WARNING:
SIGNIFICANT DRUG INTERACTIONS WITH PAXLOVID

PAXLOVID includes ritonavir,

a strong CYP3A inhibitor, which may lead to greater exposure of certain concomitant medications, resulting in potentially severe, life-threatening, or fatal events

Prior to prescribing PAXLOVID:

  1. Review all medications taken by the patient to assess for potential drug-drug interactions with a strong CYP3A inhibitor like PAXLOVID and
  2. Determine if concomitant medications require a dose adjustment, interruption, and/or additional monitoring

Consider the benefit of PAXLOVID treatment in reducing hospitalization and death, and whether the risk of potential drug-drug interactions for an individual patient can be appropriately managed

Contraindications due to drug interactions

PAXLOVID is contraindicated in patients with a history of clinically significant hypersensitivity reactions (eg, toxic epidermal necrolysis or Stevens-Johnson syndrome) to its active ingredients (nirmatrelvir or ritonavir), or any other components of the product. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue PAXLOVID and initiate appropriate medications and/or supportive care.

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 here 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.

Drugs that are primarily metabolized by CYP3A for which elevated concentrations are associated with serious and/or life-threatening reactions:

  • Alpha1-adrenoreceptor antagonist: alfuzosin
  • Antianginal: ranolazine
  • Antiarrhythmic: amiodarone, dronedarone, flecainide, propafenone, quinidine
  • Anti-gout: colchicine (in patients with renal and/or hepatic impairment)
  • Antipsychotics: lurasidone, pimozide
  • Benign prostatic hyperplasia agents: silodosin
  • Cardiovascular agents: eplerenone, ivabradine
  • Ergot derivatives: dihydroergotamine, ergotamine, methylergonovine
  • HMG-CoA reductase inhibitors: lovastatin, simvastatin (these drugs can be temporarily discontinued to allow PAXLOVID use)
  • Immunosuppressants: voclosporin
  • Microsomal triglyceride transfer protein inhibitor: lomitapide
  • Migraine medications: eletriptan, ubrogepant
  • Mineralocorticoid receptor antagonists: finerenone
  • Opioid antagonists: naloxegol
  • PDE5 inhibitor: sildenafil (Revatio®) when used for pulmonary arterial hypertension
  • Sedative/hypnotics: triazolam, oral midazolam
  • Serotonin receptor 1A agonist/serotonin receptor 2A antagonist: flibanserin
  • Vasopressin receptor antagonists: tolvaptan

Drugs that are strong CYP3A inducers:

PAXLOVID cannot be started immediately after discontinuation of any of the following medications due to the delayed offset of the recently discontinued CYP3A inducer:

  • Anticancer drugs: apalutamide
  • Anticonvulsant: carbamazepine, phenobarbital, primidone, phenytoin
  • Antimycobacterials: rifampin, rifapentine
  • Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor
  • Herbal products: St. John’s Wort (hypericum perforatum)

Risk of serious adverse reactions due to drug interactions

Initiation of PAXLOVID, which contains ritonavir, a strong 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. Medications that induce CYP3A may decrease concentrations of PAXLOVID.

These interactions may lead to:

  • Clinically significant adverse reactions, potentially leading to severe, life-threatening, or fatal events from greater exposures of concomitant medications
  • Loss of therapeutic effect of PAXLOVID and possible development of viral resistance

Severe, life-threatening, and/or fatal adverse reactions due to drug interactions have been reported in patients treated with PAXLOVID. The most commonly reported concomitant medications resulting in serious adverse reactions were calcineurin inhibitors (eg, tacrolimus, cyclosporine), followed by calcium channel blockers.

Prior to prescribing PAXLOVID, review all medications taken by the patient to assess potential drug-drug interactions and determine if concomitant medications require a dose adjustment, interruption, and/or additional monitoring (eg, calcineurin inhibitors). See the table below for clinically significant drug interactions, including contraindicated drugs. Drugs listed in the table below are a guide and not considered a comprehensive list of all possible drugs that may interact with PAXLOVID.

Consider the benefit of PAXLOVID treatment in reducing hospitalization and death, and whether the risk of potential drug-drug interactions for an individual patient can be appropriately managed.

