Nilutamide is used to treat prostate cancer that has spread to other parts of the body.

Nilutamide is for use in men who have undergone surgical castration.

Nilutamide may also be used for purposes not listed in this medication guide.

You should not use nilutamide if you have severe liver disease or severe breathing problems.

Nilutamide can cause serious lung problems. Call your doctor right away if you have chest pain, wheezing, dry cough, fever, and new or worsening shortness of breath.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Treatment with nilutamide should be started on the day of or on the day after surgical castration.

You may take nilutamide with or without food.

Do not stop taking this medication without first talking to your doctor.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Prostate Cancer:

-Initial dose: 300 mg orally once a day for first 30 days

-Maintenance dose: 150 mg orally once a day after first 30 days

-Comments: For maximum benefit, treatment should begin on the same day or the day after surgical castration.

Use: Treatment of metastatic prostate cancer (Stage D2) in combination with surgical castration.

You should not use nilutamide if you are allergic to it, or if you have:

• severe liver disease; or

• severe breathing problems.

Tell your doctor if you have ever had:

• liver disease; or

• asthma or another lung disease.

Nilutamide is not for use in women, and the effects of nilutamide during pregnancy or in breastfeeding women are unknown.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

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

Nilutamide may cause a delay in your ability to see in the dark after you have been in a lighted area. Be careful when driving at night, when entering a tunnel, and in similar situations. Wearing tinted glasses may help lessen this effect.

Drinking alcohol with nilutamide may cause dizziness, flushing (warmth, redness, or tingly feeling), or other unpleasant symptoms.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Nilutamide may cause serious side effects. Call your doctor at once if you have:

• chest pain, wheezing, dry cough, fever;

• new or worsening shortness of breath;

• flu symptoms, pale skin, feeling tired; or

• liver problems--nausea, vomiting, loss of appetite, right-sided upper stomach pain, flu-like symptoms, dark urine, jaundice (yellowing of the skin or eyes).

Common side effects of nilutamide may include:

• hot flashes;

• dizziness;

• constipation;

• nausea or vomiting, loss of appetite;

• skin rash;

• decreased libido, impotence; or

• vision changes.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect nilutamide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

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.