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U.S. Department of Health and Human Services
National Pharmacy & Therapeutics Committee

Additional Paxlovid Dose Packs Authorized for Patients with Moderate Renal Impairment

The Food and Drug Administration (FDA) revised the Emergency Use Authorization (EUA) for the COVID-19 oral antiviral therapeutic Paxlovid to authorize an additional dose pack with appropriate dosing for patients with moderate renal impairment.

Paxlovid is approved for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

eGFR
(mL/min)

Dosing

Dose Pack Contents

≥60

300 mg nirmatrelvir with 100 mg ritonavir twice daily for 5 days

300 mg nirmatrelvir;100 mg ritonavir

Each carton contains 30 tablets divided in 5 daily-dose blister cards

Each blister card contains 4 nirmatrelvir tablets (150 mg each)

and 2 ritonavir tablets (100 mg each)

≥30 to

<60

150 mg nirmatrelvir and 100 mg ritonavir twice daily for 5 days

150 mg nirmatrelvir; 100 mg ritonavir

Each carton contains 20 tablets divided in 5 daily-dose blister cards

Each blister card contains 2 nirmatrelvir tablets (150 mg each)
and 2 ritonavir tablets (100 mg each)

<30

Not Recommended

  

For more information, please consult the updated provider Fact Sheet Exit Disclaimer: You Are Leaving www.ihs.gov , Letter of Authorization Exit Disclaimer: You Are Leaving www.ihs.gov , and Dear Healthcare Provider Letter Exit Disclaimer: You Are Leaving www.ihs.gov .