IDStewardship

Ensitrelvir (Xocova)

Ensitrelvir (Xocova) photo pending

Key Points

  • Ensitrelvir (Xocova) is a SARS-CoV-2 main protease inhibitor with activity against a wide range of viral variants
  • Ensitrelivr was FDA-approved on 29 May 2026 for post-exposure prophylaxis of COVID-19 in adults and adolescents 12 years of age and older following contact with an individual with COVID-19
    • Has been approved for use in Japan since November 2022
    • Is NOT FDA-approved for treatment of COVID-19
  • Should be started as soon as possible after exposure and within 72 hours
  • Dosage is three 125-mg tablets (375 mg) oral day one, then one 125-mg tablet oral on days two through 5
    • May be taken with or without food
    • Package insert does not give dose adjustments for renal or hepatic dysfunction
  • Beware drug-drug interactions with medications metabolized by CYP3A or transported by P-gp and BCRP
    • Inducers of CYP3A may significantly reduce ensitrelvir levels, leading to loss of efficacy
    • The drug interactions are extensive and the package insert/ literature should be consulted for a complete evaluation
  • Has a warning for embryo-fetal toxicity, requiring evaluation of pregnancy status prior to use. Females of reproductive potential also should use contraception for 2 weeks after use.
  • Has a warning for anaphylaxis
  • The most common side effects are headache, diarrhea, and cough
  • Studied in the SCORPIO-PEP trial, showing a rate of 2.9% confirmed SARS-CoV-2 infection through day 10 in the modified intention to treat analysis, compared to 9% in the placebo arm
  • There is partial cross resistance with ensitrelvir and nirmatrelvir
  • Stored at room temperature
  • Manufactured by Shionigi

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