Verzenios ® ▼ (abemaciclib)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Verzenios Summary of Product Characteristics (SmPC)

How to manage pneumonitis in Verzenios® ▼ (abemaciclib) treated patients?

Based on the grade of interstitial lung disease (ILD)/pneumonitis, abemaciclib dose modifications may be required as outlined below.

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Management Recommendations for ILD/Pneumonitis

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

Permanently discontinue abemaciclib in patients with Grade 3 or 4 ILD/pneumonitis.1

Please find management recommendations for ILD/pneumonitis in Management recommendations for interstitial lung disease (ILD)/pneumonitis.

Management recommendations for interstitial lung disease (ILD)/pneumonitis1

Toxicitya

Management recommendations

Grade 1 or 2

No dose adjustment required.

Persistent or recurrent Grade 2 toxicity that does not resolve with maximal supportive measures within 7 days to baseline or Grade 1

Suspend dose until toxicity resolves to baseline or Grade 1.

Resume at next lower dose.

Grade 3 or 4

Discontinue abemaciclib.

aNCI CTCAE

Incidence of Pneumonitis in the MONARCH Trials and Postmarketing Reports

Across the MONARCH clinical trials, ILD/pneumonitis occurred in 

  • 2.3% in MONARCH 1,
  • 2.0% in MONARCH 2, and
  • 5.2% in MONARCH 3.2

Death due to ILD/pneumonitis in abemaciclib-treated patients in the United States was reported in

  • 1 patient in MONARCH 1
  • 2 patients (0.5%) in MONARCH 2, and
  • 1 patient (0.3%) in MONARCH 3.2

Interstitial lung disease/pneumonitis was identified as a common (>1.0% to <10%) adverse drug reaction based on spontaneous data from postmarketing reports.2

The reasons patients develop ILD/pneumonitis when they are taking anticancer medications are not fully understood. Based on the mechanism of action of abemaciclib and the etiology of ILD, there is no known explanation for an association of abemaciclib and ILD.2

References

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

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

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 22, 2021


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