Romidepsin (2 brand names, 2 dosage forms, 1 route)
Available dosage forms: SOLUTION, POWDER.
Routes of administration: INTRAVENOUS.
Brand Names
- ISTODAX
- ROMIDEPSIN
Indications and Usage
Romidepsin injection is indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy.
Contraindications
None.
Adverse Reactions
The following clinically significant 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)]
Mechanism of Action
Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression. HDACs also deacetylate non-histone proteins, such as transcription factors. In vitro, romidepsin causes the accumulation of acetylated histones, and induces cell cycle arrest and apoptosis of some cancer cell lines with IC50 values in the nanomolar range. The mechanism of the antineoplastic effect of romidepsin observed in nonclinical and clinical studies has not been fully characterized.
Overdosage
No specific information is available on the treatment of overdosage of romidepsin. Toxicities in a single-dose study in rats or dogs, at intravenous romidepsin doses up to 2.2-fold the recommended human dose based on the body surface area, included irregular respiration, irregular heartbeat, staggering gait, tremor, and tonic convulsions. In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., clinical monitoring and supportive therapy, if required. There is no known antidote for romidepsin and it is not known if romidepsin is dialyzable.