Pronunciation:

FLOO-ta-mide

Brand Names:

• Eulexin

Dosage Forms:

• Capsule

Warnings:

Liver failure has been reported in patients taking flutamide. Evidence of hepatic injury occurred usually within the first 3 months and included elevated serum transaminase levels, jaundice, hepatic encephalopathy, and death related to acute hepatic failure. Serum transaminase levels should be measured prior to starting treatment, monthly for the first 4 months of therapy, and periodically thereafter. Flutamide is not recommended in patients whose ALT values exceed twice the upper limit of normal and should be discontinued if the ALT rises above 2 times the upper limit of normal or jaundice occurs during therapy .

Classifications:

Therapeutic—

Antiandrogen

Uses of This Medicine:

Flutamide is used together with a luteinizing hormone-releasing hormone (LHRH) agonist to treat metastatic (cancer that has spread) prostate cancer in men. Flutamide belongs to the group of medicines called antiandrogens. It works by blocking the effects of androgen (a male hormone), to stop the growth and spread of cancer cells.

This medicine is available only with your doctor's prescription.

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—

No information is available on the relationship of age to the effects of flutamide in the pediatric population. Safety and efficacy have not been established.

Older adults—

No information is available on the relationship of age to the effects of flutamide in geriatric patients.

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 taking 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bacillus of Calmette and Guerin Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine
• Typhoid Vaccine
• Varicella Virus Vaccine
• Yellow Fever Vaccine

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.

• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Azathioprine
• Cholera Vaccine
• Ebola Zaire Vaccine, Live
• Influenza Virus Vaccine, Live
• Levoketoconazole
• Mercaptopurine
• Methotrexate
• Pexidartinib
• Rotavirus Vaccine, Live

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:

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency or
• Hemoglobin M disease (blood disorder) or
• Tobacco smoking—This medicine contains aniline, which may cause problems in patients with these conditions.

• Liver disease, severe—Should not be used in patients with this condition.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Flutamide should be taken together with other medicines used for surgery. Do not stop taking these medicines without checking with your doctor first.

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

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For prostate cancer:
    • Adults—Two 125-milligram (mg) capsules three times a day every eight hours for a total daily dose of 750 mg.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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.

Liver problems may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you are having more than one of these symptoms: clay-colored stools; dark urine; fever; headache; loss of appetite; nausea and vomiting; pain or tenderness in the upper right side of the stomach; unusual tiredness or weakness; or yellow eyes or skin.

This medicine may cause gynecomastia (swelling of the breasts and breast soreness) in some patients. If you have questions on this, ask your doctor.

Do not take other medicines unless they have been discussed with your doctor. Your doctor may adjust the doses of your medications or monitor you carefully for side effects.

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 immediately if any of the following side effects occur:

More common

Black, tarry stools

bloody or cloudy urine

continuing diarrhea

continuing stomach pain

difficult, burning, or painful urination

frequent urge to urinate

pale skin

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

Less common

Blurred vision

chest pain

chills

cough

difficulty with breathing

dizziness

drowsiness

fever

headache

nervousness

pounding in the ears

shortness of breath

slow or fast heartbeat

sore throat

sores, ulcers, or white spots on the lips or in the mouth

swelling

swollen glands

Rare

Abdominal or stomach pain

clay-colored stools

dark urine

general tiredness and weakness

itching

light-colored stools

loss of appetite

nausea and vomiting

rash

tumor

unpleasant breath odor

upper right abdominal pain

vomiting of blood

yellow eyes and skin

Incidence not known

Back, leg, or stomach pains

bleeding gums

blistering, peeling, or loosening of the skin

bluish-colored lips, fingernails, or palms

discoloration of the urine

dizziness or lightheadedness

flushing or redness of the skin

general body swelling

headache

itching

joint or muscle pain

nosebleeds

rapid heart rate

red irritated eyes

red skin lesions, often with a purple center

unusually warm skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Goosebumps

shakiness and unsteady walk

tearing of the eyes

unsteadiness, trembling, or other problems with muscle control or coordination

weight loss

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

Decreased interest in sexual intercourse

diarrhea

feeling of warmth

inability to have or keep an erection

indigestion

loss in sexual ability, desire, drive, or performance

passing of gas

redness of the face, neck, arms and occasionally, upper chest

stomach pain, fullness, or discomfort

sudden sweating

swelling of the breasts or breast soreness in both females and males

Less common

Depression

drowsiness

fear or nervousness

mood or mental changes

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.