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FDA EUA Letter Important Safety Information Telehealth Resources

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Important Safety Information Telehealth Resources

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.

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 88 pounds (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.

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^*By using the Pharmacy Finder, you understand that the results are being generated by a third party and Pfizer is not responsible for the information listed above.

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Important Safety Information

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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 of the possible side effects of PAXLOVID. For more information, ask your healthcare professional or pharmacist.

There is limited 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 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 is not FDA-approved or available under EUA for use in children younger than 12 years of age or weighing less than 88 pounds (40 kg). There is limited information about the safety and effectiveness of using PAXLOVID in these patients.

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 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 is not FDA-approved or available under EUA for use in children younger than 12 years of age or weighing less than 88 pounds (40 kg). There is limited information about the safety and effectiveness of using PAXLOVID in these patients.

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 of the possible side effects of PAXLOVID. For more information, ask your healthcare professional or pharmacist.

There is limited 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.