Potential for PAXLOVID to affect other drugs

PAXLOVID is a strong inhibitor of CYP3A, and an inhibitor of CYP2D6, P-gp, and OATP1B1. Coadministration of PAXLOVID with drugs that are primarily metabolized by CYP3A and CYP2D6 or are transported by P-gp or OATP1B1 may result in increased plasma concentrations of such drugs and increase the risk of adverse events. Coadministration of PAXLOVID with drugs highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated. Coadministration with other CYP3A substrates may require a dose adjustment or additional monitoring as shown in the table below.

Potential for other drugs to affect PAXLOVID

Nirmatrelvir and ritonavir are CYP3A substrates; therefore, drugs that induce CYP3A may decrease nirmatrelvir and ritonavir plasma concentrations and reduce PAXLOVID therapeutic effect.

Established and other potentially significant drug interactions

The table below provides a listing of clinically significant drug interactions, including contraindicated drugs. Drugs listed in the table are a guide and not considered a comprehensive list of all possible drugs that may interact 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, such as ritonavir. References contained in the table below are to the applicable section of the Fact Sheet for Healthcare Providers.

Drug Class: A–B

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Alpha1-adrenoreceptor antagonist

Drugs within Class that are Contraindicated

  • alfuzosin

Effect on Concentration

↑ alfuzosin

Clinical Comments

Coadministration contraindicated due to potential hypotension [see Contraindications (4)].

Alpha1-adrenoreceptor antagonist

Drugs within Class that are Contraindicated

  • tamsulosin

Effect on Concentration

↑ tamsulosin

Clinical Comments

Avoid concomitant use with PAXLOVID.

Antianginal

Drugs within Class that are Contraindicated

  • ranolazine

Effect on Concentration

↑ ranolazine

Clinical Comments

Coadministration contraindicated due to potential for serious and/or life-threatening reactions [see Contraindications (4)].

Antiarrhythmics

Drugs within Class that are Contraindicated

  • amiodarone
  • dronedarone
  • flecainide
  • propafenone
  • quinidine

Effect on Concentration

↑ antiarrhythmic

Clinical Comments

Coadministration contraindicated due to potential for cardiac arrhythmias [see Contraindications (4)].

Antiarrhythmics

Drugs within Class that are Contraindicated

  • lidocaine (systemic)
  • disopyramide

Effect on Concentration

↑ antiarrhythmic

Clinical Comments

Caution is warranted and therapeutic concentration monitoring is recommended for antiarrhythmics if available.

Anticancer drugs

Drugs within Class that are Contraindicated

  • apalutamide

Effect on Concentration

↓ nirmatrelvir/ritonavir

Clinical Comments

Coadministration contraindicated due to potential loss of virologic response and possible resistance [see Contraindications (4)].

Drugs within Class that are Contraindicated

  • abemaciclib
  • ceritinib
  • dasatinib
  • encorafenib
  • ibrutinib
  • ivosidenib
  • neratinib
  • nilotinib
  • venetoclax
  • vinblastine
  • vincristine

Effect on Concentration

↑ anticancer drugs

Clinical Comments

Avoid coadministration of encorafenib or ivosidenib due to potential risk of serious adverse events such as QT interval prolongation. Avoid use of neratinib, venetoclax or ibrutinib.

Coadministration of vincristine and vinblastine may lead to significant hematologic or gastrointestinal side effects.

For further information, refer to individual product label for anticancer drug.

Anticoagulants

Drugs within Class that are Contraindicated

  • warfarin
  • rivaroxaban
  • dabigatrana
  • apixaban

Effect on Concentration

↑↓ warfarin

↑ rivaroxaban

↑ dabigatrana

↑ apixaban

Clinical Comments

Closely monitor international normalized ratio (INR) if coadministration with warfarin is necessary.

Increased bleeding risk with rivaroxaban. Avoid concomitant use.

Increased bleeding risk with dabigatran. Depending on dabigatran indication and renal function, reduce dose of dabigatran or avoid concomitant use. Refer to the dabigatran product label for more information.

