Nilutamide

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Nilutamide
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]

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Black Box Warning

Warning
See full prescribing information for complete Boxed Warning.
Interstitial Pneumonia: Interstitial pneumonitis has been reported in 2% of patients in controlled clinical trials in patients exposed to nilutamide. A small study in Japanese subjects showed that 8 of 47 patients (17%) developed interstitial pneumonitis. Reports of interstitial changes including pulmonary fibrosis that led to hospitalization and death have been reported rarely post-marketing. Symptoms included exertional dyspnea, cough, chest pain, and fever. X-rays showed interstitial or alveolo-interstitial changes, and pulmonary function tests revealed a restrictive pattern with decreased DLco. Most cases occurred within the first 3 months of treatment with NILANDRON, and most reversed with discontinuation of therapy. A routine chest X-ray should be performed prior to initiating treatment with NILANDRON. Baseline pulmonary function tests may be considered. Patients should be instructed to report any new or worsening shortness of breath that they experience while on NILANDRON. If symptoms occur, NILANDRON should be immediately discontinued until it can be determined if the symptoms are drug related.

Overview

Nilutamide is an antiandrogen that is FDA approved for the treatment of metastatic prostate cancer. There is a Black Box Warning for this drug as shown here. Common adverse reactions include hypertension, hot sweats, constipation, nausea, dizziness an abnormal vision.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Nilutamide FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Nilutamide in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Nilutamide in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Nilutamide FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Nilutamide in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Nilutamide in pediatric patients.

Contraindications

NILANDRON tablets are contraindicated:

Warnings

Warning
See full prescribing information for complete Boxed Warning.
Interstitial Pneumonia: Interstitial pneumonitis has been reported in 2% of patients in controlled clinical trials in patients exposed to nilutamide. A small study in Japanese subjects showed that 8 of 47 patients (17%) developed interstitial pneumonitis. Reports of interstitial changes including pulmonary fibrosis that led to hospitalization and death have been reported rarely post-marketing. Symptoms included exertional dyspnea, cough, chest pain, and fever. X-rays showed interstitial or alveolo-interstitial changes, and pulmonary function tests revealed a restrictive pattern with decreased DLco. Most cases occurred within the first 3 months of treatment with NILANDRON, and most reversed with discontinuation of therapy. A routine chest X-ray should be performed prior to initiating treatment with NILANDRON. Baseline pulmonary function tests may be considered. Patients should be instructed to report any new or worsening shortness of breath that they experience while on NILANDRON. If symptoms occur, NILANDRON should be immediately discontinued until it can be determined if the symptoms are drug related.

There is limited information regarding Nilutamide Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Nilutamide Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Nilutamide Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Nilutamide Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Nilutamide in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Nilutamide in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Nilutamide during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Nilutamide in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Nilutamide in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Nilutamide in geriatric settings.

Gender

There is no FDA guidance on the use of Nilutamide with respect to specific gender populations.

Race

There is no FDA guidance on the use of Nilutamide with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Nilutamide in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Nilutamide in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Nilutamide in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Nilutamide in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Nilutamide Administration in the drug label.

Monitoring

There is limited information regarding Nilutamide Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Nilutamide and IV administrations.

Overdosage

There is limited information regarding Nilutamide overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Nilutamide Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Nilutamide Mechanism of Action in the drug label.

Structure

There is limited information regarding Nilutamide Structure in the drug label.

Pharmacodynamics

There is limited information regarding Nilutamide Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Nilutamide Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Nilutamide Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Nilutamide Clinical Studies in the drug label.

How Supplied

There is limited information regarding Nilutamide How Supplied in the drug label.

Storage

There is limited information regarding Nilutamide Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Nilutamide Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Nilutamide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Nilutamide Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Nilutamide Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

Nilutamide
Clinical data
ATC code
Pharmacokinetic data
Elimination half-life38.0 to 59.1 hours
Identifiers
CAS Number
PubChem CID
DrugBank
E number{{#property:P628}}
ECHA InfoCard{{#property:P2566}}Lua error in Module:EditAtWikidata at line 36: attempt to index field 'wikibase' (a nil value).
Chemical and physical data
FormulaC12H10F3N3O4
Molar mass317.221 g/mol

Template:Search infobox Steven C. Campbell, M.D., Ph.D.


Overview

Nilutamide is an antiandrogen medication used in the treatment of advanced stage prostate cancer. Nilutamide blocks the androgen receptor, preventing its interaction with testosterone. Because most prostate cancer cells rely on the stimulation of the androgen receptor for growth and survival, nilutamide can prolong life in men with prostate cancer. Nilutamide is marketed under the name Nilandron in the United States.

References

  • Kassouf W, Tanguay S, Aprikian AG. Nilutamide as second line hormone therapy for prostate cancer after androgen ablation fails. J. Urol. 2003 May;169(5):1742-4. PMID 12686822

Template:Sex hormones

Template:WikiDoc Sources

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