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Drug Interactions between copanlisib and roflumilast

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

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Interactions between your drugs

Moderate

roflumilast copanlisib

Applies to: roflumilast and copanlisib

GENERALLY AVOID: The concomitant use of roflumilast with immunosuppressive agents has not been adequately studied. Roflumilast is a selective phosphodiesterase 4 (PDE4) inhibitor and a nonsteroidal anti-inflammatory agent. In experimental models and in vitro studies, roflumilast has exhibited immunomodulatory effects. Specifically, roflumilast and its active metabolite, roflumilast N-oxide, suppress the release of inflammatory mediators including leukotriene B4, reactive oxygen species, tumor necrosis factor alpha, interferon gamma, and granzyme B. Roflumilast also reduces sputum neutrophils and attenuates influx of neutrophils and eosinophils into the airways.

MANAGEMENT: According to the product labeling for roflumilast in some countries such as Canada and the U.K., concomitant use with immunosuppressive agents such as methotrexate, azathioprine, infliximab, etanercept, and systemic corticosteroids (except when used short-term, e.g., in the treatment of COPD exacerbations) should be avoided if possible. Due to a lack of clinical experience, treatment with roflumilast should not be initiated, or existing treatment should be stopped, in patients receiving immunosuppressive agents and in patients with severe acute infectious diseases, cancers (except basal cell carcinoma), or severe immunological diseases (e.g., HIV infection, multiple sclerosis, lupus erythematosus, progressive multifocal leukoencephalopathy).

References

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. (2011) "Product Information. Daxas (roflumilast)." Nycomed Inc

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Drug and food interactions

Moderate

copanlisib food

Applies to: copanlisib

GENERALLY AVOID: Grapefruit juice may increase the plasma concentrations of copanlisib. The proposed mechanism is inhibition of CYP450 3A4-mediated metabolism of copanlisib by certain compounds present in grapefruit. When a single 60 mg intravenous dose of copanlisib was administered to cancer patients in combination with the potent CYP450 3A4 and P-gp inhibitor, itraconazole (200 mg once daily for 10 days), mean copanlisib peak plasma concentration (Cmax) did not change but systemic exposure (AUC) increased by 53%. The interaction has not been studied with grapefruit juice. In general, the effect of grapefruit juice is concentration-, dose- and preparation-dependent, and can vary widely among brands. Certain preparations of grapefruit juice (e.g., high dose, double strength) have sometimes demonstrated potent inhibition of CYP450 3A4, while other preparations (e.g., low dose, single strength) have typically demonstrated moderate inhibition. Increased exposure to copanlisib may increase the risk of adverse effects such as nausea, vomiting, diarrhea, stomatitis, hyperglycemia, hypertension, noninfectious pneumonitis, cutaneous reactions (e.g., exfoliative dermatitis, maculopapular rash), anemia, neutropenia, thrombocytopenia, and infections.

MANAGEMENT: Patients should avoid the consumption of grapefruit and grapefruit juice during treatment with copanlisib.

References

  1. (2017) "Product Information. Aliqopa (copanlisib)." Bayer Pharmaceutical Inc

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Minor

roflumilast food

Applies to: 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.

See also

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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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