Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 February 2024

EMA’s safety committee (PRAC) is reminding healthcare professionals of the risk of serious and potentially fatal adverse reactions with Paxlovid (nirmatrelvir, ritonavir) when used in combination with certain immunosuppressants that have a narrow safe dosage range (where small changes in the dose can lead to serious adverse reactions), due to drug-drug interactions reducing the body’s ability to eliminate these medicines.

Paxlovid is a medicine used for treating COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of the disease becoming severe. The immunosuppressants concerned are called calcineurin inhibitors (tacrolimus, ciclosporin) and mTOR inhibitors (everolimus, sirolimus), which reduce the activity of the immune system. They are used for treating certain autoimmune disorders or for preventing the body from rejecting transplanted organs.

Paxlovid should only be given with tacrolimus, ciclosporin, everolimus or sirolimus if close and regular monitoring of their blood levels is possible, to reduce the risk of drug-drug interactions causing serious reactions. Healthcare professionals need to consult with a multidisciplinary group of specialists to manage the complexity of taking these medicines together…