Notable was the higher incidence of visual disturbances (variously described as impaired adaptation to darkness, abnormal vision, and colored vision), which led to treatment discontinuation in 1% to 2% of patients.Interstitial pneumonitis occurred in one (<1%) patient receiving NILANDRON in combination with surgical castration and in seven patients (3%) receiving NILANDRON in combination with leuprolide and one patient receiving placebo in combination with leuprolide. The maximal dose at which nilutamide did not affect reproductive function in either sex or have an effect on fetuses was estimated to be 45 mg/kg orally (AUC exposures in rats approximately 1–2 times human therapeutic AUC exposures).Animal reproduction studies have not been conducted with nilutamide.

Hepatitis or marked increases in liver enzymes leading to drug discontinuation occurred in 1% of NILANDRON patients in controlled clinical trials.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.Patients whose disease progresses while being treated with an antiandrogen may experience clinical improvement with discontinuation of the antiandrogen.Patients should be informed that NILANDRON tablets should be started on the day of or on the day after, surgical castration. Copy the URL below and paste it into your RSS Reader application. It is highly stable in a normal human serum. There were no clinical signs or symptoms or changes in parameters such as transaminases or chest X-ray. Each box contains 3 child-resistant, PVC, aluminum foil-backed blisters of 10 tablets (NDC 59212-111-14). For example, when vitamin K antagonists are administered concomitantly with nilutamide, prothrombin time should be carefully monitored and, if necessary, the dosage of vitamin K antagonists should be reduced.Administration of nilutamide to rats for 18 months at doses of 0, 5, 15, or 45 mg/kg/day produced benign Leydig cell tumors in 35% of the high-dose male rats (AUC exposures in high-dose rats were approximately 1–2 times human AUC exposures with therapeutic doses). Due to inconsistencies between the drug labels on DailyMed and the pill images provided by It is also not known whether nilutamide can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. ... Package/NDC: 10 / 67457-437-10. Since nilutamide is protein bound, dialysis may not be useful as treatment for overdose. Pegaptanib sodium for neovascular age-related macular degeneration: two-year safety results of the two prospective, multicenter, controlled clinical trials. A small study in Japanese subjects showed that 8 of 47 patients (17%) developed interstitial pneumonitis. The effects of the combined therapy were studied in patients with previously untreated metastatic prostate cancer.In a double-blind, randomized, multicenter study that enrolled 457 patients (225 treated with orchiectomy and NILANDRON, 232 treated with orchiectomy and placebo), the NILANDRON group showed a statistically significant benefit in time to progression and time to death. There is moderate binding of the drug to plasma proteins and low binding to erythrocytes. For comparison, adverse experiences seen with surgical castration and placebo are also listed.The overall incidence of adverse experiences was 86% (194/225) for the NILANDRON group and 81% (188/232) for the placebo group.The following adverse experiences were reported during a multicenter clinical trial comparing NILANDRON + leuprolide versus placebo + leuprolide.

Nilutamide had no effect on the incidence, size or time of onset of any spontaneous tumor in rats.Nilutamide displayed no mutagenic effects in a variety of in vitro and in vivo tests (Ames test, mouse micronucleus test, and two chromosomal aberration tests).In reproduction studies in rats, nilutamide had no effect on the reproductive function of males and females, and no lethal, teratogenic or growth-suppressive effects on fetuses were found.