Faslodex

Generic name: Fulvestrant

Usage of Faslodex

Faslodex is an anti-estrogen medication. It works by blocking the actions of estrogen in the body. Certain types of breast cancer use estrogen to grow and multiply in the body.

Faslodex is used in postmenopausal women with hormone-related breast cancer that is advanced or has spread to other parts of the body (metastatic).

Faslodex is used alone or in combination with another medicine called ribociclib (Kisqali) to treat HR-positive, HER2-negative breast cancer in:

  • women with no prior treatment; or
  • women whose cancer has progressed after treatment with anti-estrogen medication.
  • Faslodex is used in combination with palbociclib (Ibrance) or abemaciclib (Verzenio) when the cancer has progressed after treatment with anti-estrogen medication.

    Faslodex side effects

    Get emergency medical help if you have signs of an allergic Reaction to Faslodex: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

    Call your doctor at once if you have:

  • signs of nerve damage - numbness, tingling, weakness, or burning pain in your buttocks, back, or leg.
  • Common Faslodex side effects may include:

  • pain where the medicine was injected;
  • headache;
  • pain in your arms, legs, feet, or back;
  • bone pain, joint pain, muscle pain;
  • nausea, vomiting, loss of appetite;
  • diarrhea, constipation;
  • weakness, feeling tired;
  • cough, feeling short of breath;
  • hot flashes; or
  • abnormal liver function tests.
  • This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Before taking Faslodex

    You should not be treated with Faslodex if you are allergic to fulvestrant, or if you are pregnant.

    Tell your doctor if you have ever had:

  • liver disease;
  • bleeding problems; or
  • thrombocytopenia (a low level of platelets in the blood).
  • You may need to have a negative pregnancy test 7 days before starting this treatment.

    Fulvestrant may harm an unborn baby. Use effective birth control to prevent pregnancy while using this medicine and for at least 1 year after your last dose. Tell your doctor right away if you become pregnant during this time.

    Faslodex may affect fertility (ability to have children) in both men and women. However, it is important for women to use birth control to prevent pregnancy because fulvestrant can harm an unborn baby.

    Do not breastfeed while using Faslodex, and for at least 1 year after your last dose.

    How to use Faslodex

    Usual Adult Dose of Faslodex for Breast Cancer:

    Monotherapy: 500 mg IM into the buttocks (gluteal area) slowly (1 to 2 minutes per injection) as two 5 mL injections, one in each buttock, on days 1, 15, 29 and once monthly thereafter Combination Therapy: In combination with palbociclib or abemaciclib: 500 mg IM into the buttocks (gluteal area) slowly (1 to 2 minutes per injection) as two 5 mL injections, one in each buttock, on days 1, 15, 29 and once monthly thereafter Comments: -This drug is not recommended for use in men. -When this drug is used in combination with palbociclib, the recommended dose of palbociclib is 125 mg orally once daily for 21 consecutive days followed by 7 days off therapy for a complete cycle of 28 days. Palbociclib should be taken with food. Refer to the prescribing information for palbociclib. -When this drug is used in combination with abemaciclib, the recommended dose of abemaciclib is 150 mg orally 2 times a day. Abemaciclib may be taken with or without food. Refer to the prescribing information for abemaciclib. -Pre- or peri-menopausal women treated with the combination of this drug plus palbociclib or abemaciclib should be treated with luteinizing hormone-releasing hormone (LHRH) agonists according to current guidelines. Uses: -As monotherapy for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy or HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy -For HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy

    Warnings

    You should not receive Faslodex if you are pregnant.

    Avoid getting pregnant or breast-feeding a baby for at least 1 year after you stop using this medicine.

    Before you receive Faslodex, tell your doctor if you have liver disease, a bleeding or blood-clotting disorder, or thrombocytopenia (a low level of platelets in the blood). Also tell your doctor if you are taking a blood thinner such as Warfarin (Coumadin, Jantoven).

    Call your doctor for instructions if you miss an appointment for your injection.

    What other drugs will affect Faslodex

    Tell your doctor about all your other medicines, especially:

  • a blood thinner - warfarin, Coumadin, Jantoven.
  • This list is not complete. Other drugs may interact with fulvestrant, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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