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The U.S. Food and Drug Administration has issued an Emergency Use Authorization (EUA) to make PAXLOVID available during the
What is mild-to-moderate
What can happen with severe
If
Hospitalization and intensive care
Needing a ventilator to receive enough oxygen
Death
How does PAXLOVID work?
When taken within the first 5 days of symptoms,
PAXLOVID can help keep
All people who participated:
The study looked at whether PAXLOVID helped prevent hospitalization or death when compared to placebo.
In a clinical trial vs placebo, 9 out of 1039 people who started treatment with PAXLOVID within 5 days of their first
For those who took a placebo, 66 out of 1046 people were hospitalized and 12 died (from any cause).
The study group included:
Everyone studied had at least one risk factor for progression to severe COVID-19. The most common risk factors among study participants included†:
Additionally, 61% of people in the study had two or more high-risk factors.
*The authorized use of PAXLOVID isn’t limited to unvaccinated people, but all people who participated in the clinical trial were unvaccinated.
†Participants all had at least one of these high-risk factors: diabetes, overweight (BMI >25), chronic lung disease (including asthma), chronic kidney disease, current smoker, a disease or treatment that causes a weakened immune system, heart disease, high blood pressure, sickle cell disease, neurodevelopmental disorders, active cancer, medically related technological dependence, or were 60 years of age and older. Based on the latest guidance, some of this high-risk inclusion criteria may differ from the CDC’s list of high-risk factors (ie, the CDC defines high risk as 50+). PAXLOVID is authorized for emergency use in patients at high risk for severe COVID-19 as defined by the CDC.
‡While the clinical trial did not include people under the age of 18, PAXLOVID is authorized for children ages 12-17 who weigh at least 88 pounds (40 kg).
It’s important to understand the possible risks and side effects before taking PAXLOVID.
Learn about PAXLOVID safetyIt’s important to understand the possible risks and side effects before taking PAXLOVID.
Learn about PAXLOVID safetyImportant Safety Information
Before taking PAXLOVID, tell your healthcare provider if you:
Some medicines may interact with PAXLOVID and may cause serious side effects.
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:
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:
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
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:
Some medicines may interact with PAXLOVID and may cause serious side effects.
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:
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:
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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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
PAXLOVID is still being studied. There is limited information about the safety and effectiveness of PAXLOVID.
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By clicking this link, you will be redirected to a website that is neither owned nor controlled by Pfizer. Pfizer is not responsible for the content of this site or service.
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The information provided at PAXLOVIDHCP.com is intended only for healthcare professionals in the United States.
