Fulvestrant (Intramuscular route)

Pronunciation:

ful-VES-trant

Brand Names:

  • Faslodex

Dosage Forms:

  • Solution

Classifications:

Therapeutic—

Antiestrogen

Uses of This Medicine:

Fulvestrant injection is used to treat hormone-receptor (HR) positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women who have not been previously treated with other medicines. It is also used to treat HR positive breast cancer that has progressed or worsened after hormonal therapy.

Fulvestrant injection is also used together with ribociclib to treat HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women who have not been previously treated with other medicines or whose cancer has progressed or worsened after hormonal therapy.

Fulvestrant injection is also used in combination with palbociclib or abemaciclib to treat HR positive, HER2-negative advanced or metastatic (cancer that has spread) 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 estrogen 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:

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.

Children—

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.

Older adults—

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

Breast-feeding—

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.

Other medicines—

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.
  • Liver disease, severe—Use has not been studied in patients with this condition.

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.

A nurse or other trained health professional will give you this medicine in a medical facility. It is given as a shot into the buttocks slowly on days 1, 15, 29, and once every month thereafter.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Your doctor may also give you other medicines (eg, luteinizing hormone-releasing hormone agonist) while being treated with fulvestrant and palbociclib, abemaciclib, or ribociclib, before your menopause.

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.

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 While Using This Medicine:

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

Receiving 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 receiving 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 receiving the medicine, tell your doctor right away.

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

This medicine may increase your risk of bleeding. This is more likely to occur if you have bleeding problems or if you are 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 receiving 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.

Side Effects of This Medicine:

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
Black, tarry stools
bleeding gums
bloating or swelling of the face, arms, hands, lower legs, or feet
blood in the urine or stools
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
chest pain or tightness
chills
cloudy urine
cough
difficulty breathing
fainting
fever
hoarseness
irregular heartbeat, recurrent
lower back or side pain
painful or difficult urination
pale skin
pinpoint red spots on the skin
rapid weight gain
sore throat
sores, ulcers, or white spots on the lips or in the mouth
tender, swollen glands in the neck
tingling of the hands or feet
trouble with swallowing
troubled breathing with exertion
unusual bleeding or bruising
unusual tiredness or weakness
unusual weight gain or loss
Less common
Anxiety
confusion
dizziness or lightheadedness
fast heartbeat
mood or mental changes
muscle cramps in the hands, arms, feet, legs, or face
numbness and tingling around the mouth, fingertips, or feet
pain in the chest, groin, or legs, especially the calves
pain, redness, or swelling in the arm or leg
seizures
severe, sudden headache
slurred speech
stomach cramps
sudden loss of coordination
sudden, severe weakness or numbness in the arm or leg
tremor
vision changes
Incidence not known
Dark urine
flushing or redness of the skin
general feeling of tiredness or weakness
headache
hives or welts, itching, skin rash
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
light-colored stools
nausea
stomach pain, continuing
upper right abdominal pain
vaginal bleeding
vomiting
yellow eyes or skin

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
body aches or pain
bone pain
change in or loss of taste
constipation
decreased appetite
depression
diarrhea
difficulty having a bowel movement
difficulty with moving
dry skin
dryness or soreness of the throat
feeling of warmth or heat
feeling sad or empty
frequent urge to urinate
general feeling of discomfort or illness
hair loss or thinning of hair
irritability
joint pain
lack or loss of appetite
lack or loss of strength
loss of interest or pleasure
muscle aches and pains
muscle stiffness
pain at the injection site
pain in the arms or legs
pelvic pain
shivering
stomach pain
sudden sweating
trouble concentrating
voice changes
weight loss
Less common
Dry eye
dry mouth
increased tearing
nervousness
swelling or redness in the joints
Incidence not known
Feeling of constant movement of self or surroundings
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.


Last Updated: 6/18/2019

The information provided herein should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed medical professional should be consulted for diagnosis and treatment of any and all medical conditions. Call 911 for all medical emergencies. Links to other sites are provided for information only -- they do not constitute endorsements of those other sites.

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The information provided herein should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed medical professional should be consulted for diagnosis and treatment of any and all medical conditions. Call 911 for all medical emergencies. Links to other sites are provided for information only -- they do not constitute endorsements of those other sites.
All rights reserved.

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