nilutamide

Therapeutic Classification: antineoplastics

Pharmacologic Classification: antiandrogens

Indications ⬆ ⬇

High Alert

Metastatic prostate cancer (with surgical castration).

Action ⬆ ⬇

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

Therapeutic effects:

Decreased spread of prostate cancer.

Pharmacokinetics ⬆ ⬇

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.

Time/Action Profile ⬆ ⬇

(antiandrogenic effects)

ROUTE	ONSET	PEAK	DURATION
PO	rapid	unknown	24 hr

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Severe hepatic impairment;
Severe respiratory insufficiency.

Use Cautiously in:

Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

CV: hypertension

Derm: hot flashes, hair loss, sweating

EENT: impaired adaptation to darkness, abnormal vision

GI: ↑liver enzymes, constipation, HEPATOTOXICITY, nausea

Neuro: dizziness

Resp: interstitial pneumonitis

Interactions ⬆ ⬇

Drug-drug:

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

Route/Dosage ⬆ ⬇

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

Availability ⬆ ⬇

(Generic available)

Tablets: 50 mg; 150 mg

Assessment ⬆ ⬇

Obtain a chest x-ray prior to starting therapy. Assess for interstitial pneumonitis. If dyspnea or worsening of pre-existing dyspnea occur, discontinue nilutamide until cause can be determined. Pneumonitis usually occurs during the first 3 mo of therapy.

Lab Test Considerations:

Monitor hepatic function prior to and every 3 mo throughout therapy. If AST or ALT ↑ >2–3 times upper limit of normal, discontinue treatment.
- May cause hyperglycemia; ↑ alkaline phosphatase, BUN, and serum creatinine; and leukopenia.

Implementation ⬆ ⬇

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

Patient/Family Teaching ⬆ ⬇

Instruct patient to take 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 when dark. Wearing tinted glasses may minimize this effect.
Advise patient to notify heath care professional immediately for difficulty breathing.
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.
Advise patient to avoid alcohol during therapy to ↓ risk of intolerance (flushing, malaise, hypotension).

Evaluation/Desired Outcomes ⬆ ⬇

Decrease in the spread of prostate cancer.

US Brand Names ⬆ ⬇

Canadian Brand Names ⬆ ⬇

Code ⬆

NDC Code

53220- KEKULE PHARMA LIMITED
- 53220-123-
  - 53220-123-01- 15 kg in 1 DRUM (53220-123-01)

59212- Advanz Pharma (US) Corp.
- 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

76055- Sionc Pharmaceutical Private Limited
- 76055-0012-
  - 76055-0012-1- 25 kg in 1 DRUM (76055-0012-1)

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Pronunciation ⬇

Classifications ⬆ ⬇