Drug Guide
Nilutamide
Classification
Therapeutic: Anti-androgen, prostate cancer agent
Pharmacological: Nonsteroidal anti-androgen
FDA Approved Indications
- Treatment of metastatic prostate cancer as adjunct to hormone therapy
Mechanism of Action
Nilutamide binds to androgen receptors, inhibiting the action of endogenous androgens, thereby reducing tumor growth in prostate cancer.
Dosage and Administration
Adult: Initially, 300 mg once daily, may be adjusted based on response and tolerance.
Pediatric: Not indicated for pediatric use.
Geriatric: Use with caution, considering renal and hepatic function; no specific dosage adjustment provided.
Renal Impairment: No specific guidelines; use cautiously.
Hepatic Impairment: Use cautiously; monitor liver function regularly.
Pharmacokinetics
Absorption: Well absorbed orally.
Distribution: Widely distributed in body tissues, crosses blood-brain barrier.
Metabolism: Metabolized in the liver, primarily via conjugation.
Excretion: Excreted mainly in urine and feces.
Half Life: Approximately 27 hours.
Contraindications
- Hypersensitivity to nilutamide or other anti-androgens
Precautions
- Liver function impairment, respiratory issues, and ocular effects; monitor hepatic function and for visual disturbances regularly.
Adverse Reactions - Common
- Hot flashes (Very common)
- Gastrointestinal disturbances (Common)
- Nausea (Common)
Adverse Reactions - Serious
- Liver toxicity or hepatitis (Uncommon)
- Pulmonary reactions like pneumonitis (Rare)
- Ocular effects, including visual disturbances (Rare)
Drug-Drug Interactions
- CYP3A4 inhibitors or inducers may alter nilutamide levels.
Drug-Food Interactions
N/ADrug-Herb Interactions
N/ANursing Implications
Assessment: Monitor liver function tests, ocular health, respiratory status, and reaction to therapy.
Diagnoses:
- Risk for hepatic toxicity
- Risk for impaired vision
Implementation: Administer with food if GI upset occurs, monitor for adverse effects, educate patient about potential side effects.
Evaluation: Assess for signs of toxicity, effectiveness in tumor control, and adverse effects.
Patient/Family Teaching
- Report any visual disturbances, respiratory issues, or signs of liver problems.
- Use contraception if applicable, and inform about potential hot flashes and other side effects.
- Importance of regular follow-up and laboratory testing.
Special Considerations
Black Box Warnings:
- Potential for hepatotoxicity, liver failure—patients should be monitored regularly.
Genetic Factors: N/A
Lab Test Interference: N/A
Overdose Management
Signs/Symptoms: Nausea, vomiting, dizziness, somnolence, hepatic dysfunction.
Treatment: Supportive care, symptomatic management, and liver function tests; no specific antidote.
Storage and Handling
Storage: Store at room temperature, away from moisture and sunlight.
Stability: Stable under recommended storage conditions.