Combined P-gp and strong CYP3A inhibitors increase blood levels of apixaban and increase the risk of bleeding. Dosing recommendations for coadministration of apixaban with PAXLOVID depend on the apixaban dose. Refer to the apixaban product label for more information.

Anticonvulsants

Drugs within Class that are Contraindicated

  • carbamazepinea
  • phenobarbital
  • primidone
  • phenytoin

Effect on Concentration

↓ nirmatrelvir/ritonavir

Clinical Comments

Coadministration contraindicated due to potential loss of virologic response and possible resistance [see Contraindications (4)].

Anticonvulsants

Drugs within Class that are Contraindicated

  • clonazepam

Effect on Concentration

↑ anticonvulsant

Clinical Comments

A dose decrease may be needed for clonazepam when coadministered with PAXLOVID and clinical monitoring is recommended.

Antidepressants

Drugs within Class that are Contraindicated

  • bupropion
  • trazodone

Effect on Concentration

↓ bupropion and active metabolite hydroxy-bupropion

↑ trazodone

Clinical Comments

Monitor for an adequate clinical response to bupropion.

Adverse reactions of nausea, dizziness, hypotension, and syncope have been observed following coadministration of trazodone and ritonavir. A lower dose of trazodone should be considered. Refer to trazodone product label for more information.

Antifungals

Drugs within Class that are Contraindicated

  • voriconazole
  • ketoconazole
  • isavuconazonium sulfate
  • itraconazolea

Effect on Concentration

↓ voriconazole

↑ ketoconazole

↑ isavuconazonium sulfate

↑ itraconazole

↑ nirmatrelvir/ritonavir

Clinical Comments

Avoid concomitant use of voriconazole.

Refer to ketoconazole, isavuconazonium sulfate, and itraconazole product labels for more information.

A nirmatrelvir/ritonavir dose reduction is not needed.

Anti-gout

Drugs within Class that are Contraindicated

  • colchicine

Effect on Concentration

↑ colchicine

Clinical Comments

Coadministration contraindicated due to potential for serious and/or life-threatening reactions in patients with renal and/or hepatic impairment [see Contraindications (4)].

Anti-HIV

Drugs within Class that are Contraindicated

  • efavirenz
  • maraviroc
  • nevirapine
  • zidovudine
  • bictegravir/emtricitabine/tenofovir

Effect on Concentration

↑ efavirenz

↑ maraviroc

↑ nevirapine

↓ zidovudine

↑ bictegravir

←→ emtricitabine

↑ tenofovir

Clinical Comments

For more information, refer to the respective anti-HIV drugs prescribing information.

Anti-HIV protease inhibitors

Drugs within Class that are Contraindicated

  • atazanavir
  • darunavir
  • tipranavir

Effect on Concentration

↑ protease inhibitor

Clinical Comments

For more information, refer to the respective protease inhibitors’ prescribing information.

Patients on ritonavir- or cobicistat-containing HIV regimens should continue their treatment as indicated. Monitor for increased PAXLOVID or protease inhibitor adverse events.

Anti-infective

Drugs within Class that are Contraindicated

  • clarithromycin
  • erythromycin

Effect on Concentration

↑ clarithromycin

↑ erythromycin

Clinical Comments

Refer to the respective prescribing information for anti-infective dose adjustment.

Antimycobacterial

Drugs within Class that are Contraindicated

  • rifampin
  • rifapentine

Effect on Concentration

↓ nirmatrelvir/ritonavir

Clinical Comments

Coadministration contraindicated due to potential loss of virologic response and possible resistance. Alternate antimycobacterial drugs such as rifabutin should be considered [see Contraindications (4)].

Antimycobacterial

Drugs within Class that are Contraindicated

  • bedaquiline
  • rifabutin

Effect on Concentration

↑ bedaquiline

↑ rifabutin

Clinical Comments

Refer to the bedaquiline product label for more information.

Refer to rifabutin product label for more information on rifabutin dose reduction.

Antipsychotics

Drugs within Class that are Contraindicated

  • lurasidone
  • pimozide

Effect on Concentration

↑ lurasidone

↑ pimozide

Clinical Comments

Coadministration contraindicated due to serious and/or life-threatening reactions such as cardiac arrhythmias [see Contraindications (4)].

