FACT SHEET FOR PATIENTS, PARENTS, AND CAREGIVERS

EMERGENCY USE AUTHORIZATION (EUA) OF PAXLOVID

FOR CORONAVIRUS DISEASE 2019 (COVID-19)

You are being given this Fact Sheet because your healthcare provider believes it is
necessary to provide you with PAXLOVID for the treatment of mild-to-moderate
coronavirus disease (COVID-19) caused by the SARS-CoV-2 virus. This Fact Sheet
contains information to help you understand the risks and benefits of taking the
PAXLOVID you may receive. This Fact Sheet also contains information about how to
take PAXLOVID and how to report side effects or problems with the appearance or
packaging of PAXLOVID.

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use
Authorization (EUA) to make PAXLOVID available 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 (for more details about an EUA please see “What is an
Emergency Use Authorization?” at the end of this document). Read this Fact Sheet
for information about PAXLOVID. Talk to your healthcare provider about your options or
if you have any questions. It is your choice to take PAXLOVID.

What is COVID-19?
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.

What is PAXLOVID?
PAXLOVID is a medicine that is available under EUA 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.

PAXLOVID is FDA-approved for the treatment of COVID-19 in certain adults (see

section What other treatment choices are there?).

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 to
treat children younger than 12 years of age or weighing less than 88 pounds (40 kg)
with mild-to-moderate COVID-19.

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What is the most important information I should know about PAXLOVID?
PAXLOVID can interact with other medicines causing severe or life-threatening side
effects or death. It is important to know the medicines that should not be taken with
PAXLOVID.

Do not take PAXLOVID if:

• you are taking any of the following medicines:
o alfuzosin o lomitapide o ranolazine
o amiodarone o lovastatin o rifampin
o apalutamide o lumacaftor/ivacaftor o rifapentine
o carbamazepine o lurasidone o St. John’s Wort
o colchicine o methylergonovine (hypericum perforatum)
o dihydroergotamine o midazolam (oral) o sildenafil (Revatio®) for
o dronedarone o naloxegol pulmonary arterial
o eletriptan o phenobarbital hypertension
o eplerenone o phenytoin o silodosin
o ergotamine o pimozide o simvastatin
o finerenone o primidone o tolvaptan
o flecainide o propafenone o triazolam
o flibanserin o quinidine o ubrogepant
o ivabradine o 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
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 during treatment with 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 are allergic to nirmatrelvir, ritonavir, or any of the ingredients in PAXLOVID.

See the end of this leaflet for a complete list of ingredients in PAXLOVID. See
“What are the important possible side effects of PAXLOVID?” for signs and
symptoms of allergic reactions.

What should I tell my healthcare provider before I take PAXLOVID?

Tell your healthcare provider if you:

• have kidney problems. You may need a different dose of PAXLOVID.
• have 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.

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 • are pregnant or plan to become pregnant. It is not known if PAXLOVID can harm
your unborn baby. Tell your healthcare provider right away if you are or if you
become pregnant.
• are breastfeeding or plan to breastfeed. It is not known if PAXLOVID can pass
into your breast milk. Talk to your healthcare provider about the best way to feed
your baby during treatment with PAXLOVID.

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 birth control (hormonal
contraceptive). PAXLOVID may affect how your hormonal contraceptives work.
Females who are able to become pregnant should use another effective alternative
form of contraception or an additional barrier method of contraception during treatment
with PAXLOVID. Talk to your healthcare provider if you have any questions about
contraceptive methods that might be right for you.

How do I take PAXLOVID?

• Take PAXLOVID exactly as your healthcare provider tells you to take it.
• PAXLOVID consists of 2 medicines: nirmatrelvir tablets and ritonavir
tablets. The 2 medicines are taken together 2 times each day for 5 days.
o Nirmatrelvir is an oval, pink tablet.
o Ritonavir is a white or off-white tablet.
• You will receive a Dose Pack containing either:
o Two-dose blister cards (containing 5 blister cards) or
o Single-dose blister cards (containing 10 blister cards).
• See Figure A or Figure B below on how to take the PAXLOVID Dose Pack you
receive and follow the instructions on how to take it correctly.
• If you have kidney disease, your healthcare provider may prescribe a lower
dose (see Figure A or Figure B). Talk to your healthcare provider to make
sure you receive the correct Dose Pack.

