Kommersiellt obunden läkemedelsinformation riktad till läkare och sjukvårdspersonal

Palbociklib

Klassificering: B

Preparat: IBRANCE

ATC kod: L01XE33

Substanser: palbociklib

Sammanfattning

I nuläget saknas studier som jämfört effekt av palbociklib mellan kvinnor och män eftersom den aktuella godkända indikationen endast omfattar kvinnor. Det finns studier som indikerar lägre absolut neutrofilantal hos kvinnor men den kliniska relevansen av detta är oklar.

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).

Försäljning på recept

Fler kvinnor än män hämtade ut läkemedel innehållande palbociklib (ATC-kod L01XE33) på recept i Sverige år 2017, totalt 141 kvinnor och 2 män [5].

Uppdaterat: 2018-12-20

Litteratursökningsdatum: 2018-12-17

Referenser

  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

Författare: Mia von Euler

Faktagranskat av: Karin Schenck-Gustafsson

Godkänt av: Karin Schenck-Gustafsson