Midostaurin and Palbociclib: Interaction Details
AI-assisted, pharmacist-reviewed · Source data updated Aug 8, 2026 · Sources: FDA labeling, DDInter 2.0, cited literature
Palbociclib
Midostaurin
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 exposure to CYP3A substrates with a narrow therapeutic index
Interaction Deep Dive
Concomitant use of palbociclib (a weak and time-dependent CYP3A inhibitor) and a CYP3A substrate with a narrow therapeutic index (NTI) may increase exposure to and adverse effects of the substrate. During drug interaction studies, coadministration of midazolam with multiple doses of palbociclib resulted in an increase in midazolam AUC and Cmax. Consider dose reductions of the CYP3A substrate if used concomitantly and monitor patients for toxicity1.
Why it happens (mechanism)
Inhibition of CYP3A substrate metabolism by palbociclib
Literature reports
1 report — tap to read
a) Coadministration of midazolam (a CYP3A substrate) with multiple doses of palbociclib 125 mg/day in healthy subjects (N=26), resulted in an increase in midazolam AUC and Cmax by 61% and 37%, respectively 1.
Common questions
Can I take Midostaurin and Palbociclib together?
Increased exposure to CYP3A substrates with a narrow therapeutic index Always confirm with your pharmacist or prescriber before making any change.
How serious is the Midostaurin and Palbociclib 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 "theoretical". Predicted from the drugs' pharmacology; not yet confirmed in people.
Questions for your pharmacist
- Does my dose of Midostaurin or Palbociclib 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: IBRANCE(R) oral capsules, palbociclib oral capsules. Pfizer Labs (per FDA), New York, NY, 2019. DailyMed
Keep reading about Palbociclib
Keep reading about Midostaurin
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