Dosing

ISTODAX is administered once a week for 3 weeks—with 1 week off each dosing cycle1

The recommended dose is 14 mg/m2 administered intravenously over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle1

ISTODAX is supplied as a kit which includes a 10 mg single-dose vial of ISTODAX and one single-dose vial with 2.2 mL (deliverable volume) of diluent.

Dosing administration chart for ISTODAX® (romidepsin) for Injection

Cycles should be repeated every 28 days provided the
patient continues to benefit from and tolerate
the drug.1

Patient Counseling Information for Tumor Lysis Syndrome
Advise patients of risk of tumor lysis syndrome (especially those with advanced stage disease and/or high tumor burden) to maintain high fluid intake for at least 72 hours after each dose.

DRUG INTERACTIONS

  • Monitor more frequently prothrombin time and International Normalized Ratio in patients concurrently administered ISTODAX and warfarin or coumarin derivatives
  • Romidepsin is metabolized by CYP3A4
    • Monitor patients for toxicity related to increased romidepsin exposure and follow dose modifications for toxicity when ISTODAX is initially co-administered with strong CYP3A4 inhibitors
    • Avoid co-administration of ISTODAX (romidepsin) with rifampin and other potent inducers of CYP3A4
  • Exercise caution with concomitant use of ISTODAX and P-glycoprotein (P-gp, ABCB1) inhibitors
NEXT: DOSING MODIFICATION

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

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