Faslodex

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.

This product is available in the following dosage forms:

• Solution

Before Using

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.

Geriatric

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

Breastfeeding

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.

Drug Interactions

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 problemsa€”May be worsened by fulvestrant

• Liver diseasea€”Effects of fulvestrant may be increased because of slower removal from the body

Proper Use

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:
    
    
    
    • Adultsa€”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

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 agea€”It is very important that you do not become pregnant while taking fulvestrant.

Side Effects

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 .

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.