Pronunciation:

nye-LOO-ta-mide

Brand Names:

• Nilandron

Dosage Forms:

• Tablet

Warnings:

Interstitial pneumonitis has been reported in 2% of patients in controlled clinical trials of nilutamide. Reports of interstitial changes including pulmonary fibrosis that led to hospitalization and death have been reported rarely post-marketing. Symptoms included exertional dyspnea, cough, chest pain, and fever. A routine chest X-ray should be performed prior to initiating treatment and baseline pulmonary function tests may be considered. Patients should be instructed to report any new or worsening shortness of breath, and if symptoms occur, nilutamide should be discontinued until it can be determined if the symptoms are drug-related .

Classifications:

Therapeutic—

Antiandrogen

Uses of This Medicine:

Nilutamide is used with surgery to treat metastatic prostate cancer (cancer that has spread) in men. Nilutamide belongs to the group of medicines called antiandrogens. It works by blocking the effects of testosterone (a male hormone), which helps stop the growth and spread of cancer cells. .

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of nilutamide in the pediatric population. Safety and efficacy have not been established.

Older adults—

No information is available on the relationship of age to the effects of nilutamide in geriatric patients.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Levoketoconazole
• Methotrexate

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Fosphenytoin
• Phenytoin
• Theophylline
• Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Liver disease, severe or
• Lung disease, severe—Should not be used in patients with these conditions.

• Lung disease or other breathing problems—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

You should begin taking this medicine on the day of or the day after your surgery. Do not stop taking this medicine without checking with your doctor first.

You may take this medicine with food or on an empty stomach.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For prostate cancer:
    • Adults—300 milligrams (mg) once a day for the first 30 days, then 150 mg once a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Check with your doctor right away if you have shortness of breath, difficulty with breathing, or chest pain while you are using this medicine.

Liver problems may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you are having more than one of these symptoms: clay-colored stools; dark urine; fever; headache; loss of appetite; nausea or vomiting; pain or tenderness in the upper right side of the stomach; unusual tiredness or weakness; or yellow eyes or skin.

Drinking alcoholic beverages while taking nilutamide may cause unwanted effects in some people. Possible effects include feeling dizzy or lightheaded when getting up from a lying or sitting position suddenly; having flu-like symptoms; or flushing of the face. If you notice any of these effects, avoid drinking alcohol while you are taking this medicine.

Be very careful while driving, especially at night or when you drive into or out of tunnels. Nilutamide can temporarily change the way your eyes react to light. You may not be able to see as well as usual for several minutes after going from bright light to darkness. Wearing eyeglasses with tinted lenses may help reduce these effects.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Blood in the urine

blurred vision

chest pain

chills

cough

diarrhea

difficult or labored breathing

dizziness

fever or chills

general feeling of discomfort or illness

headache

joint pain

loss of appetite

muscle aches and pains

nausea

nervousness

pale skin

pounding in the ears

runny nose

shivering

shortness of breath

slow or fast heartbeat

sneezing

sore throat

sweating

tightness in the chest

trouble with sleeping

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

wheezing

Less common

Arm, back, or jaw pain

blindness

bloody, black, or tarry stools

change in color vision

decreased urine output

decreased vision

difficulty seeing at night

dilated neck veins

fainting

fast or irregular heartbeat

increased cough

increased sensitivity of the eyes to sunlight

irregular breathing

swelling of the face, fingers, feet, or lower legs

vomiting of blood or material that looks like coffee grounds

weight gain or loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Acid or sour stomach

belching

body hair loss

bone pain

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

changes in vision

decrease in testicle size

decreased interest in sexual intercourse

depression

difficulty having a bowel movement (stool)

dizziness

dry skin

feeling of warmth

heartburn

inability to have or keep an erection

increased urge to urinate during the night

indigestion

loss in sexual ability, desire, drive, or performance

pain

rash

redness of the face, neck, arms and occasionally, upper chest

sleeplessness

stomach discomfort, upset, or pain

sudden sweating

unable to sleep

waking to urinate at night

Less common

Difficulty with moving

dry mouth

general feeling of discomfort or illness

itching

muscle pain or stiffness

pain, swelling, or redness in the joints

passing of gas

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.