Antipsychotics

Drugs within Class that are Contraindicated

  • quetiapine
  • clozapine

Effect on Concentration

↑ quetiapine

↑ clozapine

Clinical Comments

If coadministration is necessary, reduce quetiapine dose and monitor for quetiapine-associated adverse reactions. Refer to the quetiapine prescribing information for recommendations.

If coadministration is necessary, consider reducing the clozapine dose and monitor for adverse reactions.

Benign prostatic hyperplasia agents

Drugs within Class that are Contraindicated

  • silodosin

Effect on Concentration

↑ silodosin

Clinical Comments

Coadministration contraindicated due to potential for postural hypotension [see Contraindications (4)].

Drug Class: C–L

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Calcium channel blockers

Drugs within Class that are Contraindicated

  • amlodipine
  • diltiazem
  • felodipine
  • nicardipine
  • nifedipine
  • verapamil

Effect on Concentration

↑ calcium channel blocker

Clinical Comments

Caution is warranted and clinical monitoring of patients is recommended. A dose decrease may be needed for these drugs when coadministered with PAXLOVID.

If coadministered, refer to individual product label for calcium channel blocker for more information.

Cardiac glycosides

Drugs within Class that are Contraindicated

  • digoxin

Effect on Concentration

↑ digoxin

Clinical Comments

Caution should be exercised when coadministering PAXLOVID with digoxin, with appropriate monitoring of serum digoxin levels.

Refer to the digoxin product label for more information.

Cardiovascular agents

Drugs within Class that are Contraindicated

  • eplerenone
  • ivabradine

Effect on Concentration

↑ eplerenone

↑ ivabradine

Clinical Comments

Coadministration with eplerenone is contraindicated due to potential for hyperkalemia [see Contraindications (4)].

Coadministration with ivabradine is contraindicated due to potential for bradycardia or conduction disturbances [see Contraindications (4)].

Cardiovascular agents

Drugs within Class that are Contraindicated

  • aliskiren
  • ticagrelor
  • vorapaxar
  • clopidogrel

Effect on Concentration

↑ aliskiren

↑ ticagrelor

↑ vorapaxar

↓ clopidogrel active metabolite

Clinical Comments

Avoid concomitant use with PAXLOVID.

Drugs within Class that are Contraindicated

  • cilostazol

Effect on Concentration

↑ cilostazol

Clinical Comments

Dosage adjustment of cilostazol is recommended. Refer to the cilostazol product label for more information.

Corticosteroids primarily metabolized by CYP3A

Drugs within Class that are Contraindicated

  • betamethasone
  • budesonide
  • ciclesonide
  • dexamethasone
  • fluticasone
  • methylprednisolone
  • mometasone
  • triamcinolone

Effect on Concentration

↑ corticosteroid

Clinical Comments

Coadministration with corticosteroids (all routes of administration) of which exposures are significantly increased by strong CYP3A inhibitors can increase the risk for Cushing’s syndrome and adrenal suppression. However, the risk of Cushing’s syndrome and adrenal suppression associated with short-term use of a strong CYP3A inhibitor is low.

Alternative corticosteroids including beclomethasone, prednisone, and prednisolone should be considered.

Cystic fibrosis transmembrane conductance regulator potentiators

Drugs within Class that are Contraindicated

  • lumacaftor/ivacaftor

Effect on Concentration

↓ nirmatrelvir/ritonavir

Clinical Comments

Coadministration contraindicated due to potential loss of virologic response and possible resistance [see Contraindications (4)].

Cystic fibrosis transmembrane conductance regulator potentiators

Drugs within Class that are Contraindicated

  • ivacaftor
  • elexacaftor/tezacaftor/ivacaftor
  • tezacaftor/ivacaftor

Effect on Concentration

↑ ivacaftor

↑elexacaftor/tezacaftor/ivacaftor

↑ tezacaftor/ivacaftor

Clinical Comments

Reduce dosage when coadministered with PAXLOVID. Refer to individual product labels for more information.

Dipeptidyl peptidase 4 (DPP4) inhibitors

Drugs within Class that are Contraindicated

  • saxagliptin

Effect on Concentration

↑ saxagliptin

Clinical Comments

Dosage adjustment of saxagliptin is recommended. Refer to the saxagliptin product label for more information.

