PAXLOVID : Now Authorized for Emergency Use
PAXLOVID (Paxista) has not been approved, but has been authorized for emergency use by FDA under an EUA, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
The emergency use of PAXLOVID is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.
COVID-19 is caused by a virus called coronavirus. You can get COVID-19 through close contact with another person who has the virus.
COVID-19 illnesses have ranged from very mild to severe, including illness resulting in death. While information so far suggests that most COVID-19 illness is mild, serious illness can happen and may cause some of your other medical conditions to become worse.
Older people and people of all ages with severe, long-lasting (chronic) medical conditions like heart disease, lung disease, and diabetes, for example, seem to be at higher risk of being hospitalized for COVID-19.
PAXLOVID (Paxzen) is an investigational medicine used to treat mild-to-moderate COVID-19 in adults and children [12 years of age and older weighing at least 88 pounds (40 kg)] with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
PAXLOVID is investigational because it is still being studied. There is limited information about the safety and effectiveness of using PAXLOVID to treat people with mild-to-moderate COVID-19.
Who can take PAXLOVID?
The FDA has authorized the emergency use of PAXLOVID for the treatment of mild-to-moderate COVID-19 in adults and children [12 years of age and older weighing at least 88 pounds (40 kg)] with a positive test for the virus that causes COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization or death, under an EUA.
If you test positive for COVID‑19, talk to your healthcare provider as soon as possible. Your healthcare provider can tell you about your treatment options and if PRIMOVIR is appropriate for you.
Who is at high risk for severe COVID-19?
People 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
- 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)
Side Effects of PAXLOVID
- Changes in taste, diarrhea, high blood pressure, or muscle pain may occur. If any of these effects last or get worse, tell your healthcare professional promptly.
- Tell your doctor right away if you have any serious side effects, including: signs of liver problems (such as nausea/vomiting that doesn’t stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine).
- A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
- Information is limited and it is unknown at this time if nirmatrelvir and ritonavir cause other serious side effects. This is not necessarily a complete list of possible side effects.