Kommersiellt obunden läkemedelsinformation riktad till läkare och sjukvårdspersonal

Nirmatrelvir

Klassificering: A

Preparat: Paxlovid

ATC kod: J05

Substanser: nirmatrelvir

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

  1. Paxlovid (nirmatrelvir, ritonavir). Pfizer Europe MA EEIG. EMA EPAR Product Information. Updated 03/11/2022.
  2. EMA. Assessment report Paxlovid. EMA [www]. [updated 2021-12-16, cited 2022-04-14]. EMA
  3. 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
  4. VAL-databasen. Region Stockholm. 2021 [cited 2023-01-20.] länk

Författare: Linnéa Karlsson Lind

Faktagranskat av: Diana Rydberg, Carl-Olav Stiller, Pauline Raaschou

Godkänt av: Karin Schenck-Gustafsson