HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ISTODAX safely and effectively.  See full prescribing information for ISTODAX.
ISTODAX® (romidepsin) for injection
For intravenous infusion only
Initial U.S. Approval:  2009
Celgene Corporation
INDICATIONS AND USAGE
ISTODAX is a histone deacetylase (HDAC) inhibitor indicated for:
Treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy (1).
DOSAGE AND ADMINISTRATION
14 mg/m2 administered intravenously (IV) over a 4-hour period on days 1, 8 and 15 of a 28-day cycle. Repeat cycles every 28 days provided that the patient continues to benefit from and tolerates the drug (2.1).
Treatment discontinuation or interruption with or without dose reduction to 10 mg/m2 may be needed to manage adverse drug reactions (2.2).
DOSAGE FORMS AND STRENGTHS
ISTODAX for injection, 10 mg, supplied with one Diluent vial containing 2 mL (deliverable volume) of solution (3)
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
Due to the risk of QT prolongation ensure that potassium and magnesium are within the normal range before administration of ISTODAX (5.1).
Treatment with ISTODAX has been associated with thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia; therefore, monitor these hematological parameters during treatment with ISTODAX, modify the dose as necessary (5.2).
Electrocardiographic (ECG) changes have been observed. Consider cardiovascular monitoring precautions in patients with congenital long QT syndrome, a history of significant cardiovascular disease, and patients taking medicinal products that lead to significant QT prolongation (5.3).
Based on its mechanism of action, ISTODAX may cause fetal harm when administered to a pregnant woman. Advise women of potential harm to the fetus (5.4, 8.1).
ISTODAX binds to estrogen receptors. Advise women of childbearing potential that ISTODAX may reduce the effectiveness of estrogen-containing contraceptives (5.5).
ADVERSE REACTIONS
The most common adverse reactions in Study 1 were nausea, fatigue, infections, vomiting, and anorexia, and in Study 2 were nausea, fatigue, anemia, thrombocytopenia, ECG T-wave changes, neutropenia, and lymphopenia (6).
To report SUSPECTED ADVERSE REACTIONS, contact Celgene Corporation at 1-888-423-5436 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Carefully monitor prothrombin time (PT) and International Normalized Ratio (INR) in patients concurrently administered ISTODAX and Coumadin derivatives (7.1).
Strong CYP3A4 inhibitors may increase concentrations of ISTODAX and should be avoided (7.2).
Potent CYP3A4 inducers may decrease concentrations of ISTODAX and should be avoided (7.2).
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling 
Revised: 06/2010
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FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed 

1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dosing Information
2.2 Dose Modification
2.3 Instructions for Preparation and Intravenous Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICAT