Verzenios ® ▼ (abemaciclib)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information.For current prescribing information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).

Has Verzenios® ▼ (abemaciclib) been studied in patients with COVID-19 (Coronavirus disease 2019)?

The use of abemaciclib in patients with COVID-19 has not been studied.

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Abemaciclib Treatment and Coronavirus (COVID-19)

Coronavirus disease (COVID-19) is an infectious respiratory disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), previously referred to as "2019 novel coronavirus."1

Eli Lilly and Company has not studied the use of abemaciclib in patients with COVID-19 nor in patients at risk of contracting COVID-19.

Potential Risk and Benefit Considerations

Clinical Use

Treating physicians should assess the patient’s individual benefit/risk ratio considering the patient's signs and symptoms, prior medical history, concomitant medications, and other individual factors when making abemaciclib treatment decisions in the context of COVID-19. Adverse reactions of abemaciclib to be considered in particular, in the context of COVID-19, include interstitial lung disease (ILD)/pneumonitis and neutropenia (see below for further information).  Abemaciclib dose adjustments, made at the physician’s discretion, should follow the label. Supportive treatment should be provided as clinically indicated and patients monitored appropriately.  Drug interactions between abemaciclib and potential COVID-19 treatments should be considered and are described below.2

ILD-Related Warnings and Precautions

Interstitial lung disease and/or pneumonitis was reported in patients receiving abemaciclib. Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis and treat as medically appropriate.3 Symptoms may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams. Infectious, neoplastic, and other causes for such symptoms should be excluded by means of appropriate investigations.2 Based on the severity of ILD/pneumonitis, abemaciclib may require dose modification.2

Neutropenia-Related Warnings and Precautions

Neutropenia was reported in patients receiving abemaciclib. 3

Complete blood counts should be monitored prior to the start of Abemaciclib therapy, every two weeks for the first two months, monthly for the next two months, and as clinically indicated. 3

Dose modification is recommended for patients who develop Grade 3 or 4 neutropenia.3

Drug Interactions

Hydroxychloroquine or chloroquine are not expected to have a clinically relevant effect on abemaciclib exposure.2

Remdesivir, favipiravir or azithromycin are not expected to have a clinically relevant effect on abemaciclib exposure.2

The combination of lopinavir/ritonavir is a strong CYP3A inhibitor.2 With concomitant use of strong CYP3A inhibitors other than ketoconazole, in patients with recommended starting doses of 200 mg twice daily or 150 mg twice daily, reduce the abemaciclib dose to 100 mg twice daily. In patients who have had a dose reduction to 100 mg twice daily due to adverse reactions, further reduce the abemaciclib dose to 50 mg twice daily.4

Palbociclib and COVID-19

Updated preplanned final analysis results for PALLAS, a phase 3 ongoing trial studying palbociclib in metastatic breast cancer, were published in December 2021.5

Part of this update included information on the use of palbociclib in COVID-19.5

From December 1, 2019, to November 20, 2020, 721 (14.1%) of 5125 patients who remained on study treatment in the PALLAS trial were tested for COVID-19. Of these 721 patients, 88 (12.2%) patients tested positive for COVID-19. There was no clinically meaningful difference in infection rate between the palbociclib + endocrine therapy (ET) and ET only treatment arms.5

No patients discontinued ET due to COVID-19-related reasons, and only 27 (1.1%) patients in the palbociclib + ET arm discontinued treatment due to COVID-19 related reasons.5

At the time of data collection, there were no COVID-19 vaccine programs.5

No studies have been conducted to determine whether patients with COVID-19 should continue to use abemaciclib. Cross-trial comparisons cannot be made with regard to safety and efficacy in patients with COVID-19.

Infectious Disease Resources

For the most current information regarding COVID-19, please refer to the following resources: 

References

1Naming the coronavirus disease (COVID-19) and the virus that causes it. World Health Organization. Accessed March 17, 2020. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/naming-the-coronavirus-disease-(covid-2019)-and-the-virus-that-causes-it

2Data on file, Eli Lilly and Company and/or one of its subsidiaries.

3Verzenios [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

4Verzenio [package insert]. Indianapolis, IN: Eli Lilly and Company; 2020.

5Pfeiler G, DeMichele A, Dueck A, et al. Safety of adjuvant CDK4/6 inhibitors during the COVID-19 pandemic. Lancet Oncol. 2022;23(2):195-197. https://doi.org/10.1016/S1470-2045(21)00708-7

6Coronavirus disease (COVID-19) outbreak. World Health Organization Europe. Accessed March 20, 2020. http://www.euro.who.int/en/health-topics/health-emergencies/coronavirus-covid-19/novel-coronavirus-2019-ncov

7COVID-19. European Centre for Disease Prevention and Control. Accessed March 20, 2020. https://www.ecdc.europa.eu/en/novel-coronavirus-china

8European Society for Medical Oncology. Accessed March 23th. https://www.esmo.org/newsroom/covid-19-and-cancer/covid-19-useful-resources

 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: 29 March 2022


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