(nirmatrelvir tablets; ritonavir tablets)

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Contraindications

4 CONTRAINDICATIONS

PAXLOVID is contraindicated in patients with a history of clinically significant hypersensitivity reactions [e.g., toxic epidermal necrolysis (TEN) or Stevens-Johnson syndrome] to its active ingredients (nirmatrelvir or ritonavir) or any other components of the product.

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 in this section 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 [see Drug Interactions (7.3)]:

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Drugs that are primarily metabolized by CYP3A for which elevated concentrations are associated with serious and/or life-threatening reactions [see Drug Interactions (7.3)]:
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Alpha 1-adrenoreceptor antagonist: alfuzosin
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Antianginal: ranolazine
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Antiarrhythmic: amiodarone, dronedarone, flecainide, propafenone, quinidine
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Anti-gout: colchicine (in patients with renal and/or hepatic impairment [see Table 2, Drug Interactions (7.3)])
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Antipsychotics: lurasidone, pimozide
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Benign prostatic hyperplasia agents: silodosin
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Cardiovascular agents: eplerenone, ivabradine
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Ergot derivatives: dihydroergotamine, ergotamine, methylergonovine
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HMG-CoA reductase inhibitors: lovastatin, simvastatin (these drugs can be temporarily discontinued to allow PAXLOVID use [see Table 2, Drug Interactions (7.3)])
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Immunosuppressants: voclosporin
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Microsomal triglyceride transfer protein inhibitor: lomitapide
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Migraine medications: eletriptan, ubrogepant
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Mineralocorticoid receptor antagonists: finerenone
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Opioid antagonists: naloxegol
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PDE5 inhibitor: sildenafil (Revatio®) when used for pulmonary arterial hypertension (PAH)
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Sedative/hypnotics: triazolam, oral midazolam
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Serotonin receptor 1A agonist/serotonin receptor 2A antagonist: flibanserin
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Vasopressin receptor antagonists: tolvaptan
➢
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. PAXLOVID cannot be started immediately after discontinuation of any of the following medications due to the delayed offset of the recently discontinued CYP3A inducer [see Drug Interactions (7.3)]:
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Anticancer drugs: apalutamide, enzalutamide
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Anticonvulsant: carbamazepine, phenobarbital, primidone, phenytoin
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Antimycobacterials: rifampin, rifapentine
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Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor
•
Herbal products: St. John's Wort (hypericum perforatum)
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