Nilutamide

What is Nilutamide?

• Nilutamide (Nilandron) is an oral nonsteroidal antiandrogen similar in structure to flutamide that is used widely in the therapy of prostate cancer.

Nilutamide

Nilutamide molecule ball

Nilutamide Structure

What are the uses of this medicine?

Nilutamide (Nilandron) is used to treat:

• Prostate cancer that has metastasized (spread to other parts of the body). It is used in patients who have had surgery to remove the testicles (orchiectomy).

How does this medicine work?

• Nilutamide (nye loo' ta mide) is an anilide that blocks the binding of endogenous androgens to intracellular androgen receptors blocking their effects and is used to treat prostate cancer.
• Nilutamide has been shown to be effective in reducing pain and disease progression in metastatic prostate cancer when administered in conjunction with orchiectomy or other antiandrogen agents such as luteinizing hormone releasing hormone (LHRH) agonists.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with severe hepatic impairment
• with severe respiratory insufficiency
• with hypersensitivity to nilutamide or any component of this preparation

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
• Be sure to mention any of the following:
• anticoagulants ('blood thinners') such as warfarin (Coumadin), phenytoin (Dilantin), and theophylline (Theo-Dur, Slo-Phyllin, others)

Is this medicine FDA approved?

• Nilutamide was approved for use in the United States in 1996.

How should this medicine be used?

Recommended dosage:

• The recommended dosage is 300 mg once a day for 30 days, followed thereafter by 150 mg once a day.

Administration:

• Nilutamide comes as a tablet to take by mouth.
• It is usually taken with or without food once daily.
• Take nilutamide at around the same time every day.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Nilutamide Tablet contains 150 mg of nilutamide

This medicine is available in fallowing brand namesː

• Nilandron

What side effects can this medication cause?

The most common side effects of this medicine include:

• Hypertension
• Nausea
• Constipation
• Hot flushes
• Increased AST
• Increased ALT
• Dizziness
• Dyspnea
• Impaired adaptation to dark
• Abnormal vision
• Urinary tract infection

What special precautions should I follow?

• Interstitial pneumonitis has been reported in patients exposed to nilutamide. If symptoms occur, Nilutamide Tablets should be immediately discontinued until it can be determined if the symptoms are drug related.
• Rare cases of death or hospitalization due to severe liver injury have been reported post-marketing in association with the use of Nilutamide Tablets. If at any time, a patient has jaundice, or their ALT rises above 2 times the upper limit of normal, Nilutamide Tablets should be immediately discontinued with close follow-up of liver function tests until resolution.
• Patients should be informed that Nilutamide Tablets should be started on the day of, or on the day after, surgical castration. They should also be informed that they should not interrupt their dosing of Nilutamide Tablets or stop taking this medication without consulting their physician.
• Because of the possibility of an intolerance to alcohol (facial flushes, malaise, hypotension) following ingestion of Nilutamide Tablets, it is recommended that intake of alcoholic beverages be avoided by patients who experience this reaction.
• Patients receiving Nilutamide Tablets reported a delay in adaptation to dark, ranging from seconds to a few minutes, when passing from a lighted area to a dark area. Patients who experience this effect should be cautioned about driving at night or through tunnels. This effect can be alleviated by the wearing of tinted glasses.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• vomiting
• malaise
• headache
• dizziness
• elevation in hepatic enzyme

Management of overdosage:

• Since nilutamide is protein bound, dialysis may not be useful as treatment for overdose.
• General supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated.

Can this medicine be used in pregnancy?

• It is also not known whether nilutamide can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.
• Nilutamide should be given to a pregnant woman only if clearly needed.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been determined.

What are the active and inactive ingredients in this medicine?

Active Ingredient:

• NILUTAMIDE

Inactive Ingredients:

• STARCH, CORN
• LACTOSE MONOHYDRATE
• POVIDONE K30
• DOCUSATE SODIUM
• TALC
• CALCIUM STEARATE

Who manufactures and distributes this medicine?

Manufactured by:

• ANI Pharmaceuticals, Inc.
• Baudette, MN

What should I know about storage and disposal of this medication?

• Store at 25°C (77°F); excursions permitted between 15 to 30°C (59 to 86°F).
• Protect from light.
• Keep out of reach of children.

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• Dailymed label info on Nilutamide
• FDA Nilutamide