What is Nilutamide?

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 .

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.

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.

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.

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

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.

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:

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.

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.

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

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.

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 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

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.

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.

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.