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 Figure A (Two-dose Blister Card)
If you are prescribed PAXLOVID 300 mg; 100 mg Dose Pack:
each dose contains 3 tablets.

How to take PAXLOVID 300 mg; 100 mg Dose Pack

Morning Dose:
Take the 2 pink nirmatrelvir tablets and
1 white to off-white ritonavir tablet
together at the same time.

Evening Dose:
Take the 2 pink nirmatrelvir tablets and
1 white to off-white ritonavir tablet
together at the same time.

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 Figure A (Two-dose Blister Card)
If you are prescribed PAXLOVID 150 mg; 100 mg Dose Pack:
each dose contains 2 tablets.

How to take PAXLOVID 150 mg; 100 mg Dose Pack

Morning Dose:
Take the 1 pink nirmatrelvir tablet and
1 white to off-white ritonavir tablet
together at the same time.

Evening Dose:
Take the 1 pink nirmatrelvir tablet and
1 white to off-white ritonavir tablet
together at the same time.

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 Figure B (Single-dose Blister Card)
If you are prescribed PAXLOVID 300 mg; 100 mg Dose Pack:
each dose contains 3 tablets.

How to take PAXLOVID 300 mg; 100 mg Dose Pack

Morning Dose:
Take the 2 pink nirmatrelvir tablets and
1 white to off-white ritonavir tablet together.

Bedtime Dose:
Take the 2 pink nirmatrelvir tablets and
1 white to off-white ritonavir tablet together.

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 Figure B (Single-dose Blister Card)
If you are prescribed PAXLOVID 150 mg; 100 mg Dose Pack:
each dose contains 2 tablets.

How to take PAXLOVID 150 mg; 100 mg Dose Pack

Morning Dose:
Take the 1 pink nirmatrelvir tablet and
1 white to off-white ritonavir tablet together.

Bedtime Dose:
Take the 1 pink nirmatrelvir tablet and
1 white to off-white ritonavir tablet together.

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 • Do not remove your PAXLOVID tablets from the blister card before you are
ready to take your dose.
o Take your first dose of PAXLOVID in the morning or evening, depending
on when you pick up your prescription, or as your healthcare provider tells
you to.
• Swallow the tablets whole. Do not chew, break, or crush the tablets.
• Take PAXLOVID with or without food.
• Do not stop taking PAXLOVID without talking to your healthcare provider, even if
you feel better.
• 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.
• 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 by
your healthcare provider.

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

What are the important possible side effects of PAXLOVID?

PAXLOVID may cause serious side effects, including:

• Allergic reactions, including severe allergic reactions (anaphylaxis) have
happened during treatment with PAXLOVID. Stop taking PAXLOVID and get
medical help right away if you get any of the following symptoms of an allergic
reaction:
o skin rash, hives, blisters or peeling skin o trouble swallowing or breathing
o painful sores or ulcers in the mouth, o throat tightness
nose, throat or genital area o hoarseness
o swelling of the mouth, lips, tongue or
face
• Liver Problems. Tell your healthcare provider right away if you get any of the
following signs and symptoms of liver problems during treatment with
PAXLOVID:
o loss of appetite o pale colored stools
o yellowing of your skin and the white of o itchy skin
eyes o stomach-area (abdominal) pain
o dark-colored urine

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

Other possible side effects include:

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

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

What other treatment choices are there?

PAXLOVID is FDA-approved for the treatment of mild-to-moderate COVID-19 in certain
adults; however, there are not sufficient quantities of the approved presentations (i.e.,
dose packs) of PAXLOVID at this time. This EUA continues to authorize the emergency
use of PAXLOVID for the approved patient population to ensure continued access in
order to meet the public health need.

