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Verzenios ® ▼ (abemaciclib)
Can I give Verzenios® ▼ (abemaciclib) and oral anticoagulants concomitantly?
The concomitant use of Verzenios (abemaciclib) and oral anticoagulants is not contraindicated. We did not systematically collect drug-drug interaction data.
Pharmacokinetic Considerations Based on in-vitro Inhibition
Abemaciclib inhibits P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) in vitro. Based on this observation, an in-vivo interaction of abemacicilib with narrow therapeutic index substrates of these transporters, such as the oral anticoagulant dabigatran etexilate, and others, may occur.3
Dabigatran etexilate is an anticoagulant and a substrate of P-gp. The information in the Summary of Product Characteristics (SmPC) that DDI between abemaciclib and dabigatran etexilate may occur is based on the observation that
abemaciclib is known to inhibit P-gp transporter in vitro and
abemaciclib increased loperamide as another P-gp substrate to an extent that was considered not to be clinically relevant.
However, the DDI of abemaciclib with dabigatran has not been tested in patients and therefore the actual extent of increase in dabigatran plasma exposure when administered in combination with abemaciclib has not been established in vivo.3
Safety Considerations Based on the SmPCs
We did not systematically study interactions between abemaciclib and oral anticoagulants, therefore the following considerations are of theoretical nature based on the safety profile of abemaciclib. We do not know if these considerations are clinically relevant.
Please note that abemaciclib indicated for the treatment of women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with
an aromatase inhibitor, or
Thrombocytopenia has been reported as very common adverse event in the phase-3-studies of abemaciclib with
14.3% all grades toxicity
2.2% grade 3 toxicity, and
1.0% grade 4 toxicity.3
Diarrhoea is the most common adverse event associated with abemaciclib with
84.6% all grades toxicity,
11.7% grade 3 toxicity, and
0% grade 4 toxicity.3
Abemaciclib is not associated with an increased risk of bleeding.3
2. Sledge GW Jr et al. MONARCH 2: Abemaciclib in Combination With Fulvestrant in Women With HR+/HER2- Advanced Breast Cancer Who Had Progressed While Receiving Endocrine Therapy. J Clin Oncol. 2017 Sep 1;35(25):2875-2884. doi: 10.1200/JCO.2017.73.7585. Epub 2017 Jun 3
3. Verzenios [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Date of Last Review: April 23, 2021