PAXLOVID Patient Eligibility Screening Checklist Tool for Prescribers
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March 13, 2024
This checklist is intended as an aid to support clinical decision making for prescribers.
However, use of this checklist is not required to prescribe PAXLOVID.
Medical History
❑ Has mild to moderate COVID-19 (symptomatic SARS-CoV-2 infection not requiring
hospitalization).
❑ Age ≥ 18 years OR > 12 years of age and weighing at least 40 kg
❑ Has one or more risk factors for progression to severe COVID-19
1
❑ Not requiring hospitalization due to severe or critical COVID-19 at treatment initiation
❑ No known or suspected severe renal impairment (eGFR < 30 mL/min)
• Note that a dose reduction is required for patients with moderate renal impairment
(eGFR ≥30-<60 mL/min); see the Fact Sheet for Healthcare Providers.
• To assess renal function:
o Physicians, advanced practice registered nurses, and physician assistants who are licensed
or authorized under state law to prescribe drugs may rely on patient history and access to
the patient’s health records to make an assessment regarding the likelihood of renal
impairment. Providers may consider ordering a serum creatinine or calculating the
estimated glomerular filtration rate (eGFR) for certain patients after assessment on a
case-by-case basis based on history or exam.
o State-licensed pharmacists must have sufficient information available, such as through
access to health records less than 12 months old or consultation with a health care
provider in an established provider-patient relationship with the individual patient; see
the Fact Sheet for Healthcare Providers.
❑ No known or suspected severe hepatic impairment (Child-Pugh Class C)
• To assess hepatic impairment:
o Physicians, advanced practice registered nurses, and physician assistants who are licensed
or authorized under state law to prescribe drugs may rely on patient history and access to
the patient’s health records to make an assessment regarding the likelihood of hepatic
impairment.
o State-licensed pharmacists must have sufficient information available, such as through
access to health records less than 12 months old or consultation with a health care
provider in an established provider-patient relationship with the individual patient; see
the Fact Sheet for Healthcare Providers.
❑ No history of clinically significant hypersensitivity reactions [e.g., toxic epidermal
necrolysis (TEN) or Stevens-Johnson syndrome] to the active ingredients (nirmatrelvir or
ritonavir) or other components of the product
NOTES:
1
Determining whether a patient is at high risk for progression to severe COVID-19, including hospitalization or death, is
based on the provider’s assessment of the individual patient being considered for treatment of COVID-19 and that
patient’s medical history. For information on medical conditions and factors associated with increased risk for progression
to severe COVID-19, see the Centers for Disease Control and Prevention (CDC) website:
https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html
PAXLOVID Patient Eligibility Screening Checklist Tool for Prescribers
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March 13, 2024
Concomitant Medications
NOTE: The state-licensed pharmacist should refer an individual patient for clinical evaluation
(e.g., telehealth, in-person visit) with a physician, advanced practice registered nurse, or physician
assistant licensed or authorized under state law to prescribe drugs, if:
• Sufficient information is not available to assess for a potential drug interaction
• Modification of other medications is needed due to a potential drug interaction.
• PAXLOVID is not an appropriate therapeutic option based on the authorized Fact Sheet for
Healthcare Providers or due to potential drug interactions for which recommended
monitoring would not be feasible.
See the Fact Sheet for Healthcare Providers and USPI for the full Limitations of Authorized Use.
❑ HMG-CoA reductase inhibitors (statins)
• If the patient is taking lovastatin or simvastatin, which are contraindicated with
PAXLOVID coadministration, PAXLOVID can be given if the statin can be held 12
hours prior to the first dose of PAXLOVID treatment, held during the 5 days of
treatment, and restarted 5 days after completing PAXLOVID.
• If the patient is taking atorvastatin or rosuvastatin, consider temporary
discontinuation of atorvastatin and rosuvastatin during treatment with
PAXLOVID. Atorvastatin and rosuvastatin do not need to be held prior to or after
completing PAXLOVID.
