Romidepsin and Ketoconazole Topical: Interaction Details
AI-assisted, pharmacist-reviewed · Source data updated Aug 8, 2026 · Sources: FDA labeling, DDInter 2.0, cited literature
Ketoconazole Topical
Romidepsin
No brand names on record
How we grade severity & evidence
Severity levels
- Contraindicated: These should generally not be used together.
- Major: Potentially serious — often needs a change or close monitoring.
- Moderate: Can be significant — usually manageable with monitoring.
- Minor: Usually limited clinical impact.
Evidence grades
- Established: Well documented — supported by controlled studies or strong clinical data.
- Probable: Good supporting evidence, though not definitively proven.
- Suspected: Some evidence suggests this interaction, but it is not well established.
- Possible: Limited or conflicting evidence; the interaction may occur.
- Theoretical: Predicted from the drugs' pharmacology; not yet confirmed in people.
Ratings come from the documented interaction literature and are reviewed by a pharmacist. They describe the documented risk of the combination, not what will necessarily happen to you — your dose, timing, and health picture all matter.
What happens
Increased romiDEPsin exposure
Interaction Deep Dive
The concomitant use of romiDEPsin (a CYP3A4 substrate) and a strong CYP3A4 inhibitor may increase romiDEPsin exposure and increase the risk of romiDEPsin-related toxicity. Monitor for toxicity related to increased romiDEPsin exposure and follow the dose modifications for toxicity as needed. For non-hematologic toxicities (except alopecia): Grade 2 or 3 toxicity: Hold treatment until toxicity returns to Grade 0 to 1 or baseline. Then restart at 14 mg/m(2). If Grade 3 recurs, hold again until Grade 0 to 1, then permanently reduce dose to 10 mg/m(2). Grade 4 toxicity: Hold treatment until toxicity returns to Grade 0 to 1 or baseline. Then permanently reduce dose to 10 mg/m(2). If Grade 3 or 4 toxicities recur after a dose reduction, discontinue romiDEPsin. For hematologic toxicities: Grade 3 or 4 neutropenia or thrombocytopenia: Hold treatment until ANC more than or equal to 1.5 x 10(9)/L, and platelets are at or above 75 x 10(9)/L or back to baseline. Then restart at 14 mg/m(2). Grade 4 febrile neutropenia or Grade 4 thrombocytopenia requiring transfusion: Hold treatment until toxicity returns to Grade 1 or baseline. Then permanently reduce dose to 10 mg/m(2)1.
Why it happens (mechanism)
Inhibition of CYP3A4-mediated metabolism of romiDEPsin
Literature reports
1 report — tap to read
a) Coadministration of romiDEPsin 8 mg/m(2) with ketoconazole significantly increased romiDEPsin AUC(0 to infinity) by approximately 25% and Cmax by 10% compared with romiDEPsin alone 1.
Common questions
Can I take Romidepsin and Ketoconazole Topical together?
Increased romiDEPsin exposure Always confirm with your pharmacist or prescriber before making any change.
How serious is the Romidepsin and Ketoconazole Topical interaction?
It is rated moderate. Can be significant — usually manageable with monitoring.
How quickly could this interaction happen?
The documented onset is "unspecified". The timing of this interaction is not well characterized.
How strong is the evidence for this interaction?
The evidence is graded "probable". Good supporting evidence, though not definitively proven.
Questions for your pharmacist
- Does my dose of Romidepsin or Ketoconazole Topical need adjusting while I take them together?
- What symptoms should prompt me to call you or my prescriber right away?
- Does the timing of my doses matter for this combination?
- Is there anything you'd monitor while I'm on both?
References (1)
- Product Information: ISTODAX® intravenous injection, romidepsin intravenous injection. Celgene Corporation (per Dailymed), Summit, NJ, 2023. DailyMed
Keep reading about Ketoconazole Topical
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