ROMIDEPSIN

Other

Brand names: ISTODAX

Oral

Mechanism of Action

12.1 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 IC 50 values in the nanomolar range. The mechanism of the antineoplastic effect of romidepsin observed in nonclinical and clinical studies has not been fully characterized.

Indications

See full prescribing information

Contraindications

• 4 CONTRAINDICATIONS None. None ( 4 ).

FDA Warnings

5 WARNINGS AND PRECAUTIONS • Myelosuppression: ISTODAX can cause thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia; monitor blood counts during treatment with ISTODAX; interrupt and/or modify the dose as necessary ( 5
• Infections: Fatal and serious infections
• Tumor lysis syndrome: Patients with advanced stage disease and/or high tumor burden are at greater risk and should be closely monitored and appropriate precautions taken ( 5
Advise females of reproductive potential and males with female partners of reproductive potential of potential risk to a fetus and to use effective contraception ( 5

Known Side Effects

6 documented side effects by frequency

Nausea

1-10%

Fever

1-10%

Drug Not Working

1-10%

Fatigue

1-10%

Vomiting

1-10%

Decreased Appetite

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral