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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Fluoroestradiol F 18
• Levoketoconazole
• Methotrexate

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.