Nirmatrelvir
Klassificering: AATC kod: J05
Sammanfattning
De pivotala kliniska studierna visar likartad effekt av nirmatrelvir/ritonavir hos kvinnor och män.
Additional information
Pharmacokinetics and dosing
Influence of patient’s sex on nirmatrelvir pharmacokinetics have not been evaluated [1, 2].
Effects
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 [2].
Adverse effects
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 [3].
Reproductive health issues
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Försäljning på recept
Läkemedel innehållande kombination av nirmatrelvir och ritonavir (ATC-kod J05) används huvudsakligen på sjukhus och därför saknas könsspecifika användningsdata [4].
Uppdaterat: 2023-01-20
Litteratursökningsdatum: 2023-01-12
Referenser
- 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
Faktagranskat av: Diana Rydberg, Carl-Olav Stiller, Pauline Raaschou
Godkänt av: Karin Schenck-Gustafsson