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ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS › ANTINEOPLASTIC AGENTS › OTHER ANTINEOPLASTIC AGENTS › Histone deacetylase (HDAC) inhibitors
romidepsin
L01XH02
Forms & Strengths
- Lyophilized powder for injection: 10 mg/2 mL single-dose vial
Adult Dosing
- Cutaneous T-cell lymphoma (CTCL): 14 mg/m² administered intravenously over a 4-hour period on days 1, 8, and 15 of a 28-day cycle
- Peripheral T-cell lymphoma (PTCL): 14 mg/m² administered intravenously over a 4-hour period on days 1, 8, and 15 of a 28-day cycle
- Continue treatment until disease progression or unacceptable toxicity
Pediatric Dosing
- Safety and efficacy in pediatric patients have not been established
Indications
- Treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy
- Treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior therapy
Mechanism of Action
- Histone deacetylase (HDAC) inhibitor
- Causes accumulation of acetylated histones, leading to cell cycle arrest and apoptosis of cancer cells
Contraindications
- Known hypersensitivity to romidepsin or any of its components
Adverse Reactions
- Nausea, vomiting, diarrhea, constipation
- Fatigue, asthenia
- Infections
- Thrombocytopenia, neutropenia, anemia
- Electrocardiographic changes (QTc prolongation, T-wave flattening)
- Hypomagnesemia, hypokalemia
Drug Interactions
- Strong CYP3A4 inhibitors (may increase romidepsin exposure and toxicity)
- Strong CYP3A4 inducers (may decrease romidepsin efficacy)
- Drugs known to prolong the QTc interval (additive risk of arrhythmia)
Curated Content: Needs Vetting Before Put to Clinical Use