Nilutamide may cause lung disease that can be serious or life-threatening. Tell your doctor if you have or have ever had any type of lung disease. If you experience any of the following symptoms, stop taking nilutamide and call your doctor immediately: shortness of breath, cough, chest pain, or fever.

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

Talk to your doctor about the risks of taking nilutamide.

Nilutamide is used after surgery to treat prostate cancer. Nilutamide is in a class of medications called antiandrogens. It works by blocking the effect of androgen (a male hormone), to stop the growth and spread of cancer cells.

Nilutamide comes as a tablet to take by mouth. It is usually taken with or without food once daily. Take nilutamide at around the same time 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 nilutamide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

You should begin taking nilutamide the day of or the day after your surgery. After about 30 days of treatment, your doctor will probably decrease your dose. The length of treatment depends on how well your body responds to nilutamide. Continue to take nilutamide even if you feel well. Do not stop taking nilutamide without talking to your doctor.

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

Before taking nilutamide,

• tell your doctor and pharmacist if you are allergic to nilutamide, bicalutamide, 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 any of the following: anticoagulants (‘blood thinners’) such as warfarin (Coumadin), phenytoin (Dilantin), and theophylline (Theo-Dur, Slo-Phyllin, others). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had liver or lung disease.
• you should know that nilutamide is only for use in men. Women should not take nilutamide, especially if they are pregnant or could become pregnant or are breast-feeding. If a pregnant woman takes nilutamide, she should call her doctor.
• ask your doctor about the safe use of alcoholic beverages while you are taking nilutamide. Alcohol can make the side effects from nilutamide worse.
• you should know that you may have trouble seeing for a few seconds to a few minutes when you move from a lighted area to a dark area. You should be careful driving at night or through tunnels. Wearing tinted glasses may help your eyes adjust to changes in light while you are taking nilutamide.

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.

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

• constipation
• dizziness
• hot flashes
• visual changes

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• yellowing of the skin or eyes
• nausea
• vomiting
• stomach pain
• pain in the upper right part of the stomach
• extreme tiredness
• loss of appetite
• flu-like symptoms
• dark urine

Nilutamide 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).

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.

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

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:

• nausea
• vomiting
• headache
• dizziness

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.

• Nilandron^®