AUTHORIZED USE
The FDA has authorized the emergency use of PAXLOVID, an investigational medicine, 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]) with a positive test for the virus that causes COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization or death, under an EUA.
PAXLOVID is investigational because it is still being studied. There is limited information about the safety and effectiveness of using PAXLOVID to treat people with mild-to-moderate COVID-19.
PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets) 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 adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and 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.
PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets) 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 adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and 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.
NOTE: This information is for patients receiving the standard dose. If you have kidney disease, you may
need a different dose. Talk to your healthcare provider and learn more about renal impairment dosing below.
NOTE: This information is for patients receiving the standard dose. If you have kidney disease, you may need a different dose. Talk to your healthcare provider and learn more about renal impairment dosing below.
ritonavir tablet
(100 mg)
nirmatrelvir tablet
(150 mg)
nirmatrelvir tablet
(150 mg)
Take 3 tablets at the same time.
ritonavir tablet
(100 mg)
nirmatrelvir tablet
(150 mg)
nirmatrelvir tablet
(150 mg)
nirmatrelvir tablet
(150 mg)
Take 3 tablets at the same time.
Do not stop taking PAXLOVID without talking to your healthcare provider, even if you feel better.
Related Pages
PAXLOVID must be prescribed by a licensed healthcare provider 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 altered to ensure you receive the correct dose.
Tablet |
Text |
---|---|
nirmatrelvir |
Front: 3CL | Back: PFE |
ritonavir, manufactured by AbbVie |
Front: |
ritonavir, manufactured by Hetero |
Front: H | Back: R9 |
Pfizer is committed to patient safety and ensuring that people have accurate information about the investigational drug 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.
AUTHORIZED USE
The FDA has authorized the emergency use of PAXLOVID, an investigational medicine, 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]) with a positive test for the virus that causes COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization or death, under an EUA.
PAXLOVID is investigational because it is still being studied. There is limited information about the safety and effectiveness of using PAXLOVID to treat people with mild-to-moderate COVID-19.
IMPORTANT SAFETY INFORMATION