Romidepsin (romidepsin)

The recommended adult IV dosage of romidepsin for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least 1 prior systemic therapy is 14 mg/m2 administered by IV infusion over 4 hours on days 1, 8, and 15 of a 28-day cycle. Cycles should be repeated every 28 days as long as the patient derives benefit and tolerates therapy. In clinical trials, treatment generally was continued until evidence of disease progression was observed. Although therapy was continued for up to 83 months in clinical trials, the optimal duration of romidepsin treatment has not been clearly established.

In patients experiencing grade 3 or 4 neutropenia or thrombocytopenia, romidepsin treatment should be delayed until the specific cytopenia returns to an absolute neutrophil count (ANC) of 1500 cells/mm3 (or greater) and/or a platelet count of 75,000 cells/mm3 (or greater) or to baseline, then treatment may be restarted at 14 mg/m2.

In patients experiencing grade 4 febrile neutropenia (a temperature of 38.5degreesC or higher) or thrombocytopenia requiring a platelet transfusion, romidepsin treatment should be delayed until the specific cytopenia returns to grade 1 (or less) or to baseline, and the dosage should be permanently reduced to 10 mg/m2.

In patients experiencing grade 2 or 3 toxicity, romidepsin therapy should be delayed until toxicity returns to grade 1 (or less) or to baseline. Then therapy may be restarted at 14 mg/m2. If grade 3 toxicity recurs, therapy should be delayed until toxicity returns to grade 1 (or less) or baseline and the dosage should be permanently reduced to 10 mg/m2.

In patients experiencing grade 4 toxicity, romidepsin therapy should be delayed until toxicity returns to grade 1 (or less) or to baseline and the dosage should be permanently reduced to 10 mg/m2.

Romidepsin should be discontinued if grade 3 or 4 toxicities recur after dosage reduction.

Romidepsin is administered by IV infusion only. The drug is commercially available as a kit that includes a single-use vial containing 10 mg of romidepsin and a vial containing 2 mL of diluent (composed of 80% propylene glycol and 20% dehydrated alcohol).

No dosing information is available for this tab.

No dosing information is available for this tab.

Romidepsin is metabolized principally by cytochrome P-450 (CYP) isoenzyme 3A4 and, to a lesser extent, by CYP3A5, CYP1A1, CYP2B6, and CYP2C19. The drug also is a substrate of P-glycoprotein.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

The manufacturer states that there are no known contraindications to the use of romidepsin.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Adverse events reported in 10% or more of patients receiving romidepsin include nausea, asthenia/fatigue, infections, vomiting, anorexia, hypomagnesemia, diarrhea, pyrexia, anemia, thrombocytopenia, dysgeusia, constipation, neutropenia, hypotension, pruritus, hypokalemia, dermatitis/exfoliative dermatitis, hypocalcemia, leukopenia, lymphopenia, elevated transaminase concentrations, hypoalbuminemia, ECG changes (ST-T wave changes), hyperglycemia, hyponatremia, hypermagnesemia, hypophosphatemia, and hyperuricemia.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

Safety and efficacy not established in children younger than 18 years of age.

In a limited number of pediatric patients from 2-21 years of age, the pharmacokinetics of romidepsin were found to be similar to those reported in adults in a phase I trial.

Category D. (See Users Guide and also see Fetal/Neonatal Morbidity and Mortality under Cautions: Warnings/Precautions.)

Not known whether romidepsin is distributed into human milk. Because of the potential for serious adverse reactions to romidepsin in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

Of the 167 patients with CTCL in clinical trials, 23% were older than 65 years of age. Although no overall differences in safety or efficacy were observed between geriatric and younger individuals, the possibility of greater sensitivity in some geriatric patients cannot be ruled out.