PRAC to assess reports of acute kidney injury in with remdesivir (Veklury) in patients with COVID-19

Renal toxicity with remdesivir, evaluated at time of marketing authorisation application, was based on animal studies. Although at this stage, a causal relationship has not been determined, reports of acute kidney injury, form a ‘safety signal’ and require further investigation.

SPS commentary:

Recommendations for the use of remdesivir have not changed. The product information already advises doctors to monitor patients for renal impairment prior to and during treatment and not start treatment in patients with an important decrease in renal function.


European Medicines Agency