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Paxlovid: Uses, Dosage, Side Effects, Warnings - Drugs.com
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Paxlovid
Pronunciation: pax-LO-vid
Generic name: nirmatrelvir and ritonavir
Dosage form: tablets, co-packaged for oral use
Drug class: Antiviral combinations
Medically reviewed by Melisa Puckey, BPharm. Last updated on Feb 29, 2024.
Uses
Side effects
Before taking
Dosage
Overdose
Interactions
FAQ
What is Paxlovid?
Paxlovid is an antiviral medication used to treat COVID-19 to help decrease symptoms or avoid severe illness in certain patients. Paxlovid works by stopping the virus that causes COVID-19 (SARS-CoV-2) from multiplying. Paxlovid should be taken as soon as possible after diagnosis of COVID-19. Paxlovid contains two medications called nirmatrelvir (pink tablets) and ritonavir (white tablets).
Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions.
Is Paxlovid FDA approved?
Yes, Paxlovid is an FDA-approved medicine; it was FDA-approved on May 25, 2023. Paxlovid is used for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.
Paxlovid is also available under an Emergency Use Authorisation (EUA) to treat patients 12 to 18 years old for mild-to-moderate COVID-19 who are at high risk for progression to severe COVID-19, including hospitalization or death.
Paxlovid is not approved for use as pre-exposure or post-exposure prophylaxis for the prevention of COVID-19 or prevention of Long COVID.
Paxlovid side effects
Common Paxlovid side effects
Common Paxlovid side effects include a bad taste or change in taste, diarrhea, headache, vomiting, stomach pain, nausea, or high blood pressure.
Serious Paxlovid side effects
Get emergency medical help if you have signs of an allergic reaction (hives, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Call your doctor at once if you have:
liver problems symptoms include loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Ritonavir affects your immune system, which may cause certain side effects (even weeks or months after you've taken nirmatrelvir and ritonavir). Tell your doctor if you have:
signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.
This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Paxlovid side effects (more detail)
Related/similar drugs
Lagevrio, molnupiravir, Actemra, remdesivir, nirmatrelvir / ritonavir, Olumiant
Paxlovid rebound and COVID-19 rebound
COVID-19 rebound is when COVID-19 symptoms return between 2 and 8 days after initial COVID-19 recovery, this can happen in some people that are in vaccinated, unvaccinated, Paxlovid treated and people who have not been treated with Paxlovid. When COVID-19 symptoms return in Paxlovid treated patients, some people have called it Paxlovid rebound.
The CDC states that “There is currently no evidence that additional treatment is needed with Paxlovid or other anti-SARS-CoV-2 therapies in cases where COVID-19 rebound is suspected.”
How does Paxlovid work?
Paxlovid works as nirmatrelvir, is an antiviral medication that stops the virus from multiplying. Nirmatrelvir is a SARS-CoV-2 main protease (Mpro) inhibitor (also known as SARS-CoV2 3CL protease inhibitor) that works by inhibiting viral replication in the early stages of the disease to prevent progression to severe COVID-19.
Ritonavir is taken with nirmatrelvir to help slow the metabolism of nirmatrelvir so that it stays in the body for longer periods of time at higher concentrations to help combat the virus.
Before taking this medicine
You should not use Paxlovid if you are allergic to the active ingredients nirmatrelvir and ritonavir, or any of the inactive ingredients. Click here for a full list of Paxlovid ingredients.
Some drugs have drug interactions with Paxlovid, and they should not be used with Paxlovid, such as those listed below.
alfuzosin, colchicine;
sildenafil (Revatio) when used to treat pulmonary arterial hypertension (PAH);
pain medicine - pethidine, piroxicam, propoxyphene;
heart medicine - amiodarone, dronedarone, flecainide, propafenone, quinidine, ranolazine;
antipsychotic medicine - lurasidone, pimozide, clozapine;
ergot medicine - dihydroergotamine, ergotamine, methylergonovine;
cholesterol-lowering medicine - lovastatin, simvastatin; or
a sedative - riazolam, oral midazolam.
Paxlovid should not be started immediately after discontinuation of any of the following drugs:
rifampin;
St. John's Wort;
a cancer medicine - apalutamide; or
seizure medicine - carbamazepine, phenobarbital, phenytoin.
Also, see the Interactions section below.
Tell your doctor if:
you have liver problems or a liver disease such as hepatitis;
you have kidney problems;
you have an HIV-1 infection;
you are pregnant or breastfeeding; or
you have any serious or chronic disease.
Pregnancy
Tell your healthcare provider right away if you are or if you become pregnant. It is not known if Paxlovid can harm your unborn baby. Ritonavir can make birth control pills or birth control skin patches less effective. Ask your doctor about other birth control options such as an injection, implant, vaginal ring, condom, diaphragm, cervical cap, or contraceptive sponge.
Breastfeeding
Tell your healthcare provider are breastfeeding or plan to breastfeed. It is not known if Paxlovid can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with this medicine.
Paxlovid pregnancy and breastfeeding warnings (more detail)
Paxlovid pregnancy and breastfeeding warnings (more detail)
How should I take Paxlovid?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Paxlovid Instructions
Take nirmatrelvir together with ritonavir (two tablets of nirmatrelvir and one tablet of ritonavir) twice a day for 5 consecutive days. If you have kidney disease, talk to your healthcare provider, as you may need to take a different dose.
Take Paxlovid as soon as possible after diagnosis of COVID-19 and within 5 days of when symptoms first appear.
You may take Paxlovid with or without food.
Swallow the tablets whole and do not crush, chew, or break them.
General Information
You may need frequent blood tests to check your liver function.
If you are taking a ritonavir- or cobicistat-containing medicine to treat hepatitis C or Human Immunodeficiency Virus (HIV), you should continue to take your medicine as prescribed by your healthcare provider.
Talk to your healthcare provider if you do not feel better or if you feel worse after 5 days.
If you have kidney disease, your prescriber may prescribe you a lower dose. Talk to
your healthcare provider to make sure you receive the correct Dose Pack.
Paxlovid Dosage information
Usual Paxlovid Dosing for Adult COVID-19 (FDA-approved)
Nirmatrelvir: 300 mg orally twice a day
Ritonavir: 100 mg orally twice a day
Duration of therapy: 5 days
Comments:
If you have kidney disease, your healthcare provider may prescribe a lower dose. Talk to your healthcare provider to ensure you receive the correct Dose Pack.
Nirmatrelvir must be taken together with ritonavir; the dosage consists of 3 tablets (2 nirmatrelvir 150-mg tablets and 1 ritonavir 100-mg tablet), and all 3 of those tablets should be taken together. Prescriptions should specify the numeric dose of each active component within this product.
This product should be started as soon as possible after COVID-19 has been diagnosed and within 5 days of symptom onset.
If hospitalization is required due to severe/critical COVID-19 after starting treatment with this product, the patient should complete the full 5-day treatment course per health care provider's discretion.
Use: For the treatment of mild to moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.
Usual Paxlovid Dosing for 12 to 18 Year Old COVID-19 (EUA)
For investigational use only
Use: Patients 12 to 18 years old weighing at least 40 kg:
Nirmatrlvir: 300 mg orally twice a day
Ritonavir: 100 mg orally twice a day
Duration of therapy: 5 days
Comments:
If you have kidney disease, your healthcare provider may prescribe a lower dose. Talk to your healthcare provider to make sure you receive the correct Dose Pack.
