This medication is used to treat prostate cancer. Nilutamide belongs to a class of drugs known as anti-androgens (anti-testosterone). Testosterone, a natural hormone, helps prostate cancer to grow and spread. Nilutamide works by blocking the effects of testosterone, thereby slowing the growth and spread of prostate cancer.

Take this medication by mouth with or without food as directed by your doctor, usually once daily. If you are taking nilutamide after surgery, it is usually started on the day of surgery or the day after. After 30 days of treatment, your doctor will usually decrease your dose.

The dosage is based on your medical condition and response to treatment. The length of treatment depends on how your body and the cancer respond to nilutamide and other treatments.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Do not stop any medications for your prostate cancer unless told to do so by your doctor. Stopping your medications could allow the cancer to spread more rapidly.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Tell your doctor if your condition lasts or gets worse (such as urination becomes more difficult, bone pain increases).

See also Warning section.

Because nilutamide may be used with other medications, the side effects may be due to any one medicine or the combination of medications. Hot flashes, sweating, dizziness, loss of sexual interest/ability, vision changes (such as difficulty seeing when moving into the dark or light, changes in color vision), stomach pain, constipation, nausea, signs of alcohol intolerance (such as flushing, tiredness) dry skin, increased sensitivity to touch/pain, and loss of body hair may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Rarely, nilutamide has caused severe (sometimes fatal) liver problems. Get medical help right away if you develop symptoms of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine). Liver problems can happen at any time while taking nilutamide, but they occur most often during the first 3-4 months of treatment. Your doctor will tell you whether to stop or continue nilutamide. Your doctor will monitor your liver function with blood tests before you start and while you are taking nilutamide. Keep all medical and lab appointments.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking nilutamide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• lung disease (such as asthma, chronic obstructive pulmonary disease-COPD, emphysema)
• liver problems

This drug may rarely make you dizzy or drowsy or cause vision changes. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. You may also develop intolerance to alcohol while taking this medication. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Nilutamide should not be used by women, especially during pregnancy or breastfeeding. It may harm an unborn or breastfeeding baby. Consult your doctor for more details.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some of the products that may interact with this drug include:

• testosterone (patch, gel, injection)
• anabolic steroids (including over-the-counter androgens/anabolics/testosterone precursors)
• DHEA
• phenytoin
• warfarin

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as liver function, blood PSA test) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details. (See also Warning section.)

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.