Clarithromycin with Midostaurin Interaction Details
Brand Names Associated with Clarithromycin
- Biaxin® Filmtab®
- Biaxin® Granules
- Biaxin® XL Filmtab
- Biaxin® XL Pac
- Clarithromycin
Brand Names Associated with Midostaurin
- Midostaurin
- Rydapt®
Medical Content Editor Dr. Brian Staiger, PharmD
Last updated
Nov 08, 2023
Interaction Effect
Increased midostaurin exposure
Interaction Summary
Concomitant use of midostaurin with a strong CYP3A4 inhibitor may result in an increase in exposure of midostaurin, which may be pronounced during the first week of midostaurin therapy. Increased midostaurin exposure may lead to an increase in drug-related toxicities. AUC of midostaurin was increased 10.4-fold with a single dose coadministered with ketoconazole and midostaurin minimum concentration levels were increased 2.1-fold when multiple doses were coadministered with itraconazole. Exposure to the active metabolites was also increased. Consider alternative therapies with agents that are not strong CYP3A4 inhibitors, or when coadministration is required, monitor for an increased risk of adverse reactions, especially during the first week of consecutive midostaurin therapy for advanced systemic mastocytosis and during the first week of each cycle of therapy for acute myeloid leukemia.
Severity
Major
Onset
Unspecified
Evidence
Theoretical
How To Manage Interaction
Concomitant use of midostaurin with a strong CYP3A4 inhibitor may increase exposure to midostaurin, which may be pronounced during the first week of midostaurin therapy. Increased exposure may lead to an increase in drug-related toxicities. Consider alternative therapy with agents that are not strong CYP3A4 inhibitors, or when coadministration is required, monitor for an increased risk of adverse reactions, especially during the first week of consecutive midostaurin therapy for advanced systemic mastocytosis or during the first week of each cycle of therapy for acute myeloid leukemia.
Mechanism Of Interaction
Inhibition of CYP3A4-mediated midostaurin metabolism
Literature Reports
A) AUC(infinity) levels of midostaurin and the active metabolite CGP62221 were increased by 10.4-fold and 3.5-fold, and AUC(0 to tau) levels of the active metabolite CGP52421 were increased 1.2-fold when the strong CYP3A4 inhibitor ketoconazole 400 mg/day for 10 days was coadministered on day 6 with a single 50-mg dose of midostaurin, compared with AUC levels when a single midostaurin dose was coadministered with placebo .
B) Day 28 minimum concentration (Cmin) levels of midostaurin and the active metabolites CGP62221 and CGP52421 were increased by 2.1-fold, 1.2-fold, and 1.3-fold respectively, when the strong CYP3A4 inhibitor itraconazole 100 mg twice daily on days 22 to 28 for 13 doses was coadministered with multiple doses of midostaurin 100 mg twice daily on days 1 to 2 and 50 mg twice daily on days 3 to 28, compared with day 21 Cmin levels when midostaurin was administered alone .
Clarithromycin Overview
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Clarithromycin is used to treat certain bacterial infections, such as pneumonia (a lung infection), bronchitis (infection of the tubes leading to the lungs), and infections of the ears, sinuses, skin, and throat. It also is used to treat and prevent disseminated Mycobacterium avium complex (MAC) infection [a type of lung infection that often affects people with human immunodeficiency virus (HIV)]. It is used in combination with other medications to eliminate H. pylori, a bacterium that causes ulcers. Clarithromycin is in a class of medications called macrolide antibiotics. It works by stopping the growth of bacteria.
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Antibiotics such as clarithromycin will not work for colds, flu, or other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
Midostaurin Overview
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Midostaurin is used with other chemotherapy drugs to treat certain types of acute myeloid leukemia (AML; a type of cancer of the white blood cells). Midostaurin is also used to certain types of mastocytosis (a blood disorder in which there are too many mast cells [a certain kind of white blood cell]). Midostaurin is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of mast and 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.