FASLODEX with VerzenioTM (abemaciclib)
Side Effects

Be sure to discuss any side effects with your doctor

As with any medication, you may experience side effects while taking FASLODEX with VerzenioTM (abemaciclib). If you are concerned about any symptoms you may be experiencing, you should contact your doctor’s office right away. The common side effects below were observed in the MONARCH 2 study and were seen more often in women receiving FASLODEX with Verzenio than in those who received FASLODEX and placebo (the control arm).

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Diarrhea

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Nausea

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Tiredness

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Decreased red blood cells, white blood cells, and/or platelets

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Decreased appetite

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Vomiting

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Headache

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Decreased taste sensitivity

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Sudden hair loss

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Swelling and sores inside the mouth

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Coughing

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Rash

Clots forming in the blood vessels (including clots in deep veins [usually legs], clots in the veins in the lungs, clots in veins that drain blood from the brain, clots in the veins under the collarbone, clots in the veins in the armpits, and clots in the veins carrying blood into the heart) were reported in 5% of patients in the FASLODEX with Verzenio arm of the MONARCH 2 study vs 0.9% of patients in the control arm.

Four patients in the FASLODEX with Verzenio arm experienced clots in the veins in the lungs, none of which resulted in death.

Because FASLODEX is metabolized, or broken down, primarily in the liver, a monthly dose of 250 mg is recommended for patients with moderate liver problems.

It is not known if FASLODEX is effective in patients with severe liver problems.

When FASLODEX is used in combination with Verzenio, please also see the Verzenio Patient 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.

    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).