Looking for information about the FDA approved indication for PAXLOVIDTM  
(nirmatrelvir tablets; ritonavir tablets) ?
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AUTHORIZED USE

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of PAXLOVIDTM  (nirmatrelvir tablets; ritonavir tablets) for the treatment of adults and pediatric patients (12 years of age and older weighing at least 40 kg) with mild-to-moderate coronavirus disease 2019 (COVID‑19) and who are at high risk for progression to severe COVID-19, including hospitalization or death.

LIMITATIONS OF AUTHORIZED USE

  • PAXLOVID is not authorized for initiation of treatment in patients requiring hospitalization due to severe or critical COVID-19
  • PAXLOVID is not authorized for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19
  • PAXLOVID is not authorized for use for longer than 5 consecutive days


PAXLOVID may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs.

PAXLOVID may also be prescribed for an individual patient by a state-licensed pharmacist under the following conditions:

  • Sufficient information is available, such as through access to health records less than 12 months old or consultation with a health care provider in an established provider‑patient relationship with the individual patient, to assess renal and hepatic function; and
  • Sufficient information is available, such as through access to health records, patient reporting of medical history, or consultation with a health care provider in an established provider‑patient relationship with the individual patient, to obtain a comprehensive list of medications (prescribed and non-prescribed) that the patient is taking to assess for potential drug interaction.
     

The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g., telehealth, in-person visit) with a physician, advanced practice registered nurse, or physician assistant licensed or authorized under state law to prescribe drugs, if any of the following apply:

  • Sufficient information is not available to assess renal and hepatic function.
  • Sufficient information is not available to assess for a potential drug interaction.
  • Modification of other medications is needed due to a potential drug interaction.
  • PAXLOVID is not an appropriate therapeutic option based on the authorized Fact Sheet for Healthcare Providers or due to potential drug interactions for which recommended monitoring would not be feasible.


PAXLOVID is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of PAXLOVID under 564(b)(1) of the Food Drug and Cosmetic Act unless the authorization is terminated or revoked sooner.

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Important Update: Emergency Use Authorization labeled PAXLOVIDTM(nirmatrelvir tablets; ritonavir tablets) will no longer be authorized for emergency use after March 8, 2024. Please click here to learn more.

PAXCESS™ Patient Support Program is now available for patients prescribed PAXLOVID. Commercially insured patients may pay as little as $0* for their prescription by downloading a copay card here

Patients on Medicare, Medicaid, TRICARE, VA Community Care Network, and those who are uninsured, may enroll in the U.S. Government's Patient Assistance Program (USG PAP) operated by Pfizer to access PAXLOVID for free* through December 31, 2024, by clicking here.

Looking for information about the FDA approved indication for PAXLOVIDTM (nirmatrelvir tablets; ritonavir tablets) ? Click here.

*Eligible commercially insured patients can save up $1,500 per prescription.  Maximum annual savings up to $1,500.  Please click here for full terms and conditions for the PAXCESSTM  copay savings program. 
The USG PAP operated by Pfizer is an independent program with separate eligibility requirements offered by the United States Department of Health and Human Services and is not owned by Pfizer.  Please click here for the full terms and conditions of the USG PAP.

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Authorized for Emergency Use

PAXLOVIDTM has not been approved, but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA), for the treatment of mild-to-moderate COVID-19 in pediatric patients (12 years of age and older weighing at least 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.


CDC Update: On December 5, 2022, the CDC changed age-related guidance for those at high risk for the progression to severe COVID-19 from 65+ to 50+. In addition, updates were made to the list of underlying medical conditions, as reflected in the "Trending Topics" section below.

Fact Sheet for ​​​​​​​Healthcare Providers​​​​ Fact Sheet for Patients, Parents, and Caregivers FDA Emergency Use Authorization Letter Important Prescribing & Dispensing Letter to Healthcare Providers (Aug. 2022) Updated Contraindications Letter to Healthcare Providers (June 2022)
Updated Contraindications Letter 
to Healthcare Providers (June 2022)

Now Authorized for Emergency Use

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.

    Fact Sheet for ​​​​​​​Healthcare Providers​​​​ Fact Sheet for Patients, Parents, and Caregivers FDA Emergency Use Authorization Letter Renal Dosing Letter for Healthcare Providers (Jan. 2022) Shelf Life Extension Letter to Healthcare Providers (April 2022)
    Product Expiration Date

    Please visit the PAXLOVID lot expiry site and enter the lot number found on the side of the carton or bottom of the blister pack foil to find the expiration date for any Pfizer PAXLOVID medication.