❑ Hormonal contraceptives containing ethinyl estradiol: If the patient is taking a hormonal
contraceptive containing ethinyl estradiol, consider an additional non-hormonal method
of contraception during the 5 days of PAXLOVID treatment and until one menstrual
cycle after stopping PAXLOVID.
❑ Medications for HIV-1 Treatment: If the patient is taking medications for the treatment
of HIV-1 infection, with the exception of maraviroc
2
, HIV antiretroviral medications can
be co-administered with PAXLOVID without dose adjustment, but arranging follow-up
by the HIV care provider to monitor for side effects is recommended.
3
,
4
,
5
2
Please see the maraviroc prescribing information here:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022128Orig1s019,208984Orig1s002lbl.pdf
3
Exposure of certain HIV medications may be altered with PAXLOVID co-administration.
4
Patients on ritonavir- or cobicistat-containing HIV or HCV regimens should continue their treatment as indicated.
5
PAXLOVID use may lead to a risk of HIV-1 developing resistance to HIV protease inhibitors in individuals with
uncontrolled or undiagnosed HIV-1 infection.
PAXLOVID Patient Eligibility Screening Checklist Tool for Prescribers
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❑ Other Drugs with Established and Other Potentially Significant Drug Interactions with
PAXLOVID
❑ Patient is not taking any other medications
❑ Patient is not taking any of the medications listed below.
• In addition, the patient’s other medications have been checked for
contraindications, the need for dose adjustment, or increased monitoring due
to drug interactions with a strong CYP3A inhibitor such as ritonavir based on
appropriate resources such as the prescribing information of these
medications.
❑ Patient is NOT taking any of the medications listed in RED but is taking one or
more of the medications listed below in YELLOW, and dose adjustment, holding
of medication, or increased monitoring is planned (additional resources which
include instructions for managing specific drug interactions are included at the
end of this document).
• In addition, the patient’s other medications not listed below have been
checked for contraindications, the need for dose adjustment, or increased
monitoring due to drug interactions with a strong CYP3A inhibitor such as
ritonavir based on appropriate resources such as the prescribing information of
these medications.
NOTES:
PAXLOVID Patient Eligibility Screening Checklist Tool for Prescribers
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March 13, 2024
Other Drugs with Established and Other Potentially Significant Drug Interactions with PAXLOVID
(listed alphabetically by generic name)
Interaction Codes:
Coadministration of this drug with PAXLOVID is CONTRAINDICATED.
For further information, refer to the Fact Sheet for Healthcare
Providers and the individual Prescribing Information for the drug.
Coadministration of this drug with PAXLOVID should be avoided
and/or holding of this drug, dose adjustment of this drug, or special
monitoring is necessary. Consultation with the prescriber of the
potentially interacting drug is recommended. For further information,
refer to the Health Care Provider Fact Sheet, the USPI, and the
individual Prescribing Information for the drug.
The table below provides a listing of clinically significant drug interactions, including
contraindicated drugs, in addition to those listed under Concomitant Medications above
(HMG-CoA reductase inhibitors [statins], hormonal contraceptives containing ethinyl
estradiol, and medications for HIV-1 treatment). Drugs listed in this table are a guide and
are 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.
