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Nilandron

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Nilandron

Nilandron

SIDE EFFECTS

The following adverse experiences were reported during a multicenter clinical trial comparing NILANDRON (nilutamide) + surgical castration versus placebo + surgical castration. The most frequently reported (greater than 5%) adverse experiences during treatment with NILANDRON (nilutamide) tablets in combination with surgical castration are listed below. For comparison, adverse experiences seen with surgical castration and placebo are also listed.

  NILANDRON + surgical castration
(N=225)
Placebo + surgical castration
(N=232)
Adverse Experience % All % All
Cardiovascular System
  Hypertension 5.3 2.6
Digestive System
  Nausea 9.8 6.0
  Constipation 7.1 3.9
Endocrine System
  Hot flushes 28.4 22.4
Metabolic and Nutritional System
  Increased AST 8.0 3.9
  Increased ALT 7.6 4.3
Nervous System
  Dizziness 7.1 3.4
Respiratory System
  Dyspnea 6.2 7.3
Special Senses
  Impaired adaptation to dark 12.9 1.3
  Abnormal vision 6.7 1.7
Urogenital System
  Urinary tract infection 8.0 9.1

The overall incidence of adverse experiences was 86% (194/225) for the NILANDRON (nilutamide) group and 81% (188/232) for the placebo group.

The following adverse experiences were reported during a multicenter clinical trial comparing NILANDRON (nilutamide) + leuprolide versus placebo + leuprolide. The most frequently reported (greater than 5%) adverse experiences during treatment with NILANDRON (nilutamide) tablets in combination with leuprolide are listed below. For comparison, adverse experiences seen with leuprolide and placebo are also listed.

  NILANDRON + leuprolide
(N=209)
Placebo + leuprolide
(N=202)
Adverse Experience % All % All
Body as a Whole
  Pain 26.8 27.7
  Headache 13.9 10.4
  Asthenia 19.1 20.8
  Back pain 11.5 16.8
  Abdominal pain 10.0 5.4
  Chest pain 7.2 4.5
  Flu syndrome 7.2 3.0
  Fever 5.3 6.4
Cardiovascular System
  Hypertension 9.1 9.9
Digestive System
  Nausea 23.9 8.4
  Constipation 19.6 16.8
  Anorexia 11.0 6.4
  Dyspepsia 6.7 4.5
  Vomiting 5.7 4.0
Endocrine System
  Hot flushes 66.5 59.4
  Impotence 11.0 12.9
  Libido decreased 11.0 4.5
Hemic and Lymphatic System
  Anemia 7.2 6.4
Metabolic and Nutritional System
  Increased AST 12.9 13.9
  Peripheral edema 12.4 17.3
  Increased ALT 9.1 8.9
Musculoskeletal System
  Bone Pain 6.2 5.0
Nervous System
  Insomnia 16.3 15.8
  Dizziness 10.0 11.4
  Depression 8.6 7.4
  Hypesthesia 5.3 2.0
Respiratory System
  Dyspnea 10.5 7.4
  Upper respiratory infection 8.1 10.9
  Pneumonia 5.3 3.5
Skin and Appendages
  Sweating 6.2 3.0
  Body hair loss 5.7 0.5
  Dry skin 5.3 2.5
  Rash 5.3 4.0
Special Senses
  Impaired adaptation to dark 56.9 5.4
  Chromatopsia 8.6 0.0
  Impaired adaptation to light 7.7 1.0
  Abnormal vision 6.2 4.5
Urogenital System
  Testicular atrophy 16.3 12.4

The overall incidence of adverse experiences is 99.5% (208/209) for the NILANDRON (nilutamide) group and 98.5% (199/202) for the placebo group.

Some frequently occurring adverse experiences, for example hot flushes, impotence, and decreased libido, are known to be associated with low serum androgen levels and known to occur with medical or surgical castration alone. 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 (nilutamide) in combination with surgical castration and in seven patients (3%) receiving NILANDRON (nilutamide) in combination with leuprolide and one patient receiving placebo in combination with leuprolide. Overall, it has been reported in 2% of patients receiving NILANDRON (nilutamide) . This included a report of interstitial pneumonitis in 8 of 47 patients (17%) in a small study performed in Japan.

In addition, the following adverse experiences were reported in 2 to 5% of patients treated with NILANDRON (nilutamide) in combination with leuprolide or orchiectomy.

Body as a Whole: Malaise (2%).

Cardiovascular System: Angina (2%), heart failure (3%), syncope (2%).

Digestive System: Diarrhea (2%), gastrointestinal disorder (2%), gastrointestinal hemorrhage (2%), melena (2%).

Metabolic and Nutritional System: Alcohol intolerance (5%), edema (2%), weight loss (2%).

Musculoskeletal System: Arthritis (2%).

Nervous System: Dry mouth (2%), nervousness (2%), paresthesia (3%).

Respiratory System: Cough increased (2%), interstitial lung disease (2%), lung disorder (4%), rhinitis (2%).

Skin and Appendages: Pruritus (2%).

Special Senses: Cataract (2%), photophobia (2%).

Laboratory Values: Haptoglobin increased (2%), leukopenia (3%), alkaline phosphatase increased (3%), BUN increased (2%), creatinine increased (2%), hyperglycemia (4%).

Read the Nilandron (nilutamide) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

In vitro, nilutamide has been shown to inhibit the activity of liver cytochrome P-450 isoenzymes and, therefore, may reduce the metabolism of compounds requiring these systems.

Consequently, drugs with a low therapeutic margin, such as vitamin K antagonists, phenytoin, and theophylline, could have a delayed elimination and increases in their serum half-life leading to a toxic level. The dosage of these drugs or others with a similar metabolism may need to be modified if they are administered concomitantly with nilutamide. 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.

Read the Nilandron Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 10/14/2008
This monograph has been modified to include the generic and brand name in many instances.

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