Paxlovid Drug Interaction Screening Checklist Updated: News From the Food and Drug Administration

The FDA has updated a checklist designed to help evaluate potential drug interactions and other patient factors before prescribing Paxlovid (copackaged nirmatrelvir and ritonavir tablets) for COVID-19. It incorporates additional guidance on drugs that should not be taken with Paxlovid or may require dose or other treatment adjustments.

The tool includes specific instructions for suspending and restarting common statins, advising what to do for patients taking hormonal contraceptives containing ethinyl estradiol, and following up on patients taking HIV antiretroviral medications. It further lists more than 120 drugs that are either contraindicated, should be avoided or held from use, or require dose adjustments or special monitoring when used with Paxlovid. Any drugs not listed also should be reviewed for potential interactions, the agency advised.

In addition, the checklist’s Medical History section outlines Paxlovid prescribing requirements in line with the latest FDA Emergency Use Authorization (EUA) letter. Eligible patients must test positive for SARS-CoV-2 and be 18 years or older or 12 years or older and weigh at least 40 kg, or 88.2 lb. They must have mild to moderate COVID-19 symptoms and be at risk for progression to severe disease. When prescribing, patients must be within 5 days of symptom onset and must not require hospitalization for severe or critical COVID-19. Kidney and liver function should be assessed.

The checklist references more detailed treatment and prescribing information, including the National Institutes of Health COVID-19 treatment guidelines and the FDA Paxlovid fact sheet. Intended as a clinical decision-making aid for prescribers including pharmacists, the checklist’s use is not required to prescribe Paxlovid under the EUA, the agency wrote.