The US FDA issued an EUA to allow the emergency use of the unapproved product, nirmatrelvir co-packaged with ritonavir, for the treatment of mild to moderate COVID-19 in are at high risk for progression to severe COVID-19, including hospitalization or death; this product is not approved by the US FDA for this use.
Nirmatrelvir must be coadministered with ritonavir; the dosage consists of 3 tablets (2 nirmatrelvir 150-mg tablets and 1 ritonavir 100-mg tablet), and all 3 of those tablets should be administered together. Prescriptions should specify the numeric dose of each active component within this product.
This product should be started as soon as possible after COVID-19 has been diagnosed and within 5 days of symptom onset.
If hospitalization is required due to severe/critical COVID-19 after starting treatment with this product, the patient should complete the full 5-day treatment course per health care provider's discretion.
Detailed Paxlovid dosage information
What happens if I miss a dose?
If you miss a dose of Paxlovid within 8 hours of the time it is usually taken, take it as soon as you remember. If you miss a dose by more than 8 hours, skip the missed dose and take the next dose at your regular time. Do not take 2 doses of Paxlovid at the same time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What other drugs will affect Paxlovid?
Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.
Many drugs can affect Paxlovid and some drugs should not be used at the same time. Paxlovid can interact with other medicines causing severe or life-threatening side effects or death. Tell your doctor about all other medicines you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.
Paxlovid Drug Interactions
Do not take Paxlovid if 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, rifapentine, St. John’s Wort (hypericum perforatum), sildenafil (Revatio®, Liqrev®) for pulmonary arterial hypertension, silodosin, simvastatin, tolvaptan, triazolam, ubrogepant, voclosporin.
These are not the only medicines that may cause serious or life-threatening side effects if taken with Paxlovid. 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 during treatment with this 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.
To check for interactions with Paxlovid click on the link below.
Paxlovid drug interactions (more detail)
Ingredients
Nirmatrelvir 150 mg tablets
Active ingredient: nirmatrelvir
Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, and sodium stearyl fumarate. The following are the ingredients in the film coating: hydroxy propyl methylcellulose, iron oxide red, polyethylene glycol, and titanium dioxide.
Ritonavir 100 mg tablets
Active ingredient: ritonavir
Inactive ingredients: anhydrous dibasic calcium phosphate, colloidal silicon dioxide, copovidone, sodium stearyl fumarate, and sorbitan monolaurate. The following are the ingredients in the film coating: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, polyethylene glycol 400, polyethylene glycol 3350, polysorbate 80, talc, and titanium dioxide.
Storage
Store at room temperature temperature 20°C to 25°C (68°F to 77°F).
Company
Distributed by Pfizer Labs, Division of Pfizer Inc. New York, NY 10001.
Popular FAQ
Paxlovid side effects: 8 key things to know
Most people tolerate Paxlovid well and don’t need to stop treatment. The top 3 most common but temporary side effects with Paxlovid are a bitter or metallic taste, diarrhea and an increase in blood pressure. Important but less common side effects or warnings can include severe allergies, liver problems and a build up of resistance to HIV infections. Continue reading
How fast does Paxlovid work?
Paxlovid, an oral antiviral medication, will start to work against COVID as soon as you take it but you may not feel better immediately. Contact your healthcare provider right away to determine if you should start treatment, even if your symptoms are mild right now. It is important you start taking Paxlovid as soon as possible, within 5 days of testing positive and symptom onset for COVID. Contact your healthcare provider if you do not feel better or if you feel worse after 5 days. Continue reading
Can you take Paxlovid twice if COVID rebounds?
No, a second round of Paxlovid treatment is not needed after the initial 5-day treatment if COVID rebound occurs. Case reports suggest that most people who develop COVID rebound after completing 5 days of treatment have either no symptoms or mild illness. To date, there is no association between Paxlovid treatment and COVID rebound. Continue reading
Does Paxlovid prevent Long COVID?
Yes, treatment with Paxlovid’s active ingredient, nirmatrelvir, showed a reduced risk of long COVID, according to a study published in the Journal of the American Medical Association. Continue reading
How effective is Paxlovid for COVID-19?
Paxlovid is effective at lowering the risk of hospitalization or death by 86% for adult patients who are at high risk of COVID-19 progressing to severe illness when Paxlovid is started within the first 3 days of COVID-19 symptoms. Continue reading
View more FAQ
References Centers fpr Disease Control and Prevention: COVID-19 rebound after Paxlovid treatment Paxlovid Package Insert FDA Fact Sheet for Healthcare Providers Emergency Use Authorization For Paxlovid
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Paxlovid
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PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets) For Patients
PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets) For Patients
Actor portrayals.
If it’s COVID,
PAXLOVID
PAXLOVID is a prescription treatment for mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.
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PAXLOVID is also authorized for certain people under an Emergency Use Authorization. Learn more.
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Who can take PAXLOVID?
As much as we all wish COVID‑19 were a thing of the past, it’s not. It’s still very much here and making some people very sick, especially people who are at high risk for progression to severe COVID‑19.
PAXLOVID is an FDA-approved oral prescription medication that can treat adults who:
have mild-to-moderate COVID‑19, and
have had symptoms for 5 days or fewer, and
have a high-risk factor for progression to severe COVID‑19, such as being 50 years or older or having certain health conditions and/or lifestyle factors.
PAXLOVID is not approved for use as pre-exposure or post-exposure treatment for prevention of COVID‑19. There are certain medications that should not be taken with PAXLOVID. Talk to your healthcare professional to see if PAXLOVID is right for you.
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Approximately 75% of American adults have at least one risk factor for progression to severe COVID‑19. You could be one of them.
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Some of the most common risk factors for progression to severe COVID‑19 include:
Age of 50+ years
Certain health conditions and diseases, such as heart disease and diabetes
Being overweight or obese
Mental health conditions
Lifestyle factors, such as smoking
Physical, mental, and developmental disabilities
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Want to learn more about PAXLOVID?
PAXLOVID is a 5-day oral prescription treatment for COVID‑19.
Learn more about how to take PAXLOVID
A trial compared the risk of COVID‑19–related hospitalization or death in people treated with PAXLOVID vs placebo.
Learn about the PAXLOVID clinical trial
It’s important to understand the risks and possible side effects of PAXLOVID before starting treatment.
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Download the COVID‑19 Preparedness Plan
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How to verify your tablets are authentic
PAXLOVID must be prescribed by a licensed healthcare professional and supplied by a government-approved pharmacy or medical facility.
Authentic PAXLOVID, from Pfizer Inc., will include the Pfizer name on the label and will be packaged in several aluminum push-through blister cards. Individual doses are not for sale. PAXLOVID will be packaged in a carton. The carton has a colorless, glossy coating that contains a repeated pattern of the Pfizer name and logo all over, and these repeating features are seen in a contrasting matte finish.
PAXLOVID consists of tablets for a 5-day oral treatment regimen, with morning and evening doses.
NOTE: If you are a patient with moderate kidney disease, you may receive a carton with daily blister cards that have been modified to ensure you receive the correct dose.
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To help determine whether the tablets are authentic, look for specific text on each side of the tablets
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Embossed Text
nirmatrelvir
Front: 3CL | Back: PFE
ritonavir, manufactured by AbbVie
Front: NK | Back: No text
For packaging options and information, see the Patient PAXLOVID Packaging Flashcard here.
