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

Verzenios® ▼ (abemaciclib): Användning med COVID-19 Vacciner

Användning av vacciner mot SARS-CoV-2 hos patienter som behandlas med Verzenios )abemaciklib= har inte studerats.

Administration of COVID-19 Vaccines to Patients Receiving Abemaciclib

Severe acute respiratory syndrome coronavirus 2 is an emerging virus that has caused the recent COVID-19 pandemic. There are several vaccines against SARS-CoV-2 currently available, and others are under development.1,2

SARS-CoV-2 Vaccination With Abemaciclib

The use of a SARS-CoV-2 vaccine in patients treated with abemaciclib has not been studied by Lilly.

It is suggested that signs of infection and labs be monitored if a patient receives a vaccine/vaccination before or during abemaciclib therapy. 

Decisions regarding the use of any vaccination, including SARS-CoV-2 vaccines, in patients treated with abemaciclib should be made at the discretion of the prescribing physician using their best clinical judgment, and must be made by the clinician after careful consideration of risk factors of the patient as well as the risks and benefits of vaccination. Consultation with an infectious disease expert may be helpful in high-risk or emergency situations such as the current COVID-19 pandemic.

Adverse events related to the use of abemaciclib that may be important to consider when managing a patient being administered a SARS-CoV-2 vaccine while being treated with abemaciclib include ILD, neutropenia, and diarrhea. 

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. 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. Based on the severity of ILD/pneumonitis, abemaciclib may require dose modification.3

Neutropenia-Related Warnings and Precautions

Grade ≥3 neutropenia was reported in patients receiving abemaciclib in breast cancer studies. Monitor complete blood counts prior to starting abemaciclib therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. Dose modification is recommended for patients who develop grade 3 or 4 neutropenia.3

Diarrhea-Related Warnings and Precautions

Diarrhea was the most frequently reported TEAE in patients receiving abemaciclib in clinical studies. Monitor patients and treat diarrhea reactively rather than routine preventive administration of antidiarrheal medications. Based on the severity of diarrhea, abemaciclib may require dose modification.3

Infectious Disease Resources for COVID-19 Vaccines

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

Additional information and considerations for the use of a SARS-CoV-2 vaccine in patients being treated for cancer is available from ESMO at: https://www.esmo.org/covid-19-and-cancer/covid-19-vaccination.

References

1. Dong Y, Dai T, Wei Y, et al. A systematic review of SARS-CoV-2 vaccine candidates. Signal Transduct Target Ther. 2020;5:237. https://doi.org/10.1038/s41392-020-00352-y

2. Jackson LA, Anderson EJ, Rouphael NG, et al; mRNA-1273 Study Group. An mRNA vaccine against SARS-CoV-2 — preliminary report. N Engl J Med. 2020;383(20):1920-1931. https://doi.org/10.1056/NEJMoa2022483

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

4. Coronavirus 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

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

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

Glossary

COVID-19 = coronavirus disease 2019

ILD = interstitial lung disease

Lilly = Eli Lilly and Company

SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2

TEAE = treatment-emergent adverse event

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 2020 M12 17


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