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Faslodex

Generic Name: Fullvestrant [ full-VEStrant]
Drug Classes: Estrogen antagonists Hormones/antineoplastics

What is Faslodex?

Faslodex is an anti-estrogen drug. It blocks the action of estrogen. Some breast cancers use estrogen to multiply and grow in the body. Faslodex can be used to treat advanced or metastatic hormone-related cancerous breasts in women who are postmenopausal. Faslodex can be used alone or with another drug called Ribociclib (Kisqali) to treat HR-positive and HER2-negative cancers in women.

  • Women who have never received treatment before;
  • Women whose cancer has advanced after anti-estrogen treatment

Faslodex can be used with Palbociclib or Abemaciclib Verzenio when cancer has progressed following treatment with anti-estrogen medications.

Warnings

If you are pregnant, it is not recommended that you receive Faslodex. After stopping this medication, you should not become pregnant or breastfeed a child for at least one year. Tell your doctor before you receive Faslodex if you suffer from liver disease, bleeding disorders, blood clotting disorders, or thrombocytopenia. Tell your doctor if warfarin, Coumadin, or Jantoven is a blood-thinning medication you take. If you are unable to attend your scheduled injection, call your doctor.

Before you take this drug

Faslodex should not be used if the patient is allergic to fulvestrant or pregnant.

Tell your doctor about any of the following:

  • Liver disease
  • Bleeding problems
  • Thrombocytopenia

Prior to beginning treatment, it may be prudent to conduct a pregnancy test seven days earlier. Fulvestrants can harm an unborn child. Prevent pregnancy by using effective birth control while taking this medication and for 1 year following your last dose. Faslodex can affect both men and women's fertility (ability to have children). It is still important that women use birth control in order to avoid pregnancy, as fulvestrants may harm the unborn child. Do not breastfeed for 1 year or more after the last dose of Faslodex.

How to take Faslodex?

Faslodex can be injected into your buttock muscle in two separate injections. This injection will be given by a healthcare professional. It can take as long as 2 minutes for each injection. Faslodex can be given up to once every two weeks initially, then once per month. These medicines must be taken orally and according to a daily schedule. Palbociclib can be taken either with or without food. Dosage instructions should be followed very closely. You should always follow the instructions on your medication, and be sure to read any medication guides that you may receive.Do not alter your dosage or schedule without consulting first with your physician. Tell your doctor, if you're a woman taking Faslodex and abemaciclib (or palbociclib), if you still have symptoms of menopause. These include irregular periods, night sweats, or vaginal drying. You may require an additional hormone medication.

Details on dosage

Faslodex adult dosage for breast cancer:
Monotherapy:
On days 1, 15, 29, and every month thereafter, inject 500 mg IM slowly into the buttocks.
Combination Therapy
On days 1, 15, 29, and every month thereafter, administer 500 mg IM in the buttocks (gluteal region) as two 5-mL injections.
Comments:
This drug is not for men.
When this drug is combined with palbociclib, the recommended dose is 125mg orally, once daily for 21 days consecutively, followed by 7 days off therapy to complete a cycle of 28 days. Palbociclib must be taken with food. Consult the Palbociclib prescribing information.
When this drug is taken in conjunction with abemaciclib, the recommended dosage of abemaciclib will be 150 mg, orally twice a day. Abemaciclib can be taken with or without food. Consult the abemaciclib prescribing information.
According to current guidelines, women who are pre- or perimenopausal and treated with this drug in combination with palbociclib (or abemaciclib) should also be treated with LHRH agonists.
Uses:
Advanced breast cancers that are hormone receptor positive (HR), human epidermal growth factor receptor 2 (HER2) positive or both in postmenopausal women without prior therapy is appropriate as an option for treatment as monotherapy.treated with endocrine treatment or in HR-positive breast cancers in postmenopausal postmenopausal patients with progression of disease following endocrine treatment
For women with a progressive disease after endocrine treatment and HR-positive or HER2-negative metastatic or advanced breast cancer, palbociclib/abemaciclib is recommended.

What happens if I miss the dose?

If you miss your Faslodex appointment, contact your physician as soon as possible for instructions.

What happens if I overdose?

Overdoses of this medication are unlikely, since it is administered under medical supervision in an institutionalized setting.

What should be avoided?

Fulvestrant may pass into bodily fluids (urine feces or vomit). Avoid letting your body fluids come into contact with surfaces or your hands for at least 48 hours after receiving a dose. While cleaning up body fluids from a patient, handling contaminated garbage or laundry, or changing diapers, caregivers should wear rubber gloves.Hands should always be washed both before and after taking off gloves.Separately, wash soiled linens and clothing.

Side effects of Faslodex

If you experience symptoms indicative of an allergic reaction such as hives, difficulty breathing or swelling to your lips, face, tongue or throat - make sure that emergency medical assistance is sought immediately.

If you experience:

  • Signs of Nerve Damage: Numbness, tingling, or weakness in your buttocks, back, or leg

Faslodex can cause a variety of side effects.

  • Pain where the medication was injected
  • Headache;
  • You may experience pain in your legs, arms, feet, or back.
  • Bone pain, joint pain, muscle pain;
  • Nausea; vomiting; loss of appetite
  • Diarrhea, constipation;
  • Feeling tired or weak
  • Feeling short of breath, coughing;
  • Hot flashes
  • Abnormal liver function tests

There may be other side effects.Call your doctor immediately if experiencing side effects; or reach out to the FDA at 1-800-FDA-1088 in order to report side effects.

Interaction with other drug

Be sure to notify your physician of all medications being taken, such as:

  • A blood thinner Warfarin Coumadin Jantoven

This list is incomplete. Other drugs, such as vitamins and herbs, may interact with the fulvestrant. This list does not encompass all possible drug interactions.

DRUG STATUS

Availability

Prescription only

Pregnancy & Lactation

CSA Schedule*
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