December 3, 2008


By Anonymous User

Class: Hormonal therapy   

Generic Name: Nilutamide (ni-LOO-te-mide)
Trade Name: Nilandron®, Anandron®

How is this drug used? Nilutamide is approved for the treatment of stage D2 prostate cancer, where cancer has spread from its site of origin to different sites in the body.  It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.

What is the mechanism of action? Nilutamide belongs to a group of drugs referred to as anti-androgens. Prostate cancer is stimulated to grow by the male hormone, testosterone. Anti-androgens inhibit the effects of testosterone on cancer cells, removing the growth stimulus. Nilutamide is often given in combination with another hormone agent, classified as a luteinizing hormone – releasing hormone (LHRH) agonist, which helps to block the production of testosterone in the body.

How is nilutamide given (administered)? Nilutamide is a tablet that is taken orally. It is typically taken once daily, and should be taken at approximately the same time each day. Nilutamide can be taken with or without food. Patients and their physicians will discuss optimal scheduling for nilutamide.

How are patients monitored? Patients will usually have scheduled meetings for follow-up treatment with nilutamide. Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems such as the kidneys and liver. Patients may also undergo physical examinations, scans and other measures to assess tolerance and response to therapy.

Uncommonly, patients treated with nilutamide will experience a side effect called pneumonitis, which is associated with lung irritation leading to difficulty breathing and cough. Pneumonitis typically occurs within the first 3 months of treatment, and although patients will be monitored for pneumonitis, patients should notify their physician if they are experiencing difficulty breathing or a cough.

What are the common (occur in 30% or more of patients) side effects of treatment with nilutamide?

• Hot flashes
• Delayed vision adjustment to darkness

What are the less common (occur in 10% to 29% of patients) side effects of treatment with nilutamide?

• Breast enlargement
• Breast pain or tenderness
• Decreased libido
• Nipple discharge
• Erectile dysfunction
• Nausea
• Loss of appetite
• Constipation
• Diarrhea
• Liver function test abnormalities
• Difficulty sleeping
• Drowsiness
• Headache
• Dizziness
• Pain
• Weakness
• Swelling

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

• Patients who experience hot flashes may wish to wear light clothing, stay in a cool environment, and place cool cloths on their body or head to relieve their symptoms.
• Patients may experience an alteration in their vision; adaptation to darkness may be impaired or delayed. Driving or operating heavy machinery should be done with caution at night. Use caution in poorly lighted or changing light situations (tunnels).
• Consuming alcoholic beverages while being treated with nilutamide may cause a reaction. Therefore, it is recommended that alcohol be avoided. Patients should discuss this with their physician.
• Eat small meals frequently to help alleviate nausea.
• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)

Are there any special precautions patients should be aware of before starting chemotherapy?

• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients taking warfarin may require additional monitoring.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
• If an oral dose is missed, do not double up on doses.  Patients should contact their physician in this event.
• Keep tablets out of reach of children and return to the pharmacy for safe disposal if treatment is terminated.
• Patients may experience drowsiness, dizziness or blurred vision. Avoid driving, operating heavy machinery or tasks acquiring mental alertness until effects of the drugs are known.

When should patients notify their physician?

• Fever
• Cough
• Difficulty breathing, shortness or breath
• Sore throat
• Signs of infection – redness, swelling
• Chest pain
• Jaw pain
• Inability to urinate, difficulty in voiding
• Changes in eyesight
• Swelling of feet or ankles
• Yellowing of skin or eyes
• Changes in color of urine or stool
• Abdominal pain
• Loss of appetite
• Prolonged headache
• Prolonged nausea and vomiting
• Persistent constipation
• Lightheadedness or dizziness

What is a package insert? 
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Copyright © 2010 CancerConnect Last updated 07/10.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.



The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.

Tags: A, Hormonal Therapy, N