Talk to your doctor about FASLODEX

FASLODEX is a prescription medicine used to treat HR-positive metastatic breast cancer in women who have gone through menopause and whose disease has spread after treatment with endocrine medicine.

Is FASLODEX, as treatment after previous hormonal therapy, right for you?

If you are postmenopausal and…

  • Have received a diagnosis of metastatic breast cancer and…
  • Your breast cancer is HR-positive and…
  • Your cancer has spread after previous endocrine medicine…

…then you and your doctor may consider whether FASLODEX is right for you.

When your doctor makes treatment decisions, he or she may also think about whether you have anything in common with the women in clinical studies. You may recognize things you have in common with the women below.

Based on these factors and more, you and your doctor can talk about whether FASLODEX is right for you. Talk to your doctor about what you may have in common with the women in the CONFIRM study.

Confirm_study

Women in the CONFIRM study*

Most women (86%) in the CONFIRM study experienced disease progression during or after 1 prior endocrine therapy.

53% of women in the CONFIRM study experienced disease recurrence during or within 12 months of completing hormonal therapy.

In the CONFIRM study, breast cancer spread to the following locations:

  • Organs, such as liver or lungs
  • Bones

If you have HR-positive advanced breast cancer that has spread to any of these locations, talk to your doctor about how FASLODEX may be able to help.

HR=hormone receptor.

*Patients studied in CONFIRM consisted of 736 postmenopausal women with advanced breast cancer who had disease progression on or after 12 months of completing adjuvant endocrine therapy or progression following endocrine therapy for advanced disease.

The CONFIRM study was not designed to suggest use in patients with specific disease characteristics, although you may have some things in common with the women in the study. The CONFIRM results applied to all patients in the study.

You should not receive FASLODEX if you have had an allergic reaction to any of the ingredients in FASLODEX. Symptoms of an allergic reaction to FASLODEX may include itching; swelling of your face, lips, tongue, or throat; or trouble breathing.

The most common side effects observed in CONFIRM included injection site pain; nausea; muscle, joint, and bone pain; headache; tiredness; hot flashes; vomiting; loss of appetite; weakness; cough; constipation; shortness of breath; and increased liver enzymes.

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.

    Before receiving FASLODEX, tell your health care provider about all of your medical conditions, including if you:

  • 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

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).

 
 
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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.

    Before receiving FASLODEX, tell your health care provider about all of your medical conditions, including if you:

  • 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

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).