HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ZOLINZA safely and effectively. See full prescribing information for ZOLINZA.
ZOLINZA® (vorinostat) Capsules
Initial U.S. Approval: 2006
RECENT MAJOR CHANGES
Dosage and Administration 
  Dose Modifications (2.2) 04/2013

INDICATIONS AND USAGE
ZOLINZA is a histone deacetylase (HDAC) inhibitor indicated 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. (1)

DOSAGE AND ADMINISTRATION
•400 mg orally once daily with food. (2.1)
•If patient is intolerant to therapy, reduce the dose to 300 mg orally once daily with food. If necessary, reduce the dose further to 300 mg once daily with food for 5 consecutive days each week. (2.2, 5)
•Reduce dose in patients with mild or moderate hepatic impairment. (2.2)
DOSAGE FORMS AND STRENGTHS
•Capsules: 100 mg (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
•Pulmonary embolism and deep vein thrombosis: Monitor for pertinent signs and symptoms. (5.1)
•Thrombocytopenia and anemia: May require dose modification or discontinuation. Monitor blood counts every 2 weeks during the first 2 months of therapy and monthly thereafter. (2.2, 5.2, 6)
•Gastrointestinal Toxicity: Nausea, vomiting and diarrhea; patients may require antiemetics, antidiarrheals, and fluid and electrolyte replacement to prevent dehydration. (5.3, 6, 17.1)
•Hyperglycemia: Monitor blood glucose every 2 weeks during the first 2 months of therapy and monthly thereafter. (5.4)
•Clinical chemistry abnormalities: Measure and correct abnormal electrolytes, creatinine, magnesium and calcium at baseline. Monitor every 2 weeks during the first 2 months of therapy and at least monthly during treatment. (5.5)
•Severe thrombocytopenia with gastrointestinal bleeding has been reported with concomitant use of ZOLINZA and other HDAC inhibitors (e.g., valproic acid). Monitor platelet counts more frequently. (5.6, 7.2)
•Fetal harm can occur when administered to a pregnant woman. Women should be apprised of the potential harm to the fetus. (5.7)
ADVERSE REACTIONS
•The most common adverse reactions (incidence ≥20%) are diarrhea, fatigue, nausea, thrombocytopenia, anorexia and dysgeusia. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS
•Coumarin-derivative anticoagulants: Prolongation of prothrombin time and International Normalized Ratio (INR) have been observed with concomitant use. Monitor INR frequently. (7.1)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 04/2013
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FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dosing Information
2.2 Dose Modifications
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Thromboembolism
5.2 Myelosuppression
5.3 Gastrointestinal Toxicity
5.4 Hyperglycemia
5.5 Clinical Chemistry Abnormalities
5.6 Severe thromb