Endothelin receptor antagonists

Drugs within Class that are Contraindicated

  • bosentan

Effect on Concentration

↑ bosentan

↓ nirmatrelvir/ritonavir

Clinical Comments

Discontinue use of bosentan at least 36 hours prior to initiation of PAXLOVID.

Refer to the bosentan product label for more information.

Ergot derivatives

Drugs within Class that are Contraindicated

  • dihydroergotamine
  • ergotamine
  • methylergonovine

Effect on Concentration

↑ dihydroergotamine

↑ ergotamine

↑ methylergonovine

Clinical Comments

Coadministration contraindicated due to potential for acute ergot toxicity characterized by vasospasm and ischemia of the extremities and other tissues including the central nervous system [see Contraindications (4)].

Hepatitis C direct-acting antivirals

Drugs within Class that are Contraindicated

  • elbasvir/grazoprevir
  • glecaprevir/pibrentasvir
  • ombitasvir/paritaprevir/ritonavir and dasabuvir
  • sofosbuvir/velpatasvir/voxilaprevir

Effect on Concentration

↑ antiviral

Clinical Comments

Increased grazoprevir concentrations can result in alanine transaminase (ALT) elevations.

Avoid concomitant use of glecaprevir/pibrentasvir with PAXLOVID.

Refer to the ombitasvir/paritaprevir/ritonavir and dasabuvir label for more information.

Refer to the sofosbuvir/velpatasvir/voxilaprevir product label for more information.

Patients on ritonavir-containing HCV regimens should continue their treatment as indicated. Monitor for increased PAXLOVID or HCV drug adverse events with concomitant use.

Herbal products

Drugs within Class that are Contraindicated

  • St. John's Wort (hypericum perforatum)

Effect on Concentration

↓ nirmatrelvir/ritonavir

Clinical Comments

Coadministration contraindicated due to potential loss of virologic response and possible resistance [see Contraindications (4)].

HMG-CoA reductase inhibitors

Drugs within Class that are Contraindicated

  • lovastatin
  • simvastatin

Effect on Concentration

↑ lovastatin

↑ simvastatin

Clinical Comments

Coadministration contraindicated due to potential for myopathy including rhabdomyolysis [see Contraindications (4)].

If treatment with PAXLOVID is considered medically necessary, discontinue use of lovastatin and simvastatin at least 12 hours prior to initiation of PAXLOVID, during the 5 days of PAXLOVID treatment and for 5 days after completing PAXLOVID.

HMG-CoA reductase inhibitors

Drugs within Class that are Contraindicated

  • atorvastatin
  • rosuvastatin

Effect on Concentration

↑ atorvastatin

↑ rosuvastatin

Clinical Comments

Consider temporary discontinuation of atorvastatin and rosuvastatin during treatment with PAXLOVID. Atorvastatin and rosuvastatin do not need to be withheld prior to or after completing PAXLOVID.

Hormonal contraceptive

Drugs within Class that are Contraindicated

  • ethinyl estradiol

Effect on Concentration

↓ ethinyl estradiol

Clinical Comments

An additional, nonhormonal method of contraception should be considered during the 5 days of PAXLOVID treatment and until one menstrual cycle after stopping PAXLOVID.

Immunosuppressants

Drugs within Class that are Contraindicated

  • voclosporin

Effect on Concentration

↑ voclosporin

Clinical Comments

Coadministration contraindicated due to potential for acute and/or chronic nephrotoxicity [see Contraindications (4)].

Immunosuppressants

Drugs within Class that are Contraindicated

  • calcineurin inhibitors:
    • cyclosporine
    • tacrolimus
  • mTOR inhibitors:
    • everolimus
    • sirolimus

Effect on Concentration

↑ cyclosporine

↑ tacrolimus

↑ everolimus

↑ sirolimus

Clinical Comments

Avoid concomitant use of calcineurin inhibitors with PAXLOVID when close monitoring of immunosuppressant concentrations is not feasible. If coadministered, dose adjustment of the immunosuppressant and close and regular monitoring for immunosuppressant concentrations and adverse reactions are recommended during and after treatment with PAXLOVID. Obtain expert consultation to appropriately manage the complexity of this coadministration [see Warnings and Precautions (5.1)].

