Adult Dosing
Metastatic prostate cancer (stage D2)
- Start 300 mg PO qd x 30 days
- Maintenance dose: 150 mg PO qd
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- In clinical trials, 2% of the patients treated with nilutamide developed interstitial pneumonitis. Post-marketing reports of incidences of interstitial changes such as pulmonary fibrosis, leading to hospitalization and death, have been reported. Symptoms included exertional dyspnea, cough, chest pain, and fever [US Black Box Warning]
- X-ray showed interstitial or alveolo-interstitial changes, and pulmonary function tests revealed a restrictive pattern with decreased DLco. Most cases were reported within the first 3 months of therapy and reversed on treatment discontinuation [US Black Box Warning]
- Perform chest X-ray prior to treatment initiation and consider baseline pulmonary function tests [US Black Box Warning]
- Instruct the patients to report their physicians if they experience any new or worsening shortness of breath, and promptly discontinue the therapy if such symptoms occur until it can be determined if the symptoms are drug related [US Black Box Warning]
- Rare cases of severe liver injury leading to death or hospitalization have been reported in post-marketing studies. Hepatotoxicity generally occurred within the first 3 to 4 months of treatment
- Monitor serum transaminase levels prior to initiation of therapy and at regular interval for the first 4 months of treatment and periodically thereafter
- Obtain LFTs at the first sign/symptom suggestive of liver dysfunction such as nausea, vomiting, abdominal pain, fatigue, anorexia, flu-like symptoms, dark urine, jaundice, or right upper quadrant tenderness
- Discontinue therapy if patients develop jaundice or their ALT rises >2 times ULN and closely follow-up LFTs until resolution
- Nilutamide has no indication for women and should not be used in this population, especially for non-serious conditions
- Isolated cases of aplastic anemia have been reported in foreign post-marketing surveillance reports, where a causal relationship with nilutamide could not be established
- Patients whose disease progresses during treatment with an antiandrogen may experience clinical improvement with discontinuation of the antiandrogen
- Nilutamide should be started on the day of, or on the day after, surgical castration
- Due to the possibility of an intolerance to alcohol following ingestion of nilutamide, patients who experience this reaction should be advised to avoid intake of alcoholic beverages
Supplemental Patient Information
- Advise patients to promptly report any dyspnea or aggravation of preexisting dyspnea, because of the possibility of interstitial pneumonitis
- Advise patients to contact their physicians if they develop nausea, vomiting, abdominal pain, jaundice
- Delay in adaptation to dark may occur when passing from a lighted area to a dark area in patients receiving nilutamide. Advise patients who experience this effect to use caution when driving at night or through tunnels. Tinted glasses may alleviate this problem
Pregnancy Category:C
Breastfeeding: Safety unknown.
Pricing data from www.DrugStore.com in U.S.A.
- Nilandron 150 MG TABS [Disp Pack] (SANOFI-AVENTIS U.S.)
30 mg = $511.79
90 mg = $1500.83
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
Drug Name: Nilandron 150 MG Oral Tablet
Ingredient(s): Nilutamide
Imprint: 168D
Color(s): White
Shape: Round
Size (mm): 10.00
Score: 1
Inactive Ingredient(s): starch, corn / lactose / povidone / docusate sodium / magnesium stearate / talc
Drug Label Author:
sanofi-aventis U.S. LLC
DEA Schedule:
Non-Scheduled
