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

Har Verzenios® ▼ (abemaciclib) patienter ökad risk för venösa tromboemboliska händelser?

Venösa tromboemboliska händelser (VTE) inträffade hos fler patienter som tog abemaciclib än hos patienter som fick placebo i fas 3 -studierna för metastatisk bröstcancer.

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en-GB

Detailed Information about VTEs in MONARCH 2 and MONARCH 3

VTEs have been identified as an adverse drug reaction for abemaciclib. This includes

  • deep vein thrombosis
  • pulmonary embolism
  • pelvic venous thrombosis
  • cerebral venous sinus thrombosis
  • subclavian and axillary vein thrombosis, and
  • inferior vena cava thrombosis.

Across the clinical development program, deaths due to VTEs have been reported.1

Most events were

  • considered non-serious
  • treated with low molecular weight heparin, and
  • not resulting in discontinuation of abemaciclib.

Risk factors for VTEs were balanced between study arms and overall, there were no specific risk factors identified that could predict VTEs with abemaciclib treatment.1

Please find the breakdown of VTEs in the phase 3 studies presented in VTEs in MONARCH 2 and MONARCH 3.

VTEs in MONARCH 2 and MONARCH 31,2

Event, n (%)

MONARCH 2

MONARCH 3

Abemaciclib + Fulvestrant
N=441

Placebo + Fulvestrant
N=223

Abemaciclib + NSAI
N=327

Placebo + NSAI
N=161

VTE (all grade)

21 (4.8)

2 (0.9)

20 (6.1)

1 (0.6)

PE

11 (2.5)

0

11 (3.4)a

1 (0.6)

DVT

10 (2.3)

2 (0.9)

9 (2.8)

0

Grade ≥3

9 (2.0)

1 (0.4)

10 (3.0)

1 (0.6)

Death

0

0

3 (0.9)b

0

SAE

8 (1.8)c

1 (0.4)

9 (2.8)

1 (0.6)

DC (all events)

2 (0.5)

0

4 (1.2)d

0

Dose reduction

2 (0.5)

0

0

1 (0.6)

Abbreviations: DC = discontinuation; DVT = deep vein thrombosis; NSAI = nonsteroidal aromatase inhibitor; PE = pulmonary embolism; SAE = serious adverse event; VTE(s) = venous thromboembolic event(s).

aThree patients experienced both PE and DVT.

bPE and DVT; Thromboembolism not further investigated; Respiratory failure.

c4 PE and 4 DVT.

dIncludes 3 patients who died.

References

1Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2Rugo HS, Huober J, Llombart-Cussac A, et al. Management of abemaciclib associated adverse events in patients with HR+, HER2- advanced breast cancer: analysis of the MONARCH trials. Poster presented at: Annual Meeting of the European Society for Medical Oncology (ESMO) European Cancer Congress (ECC); October 19-23, 2018; Munich, Germany. https://www.esmo.org/content/download/149891/2691140/file/EMSO-2018-Abstract-Book-partial-version.pdf

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 January 28, 2020


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