How ISTODAX Is
Supplied and Stored

ISTODAX® (romidepsin) is supplied as a kit including1:

  • A sterile, lyophilized powder in a 10 mg single-dose vial containing 11 mg of romidepsin and 22 mg of the bulking agent, povidone, USP
  • A single-dose sterile diluent vial containing 2.4 mL (2.2 mL deliverable volume) of 80% propylene glycol, USP, and 20% dehydrated alcohol, USP

ISTODAX kit containing one 10-mg vial of romidepsin and one 2-mL vial of diluent for romidepsin per carton

NDC 59572-984-01: ISTODAX® KIT containing one 10 mg single-dose vial of ISTODAX and one single-dose vial with 2.2 mL of diluent

  • ISTODAX must be stored at room temperature, defined as 20° to 25°C (68° to 77°F), with excursions permitted between 15° to 30°C (between 59° and 86°F)

The recommended dose is 14 mg/m2 administered
intravenously over a 4-hour period on Days 1, 8,
and 15 of a 28-day cycle.1

USE IN SPECIFIC POPULATIONS

  • Pregnancy Category D: If this drug is used during pregnancy, or if the patient becomes pregnant while taking ISTODAX, the patient should be apprised of the potential hazard to the fetus
  • Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from ISTODAX, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother
  • Patients with moderate and severe hepatic impairment and/or patients with end-stage renal disease should be treated with caution
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Important Safety Information

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

Peripheral T-Cell Lymphoma

The most common Grade 3/4 adverse reactions (>5%) regardless of causality in Study 3 (N=131) were thrombocytopenia (24%), neutropenia (20%), anemia (11%), asthenia/fatigue (8%), and leukopenia (6%), and in Study 4 (N=47) were neutropenia (47%), leukopenia (45%), thrombocytopenia (36%), anemia (28%), asthenia/fatigue (19%), pyrexia (17%), vomiting (9%), and nausea (6%).

Infections were the most common type of serious adverse event reported in Study 3 (N=131) and Study 4 (N=47). In Study 3, 26 patients (20%) experienced a serious infection, including 6 patients (5%) with serious treatment-related infections. In Study 4, 11 patients (23%) experienced a serious infection, including 8 patients (17%) with serious treatment-related infections.

The most common adverse reactions regardless of causality in Study 3 (N=131) were nausea (59%), asthenia/fatigue (55%), thrombocytopenia (41%), vomiting (39%), diarrhea (36%), and pyrexia (35%), and in Study 4 (N=47) were asthenia/fatigue (77%), nausea (75%), thrombocytopenia (72%), neutropenia (66%), anemia (62%), leukopenia (55%), pyrexia (47%), anorexia (45%), vomiting (40%), constipation (40%), and diarrhea (36%).

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

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