Flutamide may cause liver damage that can be serious or life-threatening. Tell your doctor if you have or have ever had liver disease. If you experience any of the following symptoms, call your doctor immediately: nausea, vomiting, loss of appetite, extreme tiredness, flu-like symptoms, muscle aches, soreness, pain in the upper right part of the stomach, yellowing of the skin or eyes, or dark urine.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain blood tests to check how well your liver is working before you begin taking flutamide, every month for the first 4 months of your treatment, and periodically for as long as your treatment continues.

Talk to your doctor about the risks of taking flutamide.

Flutamide is used together with a luteinizing hormone-releasing hormone agonist (LHRH; a type of hormonal injection such as leuprolide [Lupron, Eligard], goserelin [Zoladex], or triptorelin [Trelstar]) to treat certain types of prostate cancer. Flutamide is in a class of medications called nonsteroidal antiandrogens. It works by blocking the effects of androgen (a male hormone) to stop the growth and spread of cancer cells.

Flutamide comes as a capsule to take by mouth. It is usually taken with or without food every 8 hours (three times a day.) Take flutamide at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take flutamide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Continue to take flutamide along with the LHRH agonist treatment even if you feel well. Do not stop taking either medication without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking flutamide,

• tell your doctor and pharmacist if you are allergic to flutamide or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention anticoagulants (”blood thinners”) such as warfarin (Coumadin).
• tell your doctor if you smoke and if you have or have ever had any inherited blood diseases such as glucose-6-phosphate dehydrogenase (G-6-PD) deficiency or hemoglobin M disease.
• you should know that flutamide is only for use in men. If taken by pregnant women, flutamide can harm the fetus. Women who are or may become pregnant should not take flutamide. If you take flutamide while you are pregnant, call your doctor.
• ask your doctor about the safe use of alcoholic beverages while you are taking flutamide. Flutamide may cause facial flushing, and drinking alcohol can make it worse.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Flutamide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• nausea
• vomiting
• loss of appetite
• hot flashes
• decrease in sexual ability or desire
• breast enlargement in men
• drowsiness
• confusion
• depression
• anxiety
• swelling of the hands, feet, ankles, or lower legs
• blue-green or orange-colored urine

Some side effects can be serious. If you experience any of the symptoms listed in the IMPORTANT WARNING section, call your doctor immediately.

Although it is rare, some men taking flutamide have developed breast cancer. Talk to your doctor about the risks of taking this medication.

Flutamide may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• breast enlargement and tenderness

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body’s response to flutamide.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Eulexin^®¶