ISTODAX- romidepsin
Celgene Corporation
1 INDICATIONS AND USAGE
ISTODAX is indicated for:
Treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.
Treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior therapy.
These indications are based on response rate. Clinical benefit such as improvement in overall survival has not been demonstrated.
2 DOSAGE AND ADMINISTRATION
2.1 Dosing Information
The recommended dose of romidepsin is 14 mg/m2 administered intravenously over a 4-hour period on days 1, 8, and 15 of a 28-day cycle. Cycles should be repeated every 28 days provided that the patient continues to benefit from and tolerates the drug.
2.2 Dose Modification
Nonhematologic toxicities except alopecia
Grade 2 or 3 toxicity: Treatment with romidepsin should be delayed until toxicity returns to ? Grade 1 or baseline, then therapy may be restarted at 14 mg/m2. If Grade 3 toxicity recurs, treatment with romidepsin should be delayed until toxicity returns to ? Grade 1 or baseline and the dose should be permanently reduced to 10 mg/m2.
Grade 4 toxicity: Treatment with romidepsin should be delayed until toxicity returns to ? Grade 1 or baseline, then the dose should be permanently reduced to 10 mg/m2.
Romidepsin should be discontinued if Grade 3 or 4 toxicities recur after dose reduction.
Hematologic toxicities
Grade 3 or 4 neutropenia or thrombocytopenia: Treatment with romidepsin should be delayed until the specific cytopenia returns to ANC ?1.5�109 /L and platelet count ?75�109 /L or baseline, then therapy may be restarted at 14 mg/m2.
Grade 4 febrile (? 38.5�C) neutropenia or thrombocytopenia that requires platelet transfusion: Treatment with romidepsin should be delayed until the specific cytopenia returns to ? Grade 1 or baseline, and then the dose should be permanently reduced to 10 mg/m2.
