Midostaurin and Givinostat: Interaction Details
AI-assisted, pharmacist-reviewed · Source data updated Aug 8, 2026 · Sources: FDA labeling, DDInter 2.0, cited literature
Midostaurin
Givinostat
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 CYP3A4 substrate exposure and an increased risk of CYP3A4 substrate-related adverse effects and toxicity
Interaction Deep Dive
Concomitant use of givinostat (a weak intestinal CYP3A4 inhibitor) and a CYP3A4 sensitive substrate with a narrow therapeutic index may increased CYP3A4 substrate exposure and increased risk of CYP3A4 substrate-related adverse effects and toxicity. A clinical drug interaction study was conducted in healthy volunteers to assess the effects of coadministration of givinostat with other drugs and results indicated that givinostat has a weak inhibition of the intestinal CYP3A4 enzyme based on the exposure of a CYP3A4 substrate (midazolam). Closely monitor when givinostat is used in combination with orally administered CYP3A4 sensitive substrates for which a small change in substrate plasma concentration may lead to serious toxicities1.
Why it happens (mechanism)
Inhibition of CYP3A4-substrate metabolism by givinostat
Literature reports
1 report — tap to read
a) A clinical drug interaction study was conducted in healthy volunteers to assess the effects of coadministration of givinostat with other drugs and results indicated that givinostat has a weak inhibition of the intestinal CYP3A4 enzyme based on the exposure of a CYP3A4 substrate (midazolam) 1.
Common questions
Can I take Midostaurin and Givinostat together?
Increased CYP3A4 substrate exposure and an increased risk of CYP3A4 substrate-related adverse effects and toxicity Always confirm with your pharmacist or prescriber before making any change.
How serious is the Midostaurin and Givinostat interaction?
It is rated major. Potentially serious — often needs a change or close 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 Midostaurin or Givinostat 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 a safer alternative to one of these medications for me?
References (1)
- Product Information: DUVYZAT oral suspension, givinostat oral suspension. ITF Therapeutics, LLC (per FDA), Concord, MA, 2024. DailyMed
Keep reading about Midostaurin
Keep reading about Givinostat
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