FDA EUA Letter
Authorized Use

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]) who are at high risk for progression to severe COVID-19, including hospitalization or death, under an EUA.

PAXLOVID use in children is still being studied. There is limited information about the safety and effectiveness of PAXLOVID to treat children with mild-to-moderate COVID-19.

Important Safety Information
Fact Sheets
Telehealth Resources Healthcare Professionals
Fact Sheet for Patients, Parents and Caregivers HOJA INFORMATIVA PARA PACIENTES, PADRES Y CUIDADORES FICHE D’INFORMATION POUR LES PATIENTS, LES PARENTS ET LES SOIGNANTS FOLHETO INFORMATIVO PARA DOENTES, PAIS E PRESTADORES DE CUIDADOS صحيفة الحقائق للمرضى واآلباء ومقدمي الرعاية FACT SHEET FOR HEALTHCARE PROVIDERS

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Important Safety Information Telehealth Resources Healthcare Professionals

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to make PAXLOVID available for the treatment of COVID-19 in certain patients.

TREAT COVID-19

WITH PAXLOVID

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*Other administrative fees may apply. The U.S. Government has purchased PAXLOVID from Pfizer
and is continuing to make it available at no charge, regardless of insurance.

Who can take PAXLOVID?

As much as we all wish COVID-19 were a thing of the past, it’s not. It’s still very much here and making some people very sick, especially people who are at high risk for progression to severe COVID-19.

PAXLOVID is an oral prescription medication that can treat adults and children 12 years and older weighing at least 88 pounds who:

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have mild-to-moderate COVID-19, and

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have had symptoms for 5 days or fewer, and

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have a high-risk factor for progression to severe COVID-19, such as being 50 years or older or having certain health conditions and/or lifestyle factors.

PAXLOVID is not authorized for use as pre-exposure or post-exposure treatment for prevention of COVID-19. There are certain medications that should not be taken with PAXLOVID. Talk to your healthcare professional to see if PAXLOVID is right for you.

PAXLOVID is 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 pediatric patients (12 years of age and older weighing at least 40 kg) 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.

Approximately 75% of American adults have at least one risk factor for progression to severe COVID-19. You could be one of them.

Some of the most common risk factors for progression to severe COVID-19 include:

  • Age of 50+ years
  • Certain health conditions and diseases, such as heart disease and diabetes
  • Being overweight or obese
  • Mental health conditions
  • Lifestyle factors, such as smoking
  • Physical, mental, and developmental disabilities
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Not sure if you’re
at high risk?

See more risk factors

Not sure if you’re at high risk?

See more risk factors
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Some of the most common risk factors for progression to severe COVID-19 include:

  • Age of 50+ years
  • Certain health conditions and diseases, such as heart disease and diabetes
  • Being overweight or obese
  • Mental health conditions
  • Lifestyle factors, such as smoking
  • Physical, mental, and developmental disabilities
despite-covid

Despite the COVID-19 Public Health Emergency (PHE) ending, PAXLOVID still remains available to patients at no charge, regardless of insurance.†

†Other administrative fees may apply. The U.S. Government has purchased PAXLOVID from Pfizer and is continuing to make it available at no charge, regardless of insurance.

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Despite the COVID-19 Public Health Emergency (PHE) ending, PAXLOVID still remains available to patients at no charge, regardless of insurance.†

†Other administrative fees may apply. The U.S. Government has purchased PAXLOVID from Pfizer and is continuing to make it available at no charge, regardless of insurance.

Want to learn more about PAXLOVID?

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PAXLOVID is a 5-day oral prescription treatment for COVID-19.

Learn more about how to take PAXLOVID

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A trial compared the risk of COVID-19–related hospitalization or death in people treated with PAXLOVID vs placebo.

Learn about the PAXLOVID clinical trial

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It’s important to understand the risks and possible side effects of PAXLOVID before starting treatment.

See safety and possible side effects

Be prepared for COVID-19.

If you’re at high risk for progression to severe COVID-19, it’s important to be ready to take action if you have COVID-19. Fill out this COVID-19 Preparedness Plan so you can be ready to speak with a healthcare professional about PAXLOVID.

Download the COVID-19 Preparedness Plan

Be prepared for COVID-19.

If you’re at high risk for progression to severe COVID-19, it’s important to be ready to take action if you have COVID-19. Fill out this COVID-19 Preparedness Plan so you can be ready to speak with a healthcare professional about PAXLOVID.

Download the COVID-19 Preparedness Plan

How to verify your tablets are authentic

PAXLOVID must be prescribed by a licensed healthcare professional 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 modified to ensure you receive the correct dose.

