FDA EUA Letter
Authorized Use

The FDA has authorized the emergency use of PAXLOVID for the treatment of adults and children [12 years of age and older weighing at least 88 pounds (40 kg)] with a current diagnosis of mild-to-moderate COVID-19 and who are at high risk for progression to severe COVID-19, including hospitalization or death, under an EUA.

PAXLOVID is still being studied. There is limited information about the safety and effectiveness of PAXLOVID.

Important Safety Information
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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 has issued an Emergency Use Authorization (EUA) to make PAXLOVID available during the COVID-19 pandemic. PAXLOVID is not an FDA-approved medicine in the United States.

PAXLOVID is authorized for emergency use

  • PAXLOVID has not been approved, but has been authorized for emergency use by the FDA under an EUA, for adults and children [12 years of age and older weighing at least 88 pounds (40 kg)] with a current diagnosis of mild-to-moderate COVID-19 and who are at high risk for progression to severe COVID-19, including hospitalization or death; and
  • 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.

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Important Safety Information

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Before taking PAXLOVID, tell your healthcare provider if you:

  • Have any allergies, liver or kidney disease, or any serious illness;
  • Are pregnant or plan to become pregnant, or are breastfeeding a child

Some medicines may interact with PAXLOVID and may cause serious side effects.

  • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
  • Your healthcare provider can tell you if it is safe to take PAXLOVID with other medicines.
  • 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. People who are able to become pregnant should use another or an alternative effective form of contraception.

Take PAXLOVID exactly as your HCP tells you.

If you take too much PAXLOVID, call your HCP or go to the nearest hospital emergency room right away. If you are taking a ritonavir – or cobicistat-containing medicine for hepatitis C or Human Immunodeficiency Virus (HIV) continue to take your medicine as prescribed.

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

Do not take PAXLOVID if:

  • You are allergic to nirmatrelvir, ritonavir, or any of the ingredients in PAXLOVID or 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
    • St. John’s Wort (hypericum perforatum)
    • sildenafil (Revatio®) for pulmonary arterial hypertension
    • silodosin
    • simvastatin
    • tolvaptan
    • triazolam
    • ubrogepant
    • voclosporin

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 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.

Possible side effects of PAXLOVID are:

  • 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:
    • hives
    • trouble swallowing or breathing
    • swelling of the mouth, lips, or face
    • hoarseness
    • throat tightness
    • skin rash
  • Liver Problems. Tell your healthcare provider right away if you have any symptoms of liver problems (loss of appetite, yellowing of your skin and the whites of 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. Serious and unexpected side effects may happen. PAXLOVID is still being studied, so it is possible that all risks are not known at this time.

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 provider.

Contact your healthcare provider 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 adults and children [12 years of age and older weighing at least 88 pounds (40 kg)] with a current diagnosis of mild-to-moderate COVID-19 and who are at high risk for progression to severe COVID-19, including hospitalization or death, under an EUA.

PAXLOVID is still being studied. There is limited information about the safety and effectiveness of PAXLOVID.

AUTHORIZED USE

The FDA has authorized the emergency use of PAXLOVID for the treatment of adults and children [12 years of age and older weighing at least 88 pounds (40 kg)] with a current diagnosis of mild-to-moderate COVID-19 and who are at high risk for progression to severe COVID-19, including hospitalization or death, under an EUA.

PAXLOVID is still being studied. There is limited information about the safety and effectiveness of PAXLOVID.

Important Safety Information

Before taking PAXLOVID, tell your healthcare provider if you:

  • Have any allergies, liver or kidney disease, or any serious illness;
  • Are pregnant or plan to become pregnant, or are breastfeeding a child

Some medicines may interact with PAXLOVID and may cause serious side effects.

  • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
  • Your healthcare provider can tell you if it is safe to take PAXLOVID with other medicines.
  • 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. People who are able to become pregnant should use another or an alternative effective form of contraception.

Take PAXLOVID exactly as your HCP tells you.

If you take too much PAXLOVID, call your HCP or go to the nearest hospital emergency room right away. If you are taking a ritonavir – or cobicistat-containing medicine for hepatitis C or Human Immunodeficiency Virus (HIV) continue to take your medicine as prescribed.

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

Do not take PAXLOVID if:

  • You are allergic to nirmatrelvir, ritonavir, or any of the ingredients in PAXLOVID or 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
    • St. John’s Wort (hypericum perforatum)
    • sildenafil (Revatio®) for pulmonary arterial hypertension
    • silodosin
    • simvastatin
    • tolvaptan
    • triazolam
    • ubrogepant
    • voclosporin

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 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.

Possible side effects of PAXLOVID are:

  • 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:
    • hives
    • trouble swallowing or breathing
    • swelling of the mouth, lips, or face
    • hoarseness
    • throat tightness
    • skin rash
  • Liver Problems. Tell your healthcare provider right away if you have any symptoms of liver problems (loss of appetite, yellowing of your skin and the whites of 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. Serious and unexpected side effects may happen. PAXLOVID is still being studied, so it is possible that all risks are not known at this time.

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 provider.

Contact your healthcare provider 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 adults and children [12 years of age and older weighing at least 88 pounds (40 kg)] with a current diagnosis of mild-to-moderate COVID-19 and who are at high risk for progression to severe COVID-19, including hospitalization or death, under an EUA.

PAXLOVID is still being studied. There is limited information about the safety and effectiveness of PAXLOVID.