Nilandron
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Questions & Answers
Side Effects & Adverse Reactions
Interstitial pneumonitis has been reported in 2% of patients in controlled clinical trials in patients exposed to nilutamide. A small study in Japanese subjects showed that 8 of 47 patients (17%) developed interstitial pneumonitis. 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. X-rays showed interstitial or alveolo-interstitial changes, and pulmonary function tests revealed a restrictive pattern with decreased DLco. Most cases occurred within the first 3 months of treatment with NILANDRON, and most reversed with discontinuation of therapy. A routine chest X-ray should be performed prior to initiating treatment with NILANDRON. Baseline pulmonary function tests may be considered. Patients should be instructed to report any new or worsening shortness of breath that they experience while on NILANDRON. If symptoms occur, NILANDRON 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 NILANDRON. Hepatotoxicity in these reports generally occurred within the first 3 to 4 months of treatment. Hepatitis or marked increases in liver enzymes leading to drug discontinuation occurred in 1% of NILANDRON patients in controlled clinical trials.
Serum transaminase levels should be measured prior to starting treatment with NILANDRON, at regular intervals for the first 4 months of treatment, and periodically thereafter. Liver function tests should also be obtained at the first sign or symptom suggestive of liver dysfunction, e.g. nausea, vomiting, abdominal pain, fatigue, anorexia, "flu-like" symptoms, dark urine, jaundice, or right upper quadrant tenderness. If at any time, a patient has jaundice, or their ALT rises above 2 times the upper limit of normal, NILANDRON should be immediately discontinued with close followup of liver function tests until resolution.
NILANDRON has no indication for women, and should not be used in this population, particularly for non-serious or non-life threatening conditions.
Foreign postmarketing surveillance has revealed isolated cases of aplastic anemia in which a causal relationship with NILANDRON could not be ascertained.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
NILANDRON tablets are indicated for use in combination with surgical castration for the treatment of metastatic prostate cancer (Stage D2).
For maximum benefit, NILANDRON treatment must begin on the same day as or on the day after surgical castration.
History
There is currently no drug history available for this drug.
Other Information
NILANDRON® tablets contain nilutamide, a nonsteroidal, orally active antiandrogen having the chemical name 5,5-dimethyl-3-[4-nitro-3-(trifluoromethyl)phenyl]-2,4-imidazolidinedione with the following structural formula:
Nilutamide is a microcrystalline, white to practically white powder with a molecular weight of 317.25.
Its molecular formula is C12H10F3N3O4.
It is freely soluble in ethyl acetate, acetone, chloroform, ethyl alcohol, dichloromethane, and methanol. It is slightly soluble in water [<0.1% W/V at 25°C (77°F)]. It melts between 153°C and 156°C (307.4°F and 312.8°F).
Each NILANDRON tablet contains 150 mg of nilutamide. Other ingredients in NILANDRON tablets are corn starch, lactose, povidone, docusate sodium, magnesium stearate, and talc.
Sources
Nilandron Manufacturers
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Covis Pharmaceuticals, Inc.
![Nilandron (Nilutamide) Tablet [Covis Pharmaceuticals, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Nilandron | Covis Pharmaceuticals, Inc.
The recommended dosage is 300 mg once a day for 30 days, followed thereafter by 150 mg once a day. NILANDRON tablets can be taken with or without food.
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