nye-LOOT-a-mide

Therapeutic Classification: antineoplastics

Pharmacologic Classification: antiandrogens

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

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

• Decreased spread of prostate cancer.

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.

(antiandrogenic effects)

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.

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

(Generic available)

• Tablets: 50 mg; 150 mg;

• Obtain a chest x-ray prior to starting therapy. Assess patient for symptoms of interstitial pneumonitis (dyspnea or worsening of pre-existing dyspnea). If symptoms occur, discontinue nilutamide until cause can be determined. Pneumonitis usually occurs during the first 3 mo of therapy and is almost always reversible when treatment is discontinued.

• Monitor hepatic function prior to and every 3 mo throughout therapy. If AST or ALT is elevated more than 2–3 times normal, treatment should be discontinued.
  • May cause hyperglycemia; increased alkaline phosphatase, BUN, and serum creatinine; and leukopenia.

• Begin therapy on the same day as or day after surgical castration.
• PO: May be taken without regard to food.

• 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.

• Decrease in the spread of prostate cancer.

Nilandron

Anandron

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