Vorinostat

Vorinostat
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: Gloria Picoy [2]

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Overview

Vorinostat is a histone deacetylase inhibitor that is FDA approved for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies. Common adverse reactions include diarrhea, fatigue, nausea, thrombocytopenia, anorexia and dysgeusia.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Vorinostat is indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease on or following two systemic therapies.

• Dosage: 400 mg orally once daily with food.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Safety and effectiveness not established in pediatric patients

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

None

Warnings

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

Adverse Reactions

Clinical Trials Experience

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

Postmarketing Experience

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

Drug Interactions

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

Use in Specific Populations

Pregnancy

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

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

Monitoring

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

IV Compatibility

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

Overdosage

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

Mechanism of Action

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

Structure

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

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

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

Storage

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

Precautions with Alcohol

Alcohol-Vorinostat 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 Vorinostat Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Vorinostat 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.

Vorinostat

File:Vorinostat.svg
Clinical data
[[Regulation of therapeutic goods |Template:Engvar data]]	US FDA: Vorinostat
Pregnancy category	US: D (Evidence of risk)
Routes of administration	Oral
Legal status
Legal status	US: ℞-only
Pharmacokinetic data
Protein binding	71%
Metabolism	Hepatic glucuronidation and oxidation CYP system not involved
Elimination half-life	2 hours
Excretion	Renal (negligible)
Identifiers
IUPAC name N-hydroxy-N'-phenyl-octanediamide
CAS Number	149647-78-9
PubChem CID	5311
E number	{{#property:P628}}
ECHA InfoCard	{{#property:P2566}}
Chemical and physical data
Formula	C14H20N2O3
Molar mass	264.32 g/mol

WikiDoc Resources for Vorinostat
Articles
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Evidence Based Medicine
Cochrane Collaboration on Vorinostat Bandolier on Vorinostat TRIP on Vorinostat
Clinical Trials
Ongoing Trials on Vorinostat at Clinical Trials.gov Trial results on Vorinostat Clinical Trials on Vorinostat at Google
Guidelines / Policies / Govt
US National Guidelines Clearinghouse on Vorinostat NICE Guidance on Vorinostat NHS PRODIGY Guidance FDA on Vorinostat CDC on Vorinostat
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News
Vorinostat in the news Be alerted to news on Vorinostat News trends on Vorinostat
Commentary
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Definitions
Definitions of Vorinostat
Patient Resources / Community
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Healthcare Provider Resources
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Continuing Medical Education (CME)
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International
Vorinostat en Espanol Vorinostat en Francais
Business
Vorinostat in the Marketplace Patents on Vorinostat
Experimental / Informatics
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Overview

Vorinostat (rINN) or suberoylanilide hydroxamic acid (SAHA), brand name Zolinza®, is a drug currently under investigation for the treatment of cutaneous T cell lymphoma (CTCL), a type of skin cancer, to be used when the disease persists, gets worse, or comes back during or after treatment with other medicines. It is the first in a new class of agents known as histone deacetylase inhibitors.

A recent study suggested that vorinostat also possesses some activity against recurrent glioblastoma multiforme, resulting in a median overall survival of 5.7 months (compared to 4 - 4.4 months in earlier studies). Further brain tumor trials are planned in which vorinostat will be combined with other drugs.

Zolinza was approved by the U.S. Food and Drug Administration (FDA) for the treatment of CTCL on October 6, 2006, and it is manufactured by Pantheon, Inc., in Mississauga, Ontario, Canada, for Merck & Co., Inc., White House Station, New Jersey.

References

• "ZOLINZA™, Merck's Investigational Medicine for Advanced Cutaneous T-Cell Lymphoma (CTCL), To Receive Priority Review from U.S. Food and Drug Administration" (Press release). Merck & Co. June 7, 2006. Retrieved 2006-10-06.

• "FDA Approves New Drug for Skin Cancer, Zolinza" (Press release). Food and Drug Administration. October 6, 2006. Retrieved 2006-10-06.

• "Vorinostat shows anti-cancer activity in recurrent gliomas" (Press release). Mayo Clinic. June 3, 2007. Retrieved 2007-06-03.