Nilutamide

A to Z Drug Facts

Nilutamide

	Actions
	Indications
	Contraindications
	Route/Dosage
	Interactions
	Lab Test Interferences
	Adverse Reactions
	Precautions
Patient Care Considerations
	Administration/Storage
	Assessment/Interventions
	Patient/Family Education

(nye-LOO-tah-mide)

Nilandron

Tablets

50 mg.

Class: Antiandrogen

Actions Nonsteroidal with antiandrogen activity. It blocks the effects of testosterone at the androgen receptor level. The drug is rapidly and completely absorbed. There is moderate binding of the drug to plasma proteins. It is extensively metabolized. The majority is eliminated in the urine. Fecal elimination is negligible. The mean elimination half-life ranged from 38 to 59.1 hr. Metabolic enzyme inhibition may occur for this drug.

Indications Metastatic prostate cancer in combination with surgical castration.

Contraindications Severe hepatic impairment; severe respiratory insufficiency; hypersensitivity to nilutamide or any component of this preparation.

Route/Dosage

Prostate Cancer

ADULTS: PO Initial dose: 300 mg (6 tablets) PO once daily for 30 days. Maintenance dose: 150 mg (3 tablets) PO once daily.

Interactions Inhibits hepatic cytochrome P450 enzymes. May alter the elimination of other agents metabolized by the cytochrome P450 system. Monitor patients for increased serum levels and toxicity during concomitant therapy with warfarin, phenytoin, or theophylline.

Lab Test Interferences Increased ALT and AST.

Adverse Reactions

CARDIOVASCULAR: Peripheral edema, hypertension, chest pain; heart failure. CNS: Insomnia; headache; dizziness; depression; hypesthesia; asthenia; paresthesia. DERMATOLOGIC: Sweating; loss of body hair; dry skin. ENDOCRINE: Hot flashes. GI: Low potential for nausea and vomiting; constipation; anorexia; abdominal pain; hemorrhage or melena (2%). GU: Testicular atrophy; urinary tract infection. HEMATOLOGIC: Anemia. METABOLIC: Alcohol intolerance. MUSCULOSKELETAL: Pain; bone pain. RESPIRATORY: Dyspnea; pneumonia; intestinal pneumonitis. SPECIALSENSES: Delayed adjustment to dark or light; abnormal vision; cataract. OTHER: Flu-like syndrome.

Precautions

Pregnancy: Category C. Children: Safety and efficacy in pediatric patients have not been established. Hepatitis: Severe liver injury has been reported. Hepatotoxicity in these reports generally occurred within the first 3 to 4 mo of treatment. Women: Nilutamide has no indication for women. Delay in adaptation to the dark: When passing from a lighted area to a dark area.

PATIENT CARE CONSIDERATIONS

Administration/Storage

Store at room temperature; protect from light.
Initiate therapy on day of surgical castration or the day after surgery. Nilutamide may be taken without regard to meals.

Assessment/Interventions

Monitor LFTs at baseline and at 3-mo intervals during therapy.
Measure serum transaminase levels prior to starting treatment and at regular intervals for the first 4 mo of treatment and periodically thereafter. Obtain LFTs at the first sign or symptoms suggestive of liver dysfunction (eg, nausea, vomiting, abdominal pain, fatigue, anorexia, flu-like symptoms, dark urine, jaundice, right upper quadrant tenderness).
Perform a routine chest x-ray prior to initiating treatment. Baseline pulmonary function tests may be considered.
If at any time, a patient has jaundice or their ALT rises > 2 times the upper limit of normal, discontinue nilutamide with close follow up of LFTs until resolution.

OVERDOSAGE: SIGNS & SYMPTOMS
	GI disorders, including nausea and vomiting, malaise, headache, dizziness (600 and 900 mg/day)

Patient/Family Education

Start nilutamide tablets on the day of, or the day after, surgical castration. Patients should not interrupt their dosing of nilutamide or stop taking the medication without consulting their health care provider.
Delays of visual adaptation from light to dark may occur. Advise patients to use caution when driving at night or through tunnels. Patients can use tinted glasses to help decrease the problem.
Nilutamide may cause alcohol-intolerance. Avoid alcohol if facial flushing, malaise, or hypotension occurs after consuming alcoholic beverages.
Notify your doctor at the first sign or symptoms suggestive of liver dysfunction (eg, nausea, vomiting, abdominal pain, fatigue, anorexia, flu-like symptoms, dark urine, jaundice, right upper quadrant tenderness).
Tell health care provider immediately of any dyspnea or agggravation of preexisting dyspnea.
Instruct patients to report any new or worsening shortness of breath that they experience while on nilutamide. If symptoms occur, discontinue nilutamide immediately until it can be determined if the symptoms are drug-related.