Nilutamide inhibits cytochrome P-450 isoenzymes, reducing metabolism of phenytoin and increasing serum half-life, potentially leading to toxic levels. Dosage may need modification.
Source: NLP:nilutamide
Nilutamide Interactions
Brand names: Nilutamide
Androgen Receptor Inhibitor · Androgen Receptor Antagonists
Route: Oral
FDA Black Box Warning
Interstitial Pneumonitis 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 Nilutamide Tablets, and most reversed with discontinuation of therapy. A routine chest X-ray should be performed prior to initiating treatment with Nilutamide Tablets. 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 Nilutamide Tablets. If symptoms occur, Nilutamide Tablets should be immediately discontinued until it can be determined if the symptoms are drug related.
Contraindications
CONTRAINDICATIONS Nilutamide Tablets are contraindicated: • in patients with severe hepatic impairment (baseline hepatic enzymes should be evaluated prior to treatment) • in patients with severe respiratory insufficiency • in patients with hypersensitivity to nilutamide or any component of this preparation.
Pregnancy & Breastfeeding
Pregnancy Animal reproduction studies have not been conducted with nilutamide. 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.
3 interactions on record
Nilutamide inhibits cytochrome P-450 isoenzymes, reducing metabolism of theophylline and increasing serum half-life, potentially leading to toxic levels. Dosage may need modification.
Source: NLP:nilutamide
Nilutamide inhibits cytochrome P-450 isoenzymes, reducing metabolism of vitamin K antagonists and increasing serum half-life, potentially leading to toxic levels. Prothrombin time should be monitored and dosage may need reduction.
Source: NLP:nilutamide