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° to 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

Cutaneous T-Cell Lymphoma
The most common Grade 3/4 adverse reactions (>5%) regardless of causality in Study 1 (N=102) were infections (11%) and asthenia/fatigue (8%), and in Study 2 (N=83) were lymphopenia (37%), infections (33%), neutropenia (27%), leukopenia (22%), anemia (16%), asthenia/fatigue (14%), thrombocytopenia (14%), hypophosphatemia (10%), vomiting (10%), dermatitis/exfoliative dermatitis (8%), hypermagnesemia (8%), hyperuricemia (8%), hypocalcemia (6%), nausea (6%), and pruritus (6%).

Infections were the most common type of serious adverse event reported in both Study 1 (N=102) and Study 2 (N=83) with 8 patients (8%) in Study 1 and 26 patients (31%) in Study 2 experiencing a serious infection.

The most common adverse reactions regardless of causality in Study 1 (N=102) were nausea (56%), asthenia/fatigue (53%), infections (46%), vomiting (34%), and anorexia (23%), and in Study 2 (N=83) were nausea (86%), asthenia/fatigue (77%), anemia (72%), thrombocytopenia (65%), ECG ST-T wave changes (63%), neutropenia (57%), lymphopenia (57%), infections (54%), anorexia (54%), vomiting (52%), hypocalcemia (52%), hyperglycemia (51%), hypoalbuminemia (48%), leukopenia (46%), dysgeusia (40%), and constipation (39%).

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

Please click here for Full Prescribing Information.

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