Pfizer is committed to patient safety and ensuring that people have accurate information about PAXLOVID, including how it is accessed and administered. We are actively monitoring for fraudulent offers of illegitimate PAXLOVID to protect patients from products that might be dangerous and lead to serious and life-threatening harm.
If you suspect the product you have received may be counterfeit, contact us at 1-800-438-1985 or visit www.pfizersafetyreporting.com.
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For more information
Contact one of the following groups:
For medical information visit www.pfizermedicalinformation.com or call 1-800-438-1985
For general product inquiries call 1‑877‑C19‑PACK (1-877-219-7225)
13 Things To Know About Paxlovid, the Latest COVID-19 Pill > News > Yale Medicine
13 Things To Know About Paxlovid, the Latest COVID-19 Pill > News > Yale Medicine
Skip to Main Content1-877-YALEMDSSearch forSpecialistsFact SheetsDepartmentsClinical TrialsNewsPatient ToolsSearch1-877-YALEMDSDoctors & Advice13 Things To Know About Paxlovid, the Latest COVID-19 PillBY KATHY KATELLA January 10, 2024Yale experts answer commonly asked questions about the oral antiviral medication.[Originally published: March 10, 2022. Updated: Jan. 10, 2024] Note: Information in this article was accurate at the time of original publication. Because information about COVID-19 changes rapidly, we encourage you to visit the websites of the Centers for Disease Control & Prevention (CDC), World Health Organization (WHO), and your state and local government for the latest information. Paxlovid, the pill that has become the go-to treatment for COVID-19 treatment, was granted full approval in May by the Food and Drug Administration (FDA) for the treatment of mild-to-moderate COVID-19 in adults at high risk for severe disease, including hospitalization and death. The drug also remains available to everyone 12 and older (weighing at least 88 pounds) who has mild-to-moderate disease and is at high risk for severe disease under an FDA Emergency Use Authorization. Paxlovid is an oral antiviral pill that can be taken at home to help keep high-risk patients from getting so sick that they need to be hospitalized. So, if you are eligible to take the pills, you can take them at home and lower your risk of going to the hospital. The drug, developed by Pfizer, had an 89% reduction in the risk of hospitalization and death in unvaccinated people in the clinical trial that supported the EUA, a number that was high enough to prompt the National Institutes of Health (NIH) to prioritize it over other COVID-19 treatments. Studies outside of the laboratory have since confirmed Paxlovid’s effectiveness among people who have been vaccinated. It’s cheaper than many other COVID-19 drugs (at this time, U.S. residents eligible for Paxlovid will continue to receive the medicine at no charge), and it is expected to work against the latest Omicron subvariants. “It's really our first efficacious oral antiviral pill for this virus,” says Scott Roberts, MD, a Yale Medicine infectious diseases specialist. “It shows clear benefit, and it really can prevent hospitalization and death in people who are at high risk.” FDA approval will allow Paxlovid to remain available for adults indefinitely. Meanwhile, Pfizer continues to gather pediatric data to submit for FDA approval in children at a future date. As far as convenience, this medication is considered an improvement over treatments like remdesivir (approved by the FDA in October 2020), which is administered by intravenous (IV) injection. The FDA also granted an EUA in December to a pill from Merck called molnupiravir (Lagevrio), but some studies suggest that molnupiravir has only a 30% reduction in the risk for hospitalization and death from COVID-19. We asked Yale Medicine infectious diseases experts common questions about Paxlovid. Below are their responses. 1. How does Paxlovid work?Paxlovid is an antiviral therapy that consists of two separate medications packaged together. When you take your three-pill dose, two of those pills will be nirmatrelvir, which inhibits a key enzyme that the COVID virus requires in order to make functional virus particles.
After nirmatrelvir treatment, the COVID virus that is released from the cells is no longer able to enter uninfected cells in the body, which, in turn, stops the infection. The other is ritonavir, a drug that was once used to treat HIV/AIDS but is now used to boost levels of antiviral medicines. As a COVID-19 treatment, ritonavir essentially shuts down nirmatrelvir’s metabolism in the liver, so that it doesn’t move out of your body as quickly, which means it can work longer—giving it a boost to help fight the infection.2. When should I take Paxlovid?You have to take Paxlovid within five days of developing symptoms.Like all antivirals, Paxlovid works best early in the course of an illness—in this case, within the first five days of symptom onset, says Jeffrey Topal, MD, a Yale Medicine infectious diseases specialist who is involved in determining COVID-19 treatment protocols for Yale New Haven Hospital patients.“Once you’ve been ill with the virus for more than a week, the damage done to the body in a severe case can’t be undone by the antiviral,” he says.3. How often do I take Paxlovid?The standard dose is three Paxlovid pills twice daily for five days for a full course that adds up to 30 pills. It helps that the pills are packaged in a “dose card,” basically a medication blister pack that allows you to punch out the pills as needed. There is also a reduced dose (two pills instead of three) for people with moderate renal impairment.4. Is Paxlovid similar to Tamiflu?“I think it's a good comparison,” says Dr. Roberts. Tamiflu is an antiviral drug that reduces flu symptoms. Both are prescription-only oral antiviral pills given early in illness.Tamiflu is taken twice a day for five days, and it must be started within 48 hours of flu onset. “When you give a patient Tamiflu beyond that, it doesn’t really change the course of their flu,” Dr. Roberts says. But there are also differences between the two, starting with the way they were studied, Dr. Topal adds. Researchers showed that Paxlovid can prevent hospitalization and death. But since influenza causes fewer severe cases, clinical trials focused on whether Tamiflu could shorten the length of flu illness—which it did, he says.
