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

Vilken effekt har Verzenios® ▼ (abemaciklib) på serumkreatinin?

Abemaciclib orsakar en reversibel ökning av serumkreatinin utan att nedsätta njurfunktionen.

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Effect on Serum Creatinine 

Abemaciclib inhibits renal tubular secretion transporters. This increases serum creatinine without affecting the glomerular function.1,2

In the MONARCH 1, MONARCH 2, and MONARCH 3 trials, increased serum creatinine was the most common laboratory abnormality reported with 98%, 97%, and 96% of patients, respectively.3-5

A mean increase of 0.2-0.3 mg/dL

  • occurred within the first 28-day cycle of abemaciclib dosing
  • remained elevated but stable through the treatment period, and
  • was reversible upon treatment discontinuation.1,6

In healthy subjects, the maximum creatinine increased 20% to 35% over baseline after about 24 hours post-dose and then returned to baseline at about 336 hours (14 days) post-dose.1

Alternative Tests to Measure Renal Function 

Use other measures of renal function (such as cystatin C) as an alternative to either serum creatinine or creatinine-based calculated estimates of glomerular filtration rate (GFR) if

  • serum creatinine rise is progressive after the first cycle
  • there are other indications of renal injury (e.g., proteinuria, etc.), or
  • a patient has a need for precise GFR assessment (such as concomitant medications that effect kidney function).7,8

Creatinine may not be an accurate method to assess renal function in these patients.7-9

Serum or plasma cystatin C measurement is an automated test that is readily available and does not require special processing or handling of the blood sample.10

Cystatin C is a small protein that is produced by all nucleated cells and found in body fluids, including serum. It is formed at a constant rate and due to its small size is freely filtered by the glomeruli. Cystatin C is not secreted and is fully reabsorbed and broken down by the renal tubules.11 Cystatin C has been consistently found to have a higher correlation with standard measures of GFR when compared with creatinine.12

References

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

2Tolaney S, Lam AQ, Mukundan S, et al. Analysis of renal function in MONARCH 1: A phase 2 study of abemaciclib, a CDK4 & 6 inhibitor, as monotherapy, in patients with HR+/HER2- breast cancer, after chemotherapy for metastatic breast cancer (MBC). Cancer Res. 2017;77(suppl 4):P6-15-01. American Association for Cancer Research abstract P6-15-01. http://cancerres.aacrjournals.org/content/77/4_Supplement/P6-15-01

3Dickler MN, Tolaney SM, Rugo HS, et al. MONARCH 1, a phase II study of abemaciclib, a CDK4 and CDK6 inhibitor, as a single agent, in patients with refractory HR+/HER2− metastatic breast cancer. Clin Cancer Res. 2017;23(17):5218-5224. http://dx.doi.org/10.1158/1078-0432.CCR-17-0754

4Sledge 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

5Goetz 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

6Verzenio [package insert]. Indianapolis, IN: Eli Lilly and Company; 2019.

7Milburn J, Jones R, Levy JB. Renal effects of novel antiretroviral drugs. Nephrol Dial Transplant. 2017;32(3):434-439. https://doi.org/10.1093/ndt/gfw064

8Shlipak MG, Matsushita K, Ärnlöv J, et al. Cystatin C versus creatinine in determining risk based on kidney function. N Engl J Med. 2013;369(10):932-943. https://doi.org/10.1056/NEJMoa1214234

9Chappell JC, Turner PK, Pak YA, et al. Abemaciclib inhibits renal tubular secretion without changing glomerular filtration rate. Clin Pharmacol Ther. 2019;105(5):1187-1195. https://doi.org/10.1002/cpt.1296

10Shlipak MG, Mattes MD, Peralta CA. Update on cystatin C: incorporation into clinical practice. Am J Kidney Dis. 2013;62(3):595-603. https://doi.org/10.1053/j.ajkd.2013.03.027

11Chew JSC, Saleem M, Florkowski CM, George PM. Cystatin C – a paradigm of evidence based laboratory medicine. Clin Biochem Rev. 2008;29(2):47-62. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2533150/

12Inker LA, Schmid CH, Tighiouart H, et al. Estimating glomerular filtration rate from serum creatinine and cystatin C. N Engl J Med. 2012;367(1):20-29. https://doi.org/10.1056/NEJMoa1114248

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 February 06, 2020


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