Colchicine and Sevabertinib: Interaction Details
AI-assisted, pharmacist-reviewed · AI content regenerated Jul 11, 2026 · Source data updated Jul 2, 2026 · Sources: FDA labeling, DDInter 2.0, cited literature
Colchicine
Sevabertinib
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.
These two medicines can clash. Colchicine (Colcrys, Gloperba, Lodoco, Mitigare) is a drug your body clears using an enzyme called CYP3A4 and a pump called P-gp. Sevabertinib (Hyrnuo) blocks both of those pathways. When that happens, colchicine can build up to higher levels than intended.
Colchicine has a narrow safety window, so even a small increase matters. Too much can cause serious problems like stomach pain, diarrhea, muscle weakness, and effects on blood cells. The good news is your care team knows about this and can manage it, often by avoiding using the two together or by choosing a safer option. Please talk with your doctor or pharmacist before making any changes.
Interaction: Sevabertinib inhibits both CYP3A4-mediated metabolism and P-gp-mediated efflux of colchicine, a narrow-therapeutic-index (NTI) substrate of both pathways. Result: increased colchicine exposure and elevated risk of colchicine toxicity.
- Direction: Increased colchicine effect/exposure (neither drug is a prodrug here).
- Severity: Major. Evidence: Probable. Onset: Unspecified.
- Toxicity signals: GI (nausea, vomiting, diarrhea), myopathy/rhabdomyolysis, myelosuppression, multiorgan effects.
- Management: Avoid concomitant use. If unavoidable, dose may need individualized reduction and closer clinical monitoring; use caution especially with hepatic/renal impairment.
What happens
Increased) CYP3A4/P-gp substrate with NTI exposure and an increased risk of CYP3A4/P-gp substrate with NTI-related adverse reactions
Interaction Deep Dive
Sevabertinib should not be given together with a CYP3A4/P-gp substrate that has a narrow therapeutic index, because doing so can raise the exposure of that CYP3A4/P-gp substrate with NTI and can also heighten the likelihood of adverse reactions associated with the CYP3A4/P-gp substrate with NTI1.
Why it happens (mechanism)
Inhibition of P-gp-mediated efflux transport of sevabertinib; inhibition of CYP3A4-mediated metabolism by sevabertinib
How to manage this interaction
What your care team may do:
- Often avoid using these two together, since colchicine can accumulate to unsafe levels.
- If both are truly needed, your colchicine dose may need to be adjusted and individualized by your team, and they may monitor you more closely.
- Consider an alternative when appropriate.
What you should do: Keep taking both exactly as prescribed for now, and do not stop or change either one on your own. Contact your pharmacist or prescriber about this combination, and report any diarrhea, severe stomach pain, muscle weakness or pain, unusual bruising, or signs of infection right away.
Management is individual — confirm any change with your pharmacist or prescriber.
Literature reports
2 reports — tap to read
a) In a drug interaction study, taking sevabertinib 20 mg twice daily together with midazolam raised the AUC of midazolam (a CYP3A4 substrate) by 2-fold and its Cmax by 1.8-fold 1.
b) In a drug interaction study, the AUC of dabigatran etexilate (a P-gp substrate) rose 1.4-fold when it was administered concurrently with sevabertinib 20 mg twice daily 1.
Common questions
Can I take Colchicine and Sevabertinib together?
Sevabertinib can raise colchicine levels and increase the risk of serious toxicity, so this combination is usually avoided. Check with your pharmacist or doctor before taking both. Always confirm with your pharmacist or prescriber before making any change.
How serious is the Colchicine and Sevabertinib 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 is the Colchicine and Sevabertinib interaction managed?
What your care team may do: Often avoid using these two together, since colchicine can accumulate to unsafe levels. If both are truly needed, your colchicine dose may need to be adjusted and individualized by your team, and they may monitor you more closely. Consider an alternative when appropriate. What you should do: Keep taking both exactly as prescribed for now, and do not stop or change eithe… Management is individual — always follow your own care team's guidance.
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 Colchicine or Sevabertinib 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: HYRNUO® oral tablets, sevabertinib oral tablets. Bayer HealthCare Pharmaceuticals Inc. (per FDA), Whippany, NJ, 2025. DailyMed
Keep reading about Colchicine
Keep reading about Sevabertinib
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