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Olaparib

Classification: A

Drug products: Lynparza, Olaparib

ATC code: L01XX46

Substances: olaparib

Summary

At present studies concerning differences between men and women are limited as the approved indication only includes women.

Additional information

Olaparib is an oral poly ADP ribose polymerase (PARP) inhibitor. Indications are previously treated BRCA-positive or suspected BRCA-positive germline BRCA-mutated (gBRCAm) advanced ovarian cancer, maintenance treatment of recurrent epithelial ovarian, fallopian tube, or peritoneal cancer after response to platinum-based chemotherapy, previously treated HER2-negative and gBRCAm metastatic breast cancer [1]. There are studies indicating a positive effect also in men with certain types of prostate cancer [3-5]. Also, in pancreatic cancer the drug may be effective and has received orphan drug destination for this indication both by EMA and FDA [6].

Pharmacokinetics and dosing

No studies with a clinically relevant sex analysis regarding pharmacokinetics of olaparib have been found

Effects

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

Adverse effects

No studies with a clinically relevant sex analysis regarding adverse effects of olaparib have been found

Reproductive health issues

Olaparib should be avoided during pregnancy as data is lacking but animal studies indicate an increased risk of teratogenic effects and risk of still birth. Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan). 

Updated: 2018-12-18

Date of litterature search: 2018-12-06

References

  1. Physicians' Desk Reference. http://www.pdr.net. [cited 2018-12-06]. länk
  2. Fass.se [cited 2018-12-06]. länk
  3. Karzai F, VanderWeele D, Madan RA, Owens H, Cordes LM, Hankin A et al. Activity of durvalumab plus olaparib in metastatic castration-resistant prostate cancer in men with and without DNA damage repair mutations. J Immunother Cancer. 2018;6(1):141. PubMed
  4. Clarke N, Wiechno P, Alekseev B, Sala N, Jones R, Kocak I et al. Olaparib combined with abiraterone in patients with metastatic castration-resistant prostate cancer: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol. 2018;19(7):975-986. PubMed
  5. Martin GA, Chen AH, Parikh K. A Novel Use of Olaparib for the Treatment of Metastatic Castration-Recurrent Prostate Cancer. Pharmacotherapy. 2017;37(11):1406-1414. PubMed
  6. Gina Columbus. FDA Grants Olaparib Orphan Drug Designation for Pancreatic Cancer. OncLive [www]. [cited 2018-12-06]. länk
  7. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2017 [cited 2018-12-06.] länk

Authors: Mia von Euler

Reviewed by: Karin Schenck-Gustafsson

Approved by: Karin Schenck-Gustafsson