Midostaurin and Lopinavir: Interaction Details
AI-assisted, pharmacist-reviewed · Source data updated Aug 8, 2026 · Sources: FDA labeling, DDInter 2.0, cited literature
Midostaurin
Lopinavir
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 midostaurin exposure
Interaction Deep Dive
Concomitant use of midostaurin with a strong CYP3A4 inhibitor may result in an increase in exposure of midostaurin, which may be pronounced during the first week of midostaurin therapy. Increased midostaurin exposure may lead to an increase in drug-related toxicities. AUC of midostaurin was increased 10.4-fold with a single dose coadministered with ketoconazole and midostaurin minimum concentration levels were increased 2.1-fold when multiple doses were coadministered with itraconazole. Exposure to the active metabolites was also increased. Consider alternative therapies with agents that are not strong CYP3A4 inhibitors, or when coadministration is required, monitor for an increased risk of adverse reactions, especially during the first week of consecutive midostaurin therapy for advanced systemic mastocytosis and during the first week of each cycle of therapy for acute myeloid leukemia1.
Why it happens (mechanism)
Inhibition of CYP3A4-mediated metabolism of midostaurin
Literature reports
2 reports — tap to read
a) AUC(infinity) levels of midostaurin and the active metabolite CGP62221 were increased by 10.4-fold and 3.5-fold, and AUC(0 to tau) levels of the active metabolite CGP52421 were increased 1.2-fold when the strong CYP3A4 inhibitor ketoconazole 400 mg/day for 10 days was coadministered on day 6 with a single 50-mg dose of midostaurin, compared with AUC levels when a single midostaurin dose was coadministered with placebo 1.
b) Day 28 minimum concentration (Cmin) levels of midostaurin and the active metabolites CGP62221 and CGP52421 were increased by 2.1-fold, 1.2-fold, and 1.3-fold respectively, when the strong CYP3A4 inhibitor itraconazole 100 mg twice daily on days 22 to 28 for 13 doses was coadministered with multiple doses of midostaurin 100 mg twice daily on days 1 to 2 and 50 mg twice daily on days 3 to 28, compared with day 21 Cmin levels when midostaurin was administered alone 1.
Common questions
Can I take Midostaurin and Lopinavir together?
Increased midostaurin exposure Always confirm with your pharmacist or prescriber before making any change.
How serious is the Midostaurin and Lopinavir 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 Lopinavir 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: RYDAPT(R) oral capsules, midostaurin oral capsules. Novartis Pharmaceuticals Corporation (per FDA), East Hanover, NJ, 2017. DailyMed
Keep reading about Midostaurin
Keep reading about Lopinavir
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Prescription drugs aren't the whole picture — herbal and dietary supplements can interact with them too. From the evidence-graded Natural Medicines database:
major · moderate · minor — check everything you take with our drug–supplement interaction checker.
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