Romidepsin
Also known as: Depsipeptide, FK-228, FK228, Istodax, NSC-630176, Spiruchostatin-related compound
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Summary
Romidepsin (brand name Istodax) is a bicyclic depsipeptide HDAC inhibitor approved for the treatment of relapsed or refractory cutaneous T‑cell lymphoma (CTCL) and peripheral T‑cell lymphoma (PTCL). It is administered by intravenous infusion.
Mechanism of Action
Reversible inhibition of class I histone deacetylases (HDAC1, HDAC2) leading to accumulation of acetylated histones, altered transcription, cell-cycle arrest and apoptosis of malignant T‑cells.
Routes of Administration
Goals & Uses
- Treatment of peripheral T-cell lymphoma (PTCL)OncologyHigh
- Other hematologic malignanciesOncologyModerate
- HIV latency reversalInfectious Disease / ResearchLow
- Peripheral T‑cell lymphomaOncologyHigh
- Treatment of cutaneous T-cell lymphoma (CTCL)OncologyHigh
- Epigenetic modulation in solid tumorsOncology / ResearchLow
- Cutaneous T‑cell lymphomaOncologyHigh
Contraindications
- Severe hepatic impairment (Child-Pugh C)HepaticModerate
- QTc prolongation / pre-existing significant cardiac arrhythmiaCardiovascularHigh
- Severe hepatic impairmentOrganModerateLiver function concerns
- Congenital long QT syndromeCardiovascular / GeneticHigh
- PregnancyPopulationHighPotential fetal risk or insufficient safety data
- Hypersensitivity to romidepsin or any excipientsAllergyHigh
Adverse Effects
- ThrombocytopeniaHematologicCommonLow platelet count
- Nausea/vomitingGastrointestinalCommon
- QTc prolongation / ECG changesCardiovascularUncommon
- NeutropeniaHematologicCommonLow neutrophil count
- NauseaGastrointestinalCommonFeeling of sickness or urge to vomit
- FatigueGeneralCommonLow energy or tiredness
- InfectionsImmunologicCommon
- QT prolongationCardiovascularUncommonExtended QT interval on ECG
- Neutropenia/anemiaHematologicCommon
Drug Interactions
- Strong CYP3A4 inducers (e.g., rifampin, carbamazepine)High
- WarfarinModerate
- QT-prolonging agents (e.g., antiarrhythmics, certain antipsychotics)High
- Strong CYP3A4 inducers (e.g., rifampin)Moderate
- Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin)High
- Strong CYP3A4 inhibitors (e.g., ketoconazole)Moderate
Population Constraints
- PregnancyReproductive SafetyRelative
- Pediatric patientsAgeRelative
- Breastfeeding womenReproductiveAbsolute
- Patients with electrolyte abnormalities (hypokalemia, hypomagnesemia)MetabolicRelative
- Pregnant womenReproductiveAbsolute
- BreastfeedingReproductiveAbsolute
Regulatory Status
- European UnionApprovedApproved: Cutaneous T‑cell lymphoma, Peripheral T‑cell lymphomaEMA approval 2009
- United StatesApprovedApproved: Cutaneous T‑cell lymphoma, Peripheral T‑cell lymphomaFDA approval 2009
- United KingdomApprovedApproved: Cutaneous T‑cell lymphoma, Peripheral T‑cell lymphomaMHRA approval
FDA approved in 2009 for CTCL; EMA approved in 2009 for CTCL and PTCL. Marketed under the brand Istodax.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Romidepsin?
Romidepsin (brand name Istodax) is a bicyclic depsipeptide HDAC inhibitor approved for the treatment of relapsed or refractory cutaneous T‑cell lymphoma (CTCL) and peripheral T‑cell lymphoma (PTCL). It is administered by intravenous infusion.
What is Romidepsin used for?
Romidepsin is educationally associated with: Treatment of peripheral T-cell lymphoma (PTCL), Other hematologic malignancies, HIV latency reversal, Peripheral T‑cell lymphoma, Treatment of cutaneous T-cell lymphoma (CTCL), Epigenetic modulation in solid tumors, Cutaneous T‑cell lymphoma. Educational only — not medical advice.
How is Romidepsin administered?
Recorded routes of administration: Intravenous.
What are the potential side effects of Romidepsin?
Reported adverse effects include: Thrombocytopenia, Nausea/vomiting, QTc prolongation / ECG changes, Neutropenia, Nausea, Fatigue, Infections, QT prolongation, Neutropenia/anemia. This list is not exhaustive — consult a qualified clinician.
Who should avoid Romidepsin?
Recorded contraindications: Severe hepatic impairment (Child-Pugh C), QTc prolongation / pre-existing significant cardiac arrhythmia, Severe hepatic impairment, Congenital long QT syndrome, Pregnancy, Hypersensitivity to romidepsin or any excipients. Consult a qualified clinician before use.