To help determine whether the tablets are authentic, look for specific text on each side of the tablets

Tablet Embossed Text
nirmatrelvir Front: 3CL | Back: PFE
ritonavir, manufactured by AbbVie Front: iconNK | Back: No text
ritonavir, manufactured by Hetero Front: H | Back: R9

Pfizer is committed to patient safety and ensuring that people have accurate information about 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.

for-more-info

For more information

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)

Important Safety Information

Expand

Significant Drug Interactions. PAXLOVID can interact with other medicines, causing severe or life-threatening side effects or death. Do not take PAXLOVID if you are taking any of the following medicines:

  • alfuzosin
  • amiodarone
  • apalutamide
  • carbamazepine
  • colchicine
  • dihydroergotamine
  • dronedarone
  • eletriptan
  • eplerenone
  • ergotamine
  • finerenone
  • flecainide
  • flibanserin
  • ivabradine
  • lomitapide
  • lovastatin
  • lumacaftor/ivacaftor
  • lurasidone
  • methylergonovine
  • midazolam (oral)
  • naloxegol
  • phenobarbital
  • phenytoin
  • pimozide
  • primidone
  • propafenone
  • quinidine
  • ranolazine
  • rifampin
  • rifapentine
  • St. John’s Wort (hypericum perforatum)
  • sildenafil (Revatio®) for pulmonary arterial hypertension
  • silodosin
  • simvastatin
  • tolvaptan
  • triazolam
  • ubrogepant
  • voclosporin

These are not the only medicines that may cause serious or life-threatening side effects if taken with PAXLOVID. PAXLOVID may increase or decrease the levels of other medicines. It is very important to tell your healthcare professional about all the medicines you are taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements, because additional laboratory tests or changes in the dose of your other medicines may be necessary during treatment with PAXLOVID. Your healthcare professional 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. Do not start taking a new medicine without telling your healthcare professional.

Before taking PAXLOVID, tell your healthcare professional about all your medical conditions, including if you:

  • have kidney or liver problems, including hepatitis.
  • have Human Immunodeficiency Virus 1 (HIV-1) infection. PAXLOVID may lead to some
    HIV-1 medicines not working as well in the future.
  • are pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed.

Tell your healthcare professional if you are taking combined hormonal contraceptive (birth control). PAXLOVID may affect how your birth control works. People who can become pregnant should use another or an alternative effective form of birth control.

PAXLOVID may cause serious side effects, including:

  • Allergic reactions, including severe allergic reactions (anaphylaxis). Do not take PAXLOVID if you are allergic to nirmatrelvir, ritonavir, or any of the ingredients in PAXLOVID. Stop taking PAXLOVID and call your healthcare professional right away if you get any of the following symptoms of an allergic reaction:

    • skin rash, hives, blisters, or peeling skin
    • painful sores or ulcers in the mouth, nose, throat, or genital area
    • trouble swallowing or breathing
    • swelling of the mouth, lips, tongue, or face
    • hoarseness
    • throat tightness

  • Liver problems. Tell your healthcare professional right away if you have any of the following signs and symptoms of liver problems during treatment with PAXLOVID:

    • loss of appetite
    • yellowing of your skin and the whites of your eyes
    • dark-colored urine
    • pale-colored stools
    • itchy skin
    • stomach-area (abdominal) pain

The most common side effects of PAXLOVID include: altered sense of taste and diarrhea.

Other possible side effects include:

  • headache
  • abdominal pain
  • vomiting
  • high blood pressure
  • nausea
  • feeling generally unwell

These are not all the possible side effects of PAXLOVID. For more information, ask your
healthcare professional or pharmacist.



There is no experience treating pregnant women or breastfeeding mothers with PAXLOVID.
For a mother and unborn baby, the benefit of taking PAXLOVID may be greater than the risk
from the treatment. It is recommended that you use effective barrier contraception or do not
have sexual activity while taking PAXLOVID. If you are pregnant or breastfeeding, discuss
your options and specific situation with your healthcare professional.



Take PAXLOVID exactly as your healthcare professional tells you. If you take too much PAXLOVID, call your healthcare professional or go to the nearest hospital emergency room right away. If you are taking a ritonavir- or cobicistat-containing medicine to treat hepatitis C or HIV-1 infection, you should continue to take your medicine as prescribed.



Talk to your healthcare professional if you do not feel better or if you feel worse after 5 days.

Contact your healthcare professional if you have any side effects that bother you or do not
go away. 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-10881-800-FDA-1088, or you can report side
effects to Pfizer Inc. at www.pfizersafetyreporting.com, by fax at 1-866-635-83371-866-635-8337, or by
calling 1-800-438-19851-800-438-1985.


Please see Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents, and Caregivers.

AUTHORIZED USE

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]) who are at high risk for progression to severe COVID-19, including hospitalization or death, under an EUA.

PAXLOVID use in children is still being studied. There is limited information about the safety and effectiveness of PAXLOVID to treat children with mild-to-moderate COVID-19.


Please see Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents, and Caregivers.

