Nilutamide belongs to a group of medications known as nonsteroidal antiandrogens. Nonsteroidal antiandrogens such as nilutamide block the effect of the male hormone testosterone in the body. Prostate cancer cells require testosterone in order to grow and reproduce. Nilutamide is used in combination with surgery to reduce the amount of testosterone in the body for the treatment of prostate cancer.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The recommended dose for nilutamide is 300 mg once daily before breakfast for the first month of treatment, followed by 150 mg once daily before breakfast. This treatment should be started immediately after surgical removal of the testicles.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store the medication at room temperature, and protect from light and moisture and keep it out of the reach of children.

50 mg
Each 50 mg tablet is white, round, biconvex, debossed with "168" over "A" on one side and with the Roussel logo on the other side. Non-medicinal ingredients: cornstarch, lactose, magnesium stearate, povidone, sodium docusate, and talc.

Do not take this medication if you:

• are sensitive or allergic to nilutamide or any ingredients of the medication
• are a child
• are female
• have severely reduced liver function
• have severe breathing problems

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• change in colour vision
• constipation
• decrease in appetite
• dizziness
• flu-like symptoms (headache, muscle or joint pain, tiredness)
• hot flashes
• impotence or reduction in sexual desire
• nausea
• nervousness
• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• bone pain or fractures
• cough or hoarseness
• fast, uneven, pounding heart beat
• feeling faint
• reduced sensitivity of the eyes to light
• signs of breathing problems (e.g., shortness of breath, troubled breathing, wheezing, or tightness in chest, fast or irregular breathing)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• swelling of face, fingers, feet, or lower legs
• symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
• tightness in chest or wheezing
• unusual tiredness or weakness

Stop taking the medication and seek immediate medical attention if any of the following occur:

• chest pain
• shortness of breath or difficult or troubled breathing

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Alcohol consumption: Nilutamide may cause nausea and flushing if consumed at the same time as alcohol.

Anemia: Nilutamide may cause low levels of red blood cells. If you experience symptoms of anemia (reduced red blood cell count) such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.

Bone health: Long-term use of nilutamide may cause your bones to be less dense and increase the risk of fractures. Your doctor will monitor you for this while you are using this medication. If you have osteoporosis or are at risk for it (e.g., have been smoking or drinking excessive amounts of alcohol for a long time, have a family history of osteoporosis, or are taking medications such as prednisone or anti-seizure medications), discuss with your doctor how this medication may affect your medical condition and whether any special monitoring is needed.

Diabetes: Nilutamide may cause a loss of blood glucose control, and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication. If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Heart disease: This medication may increase the risk for heart disease. Nilutamide can also cause changes to the normal rhythm of the heart, including an irregular heartbeat called QT prolongation. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death. If you are at risk for heart rhythm problems (e.g., if you have heart failure, angina, or low potassium or magnesium levels), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Your doctor will monitor your heart rhythm regularly with a test called an electrocardiogram (ECG) while you are taking this medication. You should not take this medication if your ECG already shows that you have QT prolongation or if you are taking a medication that can cause QT prolongation.

Lactose: This medication contains lactose. If you have galactose intolerance (galactosemia, glucose-galactose malabsorption, or Lapp lactase deficiency), you should not take this medication.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Lung inflammation: Lung inflammation (interstitial lung disease) causing difficulty breathing has occurred rarely in some people taking this medication. This complication can be serious and sometimes fatal. If you experience new or worsening shortness of breath or cough (with or without fever) at any time while you are taking teriflunomide contact your doctor immediately.

Vision Changes:Nilutamide may make it more difficult for the eyes to adapt when moving from a well-lit area to a more dimly-lit area. This problem is usually temporary and this effect can be reduced by the use of sunglasses.

There may be an interaction between nilutamide and any of the following:

• alcohol
• certain "azole" antifungal medications (e.g., fluconazole, ketoconazole, voriconazole)
• antiarrhythmic medications (e.g., amiodarone, disopyramide, flecainide, quinidine)
• carbamazepine
• chlordiazepoxide
• chlorpromazine
• diazepam
• macrolide antibiotics (e.g., azithromycin, clarithromycin)
• methadone
• phenytoin
• propranolol
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, moxifloxacin)
• theophylline
• tricyclic antidepressants (e.g., clomipramine, imipramine, trimipramine)
• warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.