Dabigatran Etexilate with Tibolone Interaction Details
Brand Names Associated with Dabigatran Etexilate
- Dabigatran
- Pradaxa®
Medical Content Editor Dr. Brian Staiger, PharmD
Last updated
Jan 08, 2024
Interaction Effect
Increased risk of bleeding
Interaction Summary
Tibolone may increase blood fibrinolytic activity, and may enhance the effects of anticoagulants with concomitant use. Concomitant tibolone treatment led to enhanced warfarin-induced anticoagulation in healthy, postmenopausal women in a double-blind, randomized, placebo-controlled, 2-way crossover study. Use caution if coadministered, especially when starting or stopping concurrent tibolone treatment. If necessary, adjust the dose of the anticoagulant.
Severity
Moderate
Onset
Unspecified
Evidence
Theoretical
How To Manage Interaction
Tibolone may increase blood fibrinolytic activity, and may enhance the effects of anticoagulants with concomitant use. Use caution if coadministered, especially when starting or stopping concurrent tibolone treatment. If necessary, adjust the dose of the anticoagulant.
Mechanism Of Interaction
Increase in blood fibrinolytic activity and enhanced anticoagulant effects
Literature Reports
A) In a double-blind, randomized, placebo-controlled, 2-way crossover study, concomitant tibolone treatment led to enhanced warfarin-induced anticoagulation in healthy, postmenopausal women. Subjects (n=16; age range, 50 to 65 years) who were stabilized on oral warfarin (dose range, 1 to 8.5 mg), with an INR ranging between 1.4 to 2.0, were randomized to receive either tibolone 2.5 mg/day for 21 days, followed by a 7-day washout period, and then followed by placebo treatment for 21 days (n=8); or vice versa (n=8). Warfarin treatment was continued during the washout period. Compared to placebo, tibolone treatment caused a statistically significant increase in the mean INR of 0.4. Among secondary efficacy parameters, coagulation factors II, VII, VIIa, and X were all statistically significantly lower during tibolone treatment compared to placebo. The estimated mean difference was -6.9% for Factor VIIa, and -31% for Factor VII. Significant interindividual differences were noted towards response in INR and coagulation factors during the 2 treatment periods. Overall, all treatments were well tolerated, with no clinically significant adverse events. While the exact mechanism for this interaction was unclear, competition for protein binding sites or pharmacodynamic causes were postulated as potential mechanisms .
Dabigatran Etexilate Overview
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Dabigatran is used to treat deep vein thrombosis (DVT; a blood clot, usually in the leg) and pulmonary embolism (PE; a blood clot in the lung) in adults and children 3 months of age and older who have been treated with an injectable anticoagulant ('blood thinner'). It is also used to reduce the risk of a DVT and PE from happening again after initial treatment is completed in adults and children 3 months of age and older. Dabigatran is used to help prevent DVT and PE in adults who have had hip replacement surgery. Dabigatran is also used to help prevent strokes or serious blood clots in adults who have atrial fibrillation (a condition in which the heart beats irregularly, increasing the chance of clots forming in the body, and possibly causing strokes) without heart valve disease. Dabigatran is in a class of anticoagulant medications called direct thrombin inhibitors. It works by preventing blood clots from forming in the body.
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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.
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.