    ​​​​​​​As of January 18, 2023, the U.S. Food and Drug Administration (FDA) authorized an additional shelf-life extension for PAXLOVID from 18 months to 24 months. Please visit the PAXLOVID lot expiry site to confirm the most updated expiration date for any Pfizer PAXLOVID medication.

    The original product expiration date is stated on the product packaging, both on the carton and on the individual blister cards. 

    Labeled Expiration Date

    Extended Expiration Date

    December 2022

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    Labeled Expiration Date

    July 2022

    January 2023

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    May 2023

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    Extended Expiration Date

    January 2023

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    How PAXLOVID Works

    This video is intended only for healthcare professionals in the U.S. and is intended to be viewed as it was originally produced by Pfizer. The information provided is for educational purposes only.

    Mechanism of Action

    Nirmatrelvir is a peptidomimetic inhibitor of the SARS-CoV-2 main protease (Mpro), also referred to as 3C-like protease (3CLpro) or nonstructural protein 5 (nsp5) protease. Inhibition of SARS-CoV-2 Mpro renders it incapable of processing the viral polyproteins pp1a and pp1ab, preventing viral replication. Nirmatrelvir inhibited the activity of recombinant SARS-CoV-2 Mpro in a biochemical assay with a Ki value of 3.1 nM and an IC50 value of 19.2 nM. Nirmatrelvir was found to bind directly to the SARS-CoV-2 Mpro active site by X-ray crystallography.

    Ritonavir is an HIV-1 protease inhibitor but is not active against SARS-CoV-2 Mpro. Ritonavir inhibits the CYP3A-mediated metabolism of nirmatrelvir, resulting in increased plasma concentrations of nirmatrelvir.

    More InformationDosing Information

    Patients should take PAXLOVID twice daily for 5 consecutive days.

    Learn More
    Drug Interactions

    Consult appropriate references for comprehensive information.

    Find Info
    Frequently Asked Questions

    Want to learn more?

    Explore ​​​​​​​Answers
    Verifying Product Authenticity

    PAXLOVID must be prescribed by a licensed healthcare provider and supplied by a government-approved pharmacy or medical facility.

    Authentic PAXLOVID, from Pfizer Inc., may 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.

    Patients with moderate renal impairment may receive a carton that has been opened and modified by the pharmacist to indicate a dose adjustment. To view PAXLOVID dispensing information for patients with moderate renal impairment, see the Fact Sheet for Healthcare Providers. Also see the Pharmacist Instruction Sheet for Patients with Moderate Renal Impairment.

    To help determine whether the tablets are authentic, look for specific text on each side of the tablets

    Tablet

    Embossed Text

    nirmatrelvir

    Front: 3CL | ​​​​​​​Back: PFE

    ritonavir, manufactured by AbbVie

    Front: iconNK | Back: No text

    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.

    References:
     

    For more  information

    Contact One of the Following Groups

    For Medical Information visit www.pfizermedicalinformation.com or call 1‑800‑438‑1985

    For General Product Inquiries call 1‑877‑C19PACK (1‑877‑219‑7225)

    To find COVID-19 treatments, please use the U.S. Dept. of Health and Human Services (HHS) COVID-19 Therapeutics Locator.* Alternatively, HHS has launched Test-to-Treat* to help appropriate patients access COVID-19 testing and treatment options in one location. Patients can find a location near them here* or call 1-800-232-0233.
    *These links will take you to websites that are owned and operated by HHS. Pfizer is not responsible for the content or maintenance of these sites.

    Therapeutics Locator
    Test-to-Treat Locator

    AUTHORIZED USE

    AUTHORIZED USE

    The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of PAXLOVID for the treatment of adults and pediatric patients (12 years of age and older weighing at least 40 kg) with mild-to-moderate coronavirus disease 2019 (COVID-19) and who are at high risk for progression to severe COVID-19, including hospitalization or death.


    LIMITATIONS OF AUTHORIZED USE​​​​​​​

    • PAXLOVID is not authorized for initiation of treatment in patients requiring hospitalization due to severe or critical COVID-19
    • PAXLOVID is not authorized for use as pre-exposure or post-exposure prophylaxis for prevention of
      COVID-19

    • PAXLOVID is not authorized for use for longer than 5 consecutive days

    PAXLOVID may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs.

    PAXLOVID may also be prescribed for an individual patient by a state-licensed pharmacist under the following conditions:

    • Sufficient information is available, such as through access to health records less than 12 months old or consultation with a health care provider in an established provider-patient relationship with the individual patient, to assess renal and hepatic function; and
    • Sufficient information is available, such as through access to health records, patient reporting of medical history, or consultation with a health care provider in an established provider-patient relationship with the individual patient, to obtain a comprehensive list of medications (prescribed and non-prescribed) that the patient is taking to assess for potential drug interaction.


