Berotralstat and Cyclosporine Injection: Interaction Details
AI-assisted, pharmacist-reviewed · Source data updated Aug 8, 2026 · Sources: FDA labeling, DDInter 2.0, cited literature
Berotralstat
Cyclosporine Injection
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/P-gp substrate exposure
Interaction Deep Dive
Concomitant administration of berotralstat and CYP3A4/P-gp substrate may increase CYP3A4/P-gp substrate exposure. Monitor appropriately and titrate the dose for CYP3A4/P-gp substrate when coadministered with berotralstat1.
Why it happens (mechanism)
Inhibition of CYP3A4-substrate metabolism by berotralstat; inhibition of P-gp-mediated efflux transport by berotralstat
Literature reports
1 report — tap to read
a) In drug interaction study, coadministration of berotralstat with digoxin at the dose of 300 mg increased the AUC by 1.5 fold approximately and Cmax by 1.5 fold approximately 1.
Common questions
Can I take Berotralstat and Cyclosporine Injection together?
Increased CYP3A4/P-gp substrate exposure Always confirm with your pharmacist or prescriber before making any change.
How serious is the Berotralstat and Cyclosporine Injection 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 Berotralstat or Cyclosporine Injection 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: ORLADEYO(R) oral capsules, berotralstat oral capsules. BioCryst Pharmaceuticals Inc (per manufacturer), Durham, NC, 2023. DailyMed
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Keep reading about Cyclosporine Injection
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