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.

ISTODAX dosing schedule

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

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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