Fulvestrant, Injection

________________________________________________________________________

KEY POINTS

• This medicine is given by injection to treat breast cancer.
• Keep all appointments for checkups to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: antineoplastic (anticancer); estrogen receptor antagonist

Generic and brand names: fulvestrant, injection; Faslodex

What is this medicine used for?

This medicine is given by injection (shot) to treat breast cancer in women who have been through menopause (no longer have monthly periods). This treatment is used when the cancer has continued after antiestrogen treatment.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A bleeding disorder
• Liver disease

Also, tell your provider if you take medicine that reduces the chance of blood clots forming such as warfarin (Coumadin) or dabigatran (Pradaxa).

This medicine may make you sterile (unable to have children). If you plan to have children someday, talk with your healthcare provider before you start treatment.

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. Use an effective method of birth control while you are receiving this medicine and for 1 year after your therapy is completed. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are receiving this medicine

How do I use it?

Your healthcare provider will give you the shots. The first 3 shots will be given every 2 weeks. Then the shots will be given once a month. This medicine is given by a shot deep into a muscle of the buttocks. The length of treatment will depend on your response to this medicine. Keep all appointment for shots.

What should I watch out for?

You need regular checkups while receiving this medicine. Keep all appointments.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you have received this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Unusual bruising or bleeding; severe dizziness; fever; chest pain; shortness of breath; numbness, weakness, or tingling in the legs or feet; vaginal bleeding; severe stomach pain; light-colored bowel movements; dark urine; yellowing of eyes or skin.

Other: Nausea, vomiting, constipation, diarrhea, abdominal pain, headache, hot flashes, cough, hoarseness, trouble sleeping, swelling or pain at the injection site, bone or joint pain, back pain, weakness, urinary tract infection, loss of appetite, dizziness, swelling of hands or feet.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Medicines to treat or prevent blood clots such as apixaban (Eliquis), clopidogrel (Plavix), dabigatran (Pradaxa), dalteparin (Fragmin), edoxaban (Savaysa), enoxaparin (Lovenox), heparin, rivaroxaban (Xarelto), ticagrelor (Brilinta), and warfarin (Coumadin)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.