Generic drug of the therapeutic class: Oncology and Hematology
Active ingredients: Nilutamide
laboratory: Sanofi-Aventis France
Box of 90
Metastatic prostate cancer co-prescribed with surgical or chemical castration, the efficacy being observed in previously untreated patients (less than 10% of responses when a first hormonal treatment was attempted and was ineffective or outdated).
Dosage ANANDRON 50 mg Tablet Box of 90
· Treatment with nilutamide should be started immediately after castration, whether medical or surgical.
· Attack treatment: 300 mg / day for 4 weeks.
· Maintenance treatment: 150 mg / day.
The daily dose may be absorbed in 1 or more doses.
The transition to maintenance treatment may be earlier in case of occurrence of adverse effects, especially digestive.
· Hypersensitivity to nilutamide,
· Severe hepatic insufficiency,
· History of liver injury related to nilutamide intake,
· Severe respiratory failure.
Anandron side effects
· Visual disturbances
Disturbances of accommodation in darkness and color vision (about 25% of treated patients).
These disorders, which may decrease despite continued treatment, are mild and always reversible when treatment is stopped. They can be improved by wearing tinted glasses.
· Respiratory attack
Cases of interstitial lung disease have been reported with an incidence of 1 to 2% in clinical trials. The onset usually occurs during the first 3 months of treatment. Typically, patients experience progressive dyspnea with cough, chest pain, and / or fever. The chest x-ray shows interstitial or alveolar-interstitial anomalies. Very rarely, pneumonia develops abruptly with acute respiratory failure or progresses to acute respiratory failure (see Warnings and Precautions ).
· Liver injury.
Moderate increase in transaminases (remaining less than 3 times the upper limit of normal) may regress under treatment.
Possibility of cytolytic or mixed hepatitis, exceptionally fulminant hepatitis (see section Warnings and precautions for use ). These attacks occur mainly during the first 6 months of treatment.
· Hematological abnormalities
Exceptionally aplastic anemia, although the role of nilutamide has not been established.
· Digestive disorders
· Endocrine manifestations
Impotence, low libido, hot flushes, gynecomastia, hyper-sweating, alopecia; these signs are consequences of the desired therapeutic effect.
· Intolerance to alcohol: discomfort with flushing.