    The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g., telehealth, in-person visit) with a physician, advanced practice registered nurse, or physician assistant licensed or authorized under state law to prescribe drugs, if any of the following apply:

    • Sufficient information is not available to assess renal and hepatic function.
    • Sufficient information is not available to assess for a potential drug interaction.
    • Modification of other medications is needed due to a potential drug interaction.
    • PAXLOVID is not an appropriate therapeutic option based on the authorized Fact Sheet for Healthcare Providers or due to potential drug interactions for which recommended monitoring would not be feasible.

    PAXLOVID is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of PAXLOVID under 564(b)(1) of the Food Drug and Cosmetic Act unless the authorization is terminated or revoked sooner.

    IMPORTANT SAFETY
    INFORMATION

    Expand

    IMPORTANT SAFETY INFORMATION

    Expand


    WARNING: SIGNIFICANT DRUG INTERACTIONS WITH PAXLOVID

    • PAXLOVID includes ritonavir, a strong CYP3A inhibitor, which may lead to greater exposure of certainconcomitant medications, resulting in potentially severe, life-threatening, or fatal events
    • Prior to prescribing PAXLOVID: 1) Review all medications taken by the patient to assess for potential drug-drug interactions with a strong CYP3A inhibitor like PAXLOVID and 2) Determine if concomitant medications require a dose adjustment, interruption, and/or additional monitoring
    • Consider the benefit of PAXLOVID treatment in reducing hospitalization and death, and whether the risk of potential drug-drug interactions for an individual patient can be appropriately managed

    PAXLOVID is contraindicated in patients with a history of clinically significant hypersensitivity reactions (eg, toxic epidermal necrolysis or Stevens-Johnson syndrome), to its active ingredients (nirmatrelvir or ritonavir), or any other components of the product. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue PAXLOVID and initiate appropriate medications and/or supportive care.


    PAXLOVID is contraindicated with drugs that are primarily metabolized by CYP3A and for which elevated concentrations are associated with serious and/or life-threatening reactions and drugs that are strong CYP3A inducers where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance. There are certain other drugs for which concomitant use with PAXLOVID should be avoided and/or dose adjustment, interruption, or therapeutic monitoring is recommended. Drugs listed here are a guide and not considered a comprehensive list of all drugs that may be contraindicated with PAXLOVID. The healthcare provider should consult other appropriate resources such as the prescribing information for the interacting drug for comprehensive information on dosing or monitoring with concomitant use of a strong CYP3A inhibitor like PAXLOVID.

    Drugs that are primarily metabolized by CYP3A for which elevated concentrations are associated with serious and/or life-threatening reactions:

    • Alpha1-adrenoreceptor antagonist: alfuzosin
    • Antianginal: ranolazine
    • Antiarrhythmic: amiodarone, dronedarone, flecainide, propafenone, quinidine
    • Anti-gout: colchicine (in patients with renal and/or hepatic impairment)
    • Antipsychotics: lurasidone, pimozide
    • Benign prostatic hyperplasia agents: silodosin
    • Cardiovascular agents: eplerenone, ivabradine
    • Ergot derivatives: dihydroergotamine, ergotamine, methylergonovine
    • HMG-CoA reductase inhibitors: lovastatin, simvastatin (these drugs can be temporarily discontinued to allow PAXLOVID use)
    • Immunosuppressants: voclosporin
    • Microsomal triglyceride transfer protein inhibitor: lomitapide
    • Migraine medications: eletriptan, ubrogepant
    • Mineralocorticoid receptor antagonists: finerenone
    • Opioid antagonists: naloxegol
    • PDE5 inhibitor: sildenafil (Revatio®) when used for pulmonary arterial hypertension
    • Sedative/hypnotics: triazolam, oral midazolam
    • Serotonin receptor 1A agonist/serotonin receptor 2A antagonist: flibanserin
    • Vasopressin receptor antagonists: tolvaptan


    Drugs that are strong CYP3A inducers: PAXLOVID cannot be started immediately after discontinuation of any of the following medications due to the delayed offset of the recently discontinued CYP3A inducer:

    • Anticancer drugs: apalutamide
    • Anticonvulsant: carbamazepine, phenobarbital, primidone, phenytoin
    • Antimycobacterials: rifampin, rifapentine
    • Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor
    • Herbal Products: St. John’s Wort (hypericum perforatum)


    Risk of Serious Adverse Reactions Due to Drug Interactions: Initiation of PAXLOVID, which contains ritonavir, a strong CYP3A inhibitor, in patients receiving medications metabolized by CYP3A or initiation of medications metabolized by CYP3A in patients already receiving PAXLOVID may increase plasma concentrations of medications metabolized by CYP3A. Medications that induce CYP3A may decrease concentrations of PAXLOVID. These interactions may lead to:

    • Clinically significant adverse reactions, potentially leading to severe, life-threatening, or fatal events from greater exposures of concomitant medications
    • Loss of therapeutic effect of PAXLOVID and possible development of viral resistance


    Severe, life-threatening, and/or fatal adverse reactions due to drug interactions have been reported in patients treated with PAXLOVID. The most commonly reported concomitant medications resulting in serious adverse reactions were calcineurin inhibitors (eg, tacrolimus, cyclosporine), followed by calcium channel blockers.

