Romidepsin (Istodax)

General information

Class/mechanism: Histone deacetylase (HDAC) inhibitor. HDACs normally catalyze removal of acetyl groups from acetylated lysine residues in histones and non-histone proteins, which helps to regulate gene expression. Inhibition of histone deacetylases results in hyperacetylation of histones and modulates gene expression by creating an open chromatin state that leads to expression of previously silenced genes. Although the mechanism of action is not fully understood, inhibiting HDACs has been observed to result in cell cycle arrest and apoptosis of cancer cells.
Route: IV
Extravasation: no information

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.

Diseases for which it is used

• Cutaneous T-cell lymphoma
• Peripheral T-cell lymphoma

Patient drug information

• Romidepsin (Istodax) package insert PDF pages 8-9
• Romidepsin (Istodax) patient drug information (UpToDate)

History of changes in FDA indication

• 11/5/2009: Initial FDA approval for "Treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy."
• 6/16/2011: Additional indication for "Treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior therapy."

Also known as

depsipeptide, FK228, FR901228, NSC 630176