Avoid concomitant use of everolimus and sirolimus and PAXLOVID.

Refer to the individual immunosuppressant product label and latest guidelines for more information.

Janus kinase (JAK) inhibitors

Drugs within Class that are Contraindicated

  • tofacitinib
  • upadacitinib

Effect on Concentration

↑ tofacitinib

↑ upadacitinib

Clinical Comments

Dosage adjustment of tofacitinib is recommended. Refer to the tofacitinib product label for more information.

Dosing recommendations for coadministration of upadacitinib with PAXLOVID depends on the upadacitinib indication. Refer to the upadacitinib product label for more information.

Long-acting beta-adrenoceptor agonist

Drugs within Class that are Contraindicated

  • salmeterol

Effect on Concentration

↑ salmeterol

Clinical Comments

Avoid concomitant use with PAXLOVID. The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations, and sinus tachycardia.

Drug Class: M–Z

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Microsomal triglyceride transfer protein (MTTP) inhibitor

Drugs within Class that are Contraindicated

  • lomitapide

Effect on Concentration

↑ lomitapide

Clinical Comments

Coadministration contraindicated due to potential for hepatotoxicity and gastrointestinal adverse reactions [see Contraindications (4)].

Migraine medications

Drugs within Class that are Contraindicated

  • eletriptan

Effect on Concentration

↑ eletriptan

Clinical Comments

Coadministration of eletriptan within at least 72 hours of PAXLOVID is contraindicated due to potential for serious adverse reactions including cardiovascular and cerebrovascular events [see Contraindications (4)].

Drugs within Class that are Contraindicated

  • ubrogepant

Effect on Concentration

↑ ubrogepant

Clinical Comments

Coadministration of ubrogepant with PAXLOVID is contraindicated due to potential for serious adverse reactions [see Contraindications (4)].

Drugs within Class that are Contraindicated

  • rimegepant

Effect on Concentration

↑ rimegepant

Clinical Comments

Avoid concomitant use with PAXLOVID.

Mineralocorticoid receptor antagonists

Drugs within Class that are Contraindicated

  • finerenone

Effect on Concentration

↑ finerenone

Clinical Comments

Coadministration contraindicated due to potential for serious adverse reactions including hyperkalemia, hypotension, and hyponatremia [see Contraindications (4)].

Muscarinic receptor antagonists

Drugs within Class that are Contraindicated

  • darifenacin

Effect on Concentration

↑ darifenacin

Clinical Comments

The darifenacin daily dose should not exceed 7.5 mg when coadministered with PAXLOVID. Refer to the darifenacin product label for more information.

Narcotic analgesics

Drugs within Class that are Contraindicated

  • fentanyl
  • hydrocodone
  • oxycodone
  • meperidine
  • methadone

Effect on Concentration

↑ fentanyl

↑ hydrocodone

↑ oxycodone

↑ meperidine

↓ methadone

Clinical Comments

Careful monitoring of therapeutic and adverse effects (including potentially fatal respiratory depression) is recommended when fentanyl, hydrocodone, oxycodone, or meperidine is concomitantly administered with PAXLOVID. If concomitant use with PAXLOVID is necessary, consider a dosage reduction of the narcotic analgesic and monitor patients closely at frequent intervals. Refer to the individual product label for more information.

Monitor methadone-maintained patients closely for evidence of withdrawal effects and adjust the methadone dose accordingly.

Neuropsychiatric agents

Drugs within Class that are Contraindicated

  • suvorexant
  • aripiprazole
  • brexpiprazole
  • cariprazine
  • iloperidone
  • lumateperone
  • pimavanserin

Effect on Concentration

↑ suvorexant

↑ aripiprazole

↑ brexpiprazole

↑ cariprazine

↑ iloperidone

↑ lumateperone

↑ pimavanserin

Clinical Comments

Avoid concomitant use of suvorexant with PAXLOVID.

