ISTODAX

In patients with T-cell lymphomas who received 14 mg/m 2 of romidepsin intravenously over a 4-hour period on days 1, 8, and 15 of a 28-day cycle, geometric mean values of the maximum plasma concentration (C max ) and the area under the plasma concentration versus time curve (AUC 0-∞ ) were 377 ng/mL and 1549 ng*hr/mL, respectively. Romidepsin exhibited linear pharmacokinetics across doses ranging from 1.0 (0.07 times the recommended dose) to 24.9 (1.76 times the recommended dose) mg/m 2 when adm...

ISTODAX was evaluated in 2 multicenter, single-arm clinical studies in patients with CTCL (Study 1 [NCT00106431] and Study 2 [NCT00007345]). Overall, 167 patients with CTCL were treated in the US, Europe, and Australia. Study 1 included 96 patients with confirmed CTCL after failure of at least 1 prior systemic therapy. Study 2 included 71 patients with a primary diagnosis of CTCL who received at least 2 prior skin directed therapies or one or more systemic therapies. Patients were treated with ISTODAX at a starting dose of 14 mg/m 2 infused over 4 hours on days 1, 8, and 15 every 28 days. In b...

The following adverse reactions are described in more detail in other sections of the prescribing information.

• Myelosuppression [see Warnings and Precautions (5.1) ]
• Infections [see Warnings and Precautions (5.2) ]
• Electrocardiographic Changes [see Warnings and Precautions (5.3) ]
• Tumor Lysis Syndrome [see Warnings and Precautions (5.4) ] The most common adverse reactions (≥30%), excluding laboratory abnormalities, are nausea, fatigue, infections, vomiting, anorexia, electrocardiogram ST...

None. None ( 4 ).

• Myelosuppression: ISTODAX can cause thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia; monitor blood counts during treatment with ISTODAX; interrupt and/or modify the dose as necessary ( 5.1 ).
• Infections: Fatal and serious infections. Reactivation of DNA viruses (Epstein Barr and hepatitis B). Consider monitoring and prophylaxis in patients with evidence of prior hepatitis B ( 5.2 ).
• Electrocardiographic (ECG) changes: Consider cardiovascular monitoring in patients wi...

7 DRUG INTERACTIONS

• Carefully monitor prothrombin time (PT) and International Normalized Ratio (INR) in patients concurrently administered ISTODAX and warfarin or coumarin derivatives ( 7.1 ).
• Monitor for toxicities related to increased romidepsin exposure when co-administering romidepsin with strong CYP3A4 inhibitors ( 7.2 ).
• Avoid use with rifampin and strong CYP3A4 inducers ( 7.3 ). 7.1 W...