AUTHORIZED USE

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]) who are at high risk for progression to severe COVID-19, including hospitalization or death, under an EUA.

PAXLOVID use in children is still being studied. There is limited information about the safety and effectiveness of PAXLOVID to treat children with mild-to-moderate COVID-19.


Please see Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents, and Caregivers.

Important Safety Information

Significant Drug Interactions. PAXLOVID can interact with other medicines, causing severe or life-threatening side effects or death. Do not take PAXLOVID if you are taking any of the following medicines:

  • alfuzosin
  • amiodarone
  • apalutamide
  • carbamazepine
  • colchicine
  • dihydroergotamine
  • dronedarone
  • eletriptan
  • eplerenone
  • ergotamine
  • finerenone
  • flecainide
  • flibanserin
  • ivabradine
  • lomitapide
  • lovastatin
  • lumacaftor/ivacaftor
  • lurasidone
  • methylergonovine
  • midazolam (oral)
  • naloxegol
  • phenobarbital
  • phenytoin
  • pimozide
  • primidone
  • propafenone
  • quinidine
  • ranolazine
  • rifampin
  • rifapentine
  • St. John’s Wort (hypericum perforatum)
  • sildenafil (Revatio®) for pulmonary arterial hypertension
  • silodosin
  • simvastatin
  • tolvaptan
  • triazolam
  • ubrogepant
  • voclosporin

These are not the only medicines that may cause serious or life-threatening side effects if taken with PAXLOVID. PAXLOVID may increase or decrease the levels of other medicines. It is very important to tell your healthcare professional about all the medicines you are taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements, because additional laboratory tests or changes in the dose of your other medicines may be necessary during treatment with PAXLOVID. Your healthcare professional 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. Do not start taking a new medicine without telling your healthcare professional.

Before taking PAXLOVID, tell your healthcare professional about all your medical conditions, including if you:

  • have kidney or liver problems, including hepatitis.
  • have Human Immunodeficiency Virus 1 (HIV-1) infection. PAXLOVID may lead to some HIV-1 medicines not working as well in the future.
  • are pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed.

Tell your healthcare professional if you are taking combined hormonal contraceptive (birth control). PAXLOVID may affect how your birth control works. People who can become pregnant should use another or an alternative effective form of birth control.

PAXLOVID may cause serious side effects, including:

  • Allergic reactions, including severe allergic reactions (anaphylaxis). Do not take PAXLOVID if you are allergic to nirmatrelvir, ritonavir, or any of the ingredients in PAXLOVID. Stop taking PAXLOVID and call your healthcare professional right away if you get any of the following symptoms of an allergic reaction:

    • skin rash, hives, blisters, or peeling skin
    • painful sores or ulcers in the mouth, nose, throat, or genital area
    • trouble swallowing or breathing
    • swelling of the mouth, lips, tongue, or face
    • hoarseness
    • throat tightness

  • Liver problems. Tell your healthcare professional right away if you have any of the following signs and symptoms of liver problems during treatment with PAXLOVID:

    • loss of appetite
    • yellowing of your skin and the whites of your eyes
    • dark-colored urine
    • pale-colored stools
    • itchy skin
    • stomach-area (abdominal) pain

The most common side effects of PAXLOVID include: altered sense of taste and diarrhea.

Other possible side effects include:

  • headache
  • abdominal pain
  • vomiting
  • high blood pressure
  • nausea
  • feeling generally unwell

These are not all the possible side effects of PAXLOVID. For more information, ask your
healthcare professional or pharmacist.



There is no experience treating pregnant women or breastfeeding mothers with PAXLOVID. For a mother and unborn baby, the benefit of taking PAXLOVID may be greater than the risk from the treatment. It is recommended that you use effective barrier contraception or do not have sexual activity while taking PAXLOVID. If you are pregnant or breastfeeding, discuss your options and specific situation with your healthcare professional.



Take PAXLOVID exactly as your healthcare professional tells you. If you take too much PAXLOVID, call your healthcare professional or go to the nearest hospital emergency room right away. If you are taking a ritonavir- or cobicistat-containing medicine to treat hepatitis C or HIV-1 infection, you should continue to take your medicine as prescribed.



Talk to your healthcare professional if you do not feel better or if you feel worse after 5 days.


Contact your healthcare professional if you have any side effects that bother you or do not go away. 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-10881-800-FDA-1088, or you can report side effects to Pfizer Inc. at www.pfizersafetyreporting.com, by fax at 1-866-635-83371-866-635-8337, or by calling 1-800-438-19851-800-438-1985.


Please see Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents, and Caregivers.

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AUTHORIZED USE

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]) who are at high risk for progression to severe COVID-19, including hospitalization or death, under an EUA.

PAXLOVID use in children is still being studied. There is limited information about the safety and effectiveness of PAXLOVID to treat children with mild-to-moderate COVID-19.