Vorinostat
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.
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| Routes of administration | Oral |
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| Pharmacokinetic data | |
| Protein binding | 71% |
| Metabolism | Hepatic glucuronidation and oxidation CYP system not involved |
| Elimination half-life | 2 hours |
| Excretion | Renal (negligible) |
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| 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 | |
| Formula | C14H20N2O3 |
| Molar mass | 264.32 g/mol |
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Ongoing Trials on Vorinostat at Clinical Trials.gov Clinical Trials on Vorinostat at Google
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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.
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