Side effects of FASLODEX

Be sure to discuss any side effects with your doctor

As with any medication, you may experience side effects while taking FASLODEX. If you are concerned about any symptoms you may be experiencing, you should contact your doctor’s office right away. The most common side effects below were reported in the CONFIRM study.

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Injection site pain

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Nausea

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Muscle, joint, and bone pain

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Headache

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Tiredness

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Hot flashes

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Vomiting

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Loss of appetite

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Weakness

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Cough

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Constipation

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Shortness of breath

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Increased liver enzymes

0.6% of patients receiving FASLODEX 500 mg and 0.8% of patients receiving FASLODEX 250 mg withdrew from treatment due to drug-related side effects.

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.

FASLODEX was not studied in patients with severe liver problems.

FASLODEX is administered as a shot into the muscle of your buttock.

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, weakness.

IMPORTANT SAFETY INFORMATION

  • 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; trouble breathing
  • 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. Especially tell your healthcare provider if you take a blood thinner medicine (anticoagulants)
  • Have liver problems
  • Are pregnant or plan to become pregnant, as 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. Tell your healthcare provider right away if you become pregnant or think you are pregnant while on FASLODEX
  • Are breast-feeding or plan to breast-feed. It is not known if FASLODEX passes into breast milk. Do not breast-feed during treatment with FASLODEX and for one year after the last dose. Talk to your healthcare provider about the best way to feed your baby during this time
  • FASLODEX is administered as a shot into the muscle of your buttock.

    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.

    The most 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; and increased liver enzymes.

Tell your healthcare 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 healthcare provider or pharmacist.

Approved Uses for FASLODEX

FASLODEX is a prescription medicine used to treat:

  • hormone receptor (HR)-positive breast cancer in women who have gone through menopause whose disease has spread after treatment with antiestrogen medicine, OR
  • HR-positive, human epidermal growth factor receptor 2 (HER2)‐negative breast cancer whose disease has spread to other parts of the body (metastatic) in combination with palbociclib in women with disease progression after hormonal therapy
  • When FASLODEX is used in combination with palbociclib, please also see the palbociclib Patient Information.

Please see FASLODEX Prescribing Information with Patient Information.

 
 
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IMPORTANT SAFETY INFORMATION

  • 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; trouble breathing
  • 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. Especially tell your healthcare provider if you take a blood thinner medicine (anticoagulants)
  • Have liver problems
  • Are pregnant or plan to become pregnant, as 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. Tell your healthcare provider right away if you become pregnant or think you are pregnant while on FASLODEX
  • Are breast-feeding or plan to breast-feed. It is not known if FASLODEX passes into breast milk. Do not breast-feed during treatment with FASLODEX and for one year after the last dose. Talk to your healthcare provider about the best way to feed your baby during this time
  • FASLODEX is administered as a shot into the muscle of your buttock.

    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.

    The most 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; and increased liver enzymes.

Tell your healthcare 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 healthcare provider or pharmacist.

Approved Uses for FASLODEX

FASLODEX is a prescription medicine used to treat:

  • hormone receptor (HR)-positive breast cancer in women who have gone through menopause whose disease has spread after treatment with antiestrogen medicine, OR
  • HR-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer whose disease has spread to other parts of the body (metastatic) in combination with palbociclib in women with disease progression after hormonal therapy
  • When FASLODEX is used in combination with palbociclib, please also see the palbociclib Patient Information.