5. Can anyone get a Paxlovid prescription?In order to qualify for a prescription, you must be at high risk for developing severe COVID-19. That means you must either be 50 or older (age remains the strongest factor for severe COVID-19 outcomes, according to the FDA), although, the agency still authorizes Paxlovid for adolescents and teenagers ages 12 and older who weigh at least 88 pounds. You also qualify if you have certain underlying conditions (including cancer, diabetes, obesity, or others). The more underlying medical conditions a person has, the higher their risk for developing a severe case of COVID-19, according to the CDC. 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 and that patient’s medical history, according to the FDA. If you are pregnant or breastfeeding, the FDA recommends discussing your options and specific situation with your health care provider, since there is no experience using the drug in these populations. If you could become pregnant, it’s recommended that you use effective barrier contraception or do not have sexual activity while taking Paxlovid. It’s important to note that although health care providers can write a prescription, pharmacists may also provide Paxlovid (with certain limitations) if they’ve opted to do so, provided you can share your electronic or printed medical records, including a list of medications you are already taking, and blood test results from the last 12 months.6. How well does Paxlovid work?The FDA’s approval of Paxlovid for adults in 2023 was based on the totality of scientific evidence submitted by Pfizer, including efficacy data from a Phase 2/3 study showing an 86% reduction in risk of COVID-19-related hospitalization or death from any cause in patients who took Paxlovid within five days of symptom onset. When it applied for FDA authorization in 2021, Pfizer presented data from a clinical trial conducted between mid-July and early December 2021. That data showed that participants, who were given Paxlovid were 89% less likely to develop severe illness and death compared to trial participants who received a placebo. All of the trial participants were unvaccinated and they took the drug within three days of symptom onset. In November 2022, the CDC reported on a real-world study that showed adults who took Paxlovid within five days of a COVID-19 diagnosis had a 51% lower hospitalization rate within the next 30 days than those who were not given the drug. The study included people who had been vaccinated or had a previous infection, which the CDC said implied the drug should be offered to people who are eligible regardless of their vaccination status.7. What do we know about how Paxlovid works in kids?Pfizer launched a clinical trial in March 2022 to study the safety and efficacy of Paxlovid in children and teenagers ages 6 to 17 who have COVID-19 symptoms and test positive for the virus, and who are neither hospitalized nor at risk for severe disease. While Paxlovid is authorized for use in adolescents and teenagers ages 12 and up, and weighing at least 88 pounds, that age group wasn’t tested in the original clinical trial. But because many children reach 88 pounds—considered to be an adult weight—the FDA has allowed extensions of EUAs for medications such as monoclonal antibodies and remdesivir in younger age groups, adds Dr. Topal. “Based on the pharmacokinetics of the drugs in Paxlovid, the differences in metabolism and excretion—liver and kidney function specifically—of these drugs in this age group are thought to be similar to that of adults,” Dr. Topal says. 8. Do antiviral treatments such as Paxlovid work against Omicron subvariant JN.1?The CDC says antiviral treatments work well against JN.1, which is currently the dominant strain in the U.S.. 9. What are the side effects from Paxlovid?The most common side effects of taking Paxlovid include impaired sense of taste (for example, a metallic taste in the mouth) and diarrhea, according to the FDA. Most people who take Paxlovid should not experience serious side effects, explains Dr. Roberts. “Paxlovid is usually very well-tolerated,” he says. But people should stop taking Paxlovid and call a health care provider right away if they experience any of the following signs of an allergic reaction: hives trouble swallowing or breathing swelling of the mouth, lips, or face throat tightness hoarseness skin rash Other possible side effects include: an altered or impaired sense of taste diarrhea increased blood pressure muscle aches abdominal pain nauseafeeling generally unwell Since Paxlovid is cleared by the kidneys, dose adjustments may be required for patients with mild-to-moderate kidney disease, explains Dr. Topal. “For patients with severe kidney disease—or who are on dialysis—or those with severe liver disease, Paxlovid is not recommended; the levels of the drug can become too high and could cause increased side effects,” he says. The FDA says that anyone who takes Paxlovid should contact their health provider right away if they have any signs and symptoms of liver problems: loss of appetite, yellowing of the skin and whites of the eyes (jaundice), dark-colored urine, pale-colored stools and itchy skin, or stomach-area (abdominal) pain. It’s worth noting that because Paxlovid is still being monitored in the real world, it is possible that all of the risks are not yet known. (The FDA has provided a fact sheet on Paxlovid with a full list of known side effects.)10. Can I take Paxlovid if I'm taking other medications?There is a long list of medications Paxlovid may interact with, and in some cases, doctors may not prescribe Paxlovid because these interactions may cause serious complications. The list of drugs that Paxlovid interacts with includes some organ anti-rejection drugs that transplant patients take, as well as more common drugs like some used to treat heart arrhythmias. Paxlovid also decreases the metabolism of anticoagulants, or blood thinners, that many older adults depend on, driving up levels of those medications in the body to a point where they are unsafe, Dr. Topal explains. Anyone who has Human Immunodeficiency Virus 1 (HIV-1) infection should talk to their health care provider before taking Paxlovid, since it may lead to some HIV-1 medicines not working as well in the future.Paxlovid also interacts with common medications, including cholesterol-lowering statins like Lipitor. But in many cases, patients can talk to their doctors about taking a temporary break from some of those drugs while taking Paxlovid, he adds. “As always, patients should speak with their providers when starting new medications and follow their providers’ directions regarding the stopping or holding of any medications,” Dr. Topal says.11. What is the rebound effect of Paxlovid?There have been reports of a “rebound” of COVID-19 symptoms in some people within 2 to 8 days after completing the five-day course of Paxlovid; in those cases, some have tested positive again but have no symptoms; others have a recurrence of symptoms. Pfizer had said that in the clinical trial for Paxlovid, several participants appeared to have a rebound in virus levels, although this also occurred in some people who were given a placebo. When it approved Paxlovid in May, the FDA said there not a clear association between Paxlovid treatment and COVID-19 rebound based on available data, and rebound rates in clinical trials were similar among participants who took Paxlovid and those who took a placebo. However, scientists are still studying the Paxlovid rebound. The CDC says a rebound does not mean a person was resistant to Paxlovid, nor does it mean they were reinfected with the virus. In June, the CDC released guidance for clinicians, saying a brief return of symptoms may be part of the natural history of SARS-CoV-2 infection in some people, independent of treatment with Paxlovid, adding that there is no evidence additional treatment is needed. A CDC study reported