Regorafenib with Amiodarone Interaction Details

Brand Names Associated with Regorafenib

  • Regorafenib
  • Stivarga®

Brand Names Associated with Amiodarone

  • Amiodarone
  • Cordarone®
  • Pacerone®

Medical Content Editor
Last updated Feb 27, 2024

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Interaction Effect

Increased amiodarone and regorafenib exposure

Interaction Summary

As amiodarone has a variable and long half-life, potential drug interactions may occur even after amiodarone is discontinued[1]. If regorafenib, a CYP3A4 substrate and inhibitor [2], is used concomitantly with amiodarone, also a CYP3A4 inhibitor and substrate [1], exposure of both drugs may be increased. Additional monitoring and dosage adjustment may be warranted.

Severity

Major

Onset

Unspecified

Evidence

Theoretical

How To Manage Interaction

If regorafenib, a CYP3A4 substrate and inhibitor[2], is used concomitantly with amiodarone, also a CYP3A4 inhibitor and substrate [1], exposure of both drugs may be increased. Additional monitoring and dosage adjustment may be warranted.

Mechanism Of Interaction

Inhibition of CYP3A4-mediated metabolism of amiodarone and regorafenib

References

    1 ) Product Information: NEXTERONE(R) intravenous injection, amiodarone HCl intravenous injection. Baxter Healthcare Corporation (per FDA), Deerfield, IL, 2011.

    2 ) Product Information: STIVARGA(R) oral tablets, regorafenib oral tablets. Bayer HealthCare Pharmaceuticals, Inc. (per manufacturer), Wayne, NJ, 2013.

Regorafenib Overview

  • Regorafenib is used to treat colon and rectal cancer (cancer that begins in the large intestine or the rectum) that has spread to other parts of the body in people who have not been treated successfully with certain other medications. It is also used to treat gastrointestinal stromal tumors (GIST; a type of tumor that grows in the stomach, intestine [bowel], or esophagus [tube that connects the throat with the stomach]) in people who were not treated successfully with certain other medications. Regorafenib is also used to treat hepatocellular carcinoma (HCC; a type of liver cancer) in people who were previously treated with sorafenib (Nexafar). Regorafenib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps to slow or stop the spread of cancer cells.

See More information Regarding Regorafenib

Amiodarone Overview

  • Amiodarone is used to treat and prevent certain types of serious, life-threatening ventricular arrhythmias (a certain type of abnormal heart rhythm when other medications did not help or could not be tolerated. Amiodarone is in a class of medications called antiarrhythmics. It works by relaxing overactive heart muscles.

See More information Regarding Amiodarone

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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.