Ivosidenib with Norethindrone Interaction Details
Brand Names Associated with Ivosidenib
- Ivosidenib
- Tibsovo®
Medical Content Editor Dr. Brian Staiger, PharmD
Last updated
Dec 20, 2023
Interaction Effect
Decreased hormonal contraceptive exposure and increased risk of contraceptive failure
Interaction Summary
Use of ivosidenib (a CYP3A4 inducer) and a hormonal contraceptive may decrease plasma concentrations of the hormonal contraceptive and potentially diminish effectiveness when used concomitantly. Advise women of reproductive potential to use an effective non-hormonal method of contraception or a back-up method during coadministration and for at least 28 days after discontinuation of a CYP3A4 inducer . In a study, concomitant use of a CYP3A4 inducer disproportionally increased the rate of unplanned pregnancy with oral and implanted contraceptives; therefore, consider intrauterine or intravaginal routes if coadministration is required .
Severity
Major
Onset
Delayed
Evidence
Probable
How To Manage Interaction
Use of ivosidenib (a CYP3A4 inducer) and a hormonal contraceptive may decrease plasma concentrations of the hormonal contraceptive and potentially diminish effectiveness when used concomitantly. Advise women of reproductive potential to use an effective non-hormonal method of contraception or a back-up method during coadministration and for at least 28 days after discontinuation of a CYP3A4 inducer . Use of intrauterine or intravaginal contraceptives may be preferable during coadministration with a CYP3A inducer ..
Mechanism Of Interaction
Induction of CYP3A4-mediated metabolism of hormonal contraceptives
Literature Reports
A) Concomitant use of a CYP3A4 inducer with oral or implantable contraceptive products containing levonorgestrel (684 events) or etonogestrel/desogestrel (864 events) was associated with a disproportionately higher rate of unintended pregnancy compared to all other event types reported to the FDA Adverse Event Reporting System (FAERS) between 1971 and 2020 [levonorgestrel (14,504 total events); etonogestrel/desogestrel (9348 total events)]. When compared between CYP3A4 inducer exposure vs no exposure, cases of unintended pregnancy made up a significantly higher proportion of total events when levonorgestrel was administered orally (32.8% vs 10.5%) or as an implant (51.9% vs 11.9%), and a similar association was identified with implanted etonogestrel products (42.5% vs 13.1%). However, when contraceptives were administered as an intrauterine device (levonorgestrel, 10.3% vs 11.5%) or intravaginal ring (etonogestrel, 10.9% vs 8.7%), no significant associations were identified. Oral desogestrel (pro-drug of etonogestrel) in combination with ethynyl estradiol also was not significantly affected (11.8% vs 17.4%). Intrauterine and vaginal ring products may be preferred in lieu of oral and implantable contraceptive products in women concomitantly receiving CYP3A4 inducers .
Ivosidenib Overview
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Ivosidenib is used to treat a certain type of acute myeloid leukemia (AML; a type of cancer that begins in the white blood cells) that has returned or that has not improved after previous treatment(s). Ivosidenib is also used alone or in combination with azacitidine (Onureg) to treat a certain type of AML in some adults older than 75 years of age as a first treatment. Ivosidenib is also used in adults who have already received previous treatment(s) to treat a certain type of cholangiocarcinoma (bile duct cancer) that has spread to nearby tissues or other parts of the body. Ivosidenib is in a class of medications called IDH1 inhibitors. It works by slowing or stopping the growth 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.