Fulvestrant (Intramuscular route)
Uses of This Medicine:
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.
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:
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.
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.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fulvestrant injection in the elderly.
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.
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.
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 of This Medicine:
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.
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 While Using This Medicine:
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 of This Medicine:
- More common
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- rapid weight gain
- tingling of the hands or feet
- unusual weight gain or loss
- Less common
- Difficult or labored breathing
- tightness in the chest
- Incidence not known
- Black, tarry stools
- chest pain
- flushing or redness of the skin
- hives or welts, itching, or rash
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- pain in the chest, groin, or legs, especially the calves
- painful or difficult urination
- severe and sudden headache
- slurred speech
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- sudden and severe weakness or numbness in the arm or leg
- sudden loss of coordination
- sudden unexplained shortness of breath
- swollen glands
- unusual bleeding or bruising
- unusual tiredness or weakness
- vaginal bleeding
- vision changes
- 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
- difficulty having a bowel movement (stool)
- difficulty with moving
- dryness or soreness of the throat
- feeling faint, dizzy, or lightheaded
- feeling of warmth or heat
- feeling sad or empty
- frequent urge to urinate
- general feeling of discomfort or illness
- 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
- muscle stiffness
- pain at the injection site
- pain in the arms or legs
- pelvic pain
- stomach pain
- sudden sweating
- tender, swollen glands in the neck
- trouble concentrating
- trouble with swallowing
- unable to sleep
- voice changes
- weight loss
- Less common
- pain, swelling, or redness in the joints
- pale skin
- Incidence not known
- Dizziness or lightheadedness
- feeling of constant movement of self or surroundings
- sensation of spinning
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:
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:
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.
Last Updated: 9/4/2017