Nilandron

Nilandron is a prescription medication used together with surgery to treat prostate cancer. Nilandron belongs to a group of drugs called antiandrogens. It works by blocking the effects of testosterone (a male hormone), to stop the growth and spread of prostate cancer cells.

This medication comes in tablet form. It is taken once daily, with or without food.

Common side effects include nausea, constipation, and hot flashes. Nilandron can cause dizziness. Do not drive or operate heavy machinery until you know how it affects you.

Nilandron is a prescription medication used to treat prostate cancer in men who have had surgery to remove the testicles (known medically as surgical castration).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Interstitial Pneumonitis

Interstitial pneumonitis has been reported in 2% of patients in controlled clinical trials in patients exposed to Nilandron. 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.

Common side effects include:

• constipation
• hot flashes
• nausea
• headache
• dizziness
• impaired vision

This is not a complete list of Nilandron side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.