AUTHORIZED USE
The FDA has authorized the emergency use of PAXLOVID, an investigational medicine, for the treatment of mild-to-moderate COVID-19 in adults and children (12 years of age and older weighing at least 88 pounds [40 kg]) with a positive test for the virus that causes COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization or death, under an EUA.
PAXLOVID is investigational because it is still being studied. There is limited information about the safety and effectiveness of using PAXLOVID to treat people with mild-to-moderate COVID-19.
Now Authorized for Emergency Use
PAXLOVID has not been approved, but has been authorized for emergency use by FDA under an EUA, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
The emergency use of PAXLOVID is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.
CDC Update: On December 6, 2022, the CDC changed age-related guidance for those at high risk for progression to severe COVID-19 from 65+ to 50+. In addition, updates were made to the list of underlying medical conditions, as reflected in the "Who Can Take PAXLOVID" section below.
The product expiration date is stated on the product packaging, both on the carton and on the individual blister cards.
As of September 6, 2022, the U.S. Food and Drug Administration (FDA) approved a shelf-life extension for PAXLOVID from 12 months to 18 months. If you have a PAXLOVID prescription with an expiration date listed on the left column of the chart below, please see the right column to find the extended expiration date.
Labeled Expiration Date |
Extended Expiration Date |
---|---|
July 2022 |
January 2023 |
August 2022 |
February 2023 |
November 2022 |
May 2023 |
December 2022 |
June 2023 |
January 2023 |
July 2023 |
February 2023 |
August 2023 |
March 2023 |
September 2023 |
April 2023 |
October 2023 |
May 2023 |
November 2023 |
COVID-19 is caused by a virus called a coronavirus. You can get COVID-19 through close contact with another person who has the virus.
COVID-19 illnesses have ranged from very mild to severe, including illness resulting in death. While information so far suggests that most COVID-19 illness is mild, serious illness can happen and may cause some of your other medical conditions to become worse.
Older people and people of all ages with severe, long-lasting (chronic) medical conditions like heart disease, lung disease, and diabetes, for example, seem to be at higher risk of being hospitalized for COVID-19.
You can find the full list of potential COVID-19 symptoms from the CDC here.
PAXLOVID is an investigational medicine used to treat mild-to-moderate COVID-19 in adults and children [12 years of age and older weighing at least 88 pounds (40 kg)] with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
PAXLOVID is investigational because it is still being studied. There is limited information about the safety and effectiveness of using PAXLOVID to treat people with mild-to-moderate COVID-19.
The FDA has authorized the emergency use of PAXLOVID for the treatment of mild-to-moderate COVID-19 in adults and children [12 years of age and older weighing at least 88 pounds (40 kg)] with a positive test for the virus that causes COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization or death, under an EUA.
If you test positive for COVID-19, talk to your healthcare provider as soon as possible. Your healthcare provider can tell you about your treatment options and if PAXLOVID is appropriate for you.
People of all ages or groups can be infected with COVID-19. Some people are more likely than others to get very sick from COVID-19, which can lead to hospitalization or death, even when symptoms start off as mild.
Some people are at increased risk of getting very sick or dying from COVID-19 because of where they live or work, or because they can't get health care. This includes many people from racial and ethnic minority groups and people with disabilities.
In addition, having one or more of the following factors puts you at high risk of getting severe COVID-19*:
*This list does not include all possible conditions that may put you at high risk of severe illness from COVID-19. If you have questions about a condition not included on this list, talk to your healthcare provider. Visit the CDC website for the latest information and the full list of high risk factors: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html.†
†This link will take you to a website that is owned and operated by the CDC. Pfizer is not responsible for the content or services of this site.
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PAXLOVID must be prescribed by a licensed healthcare provider and supplied by a government-approved pharmacy or medical facility.
Authentic PAXLOVID, from Pfizer Inc., will include the Pfizer name on the label and will be packaged in 5 aluminum push-through blister cards. Individual doses are not for sale. PAXLOVID will be packaged in a rectangular carton. The carton has a colorless, glossy coating that contains a repeated pattern of the Pfizer name and logo all over, and these repeating features are seen in a contrasting matte finish.
PAXLOVID consists of tablets for a 5-day oral treatment regimen, with morning and evening doses.
NOTE: If you are a patient with moderate kidney disease, you may receive a carton with daily blister cards that have been altered to ensure you receive the correct dose.
Tablet |
Text |
---|---|
nirmatrelvir |
Front: 3CL | Back: PFE |
ritonavir, manufactured by AbbVie |
Front: |
ritonavir, manufactured by |
Front: H | Back: R9 |
Pfizer is committed to patient safety and ensuring that people have accurate information about the investigational drug PAXLOVID, including how it is accessed and administered. We are actively monitoring for fraudulent offers of illegitimate PAXLOVID to protect patients from products that might be dangerous and lead to serious and life-threatening harm.
If you suspect the product you have received may be counterfeit, contact us at 1-800-438-1985 or visit www.pfizersafetyreporting.com.
AUTHORIZED USE
The FDA has authorized the emergency use of PAXLOVID, an investigational medicine, for the treatment of mild-to-moderate COVID-19 in adults and children (12 years of age and older weighing at least 88 pounds [40 kg]) with a positive test for the virus that causes COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization or death, under an EUA.
PAXLOVID is investigational because it is still being studied. There is limited information about the safety and effectiveness of using PAXLOVID to treat people with mild-to-moderate COVID-19.
IMPORTANT SAFETY INFORMATION