    Hepatotoxicity: Hepatic transaminase elevations, clinical hepatitis, and jaundice have occurred in patients receiving ritonavir. Caution should be exercised when administering PAXLOVID to patients withpre-existing liver diseases, liver enzyme abnormalities, or hepatitis.

    Because nirmatrelvir is co-administered with ritonavir, there may be arisk of HIV-1 developing resistance to HIV protease inhibitors in individuals with uncontrolled or undiagnosed HIV-1 infection.

    The most common adverse reactions in the PAXLOVID group (≥1%) that occurred at a greater frequency than in the placebo group were dysgeusia (5% and <1% respectively) and diarrhea (3% and 2% respectively).

    The following adverse reactions have been identified during post-authorization use of PAXLOVID.

    Immune System Disorders: Anaphylaxis, hypersensitivity reactions
    Skin and Subcutaneous Tissue Disorders: Toxic epidermal necrolysis, Stevens-Johnson
    syndrome
    Nervous System Disorders: Headache
    Vascular Disorders: Hypertension
    Gastrointestinal Disorders: Abdominal pain, nausea, vomiting
    General Disorders and Administration Site Conditions: Malaise


    Required Reporting for Serious Adverse Events and Medication Errors: The prescribing healthcare provider and/or the provider’s designee is/are responsible for mandatory reporting of all serious adverse events and medication errors potentially related to PAXLOVID within 7 calendar days from the healthcare provider's awareness of the event.

    Submit adverse event and medication error reports to FDA MedWatch using one of the following methods:


    In addition, please provide a copy of all FDA MedWatch forms to: www.pfizersafetyreporting.com, or by fax ( 1‑866‑635‑8337) or phone ( 1‑800‑438‑1985).

    PAXLOVID is a strong inhibitor of CYP3A, and an inhibitor of CYP2D6, P-gp, and OATP1B1. Co-administration of PAXLOVID with drugs that are primarily metabolized by CYP3A and CYP2D6 or are transported by P-gp or OATP1B1 may result in increased plasma concentrations of such drugs and increase the risk of adverse events. Co-administration with other CYP3A substrates may require a dose adjustment or additional monitoring. 

    Pregnancy: Available data on the use of nirmatrelvir during pregnancy are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Published observational studies on ritonavir use in pregnant women have not identified an increase in the risk of major birth defects. Published studies with ritonavir are insufficient to identify a drug-associated risk of miscarriage. There are maternal and fetal risks associated with untreated COVID-19 in pregnancy.

    Lactation: There are no available data on the presence of nirmatrelvir in human or animal milk, the effects on the breastfed infant, or the effects on milk production. A transient decrease in body weight was observed in the nursing offspring of rats administered nirmatrelvir. Limited published data reports that ritonavir is present in human milk. There is no information on the effects of ritonavir on the breastfed infant or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for PAXLOVID and any potential adverse effects on the breastfed infant from PAXLOVID or from the underlying maternal condition. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. 

    Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. Advise patients using combined hormonal contraceptives to use an effective alternative contraceptive method or an additional barrier method of contraception. 

    Pediatrics: PAXLOVID is not authorized for use in pediatric patients younger than 12 years of age or weighing less than 40 kg. The safety and effectiveness of PAXLOVID have not been established in pediatric patients.

    Renal impairment increases nirmatrelvir exposure, which may increase the risk of adverse reactions. No dosage adjustment is recommended in patients with mild renal impairment (eGFR ≥60 to <90 mL/min). Reduce the PAXLOVID dosage in patients with moderate renal impairment (eGFR ≥30 to <60 mL/min). PAXLOVID is not recommended in patients with severe renal impairment (eGFR <30 mL/min) or patients with end stage renal disease (eGFR <15 mL/min) receiving dialysis until more data are available. Prescriptions should specify the numeric dose of each active ingredient within PAXLOVID. Providers should counsel patients about renal dosing instructions.

    PAXLOVID is not recommended for use in patients with severe hepatic impairment.

    Please see Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents, and Caregivers.