that rebound symptoms tended to be unlikely to require hospitalization and milder than symptoms experienced during the primary infection. “The hypothesis is that the immune system didn’t have a chance to see the full extent of the virus, since Paxlovid suppressed replication early in disease,” Dr. Roberts says. Scientists are studying the effects of longer treatment durations, longer periods of isolation, and other ways of managing the problem, he adds. For anyone who experiences a rebound, Pfizer recommends reporting it to them on its portal for adverse events associated with Paxlovid.12. If I'm not eligible for Paxlovid, is there something else I can take?There are other therapies for COVID-19, and anyone who cannot take Paxlovid—perhaps because it would interact with another medication—should talk to their doctor about the best approach for their situation.13. Do I still need to be 'up to date' on vaccination if Paxlovid is available?Vaccination, testing, and mitigation efforts such as masking, remain a key part of prevention, even as more drugs become available, says Dr. Topal. “Early testing is key to making these drugs work,” he says. “It’s always been the Achilles’ heel of these antiviral drugs that most people don’t get tested—or they don’t have access to testing.” He encourages taking a test even if you think you only have a cold or allergies—and if you can get one. “Home testing is a huge part of the way to really ‘operationalize’ these medications,” he says, adding that while home tests may not be as highly sensitive as the laboratory-based polymerase chain reaction (PCR) tests, they are still very helpful in making a diagnosis. Dr. Topal says people also should remember that Paxlovid, even with its high efficacy, is not perfect, and even if it were, viruses can mutate and develop resistance to antiviral medications. “Will some people still be hospitalized? Yes—no medication is perfect,” he says. “But for many high-risk patients, this medication can really reduce that risk.” If you are experiencing symptoms of COVID-19 and think you are eligible for a treatment, you can visit the government Test-to-Treat Locater. You can use the site to search for the places near you where you can fill a COVID-19 prescription, or identify sites that provide testing, medical care, and COVID-19 medications. For answers to more Paxlovid-related questions, read the Paxlovid FAQ provided by the FDA. Information provided in Yale Medicine articles is for general informational purposes only. No content in the articles should ever be used as a substitute for medical advice from your doctor or other qualified clinician. Always seek the individual advice of your health care provider with any questions you have regarding a medical condition. Read more Yale Medicine newsRelated SpecialistsScott RobertsMDMarjorie GoldenMDInfectious DiseasesShana GleesonMDInfectious DiseasesMore Related SpecialistsRelated Fact SheetsCOVID-19COVID-19 is the disease caused by the SARS-CoV-2, the 2019 novel coronavirus.Long COVID (Post-COVID Conditions, PCC)Long COVID refers to new or recurring symptoms that occur four or more weeks after an infection with SARS-CoV-2, the virus that causes COVID-19.CoronavirusCoronavirus is a term describes a family of viruses, common in both animals and humans.More Related Fact SheetsRelated Terms:COVID-19 (Coronavirus Disease 2019)Prostatic Arterial Embolization (PAE)Antiretroviral Therapy (ART)Cortisone Shots/InjectionsHuman Papilloma Virus (HPV) VaccineMore news from Yale MedicineFamily HealthThe ABCs of the HPV VaccineResearch & InnovationProstatic Artery Embolization for Benign Prostatic Hyperplasia (BPH)Family Health, Doctors & AdviceColorectal Cancer: What Millennials and Gen Zers Need to KnowMore News From Yale MedicineAbout UsContact UsDonateReferring DoctorsClinical Keywords333 Cedar St.New Haven, CT 06510Yale School of MedicineYale UniversityWebsite FeedbackTerms & Privacy PoliciesAccessibility at YSMPatient RightsHIPAA at YaleManage Cookie PreferencesCopyright 2024 Yale Medicine
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Ritonavir-Boosted Nirmatrelvir (Paxlovid) | COVID-19 Treatment Guidelines
navir-Boosted Nirmatrelvir (Paxlovid) | COVID-19 Treatment GuidelinesSkip to main contentAn official website of the United States governmentHere’s how you knowHere’s how you knowThe final update of the COVID-19 Treatment Guidelines was on February 29, 2024. PDFs of the Guidelines can be downloaded until August 16, 2024, when the website will be shut down.COVID-19 Treatment GuidelinesSearchMENUAbout the GuidelinesWhat's NewTable of ContentsGuidelines DevelopmentPanel RosterPanel Financial DisclosureGuidelines ArchiveOverviewOverview of COVID-19SARS-CoV-2 TestingPrevention of SARS-CoV-2Clinical SpectrumPrioritization of TherapeuticsManagementClinical Management of AdultsClinical Management of ChildrenCritical Care for AdultsCritical Care for ChildrenTherapiesAntivirals, Including Antibody ProductsImmunomodulatorsAntithrombotic TherapyMiscellaneous DrugsSupplementsConcomitant MedicationsSpecial PopulationsImmunocompromisedCancerTransplantPregnancyInfluenzaHIVHomeTherapies Antivirals, Including Antibody Products Ritonavir-Boosted Nirmatrelvir (Paxlovid)TherapiesAntivirals, Including Antibody ProductsSummary RecommendationsRemdesivirRitonavir-Boosted Nirmatrelvir (Paxlovid)MolnupiravirAnti-SARS-CoV-2 Monoclonal AntibodiesCOVID-19 Convalescent PlasmaInterferonsTable: Characteristics of Antiviral Agents, Including Antibody ProductsImmunomodulatorsSummary RecommendationsSystemic CorticosteroidsInhaled CorticosteroidsInterleukin-6 InhibitorsJanus Kinase InhibitorsAbataceptInfliximabInterleukin-1 InhibitorsVilobelimabTable: Characteristics of ImmunomodulatorsAntithrombotic TherapyMiscellaneous DrugsSummary RecommendationsFluvoxamineIntravenous ImmunoglobulinIvermectinMetforminTable: Characteristics of Miscellaneous DrugsSupplementsSummary RecommendationsVitamin CVitamin DZincConcomitant MedicationsGuideline PDFsSection Only (PDF | 222 KB)Full Guideline (PDF | 3.5 MB)Sign Up For UpdatesEmail Address *SubmitRelated ContentGuidelines ArchiveHow to Cite These GuidelinesRitonavir-Boosted Nirmatrelvir (Paxlovid)Drug InfoDrug-Drug InteractionsDrug InfoDrug-Drug InteractionsLast Updated: February 29, 2024Nirmatrelvir is an oral protease inhibitor that is active against MPRO, a viral protease that plays an essential role in viral replication by cleaving the 2 viral polyproteins.1 It has demonstrated antiviral activity against all coronaviruses that are known to infect humans.2 Nirmatrelvir is packaged with ritonavir (as Paxlovid), a strong cytochrome P450 (CYP) 3A4 inhibitor and pharmacokinetic boosting agent that has been used to boost HIV protease inhibitors. Coadministration of ritonavir is required to increase nirmatrelvir concentrations to the target therapeutic range. Ritonavir-boosted nirmatrelvir is approved by the Food and Drug Administration (FDA) for the treatment of mild to moderate COVID-19 in adults who are at high risk of progressing to severe COVID-19.3 The Emergency Use Authorization (EUA) for ritonavir-boosted nirmatrelvir will continue to authorize the use of the EUA-labeled product for the treatment of nonhospitalized adolescents aged 12 to 17 years and weighing ≥40 kg who are at high risk of progressing to severe COVID-19. Recommendations The COVID-19 Treatment Guidelines Panel (the Panel) recommends using nirmatrelvir 300 mg with ritonavir 100 mg (Paxlovid) orally (PO) twice daily for 5 days in nonhospitalized adults with mild to moderate COVID-19 who are at high risk of disease progression (AIIa). Treatment should be initiated as soon as possible and within 5 days of symptom onset. For information on medical conditions that confer high risk, see the Centers for Disease Control and Prevention webpage Underlying Medical Conditions Associated With Higher Risk for Severe COVID-19.Ritonavir-boosted nirmatrelvir is available through an