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.
PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets) 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.
According to the Food and Drug Administration (FDA), an Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures during public health emergencies, such as the current COVID-19 pandemic. Under an emergency use authorization, the FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products, in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Taking into consideration input from the FDA, manufacturers decide whether and when to submit an emergency use authorization request to the FDA. Once submitted, the FDA will evaluate an emergency use authorization request and determine whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence that is available to the FDA.
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.
Speak to your healthcare provider to determine if PAXLOVID is appropriate for you. PAXLOVID is not an FDA-approved medicine in the United States. 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.
Talk to your healthcare provider about your options or if you have any questions. It is your choice to take PAXLOVID.
Do not take PAXLOVID if:
Taking PAXLOVID with these medicines may cause serious or life-threatening side effects or affect how PAXLOVID works.
These are not the only medicines that may cause serious side effects if taken with PAXLOVID. PAXLOVID may increase or decrease the levels of multiple other medicines. It is very important to tell your healthcare provider about all of the medicines you are taking because additional laboratory tests or changes in the dose of your other medicines may be necessary while you are taking PAXLOVID. Your healthcare provider may also tell you about specific symptoms to watch out for that may indicate that you need to stop or decrease the dose of some of your other medicines.
You can take any available FDA-authorized COVID-19 viral test (eg, RT-PCR, rapid antigen, etc) to determine if you have COVID-19. Per the Centers for Disease Control and Prevention (CDC), a viral test checks specimens from the nose or mouth and can be performed in a laboratory, at a testing site, at home, or anywhere else.
If you test positive for COVID-19, speak to a healthcare provider as soon as possible.
For more information on COVID-19 testing, see the CDC's "COVID-19 Testing: What You Need To Know" web page.*
*This link will take you to a web page that is owned and operated by the CDC. Pfizer is not responsible for the content or services of this site.
If you test positive for COVID-19, tell your healthcare provider about your symptoms as soon as possible.
Tell your healthcare provider if you: have any allergies; have a liver or kidney disease; are pregnant or plan to become pregnant; are breastfeeding a child; or have any serious illness. Some medicines may interact with PAXLOVID and may cause serious side effects. Tell your healthcare provider about all of the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
You can ask your healthcare provider or pharmacist for a list of medicines that interact with PAXLOVID. Do not start taking a new medicine without telling your healthcare provider.
Tell your healthcare provider if you are taking combined hormonal contraceptive.
PAXLOVID may affect how your birth control pills work. Females who are able to become pregnant should use another effective alternative form of contraception or an additional barrier method of contraception. Talk to your healthcare provider if you have any questions about contraceptive methods that might be right 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.
PAXLOVID may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. State-licensed pharmacists may also prescribe PAXLOVID under certain conditions.
The Test-to-Treat initiative* can help you get tested for COVID-19 and, if appropriate, receive treatment all in the same location. Find a location near you here* or call 1-800-232-0233 (TTY 888-720-7489).
*These links will take you to websites that are owned and operated by the U.S. Department of Health and Human Services. Pfizer is not responsible for the content or services of these sites.
You can only get PAXLOVID with a prescription from physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. State-licensed pharmacists may also prescribe PAXLOVID under certain conditions. If prescribed, speak with your healthcare provider if you have additional questions.
Locations of publicly available COVID-19 therapeutics can be found by using the Test-to-Treat Locator.*
*This link will take you to a database that is owned and operated by the U.S. Dept. of Health and Human Services (HHS). Pfizer is not responsible for the content or services of this site.
As part of the Emergency Use Authorization, the U.S. Government has purchased PAXLOVID from Pfizer and is making it available to patients at no charge. Other administrative fees may apply.
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 |
The 5-day treatment course of PAXLOVID should be initiated as soon as possible after a diagnosis of COVID-19 has been made and within 5 days of symptom onset.
The U.S. Food and Drug Administration (FDA) approved a shelf-life extension for PAXLOVID from 12 months to 18 months. If you have an expiration date listed below, please see the chart to find the new 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 |
Talk to your healthcare provider if you do not feel better or if you feel worse after 5 days.
If you miss a dose of PAXLOVID within 8 hours of the time it is usually taken, take it as soon as you remember. If you miss a dose by more than 8 hours, skip the missed dose and take the next dose at your regular time. Do not take 2 doses of PAXLOVID at the same time.
If you take too much PAXLOVID, call your healthcare provider or go to the nearest hospital emergency room right away.
Do not stop taking PAXLOVID without talking to your healthcare provider, even if you feel better.
Allergic Reactions. Allergic reactions, including severe allergic reactions (known as ‘anaphylaxis’), can happen in people taking PAXLOVID, even after only 1 dose. Stop taking PAXLOVID and call your healthcare provider right away if you get any of the following symptoms of an allergic reaction:
Liver problems: Tell your healthcare provider right away if you have any of these signs and symptoms of liver problems: loss of appetite, yellowing of your skin and the whites your eyes (jaundice), dark-colored urine, pale-colored stools and itchy skin, or stomach area (abdominal) pain.
Resistance to HIV medicines: If you have untreated HIV infection, PAXLOVID may lead to some HIV medicines not working as well in the future.
Other possible side effects include: altered sense of taste, diarrhea, high blood pressure, muscle aches, abdominal pain, nausea, feeling generally unwell.
These are not all the possible side effects of PAXLOVID. Not many people have taken PAXLOVID. Serious and unexpected side effects may happen. PAXLOVID is still being studied, so it is possible that all of the risks are not known at this time.
Report side effects or problems with the appearance or packaging of PAXLOVID to FDA MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088 or you can report side effects to Pfizer Inc. at the contact information provided below.
Website |
Fax number |
Telephone number |
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Related Pages
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.
Contact One of the Following Groups
For Medical Information visit www.pfizermedicalinformation.com or call 1-800-438-1985
For General Product Inquiries call 1‑877‑C19PACK (1-877-219-7225)
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