Drug products: Paxlovid
ATC code: J05
The pivotal clinical studies show similar efficacy of nirmatrelvir/ritonavir in men and women.
Pharmacokinetics and dosing
Influence of patient’s sex on nirmatrelvir pharmacokinetics have not been evaluated [1, 2].
A phase 2/3 trial conducted by the original manufacturer showed that a similar proportion of men and women treated with nirmatrelvir/ritonavir (520 men, 519 women) had COVID-19-related hospitalization or death from any cause at day 28 .
Sex differences in adverse event reports from nirmatrelvir/ritonavir have been analyzed using the FDA Adverse Event Reporting System (FAERS). Of the 11 997 reports, 59.5% of the adverse events were reported in women. The distribution of specific adverse events was similar in men and women .
Reproductive health issues
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2023-01-12
- Paxlovid (nirmatrelvir, ritonavir). Pfizer Europe MA EEIG. EMA EPAR Product Information. Updated 03/11/2022.
- EMA. Assessment report Paxlovid. EMA [www]. [updated 2021-12-16, cited 2022-04-14]. EMA
- Li M, Zhang QS, Liu XL, Wang HL, Liu W. Adverse Events Associated with Nirmatrelvir/Ritonavir: A Pharmacovigilance Analysis Based on FAERS. Pharmaceuticals (Basel). 2022;15(12). PubMed
- VAL-databasen. Region Stockholm. 2021 [cited 2023-01-20.] länk
Reviewed by: Diana Rydberg, Carl-Olav Stiller, Pauline Raaschou
Approved by: Karin Schenck-Gustafsson