Fedratinib with Ulipristal Interaction Details
Brand Names Associated with Ulipristal
- Ella®
- Ulipristal
Medical Content Editor Dr. Brian Staiger, PharmD
Last updated
Dec 27, 2023
Interaction Effect
Increased CYP3A4 substrate exposure
Interaction Summary
Concomitant use of fedratinib (a CYP3A4 inhibitor) with CYP3A4 substrates may increase the substrate concentrations and the risk of adverse reactions of these substrates. In single-dose pharmacokinetic studies, fedratinib increased midazolam (CYP3A4 substrate) AUC by 4-fold. If coadministration is necessary, monitor for adverse reactions and adjust the dose of drugs that are CYP3A4 substrates.
Severity
Major
Onset
Unspecified
Evidence
Probable
How To Manage Interaction
Concomitant use of fedratinib (a CYP3A4 inhibitor) with CYP3A4 substrates may increase the substrate concentrations and the risk of adverse reactions of these substrates. If coadministration is necessary, monitor for adverse reactions and adjust the dose of drugs that are CYP3A4 substrates.
Mechanism Of Interaction
Inhibition of CYP3A4-mediated substrate metabolism by fedratinib
Literature Reports
A) Coadministration of a single dose of midazolam 2 mg (CYP3A4 substrate) with fedratinib increased midazolam AUC by 4-fold .
Ulipristal Overview
-
Ulipristal is used to prevent pregnancy after unprotected sexual intercourse (sex without any method of birth control or with a birth control method that failed or was not used properly [e.g., a condom that slipped or broke or birth control pills that were not taken as scheduled]). Ulipristal should not be used to prevent pregnancy on a regular basis. This medication is to be used as an emergency contraceptive or backup in case regular birth control fails or is used incorrectly. Ulipristal is in a class of medications called progestins. It works by preventing or delaying the release of an egg from the ovary. It also may work by changing the lining of the uterus (womb) to prevent development of a pregnancy. Ulipristal may prevent pregnancy, but it will not prevent the spread of human immunodeficiency virus (HIV, the virus that causes acquired immunodeficiency syndrome [AIDS]) and other sexually transmitted diseases.
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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.