Dosage adjustment of aripiprazole, brexpiprazole, cariprazine, iloperidone, lumateperone, and pimavanserin is recommended. Refer to individual product label for more information.

Opioid antagonists

Drugs within Class that are Contraindicated

  • naloxegol

Effect on Concentration

↑ naloxegol

Clinical Comments

Coadministration contraindicated due to the potential for opioid withdrawal symptoms [see Contraindications (4)].

Pulmonary hypertension agents (PDE5 inhibitors)

Drugs within Class that are Contraindicated

  • sildenafil (Revatio®)

Effect on Concentration

↑ sildenafil

Clinical Comments

Coadministration of sildenafil with PAXLOVID is contraindicated for use in pulmonary hypertension due to the potential for sildenafil associated adverse events, including visual abnormalities, hypotension, prolonged erection, and syncope [see Contraindications (4)].

Pulmonary hypertension agents (PDE5 inhibitors)

Drugs within Class that are Contraindicated

  • tadalafil (Adcirca®)

Effect on Concentration

↑ tadalafil

Clinical Comments

Avoid concomitant use of tadalafil with PAXLOVID for pulmonary hypertension.

Pulmonary hypertension agents (sGC stimulators)

Drugs within Class that are Contraindicated

  • riociguat

Effect on Concentration

↑ riociguat

Clinical Comments

Dosage adjustment is recommended for riociguat when used for pulmonary hypertension. Refer to the riociguat product label for more information.

Erectile dysfunction agents (PDE5 inhibitors)

Drugs within Class that are Contraindicated

  • avanafil
  • sildenafil
  • tadalafil
  • vardenafil

Effect on Concentration

↑ avanafil

↑ sildenafil

↑ tadalafil

↑ vardenafil

Clinical Comments

Do not use PAXLOVID with avanafil because a safe and effective avanafil dosage regimen has not been established.

Dosage adjustment is recommended for use of sildenafil, tadalafil, or vardenafil with PAXLOVID when used for erectile dysfunction. Refer to individual product label for more information.

Sedative/hypnotics

Drugs within Class that are Contraindicated

  • triazolam
  • oral midazolama

Effect on Concentration

↑ triazolam

↑ midazolam

Clinical Comments

Coadministration contraindicated due to potential for extreme sedation and respiratory depression [see Contraindications (4)].

Sedative/hypnotics

Drugs within Class that are Contraindicated

  • buspirone
  • clorazepate
  • diazepam
  • estazolam
  • flurazepam
  • zolpidem

Effect on Concentration

↑ sedative/hypnotic

Clinical Comments

A dose decrease may be needed for these drugs when coadministered with PAXLOVID and monitoring for adverse events.

Drugs within Class that are Contraindicated

  • midazolam (administered parenterally)

Effect on Concentration

↑ midazolam

Clinical Comments

Coadministration of midazolam (parenteral) should be done in a setting which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation. Dosage reduction for midazolam should be considered, especially if more than a single dose of midazolam is administered.

Refer to the midazolam product label for further information.

Serotonin receptor 1A agonist/serotonin receptor 2A antagonist

Drugs within Class that are Contraindicated

  • flibanserin

Effect on Concentration

↑ flibanserin

Clinical Comments

Coadministration contraindicated due to potential for hypotension, syncope, and CNS depression [see Contraindications (4)].

Vasopressin receptor antagonists

Drugs within Class that are Contraindicated

  • tolvaptan

Effect on Concentration

↑ tolvaptan

Clinical Comments

Coadministration contraindicated due to potential for dehydration, hypovolemia and hyperkalemia [see Contraindications (4)].

aSee Pharmacokinetics, Drug Interaction Studies Conducted with Nirmatrelvir and Ritonavir (12.3).

CNS=central nervous system; CYP3A=cytochrome P450 3A; HIV=human immunodeficiency virus; HMG-CoA=3-hydroxy-3-methylglutaryl coenzyme A; mTOR=mammalian target of rapamycin; PDE5=phosphodiesterase type 5; P-gp=glycoprotein P; sGC=soluble guanylate cyclase.

Reference:

Fact Sheet for Healthcare Providers: Emergency Use Authorization for PAXLOVIDTM. Pfizer Inc.; 2024.