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 en patient med Verzenios® ▼ (abemaciclib) vaccineras mot COVID-19?

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

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Warnings and considerations for the concomitant use of COVID-19 vaccines and abemaciclib

Monitor for signs of infections and laboratory anomalies if a patient receives a vaccination before or during the abemaciclib therapy. 

Please consider the risk and benefits of the vaccination on an individual patient basis. 

The following adverse events related to the use of abemaciclib may be important to consider when managing a patient being administered a COVID-19 vaccine or booster while concomitantly being treated with abemaciclib.1 

ILD-Related Warnings and Precautions

Interstitial lung disease (ILD) and/or pneumonitis was reported in patients receiving abemaciclib.

Monitor patients for pulmonary symptoms that could indicate ILD/pneumonitis and treat them 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.1

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.1

Diarrhea-Related Warnings and Precautions

Diarrhea was the most frequently reported treatment-emergent adverse event 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.1

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

1Verzenios [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2Coronavirus 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

3COVID-19. European Centre for Disease Prevention and Control. Accessed March 20, 2020. https://www.ecdc.europa.eu/en/novel-coronavirus-china

4European 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.

Datum fӧr senaste ӧversyn October 28, 2021


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