannot participate in cancer growth.
FASLODEX interferes with estrogen receptors’ ability to activate.
‡FASLODEX does not block 100% of estrogen receptors.
Break down the estrogen receptor
Estrogen receptors that are connected to FASLODEX break down quickly, resulting in fewer estrogen receptors in cancer cells.
Broken down estrogen receptors cannot participate in the process of cancer growth.
Decrease the number of estrogen receptors
When FASLODEX decreases the number of available estrogen receptors in breast cancer cells, estrogen receptors’ ability to cause cancer cells to divide and multiply is impacted.
FASLODEX is associated with a decrease in Ki67, a marker of cancer growth.
Having fewer available estrogen receptors makes it more difficult for estrogen receptors to support cancer growth.
IMPORTANT SAFETY INFORMATION
-
You should not receive FASLODEX if you have had an allergic reaction to fulvestrant or any of the ingredients in FASLODEX. Talk to your health care provider if you experience symptoms of an allergic reaction to FASLODEX, which may include itching or hives; swelling of your face, lips, tongue, or throat; and trouble breathing.
- Have a low level of platelets in your blood or bleed easily. Especially tell your health care provider if you take a blood thinner medicine (anticoagulant)
- Have liver problems
- Are pregnant or plan to become pregnant, because FASLODEX can harm your unborn baby. Women who are able to become pregnant should use effective birth control during treatment with FASLODEX and for 1 year after the final dose. Tell your health care provider right away if you become pregnant or think you are pregnant while on FASLODEX
- Are breastfeeding or plan to breastfeed. It is not known if FASLODEX passes into breast milk. Do not breastfeed during treatment with FASLODEX and for 1 year after the final dose. Talk to your health care provider about the best way to feed your baby during this time
Before receiving FASLODEX, tell your health care provider about all of your medical conditions, including if you:
Tell your health care provider about all of 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.
FASLODEX is administered by your health care provider as an injection into the muscle of each buttock. Your health care provider may change your dose of FASLODEX if needed.
FASLODEX may cause injection site–related nerve damage. Call your health care provider if you develop any of the following symptoms in your legs following a FASLODEX injection: numbness, tingling, or weakness.
Common side effects of FASLODEX include injection site pain; nausea; muscle, joint, and bone pain; headache; tiredness; hot flashes; vomiting; loss of appetite; weakness; cough; shortness of breath; constipation; increased liver enzymes; and diarrhea.
Tell your health care provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects with FASLODEX. For more information, ask your health care provider or pharmacist. You may report side effects to the FDA at 1-800-FDA-10881-800-FDA-1088.
Approved Uses for 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 or abemaciclib, in women whose disease has progressed after endocrine therapy
When FASLODEX is used in combination with palbociclib, please also see the palbociclib Patient Information.
When FASLODEX is used in combination with abemaciclib, please also see the abemaciclib Patient Information.
It is not known if FASLODEX is safe and effective in children or in people with severe liver problems.
Please see FASLODEX Prescribing Information with Patient Information (Medication Guide).
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-10881-800-FDA-1088.
This site is intended for US consumers only.
The information on this Web site should not take the place of talking with your doctor or health care professional. If you have any questions about your condition, or if you would like more information about FASLODEX, talk to your doctor or pharmacist. Only you and your health care professional can decide if FASLODEX is right for you.
IMPORTANT SAFETY INFORMATION
-
You should not receive FASLODEX if you have had an allergic reaction to fulvestrant or any of the ingredients in FASLODEX. Talk to your health care provider if you experience symptoms of an allergic reaction to FASLODEX, which may include itching or hives; swelling of your face, lips, tongue, or throat; and trouble breathing.
- Have a low level of platelets in your blood or bleed easily. Especially tell your health care provider if you take a blood thinner medicine (anticoagulant)
- Have liver problems
- Are pregnant or plan to become pregnant, because FASLODEX can harm your unborn baby. Women who are able to become pregnant should use effective birth control during treatment with FASLODEX and for 1 year after the final dose. Tell your health care provider right away if you become pregnant or think you are pregnant while on FASLODEX
- Are breastfeeding or plan to breastfeed. It is not known if FASLODEX passes into breast milk. Do not breastfeed during treatment with FASLODEX and for 1 year after the final dose. Talk to your health care provider about the best way to feed your baby during this time
Before receiving FASLODEX, tell your health care provider about all of your medical conditions, including if you:
Tell your health care provider about all of 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.
FASLODEX is administered by your health care provider as an injection into the muscle of each buttock. Your health care provider may change your dose of FASLODEX if needed.
FASLODEX may cause injection site–related nerve damage. Call your health care provider if you develop any of the following symptoms in your legs following a FASLODEX injection: numbness, tingling, or weakness.
Common side effects of FASLODEX include injection site pain; nausea; muscle, joint, and bone pain; headache; tiredness; hot flashes; vomiting; loss of appetite; weakness; cough; shortness of breath; constipation; increased liver enzymes; and diarrhea.
Tell your health care provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects with FASLODEX. For more information, ask your health care provider or pharmacist. You may report side effects to the FDA at 1-800-FDA-10881-800-FDA-1088.
Approved Uses for 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 or abemaciclib, in women whose disease has progressed after endocrine therapy
When FASLODEX is used in combination with palbociclib, please also see the palbociclib Patient Information.
When FASLODEX is used in combination with abemaciclib, please also see the abemaciclib Patient Information.
It is not known if FASLODEX is safe and effective in children or in people with severe liver problems.
Please see FASLODEX Prescribing Information with Patient Information (Medication Guide).