Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Faslodex

Descriptions


Fulvestrant injection is used to treat hormone-receptor positive metastatic breast cancer (cancer that has spread) in postmenopausal women that have received other cancer medicines that did not work well. This medicine is also used in combination with palbociclib to treat HR positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in women who have received hormonal therapy.

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 to be given only by or under the direct supervision of your doctor.

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.

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, moderate—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 the buttocks slowly on days 1, 15, 29 and once monthly thereafter.

This medicine 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.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test 7 days before you start using this medicine to make sure you are not pregnant. Use a highly effective form of birth control to keep from getting pregnant during treatment and for 1 year after your last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may increase your risk of bleeding. This is more likely to occur if you have bleeding problems or taking a blood thinner (eg, warfarin). Tell your doctor right away if you have unusual bleeding or bruising after receiving this medicine.

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.

Tell your doctor if you have numbness, tingling, or weakness in your legs after receiving this medicine.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests (eg, serum estradiol) may be affected by this medicine.

Talk with your doctor before using this medicine if you plan to have children. Some men and women who use this medicine have become infertile (unable to have children).

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. tightness in the chest

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, itching, or rash
  8. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  9. pain in the chest, groin, or legs, especially the calves
  10. painful or difficult urination
  11. severe and sudden headache
  12. slurred speech
  13. sore throat
  14. sores, ulcers, or white spots on the lips or in the mouth
  15. sudden and severe weakness or numbness in the arm or leg
  16. sudden loss of coordination
  17. sudden unexplained shortness of breath
  18. swollen glands
  19. unusual bleeding or bruising
  20. unusual tiredness or weakness
  21. vaginal bleeding
  22. 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. stomach pain
  34. sudden sweating
  35. tender, swollen glands in the neck
  36. trouble concentrating
  37. trouble with swallowing
  38. unable to sleep
  39. voice changes
  40. vomiting
  41. 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.