Paxlovid Special Precautions

Risk of serious adverse reactions due to 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.
Initiation of medications that inhibit or induce CYP3A may increase or decrease concentrations of PAXLOVID, respectively.
These interactions may lead to: Clinically significant adverse reactions, potentially leading to severe, life-threatening, or fatal events from greater exposures of concomitant medications.
Clinically significant adverse reactions from greater exposures of PAXLOVID.
Loss of therapeutic effect of PAXLOVID and possible development of viral resistance.
Severe, life-threatening, and fatal adverse reactions due to drug interactions have been reported in patients treated with PAXLOVID.
See Table 9 for drugs that are contraindicated for concomitant use with nirmatrelvir/ritonavir and for potentially significant interactions with other drugs (see Interactions; also see Contraindications for drugs that are contraindicated for concomitant use). Potential for drug interactions should be considered prior to and during PAXLOVID therapy; concomitant medications should be reviewed during PAXLOVID therapy and the patient should be monitored for the adverse reactions associated with the concomitant medications.
Co-administration of PAXLOVID with calcineurin inhibitors and mTOR inhibitors: Consultation of a multidisciplinary group (e.g., involving physicians, specialists in immunosuppressive therapy, and/or specialists in clinical pharmacology) is required to handle the complexity of this co-administration by closely and regularly monitoring immunosuppressant blood concentrations and adjusting the dose of the immunosuppressant in accordance with the latest guidelines (see Interactions).
Hypersensitivity reactions: Anaphylaxis, hypersensitivity reactions, and serious skin reactions (including toxic epidermal necrolysis and Stevens-Johnson syndrome) have been reported with PAXLOVID (see Adverse Reactions). If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue PAXLOVID and initiate appropriate medications and/or supportive care.
Hepatotoxicity: Hepatic transaminase elevations, clinical hepatitis and jaundice have occurred in patients receiving ritonavir. Therefore, caution should be exercised when administering PAXLOVID to patients with pre-existing liver diseases, liver enzyme abnormalities, or hepatitis.
Risk of HIV-1 resistance development: Because nirmatrelvir is co-administered with ritonavir, there may be a risk of HIV-1 developing resistance to HIV protease inhibitors in individuals with uncontrolled or undiagnosed HIV-1 infection.
Effects on ability to drive and use machines: There are no clinical studies that evaluated the effects of PAXLOVID on ability to drive and use machines.