Monograph Details
|
|
Neoplasms
> Hormones and antagonists
|
|
NILANDRON |
| Manufacturer |
|
Sanofi Aventis |
| Legal Classification |
|
Rx
|
| Pharmacological Class |
|
Antiandrogen. |
| Generic Name |
|
Nilutamide 150mg; tabs. |
| Indications |
|
Metastatic prostate cancer (Stage D2), as an adjunct to surgical castration. |
| Children |
|
Not applicable. |
| Adults |
|
300mg once daily for 30 days then 150mg once daily, starting day of or day after surgical castration. |
| Contraindications |
|
Severe hepatic impairment or respiratory insufficiency. |
| Precautions |
|
Obtain baseline liver and pulmonary function tests and chest X-ray. Monitor for interstitial pneumonitis; discontinue if occurs. Monitor liver function for first 4 months then periodically; discontinue if ALT > 2xULN or jaundice occurs. May discolor urine or sclera. Pregnancy (Cat.C): not for use in women. Nursing mothers. |
| Interactions |
|
Monitor drugs metabolized by CYP450 (eg, Vit. K antagonists, theophylline, phenytoin); may need to adjust dose. May cause alcohol intolerance. |
| Adverse Reactions |
|
Hot flushes, impaired night vision, GI upset, increased liver enzymes, constipation, dizziness, abnormal vision, hypertension, hepatitis, interstitial pneumonitis. |
| How Supplied |
|
Tabs—30 |
| Additional Resources |
|
• Related Prescribing Note |
|
|
|
|
