Verzenios ® (abemaciklib)

För fullständig produktresumé för Verzenios se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Kan Verzenios® ▼ (abemaciklib) ges tillsammans med orala antikoagulantia?

Samtidig användning av Verzenios® (abemaciklib) och orala antikoagulantia är inte kontraindicerat. Vi har inga systematiskt insamlade data om läkemedelsinteraktioner.

Subgroup Analysis has not been Performed

Patients who were taking oral anticoagulants were not excluded from the phase-3-clinical trials of abemaciclib. However, we do not have specific safety or efficacy data in these patients.1,2

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

Please refer to the SmPC of the respective oral anticoagulant for full prescribing information.

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 

  • fulvestrant.3

Please check the SmPCs of all concomitantly used medications.

Thrombocytopenia

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

Thrombocytopenia might increase the effect of anticoagulants.

Diarrhoea

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

Diarrhoea could possibly reduce the resorption of orally administered anticoagulants. 

Bleeding

Abemaciclib is not associated with an increased risk of bleeding.3

References

1. Goetz et al. MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer. J Clin Oncol. 2017 Nov 10;35(32):3638-3646. doi: 10.1200/JCO.2017.75.6155. Epub 2017 Oct 2

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.

Datum fӧr senaste ӧversyn 2021 M04 23


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