PAXLOVID 3 Serious Warnings And Precautions Box

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Serious Warnings and Precautions

Dosage Modification in Patients with Moderate Renal Impairment

PAXLOVID is a combination of nirmatrelvir tablets co-packaged with ritonavir tablets.  The daily dose is two tablets of nirmatrelvir and one ritonavir tablet twice daily.  Systemic exposure of nirmatrelvir increases in renally impaired patients with increase in the severity of renal impairment.  No dosage adjustment is needed in patients with mild renal impairment (eGFR 60 to <90 mL/min).  In patients with moderate renal impairment (eGFR ≥30 to <60 mL/min), reduce the dosage of PAXLOVID to one tablet of nirmatrelvir and one tablet ritonavir every 12 hours (see 4 DOSAGE AND ADMINISTRATION, 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING, and 10 CLINICAL PHARMACOLOGY).

PAXLOVID is not recommended in patients with severe renal impairment (eGFR <30 mL/min).

Drug Interactions

Initiation of PAXLOVID, a 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. Drug-drug interactions leading to potentially serious and/or life-threatening reactions are possible due to the effects of ritonavir on the hepatic metabolism of certain drugs.  

Consider the potential for drug interactions prior to and during PAXLOVID therapy; review concomitant medications during PAXLOVID therapy and monitor for the adverse reactions associated with the concomitant medications (see 2 CONTRAINDICATIONS and 9 DRUG INTERACTIONS).