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).

Should Verzenios® ▼ (abemaciclib) be paused before and held after surgery?

In the Monarch studies, abemaciclib was held at least 7 days before surgery and continued no earlier than 14 days after completion of surgery ± radiotherapy. In monarchE, abemaciclib was resumed after surgery as clinically indicated.

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Use of Abemaciclib During Invasive Procedures

Information on holding abemaciclib treatment for surgery is available in several clinical study protocols and is provided in this response. No additional information is available on the use of abemaciclib during invasive procedures or on the outcomes in patients who underwent surgery while on study.

Patients Undergoing Surgery in MONARCH 2 and MONARCH 3 

A patient with locally advanced (MONARCH 2) or locoregionally recurrent (MONARCH 3) breast cancer could receive surgery ± radiotherapy if study treatment rendered the tumor operable.1,2

Such a patient should not receive study treatment for the period beginning at least 7 days prior to surgery and continuing until at least 14 days after completion of surgery ± radiotherapy to allow for tissue healing and recovery.1,2

There is no restriction on the duration of this period without study treatment and, after this period ends, study treatment may resume.1,2

Patients Undergoing Surgery in monarchE

For minor surgeries and procedures (for example, ambulatory), treat as clinically indicated and closely monitor any

  • signs of infection, or
  • healing complications.3

For major surgeries, the recommendation is to suspend dosing of abemaciclib for at least 7 days before and may be resumed as clinically indicated.3

Consider monitoring neutrophils and platelets before surgery and before resuming abemaciclib.3

The scars should be aseptic and healing process be reasonable before resuming abemaciclib.3

References

1Sledge GW Jr, Toi M, Neven P, 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;35(25):2875-2884. https://doi.org/10.1200/JCO.2017.73.7585

2Goetz MP, Toi M, Campone M, et al. MONARCH 3: abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol. 2017;35(32):3638-3646. https://doi.org/10.1200/jco.2017.75.6155

3Johnston SRD, Harbeck N, Hegg R, et al. Abemaciclib combined with endocrine therapy for the adjuvant treatment of HR+, HER2−, node-positive, high risk, early breast cancer (monarchE). J Clin Oncol. 2020;38(34):3987-3998. https://pubmed.ncbi.nlm.nih.gov/32954927/

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: 10 June 2022


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