Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Faslodex

Descriptions


Fulvestrant injection is used to treat metastatic breast cancer (cancer that has spread) that is hormone-receptor positive in women who have already stopped menstruating (postmenopausal). It is used for women who have breast cancer that has not improved after using other cancer medicines.

Many of the breast cancer tumors will grow when estrogen is available in the body. 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, which will limit 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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of fulvestrant injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fulvestrant injection in the elderly.

Pregnancy

Information about this fulvestrant-intramuscular-route
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.

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 problems or
  • Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine. This medicine is given as a shot into one of your buttocks muscles.

Fulvestrant injection comes with patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that the medicine is working properly. Blood tests may be needed to check for unwanted effects.

It is unlikely that a postmenopausal woman may become pregnant. But, you should know that using this medicine while you are pregnant could harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

This medicine may cause you to have bleeding from the vagina, especially when you first start using it. If the bleeding continues or is bothersome, check with your doctor right away.

Cancer medicines can cause nausea or vomiting, even after receiving medicines to prevent it. If you have nausea and vomiting after receiving this medicine, talk to your doctor or nurse about ways to control these effects.

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 or nurse immediately if any of the following side effects occur:

More common

  1. Bloating or swelling of the face, arms, hands, lower legs, or feet
  2. rapid weight gain
  3. tingling of the hands or feet
  4. unusual weight gain or loss

Less common

  1. Difficult or labored breathing
  2. shortness of breath
  3. tightness in the chest
  4. wheezing

Incidence not known

  1. Black, tarry stools
  2. chest pain
  3. chills
  4. cough
  5. fever
  6. flushing or redness of the skin
  7. hives or welts
  8. itching
  9. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  10. pain in the chest, groin, or legs, especially the calves
  11. painful or difficult urination
  12. severe and sudden headache
  13. skin rash
  14. slurred speech
  15. sore throat
  16. sores, ulcers, or white spots on the lips or in the mouth
  17. sudden loss of coordination
  18. sudden and severe weakness or numbness in the arm or leg
  19. sudden unexplained shortness of breath
  20. swollen glands
  21. unusual bleeding or bruising
  22. unusual tiredness or weakness
  23. vaginal bleeding
  24. vision changes

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

  1. Back pain
  2. bladder pain
  3. bloody or cloudy urine
  4. body aches or pain
  5. bone pain
  6. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  7. depression
  8. diarrhea
  9. difficulty having a bowel movement (stool)
  10. difficulty with moving
  11. dizziness
  12. dryness or soreness of the throat
  13. feeling faint, dizzy, or lightheaded
  14. feeling of warmth or heat
  15. feeling sad or empty
  16. frequent urge to urinate
  17. general feeling of discomfort or illness
  18. headache
  19. hoarseness
  20. irritability
  21. joint pain
  22. lack or loss of appetite
  23. lack or loss of strength
  24. loss of interest or pleasure
  25. lower back or side pain
  26. muscle aches and pains
  27. muscle stiffness
  28. nausea
  29. pain at the injection site
  30. pain in the arms or legs
  31. pelvic pain
  32. shivering
  33. skin rash
  34. stomach pain
  35. sudden sweating
  36. tender, swollen glands in the neck
  37. trouble concentrating
  38. trouble with swallowing
  39. unable to sleep
  40. voice changes
  41. vomiting
  42. weight loss

Less common

  1. Nervousness
  2. pain, swelling, or redness in the joints
  3. pale skin

Incidence not known

  1. Dizziness or lightheadedness
  2. feeling of constant movement of self or surroundings
  3. sensation of spinning

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.