• Management of metastatic prostate cancer (with surgical castration).

Contraindicated in:

• Hypersensitivity
• Severe hepatic impairment
• Severe respiratory insufficiency.

Use Cautiously in:

• Pedi: Safety and effectiveness not established in children.

CV: hypertension.

Derm: hot flashes, hair loss, sweating.

EENT: impaired adaptation to darkness, abnormal vision.

GI: ↑ liver enzymes, constipation, hepatitis, HEPATOTOXICITY, nausea.

Neuro: dizziness.

Resp: interstitial pneumonitis.

Drug-Drug:

• May ↑ the effects of warfarin, phenytoin, and theophylline.
• May cause alcohol intolerance.

(Generic available)

• Tablets: 50 mg; 150 mg;

• PO (Adults): 300 mg once daily for 30 days, then 150 mg once daily.

Nilandron

• Blocks the effects of androgen (testosterone) at the cellular level.

• Decreased spread of prostate cancer.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: antiandrogens

Absorption: Rapidly and completely absorbed following oral administration.

Distribution: Unknown.

Metabolism/Excretion: Extensively metabolized by the liver; two metabolites have antiandrogenic activity; <2% excreted unchanged in urine.

Half-life: 41–49 hr.

Anandron

(antiandrogenic effects)

• Instruct patient to take nilutamide exactly as directed. If a dose is missed, take as soon as possible unless almost time for next dose. Do not double doses.
• Caution patient that adaptation to darkness may be impaired and may cause difficulty driving at night or through tunnels. Wearing tinted glasses may minimize this effect.
• Advise patient to notify heath care professional immediately if dark urine, fatigue, abdominal pain, yellow eyes or skin, or unexplained GI symptoms occur. Hepatotoxicity usually resolves when nilutamide is discontinued but may be progressive and fatal; requires immediate medical attention.

nye-LOOT-a-mide

NDC Code^*

• 59212- Concordia Pharmaceuticals Inc.
  • 59212-111- Nilandron
    • 59212-111-14- 3 BLISTER PACK in 1 CARTON (59212-111-14) > 10 TABLET in 1 BLISTER PACK

• 62559- ANI Pharmaceuticals, Inc.
  • 62559-173- Nilutamide
    • 62559-173-31- 3 BLISTER PACK in 1 CARTON (62559-173-31) > 10 TABLET in 1 BLISTER PACK

• 66993- Prasco Laboratories
  • 66993-212- Nilutamide
    • 66993-212-38- 3 BLISTER PACK in 1 CARTON (66993-212-38) > 10 TABLET in 1 BLISTER PACK