Talk to your doctor about FASLODEX with KISQALI® (ribociclib)

FASLODEX is a prescription medicine used to treat postmenopausal women with:

  • HR-positive, HER2-negative advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), in combination with KISQALI as initial endocrine therapy or in women whose disease has progressed after endocrine therapy

Is FASLODEX with KISQALI right for you?

If you...

  • Have gone through menopause
  • Have received a diagnosis of advanced or metastatic breast cancer
  • Your breast cancer is HR-positive, HER2-negative, and...
  • You have not yet received endocrine therapy or your cancer has spread after endocrine therapy...

...then you and your doctor may consider whether FASLODEX with KISQALI 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 who participated in the clinical studies. Talk to your doctor about what you may have in common with the women in the MONALEESA-3 study.

Women in the MONALEESA-3 study*

Almost half (49.2%) of patients received FASLODEX with KISQALI as their first endocrine therapy for advanced breast cancer, while the other half (48.8%) received it as their second.

For patients enrolled in this study, breast cancer had spread to the following locations:

  • Internal organs, such as liver or lungs (60.5% of women)
  • Bone only (21.2%)

If these characteristics apply to you, talk to your doctor about how FASLODEX with KISQALI may be able to help.

*Patients studied in MONALEESA-3 consisted of 726 postmenopausal women with advanced or metastatic breast cancer who had not yet received endocrine therapy or whose disease had progressed following another type of endocrine therapy.

Due to missing data or failing to meet study criteria, prior treatment information was unknown for 14 patients.

The MONALEESA-3 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.

You should not receive FASLODEX if you have had an allergic reaction to fulvestrant or any 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; or trouble breathing. The MONALEESA-3 results applied to all patients in the study.

The most common side effects observed in MONALEESA-3 included decreased white blood cell counts, infections, cough, nausea, diarrhea, vomiting, constipation, itching, and rash.

When FASLODEX is used in combination with KISQALI, also read the KISQALI Patient Information.

IMPORTANT SAFETY INFORMATION ABOUT FASLODEX® (fulvestrant) injection

    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. Your health care provider may perform a pregnancy test within 7 days before starting FASLODEX. Women who are able to become pregnant should use effective birth control during treatment with FASLODEX and for 1 year after the last 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 serious side effects, including 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; back pain; tiredness; pain in arms, hands, legs or feet; 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 advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic).

FASLODEX may be used alone, if you have gone through menopause, and your advanced breast cancer is:

  • hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative and has not been previously treated with endocrine therapy

or

  • HR-positive and has progressed after endocrine therapy

FASLODEX may be used in combination with ribociclib, if you have gone through menopause, and your advanced or metastatic breast cancer is HR-positive and HER2-negative, and has not been previously treated with endocrine therapy or has progressed after endocrine therapy.

FASLODEX may be used in combination with palbociclib or abemaciclib if your advanced or metastatic breast cancer is HR-positive and HER2-negative, and has progressed after endocrine therapy.

When FASLODEX is used in combination with palbociclib, abemaciclib or ribociclib, also read the Patient Information for the prescribed product.

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.

 
 
Read More

IMPORTANT SAFETY INFORMATION ABOUT FASLODEX® (fulvestrant) injection

    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. Your health care provider may perform a pregnancy test within 7 days before starting FASLODEX. Women who are able to become pregnant should use effective birth control during treatment with FASLODEX and for 1 year after the last 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 serious side effects, including 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; back pain; tiredness; pain in arms, hands, legs or feet; 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 advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic).

FASLODEX may be used alone, if you have gone through menopause, and your advanced breast cancer is:

  • hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative and has not been previously treated with endocrine therapy

or

  • HR-positive and has progressed after endocrine therapy

FASLODEX may be used in combination with ribociclib, if you have gone through menopause, and your advanced or metastatic breast cancer is HR-positive and HER2-negative, and has not been previously treated with endocrine therapy or has progressed after endocrine therapy.

FASLODEX may be used in combination with palbociclib or abemaciclib if your advanced or metastatic breast cancer is HR-positive and HER2-negative, and has progressed after endocrine therapy.

When FASLODEX is used in combination with palbociclib, abemaciclib or ribociclib, also read the Patient Information for the prescribed product.

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.