How does this medication work? What will it do for me?

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 and a hormone therapy that reduces the amount of testosterone in the body (e.g., goserelin) 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.

What form(s) does this medication come in?

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.

150 mg
Each 150 mg tablet is white, round, biconvex, engraved "168D" on one side and with the RU logoe on the other side. Non-medicinal ingredients: cornstarch, lactose, magnesium stearate, povidone, sodium docusate, and talc.

How should I use this medication?

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 at the same time as treatment with an LHRH analogue (e.g., goserelin) or 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.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Nilutamide should not be used by or given to anyone who:

  • is sensitive or allergic to nilutamide or any ingredients of the medication
  • is a child
  • is female
  • has severe liver dysfunction
  • has severe respiratory insufficiency

What side effects are possible with this medication?

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.

  • bloated feeling
  • change in colour vision
  • confusion
  • constipation
  • decrease in appetite
  • dizziness
  • drowsiness
  • dry mouth
  • flu-like symptoms (headache, muscle or joint pain, tiredness)
  • headache
  • hot flashes
  • impotence or reduction in sexual desire
  • itching
  • nausea
  • nervousness
  • sleeping problems
  • swelling of breasts with pain or tenderness
  • 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:

  • bloody or black, tarry stools
  • cough or hoarseness
  • depression
  • fever
  • itching
  • numbness, tingling, pain or muscle weakness in hands, arms, feet, or legs
  • pinpoint red spots on skin
  • reduced sensitivity to light of the eyes
  • runny nose
  • skin rash
  • sneezing
  • sore throat
  • swelling of face, fingers, feet, or lower legs
  • tightness in chest or wheezing
  • unusual bleeding or bruising
  • unusual tiredness or weakness

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

  • chest pain
  • pain or tenderness in stomach
  • shortness of breath or difficult or troubled breathing
  • signs of liver damage (e.g., persistent lack of appetite, nausea, vomiting, yellowing of eyes and skin, dark coloured urine)

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.

Are there any other precautions or warnings for 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.

Bone: Long term use of nilutamide may cause your bones to be less dense and increase your fracture risk. Your doctor may monitor your bone density and recommend anti-osteoporosis treatment.

Cardiovascular: Nilutamide may casue a side effect called QT/QTc prolongation. Your doctor may monitor your heart regularly with an electrocardiogram.

Drowsiness/reduced alertness: Nilutamide may make you feel more tired or may make it more difficult for the eyes to adapt when moving from a well lit area to a more dimly lit area. This effect can be reduced by the use of sunglasses.

Endocrine: Nilutamide may cause increased glucose intolerance in some people and cause diabetes to develop. Your doctor may monitor your blood sugar regularly.

Reduced liver function: Nilutamide is broken down by the liver. This medication should be used with caution by people with moderate to severely reduced liver function.

What other drugs could interact with this medication?

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

  • alcohol
  • chlordiazepoxide
  • diazepam
  • phenytoin
  • propranolol
  • testosterone and androgens
  • theophylline
  • 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.