VEKLURY (remdesivir) is FDA-approved for the treatment of mild-to-moderate

COVID-19 in certain adults and children. Talk with your healthcare provider to see if
VEKLURY is appropriate for you.

For information on the emergency use of other medicines that are authorized by FDA to
treat people with COVID-19, please go to https://www.fda.gov/emergency-
preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-
use-authorization. Your healthcare provider may talk with you about clinical trials for
which you may be eligible.

It is your choice to be treated or not to be treated with PAXLOVID. Should you decide
not to receive it or for your child not to receive it, it will not change your standard
medical care.

What if I am pregnant or breastfeeding?

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. If you are pregnant, discuss your options and
specific situation with your healthcare provider.

If you are breastfeeding, discuss your options and specific situation with your
healthcare provider.

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How do I report side effects or problems with the appearance or packaging of
PAXLOVID?
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 (see
Figures A and B above for examples of PAXLOVID Dose Packs) 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

www.pfizersafetyreporting.com 1-866-635-8337 1-800-438-1985

How should I store PAXLOVID?

Store PAXLOVID tablets at room temperature, between 68○F to 77○F (20○C to 25○C).
Keep PAXLOVID and all medicines out of the reach of children.

What if I have questions about the expiration date for my PAXLOVID?

The FDA has extended the expiration date (shelf-life) for some lots of PAXLOVID. To
find the extended expiration date, enter the lot number found on the side of carton or
bottom of blister pack at this website: https://www.paxlovidlotexpiry.com/ or talk with
your healthcare provider. Information on the authorized shelf-life extensions for
PAXLOVID may also be found at https://www.fda.gov/emergency-preparedness-and-
response/mcm-legal-regulatory-and-policy-framework/expiration-dating-extension.

How can I learn more about COVID-19?

• Ask your healthcare provider.
• Visit https://www.cdc.gov/COVID19.
• Contact your local or state public health department.

What is an Emergency Use Authorization (EUA)?

The United States FDA has made PAXLOVID available under an emergency access
mechanism called an Emergency Use Authorization (EUA). The EUA is supported by a
Secretary of Health and Human Services (HHS) declaration that circumstances exist to
justify the emergency use of drugs and biological products during the COVID-19
pandemic.

In issuing an EUA, the FDA has determined, among other things, that based on the
total amount of scientific evidence available including data from adequate and
well-controlled clinical trials, if available, it is reasonable to believe that the product may
be effective for diagnosing, treating, or preventing COVID-19, or a serious or
life-threatening disease or condition caused by COVID-19; that the known and potential
benefits of the product, when used to diagnose, treat, or prevent such disease or

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condition, outweigh the known and potential risks of such product; and that there are no
adequate, approved, and available alternatives.

All of these criteria must be met to allow for the product to be available under an EUA.
The EUA for PAXLOVID is in effect for the duration of the COVID-19 declaration
justifying emergency use of this product, unless the relevant EUA declaration is
terminated or the EUA revoked (after which the products may no longer be used under
the EUA).

What are the ingredients in PAXLOVID?

Active ingredient: nirmatrelvir and ritonavir
Nirmatrelvir inactive ingredients: colloidal silicon dioxide, croscarmellose sodium,
lactose monohydrate, microcrystalline cellulose, and sodium stearyl fumarate.
Film-coating contains: hydroxy propyl methylcellulose, iron oxide red, polyethylene
glycol, and titanium dioxide.
Ritonavir inactive ingredients: anhydrous dibasic calcium phosphate, colloidal silicon
dioxide, copovidone, sodium stearyl fumarate, and sorbitan monolaurate. The film
coating may contain: colloidal anhydrous silica, colloidal silicon dioxide, hydroxypropyl
cellulose, hypromellose, polyethylene glycol, polysorbate 80, talc, and titanium dioxide.

Additional Information
For general questions, visit the website or call the telephone number provided below.

Website Telephone number

www.COVID19oralRx.com

1-877-219-7225
(1-877-C19-PACK)

LAB-1494-10.2b

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