Nilutamide

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

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

Nilutamide may also be used for reasons not mentioned in this medication guide.

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

Start treatment with nilutamide on the day of or the day after surgical castration.

You can take nilutamide with or without food.

Do not stop taking this medication without first discussing it with your doctor.

Store at room temperature, away from moisture and heat.

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, or new or worsening shortness of breath.

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.

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

Nilutamide may cause serious side effects. Call your doctor immediately 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, pain in the upper right side of your stomach, 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
• changes in vision.

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.

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.

Take the medicine as soon as possible if you miss a dose, but skip it if it's almost time for your next dose. Do not take two doses at once.

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

Nilutamide may delay your ability to see in the dark after being in a lighted area. Be cautious when driving at night, entering a tunnel, and in similar situations. Wearing tinted glasses may help reduce this effect.

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

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.