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​​Paxlovid

Important Information About Paxlovid

Paxlovid (nirmatrelvir/PF-07321332 and ritonavir) is an oral antiviral drug that should be initiated as soon as possible after diagnosis of COVID-19 and within 5 days of symptom onset. Paxlovid is available for patients by prescription only. Prescriptions can be obtained from your health care provider or through the Test to Treat program.

Paxlovid is authorized for the treatment of mild to moderate COVID-19 in adult and pediatric patients age 12 years and older weighing at least 40 kg, with a positive SARS-CoV-2 test, who are at high risk for progressing to severe COVID-19, including hospitalization or death. Please see the Eligibility Screening Checklist for additional details.

Paxlovid is available in two package presentations:*

  1. Paxlovid Standard Dose that includes 300 mg nirmatrelvir (two 150 mg tablets) with 100 mg ritonavir (one 100 mg tablet) taken together twice daily for 5 days.
  2. Paxlovid Renal Dose for people with moderate renal impairment (eGFR > 30 mL/min to < 60 mL/min) that includes 150 mg nirmatrelvir (one 150 mg tablet) with 100 mg ritonavir (one 100 mg tablet) taken together twice daily for 5 days. Paxlovid is not recommended for people with severe renal impairment.

*The standard dose pack may be modified for renal dosing. Instructions can be found in the Dispensing Information for Patients with Renal Impairment Document.

Emergency Use Authorization of Paxlovid

On April 14, 2022, the U.S. Food and Drug Administration (FDA) revised the original December 22, 2021 Emergency Use Authorization (EUA) for the COVID-19 oral antiviral therapeutic Paxlovid to authorize an additional dose pack presentation with appropriate dosing for patients with moderate renal impairment within the scope of the EUA.

Paxlovid is not authorized for the pre-exposure or post-exposure prevention of COVID-19 or for initiation of treatment in those requiring hospitalization due to severe or critical COVID-19. Paxlovid is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended. There are known drug interactions with Paxlovid, see the Drug Interaction Checker for more information.

Paxlovid FDA EUA Resources

Paxlovid

 

Paxlovid

Hello, I’m Dr. Colin Shepard. I serve as the CDC Liaison to the HHS Assistant Secretary for Preparedness and Response, also called ASPR. I want to talk about one of the therapeutics that can help people with COVID-19—Paxlovid.

What is Paxlovid?

Paxlovid is an oral antiviral used to help fight the coronavirus infection by stopping the coronavirus from replicating in the body. This lowers the viral load, reducing the chances of the illness progressing to more serious symptoms and hospitalization.

Who is eligible for Paxlovid?

Paxlovid is for adults and children 12 and older who are at high risk for developing serious symptoms of COVID-19 that may lead to hospitalization and/or death. For more information about who is at high risk, please see the resources provided in the description.

Paxlovid is for people who have a positive COVID-19 rapid or PCR test with mild to moderate symptoms and who are not in the hospital. It should be administered as early as possible but needs to be given within 5 days of symptom onset.

How is Paxlovid administered?

Paxlovid requires a prescription and is available through a pharmacy or health care clinic including Test to Treat locations where these antivirals are being distributed for use at home. Patients will take a combination of pills twice a day for 5 days.

What are the limitations of use of Paxlovid?

Paxlovid is not for everyone. There are serious drug interactions with some of the ingredients that need to be considered. Paxlovid is not recommended for patients with severe renal or hepatic impairment. It is not appropriate to start Paxlovid if you are already hospitalized for COVID-19.

Paxlovid is one of several COVID-19 therapeutic options. Watch the other Outpatient COVID-19 Therapeutics Videos in this series for more information. Visit us online at https://aspr.hhs.gov/COVID-19 and please see the resources linked in the description to learn more. You can connect with ASPR on social media platforms to stay up to date on our latest posts and information that we share. Please email any questions to COVID19therapeutics@hhs.gov.

Thank you for your time.

In this video, Colin Shepard, MD, CDC liaison to ASPR, provides more information about the at home use of Paxlovid for people who test positive for COVID‑19.

Paxlovid (nirmatrelvir/PF-07321332 and ritonavir) Frequently Asked Questions

Paxlovid Information Sheet for Providers PDF

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