FDA EUA for the treatment of mild to moderate COVID-19 in nonhospitalized adolescents aged 12 to 17 years and weighing ≥40 kg.4 For recommendations on using ritonavir-boosted nirmatrelvir in nonhospitalized children with COVID-19, see Therapeutic Management of Nonhospitalized Children With COVID-19.See the section titled Considerations in Patients With Severe Renal Insufficiency below for information on managing patients with COVID-19 and severe renal insufficiency.For a discussion of the treatment of prolonged, symptomatic COVID-19 in patients with evidence of ongoing SARS-CoV-2 replication, see the section titled Patients Who Are Immunocompromised and Have Prolonged COVID-19 Symptoms and Evidence of Ongoing Viral Replication below. RationaleThe EPIC-HR trial enrolled nonhospitalized adults with mild to moderate COVID-19 who were not vaccinated and who were at high risk of progressing to severe disease.5 The trial demonstrated that starting ritonavir-boosted nirmatrelvir within 5 days of symptom onset in these patients reduced the risk of hospitalization or death through Day 28 by 89% compared to placebo. This efficacy is comparable to remdesivir (87% relative reduction)6 and greater than the efficacy reported for molnupiravir (31% relative reduction).7 However, these agents have not been directly compared in clinical trials. Although ritonavir-boosted nirmatrelvir demonstrated a clinical benefit during the EPIC-HR trial, the benefits in unvaccinated people who are at low risk of progression to severe disease or in vaccinated people who are at high risk of progression to severe disease are unclear. The EPIC-SR trial, which included both of these populations, found that ritonavir-boosted nirmatrelvir did not reduce the duration of symptoms and did not have a statistically significant effect on the risk of hospitalization or death compared to placebo, although the event rates were low in this trial.8 Some observational studies have shown a benefit of using ritonavir-boosted nirmatrelvir in vaccinated individuals who were at high risk of progressing to severe COVID-19.9-12 However, observational studies have inherent limitations. In particular, the results of these studies may be affected by residual confounding. For information on treatment considerations for vaccinated individuals, see Therapeutic Management of Nonhospitalized Adults With COVID-19. There are no data from randomized clinical trials that support the use of ritonavir-boosted nirmatrelvir in hospitalized patients with COVID-19.For more information on the use of ritonavir-boosted nirmatrelvir in patients with COVID-19, see Table 4e. Because of the potential for significant drug-drug interactions with concomitant medications, this regimen may not be the optimal choice for all patients. See Drug-Drug Interactions Between Ritonavir-Boosted Nirmatrelvir (Paxlovid) and Concomitant Medications for details.Drug-Drug InteractionsThe FDA prescribing information for ritonavir-boosted nirmatrelvir includes a boxed warning about significant drug-drug interactions between ritonavir-boosted nirmatrelvir and other medications. These interactions are primarily caused by the ritonavir component of the combination. Ritonavir, a strong CYP3A4 inhibitor and a P-glycoprotein inhibitor, may increase the blood concentration of certain concomitant medications and increase the potential for serious drug toxicities. Before prescribing ritonavir-boosted nirmatrelvir, clinicians should carefully review the patient’s concomitant medications, including over-the-counter medications, herbal supplements, and recreational drugs, to evaluate potential drug-drug interactions. Clinicians should consider both the potential benefits of treatment with ritonavir-boosted nirmatrelvir and the potential risks related to drug-drug interactions. Many drug-drug interactions between ritonavir-boosted nirmatrelvir and concomitant medications (e.g., certain statins, calcium channel blockers, or direct oral anticoagulants) can be safely managed. For the Panel’s recommendations on preferred and alternative antiviral therapies for outpatients with COVID-19, see Therapeutic Management of Nonhospitalized Adults With COVID-19. Clinicians should be aware that the drug-drug interaction potential of ritonavir-boosted nirmatrelvir may change if it is used for extended durations (i.e., ≥10 days).The following resources provide information on identifying and managing drug-drug interactions.Quick reference lists:Drug-Drug Interactions Between Ritonavir-Boosted Nirmatrelvir (Paxlovid) and Concomitant Medications. Box 1 lists select outpatient medications that are not expected to have clinically relevant interactions with ritonavir-boosted nirmatrelvir. Box 2 lists select outpatient medications that have clinically relevant drug-drug interactions with ritonavir-boosted nirmatrelvir. Web-based drug-drug interaction checker: The Liverpool COVID-19 Drug Interactions websiteTables with guidance on managing specific drug-drug interactions:The University of Waterloo/University of Toronto drug interaction guide for ritonavir-boosted nirmatrelvirThe FDA prescribing information for ritonavir-boosted nirmatrelvir Patients Who Are Immunocompromised and Have Prolonged COVID-19 Symptoms and Evidence of Ongoing Viral Replication For patients who are immunocompromised and have prolonged COVID-19 symptoms and evidence of ongoing viral replication (e.g., those with a low cycle threshold value, as measured by a reverse transcription polymerase chain reaction result or with a positive rapid antigen test result) despite receiving a course of antiviral therapy, the optimal management is unknown. Case reports and case series have described the treatment of these patients with additional antiviral treatments, prolonged courses of antiviral treatments, high-titer COVID-19 convalescent plasma, or combination therapy.13-19 For information on potential treatment options, see Special Considerations in People Who Are Immunocompromised and Therapeutic Management of Nonhospitalized Adults With COVID-19. Viral Rebound and Symptom RecurrenceObservational studies and the EPIC-HR and MOVe-OUT trials have described SARS-CoV-2 viral rebound and the recurrence of COVID-19 symptoms in some patients who have completed treatment with ritonavir-boosted nirmatrelvir or molnupiravir.3,20-23 However, viral rebound can also occur in patients who have not received treatment for COVID-19.24 Some observational studies have reported that patients who were treated with ritonavir-boosted nirmatrelvir had a higher frequency of viral rebound and symptom recurrence than those who did not receive treatment.25,26 The re-emergence of culturable SARS-CoV-2 has been reported in some individuals with viral rebound.To date, virus detection and the recurrence of COVID-19 symptoms following the use of antiviral therapies have not been associated with progression to severe COVID-19.27,28 Therefore, concerns about viral rebound or the recurrence of symptoms should not be a reason to avoid using antiviral therapies when their use is indicated.23,29-31 There are insufficient data on whether a longer course of ritonavir-boosted nirmatrelvir will prevent viral rebound or symptom recurrence. There are also insufficient data on the efficacy of administering a second course of antiviral therapy to treat viral rebound or symptom recurrence. However, a clinical trial that is evaluating the use of a second course of ritonavir-boosted nirmatrelvir to treat patients with viral rebound and symptom recurrence is underway (ClinicalTrials.gov Identifier NCT05567952).SARS-CoV-2 ResistanceViral mutations that lead to substantial resistance to nirmatrelvir have been selected for in in vitro studies; the fitness of these mutations is unclear. Surveillance for the emergence of significant resistance to nirmatrelvir is critical, particularly in patients who are severely immunocompromised and who experience prolonged replication