Paxlovid is for adults and children 12 and older weighing at least 40 kg (88.2 lbs) who are at higher risk for developing serious COVID-19 disease that may lead to hospitalization and/or death. Paxlovid should be considered for patients who meet the following criteria:

• Test positive for SARS-CoV-2 (with PCR or antigen test, including at-home tests), AND
• Are able to begin treatment as soon as possible after diagnosis of COVID-19 and within 5 days of symptom onset, AND
• Have symptoms consistent with mild-to-moderate COVID-19, AND
• Have one or more risk factors for severe COVID

The benefit of a 5-day treatment course of Paxlovid was demonstrated in the clinical trial that supported the EUA. This study showed that among non-hospitalized, unvaccinated patients at high risk of progression to severe disease, treatment with Paxlovid reduced the risk of hospitalization or death by 88%.

Observational data, including vaccinated patients, from Israel1, United States2, and Hong Kong3 is consistent with benefit in high-risk patients:

• 67% reduction in hospitalizations and 81% reduction in deaths compared to the untreated for patients over 65
• 45% reduction in hospitalization and greater reductions for obese or unvaccinated patients among adult patients
• 75% reduction in death compared to non-users.

Do not take PAXLOVID if:

• You are allergic to nirmatrelvir, ritonavir, or any of the ingredients in PAXLOVID
• You are taking any of the following medicines:
• alfuzosin
• amiodarone
• apalutamide
• carbamazepine
• colchicine
• dihydroergotamine
• dronedarone
• eletriptan
• eplerenone
• ergotamine
• finerenone
• flecainide
• flibanserin
• ivabradine
• lomitapide
• lovastatin
• lumacaftor/ivacaftor
• lurasidone
• methylergonovine
• midazolam (oral)
• naloxegol
• phenobarbital
• phenytoin
• pimozide
• primidone
• propafenone
• quinidine
• ranolazine
• rifampin
• John’s Wort (hypericum perforatum)
• sildenafil (Revatio®) for pulmonary arterial hypertension
• silodosin
• simvastatin
• tolvaptan
• triazolam
• ubrogepant
• voclosporin

Taking PAXLOVID with these medicines may cause serious or life-threatening side effects or affect how PAXLOVID works.

These are not the only medicines that may cause serious side effects if taken with PAXLOVID. PAXLOVID may increase or decrease the levels of multiple other medicines. It is very important to tell your healthcare provider about all of the medicines you are taking because additional laboratory tests or changes in the dose of your other medicines may be necessary while you are taking PAXLOVID. Your healthcare provider may also tell you about specific symptoms to watch out for that may indicate that you need to stop or decrease the dose of some of your other medicines.

You can take any available FDA-authorized COVID-19 viral test including the at-home covid test kit (eg, RT-PCR, rapid antigen, etc) to determine if you have COVID-19.

eople of all ages or groups can be infected with COVID-19. Some people are more likely than others to get very sick from COVID-19, which can lead to hospitalization or death, even when symptoms start off as mild.

Some people are at a greater risk of COVID-19 becoming severe because they meet certain criteria, including where they live, work, or have difficulty accessing health care. This includes many people from racial and ethnic minority groups and people with disabilities.

In addition, having one or more of the following factors puts you at high risk of getting severe COVID-19*:

• 65 years or older
• Cancer
• Chronic kidney disease
• Chronic liver disease
• Chronic lung disease (including moderate-to-severe asthma, chronic obstructive pulmonary disease [[COPD]], emphysema, and chronic bronchitis)
• Cystic fibrosis
• Dementia or other neurological conditions
• Diabetes (Type 1 or Type 2)
• Disabilities (including attention-deficit/hyperactivity disorder [[ADHD]], cerebral palsy, birth defects, intellectual and developmental disabilities, learning disabilities, spinal cord injuries, Down syndrome)
• Heart conditions
• HIV infection
• Immunocompromised condition or weakened immune system
• Mental health conditions (including mood disorders, schizophrenia spectrum disorders, and depression)
• Overweight or having obesity
• Physical inactivity
• Pregnant or recently pregnant (for at least 42 days following end of pregnancy)
• Sickle cell disease or thalassemia
• Smoking, current or former
• Solid organ or blood stem cell transplant
• Stroke or cerebrovascular disease
• Substance use disorders (such as alcohol, opioid, or cocaine use disorder)
• Tuberculosis