Drug Class
Interaction
Code
Anticancer drug
***
Alpha 1-adrenoreceptor
antagonist
XXX
Cardiovascular agent
***
Antiarrhythmic
XXX
Calcium channel blocker
***
Anticancer drug
XXX
Anticoagulant
***
Neuropsychiatric agent
***
PDE5 inhibitor
***
Antimycobacterial
***
Systemic corticosteroid
***
Neuropsychiatric agent
***
Endothelin receptor antagonist
***
Systemic corticosteroid
***
Antidepressant
***
***
XXX
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Drug Class
Interaction
Code
Sedative/hypnotic
***
Anticonvulsant
XXX
Neuropsychiatric agent
***
Anticancer drug
***
Systemic corticosteroid
***
Cardiovascular agent
***
Anti-infective
***
Anticonvulsant
***
Sedative/hypnotic
***
Cardiovascular agent
***
Antipsychotic
***
Anti-gout
XXX
Immunosuppressant
***
Anticoagulants
***
Muscarinic receptor antagonist
***
Hepatitis C direct acting antiviral
***
Anticancer drug
***
Systemic corticosteroid
***
Sedative/hypnotic
***
Cardiac glycoside
***
Ergot derivative
XXX
Calcium channel blocker
***
Antiarrhythmic
***
Antiarrhythmic
XXX
Hepatitis C direct acting antiviral
***
Migraine medication
XXX
Cystic fibrosis transmembrane
conductance regulator potentiator
***
Anticancer drug
***
Cardiovascular agent
XXX
Ergot derivative
XXX
Anti-infective
***
Sedative/hypnotic
***
Immunosuppressant
***
Calcium channel blocker
***
Narcotic analgesic
***
Mineralocorticoid receptor
antagonist
XXX
Antiarrhythmic
XXX
Sedative/hypnotic
***
Systemic corticosteroid
***
Serotonin receptor 1A agonist/
serotonin receptor 2A antagonist
XXX
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Drug Class
Interaction
Code
Hepatitis C direct acting antiviral
***
Narcotic analgesic
***
Anticancer drug
***
Neuropsychiatric agent
***
Antifungal
***
Antifungal
***
Cardiovascular agent
XXX
Cystic fibrosis transmembrane
conductance regulator potentiator
***
Anticancer drug
***
Antifungal
***
Antiarrhythmic
***
Microsomal triglyceride transfer
protein (MTTP) inhibitor
XXX
Cystic fibrosis transmembrane
conductance regulator potentiator
XXX
Neuropsychiatric agent
***
Antipsychotic
XXX
Narcotic analgesic
***
Narcotic analgesic
***
Ergot derivative
XXX
Systemic corticosteroid
***
Sedative/hypnotic
***
Sedative/hypnotic
XXX
Systemic corticosteroid
***
Opioid antagonist
XXX
Anticancer drug
***
Calcium channel blocker
***
Calcium channel blocker
***
Anticancer drug
***
Hepatitis C direct acting antiviral
***
Narcotic analgesic
***
Anticonvulsant
XXX
Anticonvulsant
XXX
Neuropsychiatric agent
***
Antipsychotic
XXX
Anticonvulsant
XXX
Antiarrhythmic
XXX
Antipsychotic
***
Antiarrhythmic
XXX
Antianginal
XXX
Antimycobacterial
***
Antimycobacterial
XXX
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March 13, 2024
Drug Class
Interaction
Code
Antimycobacterial
XXX
Migraine medication
***
sGC stimulator
***
Anticoagulant
***
Long-acting beta-adrenoceptor
agonist
***
DPP4 inhibitor
***
PDE5 inhibitor
***
PDE5 inhibitor
XXX
Benign prostatic hyperplasia agent
XXX
Immunosuppressant
***
Hepatitis C direct acting antiviral
***
Herbal product
XXX
Neuropsychiatric agent
***
Immunosuppressant
***
PDE5 inhibitor
***
Alpha 1-adrenoreceptor
antagonist
***
Cystic fibrosis transmembrane
conductance regulator potentiator
***
Cardiovascular agent
***
JAK inhibitor
***
Vasopressin receptor antagonist
XXX
Antidepressant
***
Systemic corticosteroid
***
Sedative/hypnotic
XXX
Migraine medication
XXX
JAK inhibitor
***
PDE5 inhibitor
***
Anticancer drug
***
Calcium channel blocker
***
Anticancer drug
***
Anticancer drug
***
Immunosuppressant
XXX
Cardiovascular agent
***
Antifungal
***
Anticoagulant
***
Sedative/hypnotic
***
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March 13, 2024
ADDITIONAL RESOURCES:
PAXLOVID - Fact Sheet for Healthcare Providers: https://www.fda.gov/drugs/emergency-
preparedness-drugs/emergency-use-authorizations-drugs-and-non-vaccine-biological-products
Prescribing Information (Label/Package Insert) for Individual Drugs and for PAXLOVID (Drugs@FDA):
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
University of Liverpool COVID-19 Drug Interactions:
https://www.covid19-druginteractions.org/checker