of SARS-CoV-2. Additional Considerations Nirmatrelvir must be administered with ritonavir to achieve sufficient therapeutic plasma concentrations.In patients with moderate renal impairment (i.e., those with an estimated glomerular filtration rate [eGFR] of ≥30 to <60 mL/min), the dose should be reduced to nirmatrelvir 150 mg with ritonavir 100 mg PO twice daily.Ritonavir-boosted nirmatrelvir is not recommended for patients with known or suspected severe hepatic impairment (i.e., Child-Pugh Class C), and it should be used with caution in patients with pre-existing liver diseases, liver enzyme abnormalities, or hepatitis. No pharmacokinetic or safety data are available for this patient population.Patients should complete the 5-day treatment course of ritonavir-boosted nirmatrelvir because there are concerns that a shorter treatment course may be less effective or may lead to the emergence of drug resistance.If a patient requires hospitalization after starting treatment, the full 5-day treatment course of ritonavir-boosted nirmatrelvir should be completed unless there are drug-drug interactions that preclude its use.There are very limited data on combining ritonavir-boosted nirmatrelvir with other antiviral therapies to treat nonhospitalized patients with COVID-19. Clinical trials are needed to determine whether combination therapy has a role in the treatment of COVID-19.The FDA prescribing information for ritonavir-boosted nirmatrelvir advises against crushing nirmatrelvir and ritonavir tablets. However, some data indicate that the tablets can be split or crushed if necessary.32Monitoring and Adverse EffectsThe most common adverse effects of ritonavir-boosted nirmatrelvir are dysgeusia, diarrhea, hypertension, and myalgia. Anaphylaxis, serious skin reactions, and other hypersensitivity reactions have also been reported. There is no need to check a patient’s renal function prior to prescribing ritonavir-boosted nirmatrelvir unless the patient is suspected to have moderate to severe renal impairment (i.e., those with an eGFR of <60 mL/min). For these patients, clinicians may consider checking the patient’s renal function to inform the dosing of ritonavir-boosted nirmatrelvir.Considerations in Patients With Severe Renal InsufficiencyThe FDA prescribing information states that ritonavir-boosted nirmatrelvir is not recommended for patients with an eGFR of <30 mL/min until more data are available to establish appropriate dosing.3 Additional information is available in the initial FDA Center for Drug Evaluation and Research review for the EUA of ritonavir-boosted nirmatrelvir.33 There is limited clinical experience with the use of ritonavir-boosted nirmatrelvir in patients with an eGFR of <30 mL/min and in those who require hemodialysis.34,35 Based on limited data, some groups have proposed dosing adjustments for ritonavir-boosted nirmatrelvir in these patients.36-38Considerations in Pregnant and Lactating PeopleSee Pregnancy, Lactation, and COVID-19 Therapeutics for the Panel’s guidance on the use of ritonavir-boosted nirmatrelvir during pregnancy and lactation. Considerations in ChildrenRitonavir-boosted nirmatrelvir is available through an FDA EUA for the treatment of mild to moderate COVID-19 in nonhospitalized adolescents aged 12 to 17 years and weighing ≥40 kg. For recommendations on using ritonavir-boosted nirmatrelvir in nonhospitalized children with COVID-19, see Therapeutic Management of Nonhospitalized Children With COVID-19.Clinical DataThe EPIC-HR study was a multinational randomized trial that compared the use of ritonavir-boosted nirmatrelvir PO twice daily for 5 days to placebo in nonhospitalized patients aged ≥18 years with mild to moderate COVID-19 who were at high risk of clinical progression.5 Eligible patients were randomized within 5 days of symptom onset, were not vaccinated against COVID-19, and had at least 1 risk factor for progression to severe disease. Patients were excluded if they used medications that were either highly dependent upon CYP3A4 for clearance or strong inducers of CYP3A4. A total of 2,246 patients enrolled in the trial. The mean age was 46 years, 51% of the patients were men, and 72% were White. Forty-seven percent of the patients tested negative for SARS-CoV-2 antibodies, and 66% started study treatment within 3 days of symptom onset. Patients who were randomized within 3 days of symptom onset (n = 1,379) were included in the modified intention-to-treat (mITT) analysis. COVID-19–related hospitalizations or all-cause deaths occurred by Day 28 in 5 of 697 patients (0.72%) in the ritonavir-boosted nirmatrelvir arm and in 44 of 682 patients (6.5%) in the placebo arm. Among the 2,085 patients who were randomized within 5 days of symptom onset (mITT1 analysis), COVID-19–related hospitalizations and all-cause deaths occurred in 8 of 1,039 patients (0.77%) in the ritonavir-boosted nirmatrelvir arm and in 66 of 1,046 patients (6.3%) in the placebo arm (89% relative risk reduction; 5.6% estimated absolute reduction; 95% CI, 7.2% to 4.0%; P < 0.001). There were no deaths in the ritonavir-boosted nirmatrelvir arm, and 13 deaths occurred in the placebo arm.A total of 2,224 patients who received at least 1 dose of either ritonavir-boosted nirmatrelvir or placebo were included in the EPIC-HR safety analysis set. Among these patients, dysgeusia and diarrhea occurred more frequently in ritonavir-boosted nirmatrelvir recipients than in placebo recipients (6% vs. 0.3% and 3% vs. 2%, respectively). Fewer ritonavir-boosted nirmatrelvir recipients discontinued the study drug due to an adverse event than placebo recipients (2% vs. 4%).ReferencesPillaiyar T, Manickam M, Namasivayam V, Hayashi Y, Jung SH. An overview of severe acute respiratory syndrome-coronavirus (SARS-CoV) 3CL protease inhibitors: peptidomimetics and small molecule chemotherapy. J Med Chem. 2016;59(14):6595-6628. Available at: https://www.ncbi.nlm.nih.gov/pubmed/26878082.Owen DR, Allerton CMN, Anderson AS, et al. An oral SARS-CoV-2 MPRO inhibitor clinical candidate for the treatment of COVID-19. Science. 2021;374(6575):1586-1593. Available at: https://www.ncbi.nlm.nih.gov/pubmed/34726479.Ritonavir-boosted nirmatrelvir (Paxlovid) [package insert]. Food and Drug Administration. 2023. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217188s000lbl.pdf.Food and Drug Administration. Fact sheet for healthcare providers: Emergency Use Authorization for Paxlovid. 2023. Available at: https://www.fda.gov/media/155050/download.Hammond J, Leister-Tebbe H, Gardner A, et al. Oral nirmatrelvir for high-risk, nonhospitalized adults with COVID-19. N Engl J Med. 2022;386(15):1397-1408. Available at: https://pubmed.ncbi.nlm.nih.gov/35172054.Gottlieb RL, Vaca CE, Paredes R, et al. Early remdesivir to prevent progression to severe COVID-19 in outpatients. N Engl J Med. 2022;386(4):305-315. Available at: https://www.ncbi.nlm.nih.gov/pubmed/34937145.Jayk Bernal A, Gomes da Silva MM, Musungaie DB, et al. Molnupiravir for oral treatment of COVID-19 in nonhospitalized patients. N Engl J Med. 2022;386(6):509-520. Available at: https://www.ncbi.nlm.nih.gov/pubmed/34914868.Pfizer. Pfizer reports additional data on PAXLOVID supporting upcoming new drug application submission to U.S. FDA. 2022. Available at: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-reports-additional-data-paxlovidtm-supporting. Accessed January 26, 2024.Dryden-Peterson S, Kim A, Kim AY, et al. Nirmatrelvir plus ritonavir for early COVID-19 in a large U.S. health system: a population-based cohort study. Ann Intern Med. 2023;176(1):77-84. Available at: https://www.ncbi.nlm.nih.gov/pubmed/36508742.Arbel R, Wolff Sagy Y, Hoshen M, et al. Nirmatrelvir use and severe COVID-19 outcomes during the Omicron surge. N Engl J Med. 2022;387(9):790-798. Available at: https://www.ncbi.nlm.nih.gov/pubmed/36001529.Ganatra S, Dani SS, Ahmad J, et al. Oral nirmatrelvir and ritonavir in nonhospitalized vaccinated patients with coronavirus disease 2019. Clin Infect Dis. 2023;76(4):563-572. Available at: https://www.ncbi.nlm.nih.gov/pubmed/35986628.Shah MM, Joyce B, Plumb ID, et al. Paxlovid associated with decreased hospitalization rate among adults with COVID-19—United States, April–September 2022. MMWR Morb Mortal Wkly Rep. 2022;71(48):1531-1537. Available at: https://www.ncbi.nlm.nih.gov/pubmed/36454693.Huygens S, Gharbharan A, Serroukh Y, et al. High-titer convalescent plasma plus nirmatrelvir/ritonavir treatment for non-resolving COVID-19 in six immunocompromised patients. J Antimicrob Chemother. 