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PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)

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 highly dependent on CYP3A for clearance and for which elevated concentrations are associated with serious and/or life-threatening reactions [see Drug Interactions (7.3)]:

  • Alpha1-adrenoreceptor antagonist: alfuzosin
  • Analgesics: pethidine, piroxicam, propoxyphene
  • Antianginal: ranolazine
  • Antiarrhythmic: amiodarone, dronedarone, flecainide, propafenone, quinidine
  • Anti-gout: colchicine
  • Antipsychotics: lurasidone, pimozide, clozapine
  • Ergot derivatives: dihydroergotamine, ergotamine, methylergonovine
  • HMG-CoA reductase inhibitors: lovastatin, simvastatin
  • PDE5 inhibitor: sildenafil (Revatio®) when used for pulmonary arterial hypertension (PAH)
  • Sedative/hypnotics: triazolam, oral midazolam

PAXLOVID is contraindicated with drugs that are 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. 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)]:

  • Anticancer drugs: apalutamide
  • Anticonvulsant: carbamazepine, phenobarbital, phenytoin
  • Antimycobacterials: rifampin
  • Herbal products: St. John's Wort (hypericum perforatum)
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