HIGHLIGHTS OF PRESCRIBING INFORMATIONThese 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 PAXLOVIDSee full prescribing information for complete boxed warning.
RECENT MAJOR CHANGESINDICATIONS AND USAGEPAXLOVID 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) PAXLOVID is not approved for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19. (1) DOSAGE AND ADMINISTRATIONPAXLOVID is nirmatrelvir tablets co-packaged with ritonavir tablets. (2.1) Nirmatrelvir must be co-administered with ritonavir. (2.1)
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONSMost 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 INTERACTIONSCo-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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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese 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 PAXLOVIDSee full prescribing information for complete boxed warning.
RECENT MAJOR CHANGESINDICATIONS AND USAGEPAXLOVID 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) PAXLOVID is not approved for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19. (1) DOSAGE AND ADMINISTRATIONPAXLOVID is nirmatrelvir tablets co-packaged with ritonavir tablets. (2.1) Nirmatrelvir must be co-administered with ritonavir. (2.1)
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONSMost 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 INTERACTIONSCo-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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