Palbociclib with Esomeprazole Interaction Details
Brand Names Associated with Palbociclib
- Ibrance®
- Palbociclib
Brand Names Associated with Esomeprazole
- Esomeprazole
- Nexium®
- Nexium® 24HR
- Vimovo® (as a combination product containing Esomeprazole, Naproxen)
Medical Content Editor Dr. Brian Staiger, PharmD
Last updated
Dec 26, 2023
Interaction Effect
Reduced efficacy of palbociclib
Interaction Summary
Coadministration of palbociclib with proton pump inhibitors (PPIs) may or may not decrease progression-free survival and overall survival in patients receiving breast cancer treatment. Consider the use of a H2-antagonist instead of a PPI in this population. If coadministration is required, use a PPI cautiously, especially long term , and consider palbociclib in tablet formulation .
Severity
Major
Onset
Unspecified
Evidence
Probable
How To Manage Interaction
Coadministration of palbociclib with proton pump inhibitors (PPIs) may decrease progression-free survival in patients taking palbociclib for breast cancer treatment. Consider the use of a H2-antagonist instead of a PPI in this population. If coadministration is required, use a PPI cautiously with palbociclib therapy, especially long term, and consider palbociclib in tablet formulation .
Mechanism Of Interaction
Unknown
Literature Reports
A) In a retrospective study of patients with estrogen-positive, HER2-negative metastatic breast cancer (N=112), concomitant administration of palbociclib with a proton pump inhibitor (PPI) significantly shortened progression-free survival (PFS) time compared with patients taking palbociclib alone with endocrine therapy (14 vs 37.9 months). Palbociclib was administered orally once daily at lunchtime for 21 days, followed by 7 days off, with either fulvestrant or letrozole. Most patients received palbociclib 125 mg (61.6%), though dose reductions for toxicity were made to 100 mg (26.8%) and 75 mg (9.8%) if necessary. Patients on concomitant PPI therapy received either lansoprazole 15 mg (n=42), omeprazole 10 mg (n=11), esomeprazole 20 mg (n=1), or pantoprazole 20 mg (n=2) once daily in the morning with breakfast. The possible mechanism for this interaction may be that the increase in gastric pH may have lowered palbociclib plasma concentrations, therefore affecting treatment efficacy. Caution should be used especially during long term use of PPIs in this population .
B) In drug interaction trials in healthy subjects, coadministration of a single palbociclib 125 mg tablet with multiple doses of rabeprazole under overnight fasted conditions had no effect on the pharmacokinetics of palbociclib when compared with palbociclib tablet administered alone . Under fasted conditions, coadministration of a single palbociclib 125 mg capsule with multiple doses of rabeprazole decreased palbociclib AUC(inf) and Cmax by 62% and 80%, respectively, when compared to palbociclib capsule alone; in fed conditions, AUC(inf) and Cmax were decreased by 41% and 13% .
C) Concomitant use of palbociclib and proton pump inhibitors (PPIs) resulted in a significantly shorter median progression-free survival compared with non-users in 2 retrospective studies of patients with breast cancer (10.6 months vs not reached; dosage form not specified ; 25.3 months vs 39.8 months; capsule formulation); overall survival (OS) was also significantly shorter in concomitant users compared with non-users in 1 of the studies (1-year OS, 83.1% vs 94%; 2-year OS, 69.5% vs 89.3%; capsule formulation) . Patients received endocrine therapy (fulvestrant or aromatase inhibitor) and PPI therapy consisted of dexlansoprazole, esomeprazole, ilaprazole, lansoprazole, omeprazole, pantoprazole, or rabeprazole .
D) Concomitant use of palbociclib and proton pump inhibitors (PPIs) did not significantly impact median progression-free survival compared with non-users in 2 retrospective studies of patients with metastatic breast cancer (14.4 months vs 15.8 months; capsule formulation ; 20.6 months vs 21 months; tablet formulation ). Patients received endocrine therapy (fulvestrant or aromatase inhibitor) and PPIs included lansoprazole, pantoprazole, esomeprazole, rabeprazole, and omeprazole .
Palbociclib Overview
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Palbociclib is used in combination with anastrozole (Arimidex), exemestane (Aromasin), or letrozole (Femara) to treat a certain type of hormone receptor–positive, advanced breast cancer (breast cancer that depends on hormones such as estrogen to grow) or breast cancer that has spread to other parts of the body in women who have experienced menopause (change of life; end of monthly menstrual periods) or in men. Palbociclib is also used along with fulvestrant (Faslodex) to treat a certain type of hormone receptor–positive, advanced breast cancer (breast cancer that depends on hormones such as estrogen to grow) or breast cancer that has spread to other parts of the body in people who have been treated with an antiestrogen medication such as tamoxifen (Nolvadex). Palbociclib 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 or slow the spread of cancer cells.
Esomeprazole Overview
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Prescription esomeprazole is used to treat the symptoms of gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube between the throat and stomach) in adults and children 1 year of age and older. Prescription esomeprazole is used to treat damage from GERD in adults and children 1 month of age and older. Prescription esomeprazole is used to allow the esophagus to heal and prevent further damage to the esophagus in adults with GERD. Prescription esomeprazole is also used to decrease the chance that people who are taking nonsteroidal anti-inflammatory drugs (NSAIDs) will develop ulcers (sores in the lining of the stomach or intestine) in adults. It is also used with other medications to treat and prevent the return of stomach ulcers caused by a certain type of bacteria (H. pylori) in adults. Prescription esomeprazole is also used to treat conditions in which the stomach produces too much acid such as Zollinger-Ellison syndrome in adults. Nonprescription (over-the-counter) esomeprazole is used to treat frequent heartburn (heartburn that occurs at least 2 or more days a week) in adults. Esomeprazole is in a class of medications called proton pump inhibitors. It works by decreasing the amount of acid made in the stomach.
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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.
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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.
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