(nirmatrelvir tablets; ritonavir tablets)

Prescribing Information
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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use PAXLOVID safely and effectively. See full prescribing information for PAXLOVID.

PAXLOVIDTM (nirmatrelvir tablets; ritonavir tablets), co-packaged for oral use
Initial U.S. Approval: 2023

WARNING: SIGNIFICANT DRUG INTERACTIONS WITH PAXLOVID

See full prescribing information for complete boxed warning.

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PAXLOVID includes ritonavir, a strong CYP3A inhibitor, which may lead to greater exposure of certain concomitant medications, resulting in potentially severe, life-threatening, or fatal events. (4, 5.1, 7)
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Prior to prescribing PAXLOVID: 1) Review all medications taken by the patient to assess 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. (7)
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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. (5.1, 7, 14)

RECENT MAJOR CHANGES

Dosage and Administration, Important Dosage and Administration Information (2.1)

01/2025

Dosage and Administration, Dosage in Patients with Renal Impairment (2.3)

01/2025

Contraindications (4)

02/2025

INDICATIONS AND USAGE

PAXLOVID which includes nirmatrelvir, a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) main protease (Mpro: also referred to as 3CLpro or nsp5 protease) inhibitor, and ritonavir, an HIV-1 protease inhibitor and CYP3A inhibitor, is indicated for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. (1)

Limitations of Use

PAXLOVID is not approved for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19. (1)

DOSAGE AND ADMINISTRATION

PAXLOVID is nirmatrelvir tablets co-packaged with ritonavir tablets. (2.1)

Nirmatrelvir must be co-administered with ritonavir. (2.1)

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Initiate PAXLOVID treatment as soon as possible after diagnosis of COVID-19 and within 5 days of symptom onset. (2.1)
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Administer orally with or without food. (2.1)
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Administer at approximately the same time each day. (2.2, 2.3)
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Dosage: 300 mg nirmatrelvir (two 150 mg tablets) with 100 mg ritonavir (one 100 mg tablet), with all 3 tablets taken together twice daily for 5 days. (2.2)
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Dose Reduction for Renal Impairment (2.3, 8.6, 12.3)
Abbreviation: eGFR=estimated glomerular filtration rate.
*
PAXLOVID should be administered at approximately the same time each day for 5 days.
†
On days of hemodialysis, the PAXLOVID dose should be administered after hemodialysis.
 
Renal Function

Days of Treatment

 
Dose and Dose Frequency*
 
Moderate renal impairment (eGFR ≥30 to <60 mL/min)
 
Days 1-5
 
150 mg nirmatrelvir (one 150 mg tablet) with 100 mg ritonavir (one 100 mg tablet) twice daily
 
Severe renal impairment (eGFR <30 mL/min) including those requiring hemodialysis†
 
Day 1
 
300 mg nirmatrelvir (two 150 mg tablets) with 100 mg ritonavir (one 100 mg tablet) once
 
Days 2-5
 
150 mg nirmatrelvir (one 150 mg tablet) with 100 mg ritonavir (one 100 mg tablet) once daily
•
PAXLOVID is not recommend in patients with severe hepatic impairment (Child-Pugh Class C). (2.4, 8.7)

DOSAGE FORMS AND STRENGTHS

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Tablets: nirmatrelvir 150 mg (3)
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Tablets: ritonavir 100 mg (3)

CONTRAINDICATIONS

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History of clinically significant hypersensitivity reactions to the active ingredients (nirmatrelvir or ritonavir) or any other components. (4)
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Co-administration with drugs highly dependent on CYP3A for clearance and for which elevated concentrations are associated with serious and/or life-threatening reactions. (4, 7.3)
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Co-administration with potent CYP3A inducers where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance. (4)

WARNINGS AND PRECAUTIONS

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The concomitant use of PAXLOVID and certain other drugs may result in potentially significant drug interactions. Consult the Full Prescribing Information prior to and during treatment for potential drug interactions. (5.1, 7)
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Hypersensitivity Reactions: Anaphylaxis, serious skin reactions (including toxic epidermal necrolysis and Stevens-Johnson syndrome), and other hypersensitivity reactions have been reported with PAXLOVID. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue PAXLOVID and initiate appropriate medications and/or supportive care. (5.2)
•
Hepatotoxicity: Hepatic transaminase elevations, clinical hepatitis, and jaundice have occurred in patients receiving ritonavir. (5.3)
•
HIV-1 Drug Resistance: PAXLOVID use may lead to a risk of HIV-1 developing resistance to HIV protease inhibitors in individuals with uncontrolled or undiagnosed HIV-1 infection. (5.4)

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥1% and greater incidence than in the placebo group) are dysgeusia and diarrhea. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Co-administration of PAXLOVID can alter the plasma concentrations of other drugs and other drugs may alter the plasma concentrations of PAXLOVID. Consider the potential for drug interactions prior to and during PAXLOVID therapy and review concomitant medications during PAXLOVID therapy. (4, 5.1, 7, 12.3)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 2/2025
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