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Drug Interactions between berotralstat and Daliresp

This report displays the potential drug interactions for the following 2 drugs:

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Interactions between your drugs

Moderate

roflumilast berotralstat

Applies to: Daliresp (roflumilast) and berotralstat

MONITOR: Coadministration with berotralstat may increase the plasma concentrations and effects of drugs that are substrates of CYP450 3A4 and/or 2D6. The mechanism is decreased clearance due to inhibition of CYP450 3A4 and 2D6 activity by berotralstat. Berotralstat is considered a moderate inhibitor of CYP450 3A4 and 2D6 and has been reported in drug interaction studies to increase the peak plasma concentration (Cmax) and systemic exposure (AUC) of sensitive CYP450 3A4 substrate midazolam by approximately 1.5-fold and 2.25-fold, respectively, and the Cmax and AUC of sensitive CYP450 2D6 substrate dextromethorphan by approximately 2.9-fold and 2.7-fold, respectively. Clinical data are not available.

MANAGEMENT: Caution is advised when berotralstat is coadministered with drugs that are substrates of CYP450 3A4 and/or 2D6, particularly those with a narrow therapeutic index including but not limited to thioridazine, pimozide, cyclosporine, and fentanyl. Clinical and laboratory monitoring are recommended following the initiation of berotralstat, and the individual dosage of the concomitant agents adjusted as needed.

References

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. (2021) "Product Information. Orladeyo (berotralstat)." BioCryst Pharmaceuticals Inc

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Drug and food interactions

Minor

roflumilast food

Applies to: Daliresp (roflumilast)

Food intake does not affect the total exposure to roflumilast and its pharmacologically active N-oxide metabolite, but delays the time to maximum concentration (Tmax) of roflumilast by one hour and reduces its peak plasma concentration (Cmax) by approximately 40%. The Tmax and Cmax of
roflumilast N-oxide are unaffected. Roflumilast may be taken with or without food.

References

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. (2011) "Product Information. Daxas (roflumilast)." Nycomed Inc
  3. (2011) "Product Information. Daliresp (roflumilast)." Astra-Zeneca Pharmaceuticals

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Therapeutic duplication warnings

No warnings were found for your selected drugs.

Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.

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Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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