FULVESTRANT (Systemic)?
Some commonly used brand names are:
In the U.S.?
? Not commercially available in Canada.
Category
Description
Fulvestrant (Fool-VES-trant) is a medicine that is used to treat breastcancer.
Many breast cancer tumors grow in response to estrogen. This medicine blocksthe effects of the estrogen hormone in the body. As a result, the amount ofestrogen that the tumor is exposed to is reduced, limiting the growth of thetumor.
This medicine is available only with your doctor's prescription, in thefollowing dosage form:
Parenteral- Injection (U.S.)
Before Using This Medicine
In decidingto use a medicine, the risks of using the medicine must be weighed againstthe good it will do. This is a decision you and your doctor will make. Forfulvestrant the following should be considered:
Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to fulvestrant. Also tell your doctor and pharmacistif you are allergic to any other substances, such as foods, preservatives,or dyes.
Pregnancy?Tell your doctor if you are pregnant or if youintend to become pregnant. Fulvestrant has not been studied in pregnant women.However, studies in animals have shown that fulvestrant causes serious problemswith the fetus. Be sure that you have discussed this with your doctor beforetaking this medicine. It is best to avoid pregnancy during treatment withthis medicine.
Tell your doctor right away if you think you have become pregnant whiletaking fulvestrant
Breast-feeding?It is not known whether fulvestrant passes intothe breast milk. However, because this medicine may cause serious side effects,breast-feeding generally is not recommended while you are taking it.
Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults or if they cause different side effectsor problems in older people.
Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your health careprofessional if you are taking any other prescription or nonprescription (over-the-counter[OTC]) medicine. When you are taking fulvestrant, it is especially importantthat your doctor and pharmacist know if you are taking any of the following:
- Anticoagulants (e.g., Coumadin, Warfarin sodium)?may increasethe risk of bleeding or bruising
Other medical problems?The presence of other medicalproblems may affect the use of fulvestrant. Make sure you tell your doctorif you have any other medical problems, especially:
- Bleeding problems?May be worsened by fulvestrant
- Liver disease?Effects of fulvestrant may be increased becauseof slower removal from the body
Proper Use of This Medicine
Fulvestrantis usually given by a health care professional. However, medicines given byinjection are sometimes used at home. If you will be using fulvestrant athome, your health care professional will teach you how the injections areto be given. Be certain that you understand exactly howthe medicine is to be injected. Do not reuse needles and syringes.
Put used needles and syringes in a puncture-resistantdisposable container, or dispose of them as directed by your healthcare professional.
Dosing?The dose of fulvestrant will be differentfor different patients.Follow your doctor's orders orthe directions on the label. The following information includes onlythe average doses of fulvestrant.
- For parenteral dosage form (injection):
- For cancer of the breast:
- Adults?250 milligrams (mg), injected into the muscle of thebuttocks 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 2.5mL (milliliter) injections, immediately following each other.
Missed dose?If you miss a dose of this medicine, take it as soon as possibleand schedule the next dose 30 days later. Do not double doses or use moreoften than one dose every 30 days. If you have any questions about this, checkwith your doctor.
Storage?To store this medicine:
- Store in the refrigerator.
- Protect from light, store in original container.
- Keep out of the reach of children.
- Do not keep outdated medicine or medicine no longer needed. Ask yourhealth care professional how you should dispose of any medicine you do notuse. Be sure that any discarded medicine is out of the reach of children.
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 properlyand to check for unwanted effects.
For women of childbearing age?It is very important that you do notbecome pregnant while taking fulvestrant.
Side Effects of This Medicine
Along with its needed effects, a medicinemay cause some unwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.
Otherside effects may occur that usually do not need medical attention. These sideeffects may go away during treatment as your body adjusts to the medicine.However, check with your doctor if any of the following side effects continueor are bothersome.
More Common
Back pain ; bladder pain; bloody or cloudy urine; body aches orpain; bone pain; burning,crawling, itching, numbness, prickling, "pins and needles" , or tingling feelings; chest pain; chills; congestion; cough, increased ; diarrhea ; difficult, burning, or painfulurination; 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 feelingof discomfort or illness; headache; hoarseness; injection site pain; irritability; joint pain; lack or loss of appetite; lack or lossof strength; loss of interest or pleasure; lower back or side pain; muscle achesand pains; nausea; pain; pelvic pain ; runny nose; shivering; shortness ofbreath; skin rash ; sleeplessness; sore throat; stomach pain; sweating; tender, swollenglands in neck; tightness in chest; trouble concentrating; trouble in swallowing; trouble sleeping; unableto sleep; unusual tiredness or weakness; voice changes; vomiting; wheezing
Rare
Black, tarry stools; feeling of constantmovement of self or surroundings; muscle achingor cramping; muscle pains or stiffness; pain in chest, groin, or legs, especially the calves; sensation of spinning; severe, suddenheadache; slurred speech; sores, ulcers, or white spots on lips or in mouth; sudden, unexplained shortness of breath; sudden lossof coordination; sudden, severe weakness or numbnessin arm or leg; swollen joints; vaginal bleeding ; vision changes
Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.
Developed: 01/21/2003
Revised: 03/10/2004
