Pronunciation:

fool-VES-trant

Brand Names:

• Faslodex

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antiestrogen

Uses of This Medicine:

Fulvestrant is a medicine that is used to treat breast cancer.

Many breast cancer tumors grow in response to estrogen. This medicine blocks the effects of the estrogen hormone in the body. As a result, the amount of estrogen that the tumor is exposed to is reduced, limiting the growth of the tumor.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Older adults—

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems—May be worsened by fulvestrant

• Liver disease—Effects of fulvestrant may be increased because of slower removal from the body

Proper Use of This Medicine:

Fulvestrant is usually given by a health care professional. However, medicines given by injection are sometimes used at home. If you will be using fulvestrant at home, your health care professional will teach you how the injections are to be given. Be certain that you understand exactly how the medicine is to be injected. Do not reuse needles and syringes.

Put used needles and syringes in a puncture-resistant disposable container, or dispose of them as directed by your health care professional.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For parenteral dosage form (injection):
  • For cancer of the breast:
    • Adults—250 milligrams (mg), injected into the muscle of the buttocks on the same day of every month (e.g., the first day of every month). The dose can be given as a single 5 mL (milliliter) injection, or as two 2.5 mL (milliliter) injections, immediately following each other.

Missed dose—

Call your doctor or pharmacist for instructions.

If you miss a dose of this medicine, take it as soon as possible and schedule the next dose 30 days later. Do not double doses or use more often than one dose every 30 days. If you have any questions about this, check with your doctor.

Storage—

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

Your doctor will want to check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for unwanted effects.

For women of childbearing age—It is very important that you do not become pregnant while taking fulvestrant.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Bloating or swelling of face, arms, hands, lower legs, or feet

rapid weight gain

tingling of hands or feet

unusual weight gain or loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

Back pain

bladder pain

bloody or cloudy urine

body aches or pain

bone pain

burning, crawling, itching, numbness, prickling, "pins and needles" , or tingling feelings

chest pain

chills

congestion

cough, increased

diarrhea

difficult, burning, or painful urination

difficult or labored breathing

difficulty having a bowel movement (stool)

discouragement

dizziness

dryness or soreness of throat

feeling faint, dizzy, or light-headedness

feeling of warmth or heat

feeling sad or empty

fever

flushing or redness of skin, especially on face and neck

frequent urge to urinate

general feeling of discomfort or illness

headache

hoarseness

injection site pain

irritability

joint pain

lack or loss of appetite

lack or loss of strength

loss of interest or pleasure

lower back or side pain

muscle aches and pains

nausea

pain

pelvic pain

runny nose

shivering

shortness of breath

skin rash

sleeplessness

sore throat

stomach pain

sweating

tender, swollen glands in neck

tightness in chest

trouble concentrating

trouble in swallowing

trouble sleeping

unable to sleep

unusual tiredness or weakness

voice changes

vomiting

wheezing

Less common

Difficulty in moving

fear

muscle pain or stiffness

nervousness

pain, swelling, or redness in joints

pale skin

troubled breathing with exertion

unusual bleeding or bruising

Rare

Black, tarry stools

feeling of constant movement of self or surroundings

muscle aching or cramping

muscle pains or stiffness

pain in chest, groin, or legs, especially the calves

sensation of spinning

severe, sudden headache

slurred speech

sores, ulcers, or white spots on lips or in mouth

sudden, unexplained shortness of breath

sudden loss of coordination

sudden, severe weakness or numbness in arm or leg

swollen joints

vaginal bleeding

vision changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.