Adult Dosing
Cutaneous T-Cell lymphoma
- 14 mg/m2 IV (over 4 hrs) on days 1, 8 and 15 of a 28 day cycle
- Repeat cycles q28 days if patient benefits from and tolerates therapy
- Modification based on toxicity
Peripheral T-cell lymphoma (PTCL)
- 14 mg/m2 IV (over 4 hrs) on days 1, 8 and 15 of a 28 day cycle
- Repeat cycles q28 days if patient benefits from and tolerates therapy
- Modification based on toxicity
- Nonhematological toxicities except alopecia
- Grade 2/3: Delay treatment until toxicity returns to
Grade 1 or baseline, restart at 14 mg/m2. If Grade 3 toxicity recurs, delay treatment until toxicity returns to
Grade 1 or baseline then permanently reduce dose to 10 mg/m2 - Grade 4: Delay treatment until toxicity returns to
Grade 1 or baseline then permanently reduce dose to 10 mg/m2 - Grade 3 or 4 toxicities recur after dose reduction; discontinue therapy
- Hematologic toxicity
- Grade 3/4 neutropenia/thrombocytopenia: Delay treatment until ANC
1.5 x 10 9/L and/or platelet count
75 x 10 9/L or baseline, then restart at 14 mg/m2 - Grade 4 toxicity (febrile
38.5 C) neutropenia/thrombocytopenia requiring platelet transfusions: Delay treatment until specific cytopenia returns to Grade
1 or baseline, then permanently reduce to 10 mg/m2
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
- QTc prolongation has been reported following romidepsin administration. Obtain baseline ECG and serum electrolyte levels (potassium & magnesium) in patients at risk for prolongation of QT/QTc interval
- It may cause thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia, modify dose accordingly
- Romidepsin may cause fetal harm when administered to a pregnant women
- It may reduce the effectiveness of estrogen containing contraceptives
Cautions: Use cautiously in
- Hepatic impairment
- Renal impairment
- Prolonged QT syndrome
- Coadministration of drugs known to prolong QT interval
- Hx of cardiac disease
- Electrolyte abnormalities
- Concurrent coumadin derivatives
- Concurrent moderate CYP3A4 inhibitors
- Concurrent CYP3A4 inducers (avoid use if possible)
- Concurrent P-gp inhibitors
Pregnancy Category:D
Breastfeeding: Safety unknown; however due to the potential for possible serious adverse reactions in nursing infants a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.