Fulvestrant Solution for injection

What is this medicine?

FULVESTRANT (ful VES trant) blocks the effects of estrogen. It is used to treat breast cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• bleeding problems

• liver disease

• low levels of platelets in the blood

• an unusual or allergic reaction to fulvestrant, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection into a muscle. It is usually given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

• medicines that treat or prevent blood clots like warfarin, enoxaparin, and dalteparin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine. You will need important blood work done while you are taking this medicine.

Do not become pregnant while taking this medicine or for at least 1 year after stopping it. Women of child-bearing potential will need to have a negative pregnancy test before starting this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Men should inform their doctors if they wish to father a child. This medicine may lower sperm counts. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine or for 1 year after the last dose.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• feeling faint or lightheaded, falls

• pain, tingling, numbness, or weakness in the legs

• signs and symptoms of infection like fever or chills; cough; flu-like symptoms; sore throat

• vaginal bleeding

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• aches, pains

• constipation

• diarrhea

• headache

• hot flashes

• nausea, vomiting

• pain at site where injected

• stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.