Apalutamide with Darolutamide Interaction Details
Brand Names Associated with Apalutamide
- Apalutamide
- Erleada®
Brand Names Associated with Darolutamide
- Darolutamide
- Nubeqa®
Medical Content Editor Dr. Brian Staiger, PharmD
Last updated
Mar 04, 2024
Interaction Effect
Decreased darolutamide exposure
Interaction Summary
Darolutamide is primarily metabolized by CYP3A4 and is also a P-gp substrate. Avoid concomitant use of darolutamide with drugs known to be combined P-gp and strong or moderate CYP3A4 inducers, as coadministration may result in decreased darolutamide exposure, which may lead to loss of therapeutic effect In a pharmacokinetic study, coadministration with rifampin (a combined P-gp and strong CYP3A4 inducer) decreased mean darolutamide AUC by 72% and Cmax by 52%[1].
Severity
Major
Onset
Unspecified
Evidence
Theoretical
How To Manage Interaction
Avoid concomitant use of darolutamide with drugs known to be combined P-gp and strong or moderate CYP3A4 inducers, as coadministration may result in decreased darolutamide exposure, which may lead to loss of therapeutic effect[1].
Mechanism Of Interaction
Induction of P-gp-mediated darolutamide efflux transport and CYP3A4-mediated darolutamide metabolism
Literature Reports
A) In a pharmacokinetic trial, coadministration of darolutamide with rifampin (combined P-gp and strong CYP3A4 inducer) decreased mean darolutamide AUC(0 to 72) by 72% and Cmax by 52%. Coadministration with a moderate CYP3A4 inducer is projected to reduce darolutamide exposure by 36% to 58% [1].
References
1 ) Product Information: NUBEQA(R) oral tablets, darolutamide oral tablets. Bayer HealthCare Pharmaceuticals Inc (per manufacturer), Whippany, NJ, 2019.
Apalutamide Overview
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Apalutamide is used to treat certain types of prostate cancer (cancer in men that begins in the prostate [a male reproductive gland]) and has spread to other parts of the body or that has not spread to other parts of the body but has not been helped by other medical treatments. Apalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of cancer cells.
Darolutamide Overview
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Darolutamide is used to treat certain types of prostate cancer (cancer that begins in the prostate [a male reproductive gland]) that has not spread to other parts of the body in men who have not been helped by other medical treatments. Darolutamide is also used to treat certain types of prostate cancer (cancer that begins in the prostate [a male reproductive gland]) that have spread to other parts of the body in men in combination with docetaxel. Darolutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of cancer cells.
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Definitions
Severity Categories
Contraindicated
These drugs, generally, should not be used together simultaneously due to the high risk of severe adverse effects. Combining these medications can lead to dangerous health outcomes and should be strictly avoided unless otherwise instructed by your provider.
Major
This interaction could result in very serious and potentially life-threatening consequences. If you are taking this drug combination, it is very important to be under close medical supervision to minimize severe side effects and ensure your safety. It may be necessary to change a medication or dosage to prevent harm.
Moderate
This interaction has the potential to worsen your medical condition or alter the effectiveness of your treatment. It's important that you are monitored closely and you potentially may need to make adjustments in your treatment plan or drug dosage to maintain optimal health.
Minor
While this interaction is unlikely to cause significant problems, it could intensify side effects or reduce the effectiveness of one or both medications. Monitoring for changes in symptoms and your condition is recommended, and adjustments may be made if needed to manage any increased or more pronounced side effects.
Onset
Rapid: Onset of drug interaction typically occurs within 24 hours of co-administration.
Delayed: Onset of drug interaction typically occurs more than 24 hours after co-administration.
Evidence
Level of documentation of the interaction.
Established: The interaction is documented and substantiated in peer-reviewed medical literature.
Theoretical: This interaction is not fully supported by current medical evidence or well-documented sources, but it is based on known drug mechanisms, drug effects, and other relevant information.
How To Manage The Interaction
Provides a detailed discussion on how patients and clinicians can approach the identified drug interaction as well as offers guidance on what to expect and strategies to potentially mitigate the effects of the interaction. This may include recommendations on adjusting medication dosages, altering the timing of drug administration, or closely monitoring for specific symptoms.
It's important to note that all medical situations are unique, and management approaches should be tailored to individual circumstances. Patients should always consult their healthcare provider for personalized advice and guidance on managing drug interactions effectively.
Mechanism Of Interaction
The theorized or clinically determined reason (i.e., mechanism) why the drug-drug interaction occurs.
Disclaimer: The information provided on this page is for informational purposes only and should not be considered medical advice. Always consult with a qualified healthcare professional regarding your specific circumstances and medical conditions.
Where Does Our Information Come From?
Information for our drug interactions is compiled from several drug compendia, including:
The prescribing information for each drug, as published on DailyMED, is also used.
Individual drug-drug interaction detail pages contain references specific to that interaction. You can click on the reference number within brackets '[]' to see what reference was utilized.
The information posted is fact-checked by HelloPharmacist clinicians and reviewed quarterly.