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Palbociclib

Classification: B

Drug products: IBRANCE

ATC code: L01EF01

Substances: palbociclib

Summary

At present, studies concerning differences in effect and safety of palbociclib between men and women are limited as the approved indication only includes women. There are studies indicating lower absolute neutrophil count in women but the clinical relevance is unclear.

Additional information

Palbociclib is an oral, cyclin-dependent kinase inhibitor that prevents the deactivation of the retinoblastoma susceptibility gene protein, thereby interfering with tumor cell progression [1]. It is used in postmenopausal women with a HR-positive, HER2-negative metastatic breast cancer [1-2].

Pharmacokinetics and dosing

The producer reports that sex did not affect exposure of palbociclib (50 men, 133 women) and no dose adjustment based on sex is thus recommended [2].

Effects

No studies with a clinically relevant sex analysis regarding effect of palbociclib have been found

Adverse effects

Neutropenia is a dose limiting adverse effect of palbociclib [3]. In a pooled analysis of three studies (50 men, 135 women) the baseline absolute neutrophile count was 34% higher in men [4].

Reproductive health issues

Palbociklib should be avoided during pregnancy. Human data is lacking but animal data suggest a teratogenic risk. Therefore, both women and men using palbociclib should us effective contraception [1,2]. Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).

Updated: 2018-12-20

Date of litterature search: 2018-12-17

References

  1. Physicians' Desk Reference. http://www.pdr.net. [cited 2018-12-17]. länk
  2. Fass.se [cited 2018-12-06]. länk
  3. Flaherty KT, Lorusso PM, Demichele A, Abramson VG, Courtney R, Randolph SS et al. Phase I, dose-escalation trial of the oral cyclin-dependent kinase 4/6 inhibitor PD 0332991, administered using a 21-day schedule in patients with advanced cancer. Clin Cancer Res. 2012;18(2):568-76. PubMed
  4. Sun W, O'Dwyer PJ, Finn RS, Ruiz-Garcia A, Shapiro GI, Schwartz GK et al. Characterization of Neutropenia in Advanced Cancer Patients Following Palbociclib Treatment Using a Population Pharmacokinetic-Pharmacodynamic Modeling and Simulation Approach. J Clin Pharmacol. 2017;57(9):1159-1173. PubMed
  5. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2017 [cited 2018-12-17.] länk

Authors: Mia von Euler

Reviewed by: Karin Schenck-Gustafsson

Approved by: Karin Schenck-Gustafsson