Midostaurin and Nirogacestat: Interaction Details
AI-assisted, pharmacist-reviewed · Source data updated Aug 8, 2026 · Sources: FDA labeling, DDInter 2.0, cited literature
Midostaurin
Nirogacestat
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 CYP3A substrate exposure and an increased risk of CYP3A substrate-related adverse effects
Interaction Deep Dive
Avoid concomitant use of nirogacestat with CYP3A substrates. Nirogacestat increases exposure of CYP3A substrates, where minimal concentration changes may lead to serious adverse reactions. Midazolam (CYP3A substrate) Cmax is predicted to increase by 1.77-fold and AUC by 2.07-fold following concomitant use with multiple doses of nirogacestat (150 mg twice daily)1.
Why it happens (mechanism)
Inhibition of CYP3A-substrate metabolism by nirogacestat
Literature reports
1 report — tap to read
a) Midazolam (CYP3A substrate) Cmax is predicted to increase by 1.77-fold and AUC by 2.07-fold following concomitant use with multiple doses of nirogacestat (150 mg twice daily) 1.
Common questions
Can I take Midostaurin and Nirogacestat together?
Increased CYP3A substrate exposure and an increased risk of CYP3A substrate-related adverse effects Always confirm with your pharmacist or prescriber before making any change.
How serious is the Midostaurin and Nirogacestat 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 Nirogacestat 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: OGSIVEO(TM) oral tablets, nirogacestat oral tablets. SpringWorks Therapeutics, Inc. (per FDA), Stamford, CT, 2023. DailyMed
Keep reading about Midostaurin
Keep reading about Nirogacestat
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