2023;78(7):1644-1648. Available at: https://www.ncbi.nlm.nih.gov/pubmed/37248664.Brosh-Nissimov T, Ma’aravi N, Leshin-Carmel D, et al. Combination treatment of persistent COVID-19 in immunocompromised patients with remdesivir, nirmatrelvir/ritonavir and tixagevimab/cilgavimab. J Microbiol Immunol Infect. 2024;57(1):189-194. Available at: https://pubmed.ncbi.nlm.nih.gov/37805361.Mikulska M, Sepulcri C, Dentone C, et al. Triple combination therapy with two antivirals and monoclonal antibodies for persistent or relapsed SARS-CoV-2 infection in immunocompromised patients. Clin Infect Dis. 2023;77(2):280-286. Available at: https://www.ncbi.nlm.nih.gov/pubmed/36976301Graziani L, Gori L, Manciulli T, et al. Successful use of nirmatrelvir/ritonavir in immunocompromised patients with persistent and/or relapsing COVID-19. J Antimicrob Chemother. 2023;78(2):555-558. Available at: https://www.ncbi.nlm.nih.gov/pubmed/36544352.Trottier CA, Wong B, Kohli R, et al. Dual antiviral therapy for persistent coronavirus disease 2019 and associated organizing pneumonia in an immunocompromised host. Clin Infect Dis. 2023;76(5):923-925. Available at: https://www.ncbi.nlm.nih.gov/pubmed/36281907.Focosi D, Maggi F, D’Abramo A, Nicastri E, Sullivan DJ. Antiviral combination therapies for persistent COVID-19 in immunocompromised patients. Int J Infect Dis. 2023;137:55-59. Available at: https://pubmed.ncbi.nlm.nih.gov/37778409.Snell LB, McGreal-Bellone A, Nye C, et al. A multinational case series describing successful treatment of persistent severe acute respiratory syndrome coronavirus 2 infection caused by Omicron sublineages with prolonged courses of nirmatrelvir/ritonavir. Open Forum Infect Dis. 2024;11(1):ofad612. Available at: https://www.ncbi.nlm.nih.gov/pubmed/38269048.Charness ME, Gupta K, Stack G, et al. Rebound of SARS-CoV-2 infection after nirmatrelvir-ritonavir treatment. N Engl J Med. 2022;387(11):1045-1047. Available at: https://www.ncbi.nlm.nih.gov/pubmed/36069968.Anderson AS, Caubel P, Rusnak JM, EPIC-HR Trial Investigators. Nirmatrelvir-ritonavir and viral load rebound in COVID-19. N Engl J Med. 2022;387(11):1047-1049. Available at: https://www.ncbi.nlm.nih.gov/pubmed/36069818.Boucau J, Uddin R, Marino C, et al. Characterization of virologic rebound following nirmatrelvir-ritonavir treatment for coronavirus disease 2019 (COVID-19). Clin Infect Dis. 2023;76(3):e526-e529. Available at: https://www.ncbi.nlm.nih.gov/pubmed/35737946.Food and Drug Administration. Fact sheet for healthcare providers: Emergency Use Authorization for Lagevrio (molnupiravir) capsules. 2023. Available at: https://www.fda.gov/media/155054/download.Deo R, Choudhary MC, Moser C, et al. Symptom and viral rebound in untreated SARS-CoV-2 infection. Ann Intern Med. 2023;176(3):348-354. Available at: https://pubmed.ncbi.nlm.nih.gov/36802755.Edelstein GE, Boucau J, Uddin R, et al. SARS-CoV-2 virologic rebound with nirmatrelvir-ritonavir therapy: an observational study. Ann Intern Med. 2023;176(12):1577-1585. Available at: https://www.ncbi.nlm.nih.gov/pubmed/37956428.Smith-Jeffcoat SE, Biddle JE, Talbot HK, et al. Symptoms, viral loads, and rebound among COVID-19 outpatients treated with nirmatrelvir/ritonavir compared to propensity score matched untreated individuals. Clin Infect Dis. 2023;Published online ahead of print. Available at: https://www.ncbi.nlm.nih.gov/pubmed/37963102.Smith DJ, Lambrou A, Patel P. SARS-CoV-2 rebound with and without use of COVID-19 oral antivirals. MMWR Morb Mortal Wkly Rep. 2023;72(51):1357-1364. Available at: https://www.ncbi.nlm.nih.gov/pubmed/38127665.Harrington PR, Cong J, Troy SB, et al. Evaluation of SARS-CoV-2 RNA rebound after nirmatrelvir/ritonavir treatment in randomized, double-blind, placebo-controlled trials - United States and international sites, 2021-2022. MMWR Morb Mortal Wkly Rep. 2023;72(51):1365-1370. Available at: https://www.ncbi.nlm.nih.gov/pubmed/38127674.Soares H, Baniecki ML, Cardin R, et al. Viral load rebound in placebo and nirmatrelvir-ritonavir treated COVID-19 patients is not associated with recurrence of severe disease or mutations. Res Sq. 2022;Preprint. Available at: https://www.researchsquare.com/article/rs-1720472/v1.Ranganath N, O’Horo JC, Challener DW, et al. Rebound phenomenon after nirmatrelvir/ritonavir treatment of coronavirus disease 2019 (COVID-19) in high-risk persons. Clin Infect Dis. 2023;76(3):e537-e539. Available at: https://www.ncbi.nlm.nih.gov/pubmed/35698452.Centers for Disease Control and Prevention. COVID-19 rebound after Paxlovid treatment. 2022. Available at: https://emergency.cdc.gov/han/2022/han00467.asp. Accessed January 26, 2024.BC COVID Therapeutics Committee COVID Therapy Review and Advisory Working Group. Therapeutic brief: crushing nirmatrelvir/ritonavir (Paxlovid). 2022. Available at: http://www.bccdc.ca/Health-Professionals-Site/Documents/COVID-treatment/Crushing_Paxlovid.pdf.Food and Drug Administration. Emergency Use Authorization (EUA) for Paxlovid (nirmatrelvir tablets co-packaged with ritonavir tablets): Center for Drug Evaluation and Research (CDER) review. 2021. Available at: https://www.fda.gov/media/155194/download.Hiremath S, Blake PG, Yeung A, et al. Early experience with modified dose nirmatrelvir/ritonavir in dialysis patients with coronavirus disease 2019. Clin J Am Soc Nephrol. 2023;18(4):485-490. Available at: https://www.ncbi.nlm.nih.gov/pubmed/36723285.Chan GCK, Lui GCY, Wong CNS, et al. Safety profile and clinical and virological outcomes of nirmatrelvir-ritonavir treatment in patients with advanced chronic kidney disease and coronavirus disease 2019 (COVID-19). Clin Infect Dis. 2023;77(10):1406-1412. Available at: https://www.ncbi.nlm.nih.gov/pubmed/37531093.University of Liverpool. Prescribing resources. 2022. Available at: https://covid19-druginteractions.org/prescribing_resources. Accessed January 31, 2024.Ontario Health. COVID-19 supplemental clinical guidance #4: nirmatrelvir/ritonavir (Paxlovid) use in patients with advanced chronic kidney disease and patients on dialysis with COVID-19. 2022. Available at: https://www.ontariohealth.ca/sites/ontariohealth/files/2022-04/PaxlovidClinicalGuide.pdf.Hiremath S, McGuinty M, Argyropoulos C, et al. Prescribing nirmatrelvir/ritonavir for COVID-19 in advanced CKD. Clin J Am Soc Nephrol. 2022;17(8):1247-1250. Available at: https://www.ncbi.nlm.nih.gov/pubmed/35680135.Guideline PDFsSection Only (PDF | 222 KB)Full Guideline (PDF | 3.5 MB)Sign Up For UpdatesEmail Address *SubmitRelated ContentGuidelines ArchiveHow to Cite These Guidelineswww.covid19treatmentguidelines.nih.govAn official website of the National Institutes of HealthAbout NIHNIH Performance ReportingFreedom of Information ActWeb Policies and NoticesNo FEAR Act DataVulnerability Disclosure PolicyOffice of Inspector GeneralTwitter buttonLooking for U.S. government information and services? Visit USA.govSite Updated: November 2, 2023Back to TopPaxlovid Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing - WebMD
Paxlovid Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing - WebMD
Skip to main content Home Conditions Back Conditions View All ADD/ADHDAllergiesArthritisAtrial fibrillationBreast CancerCancerCrohn's DiseaseDepressionDiabetesDVTEczemaEye HealthHeart DiseaseHIV & AIDSLung DiseaseLupusMental HealthMultiple SclerosisMigrainePain ManagementPsoriasisPsoriatic ArthritisRheumatoid ArthritisSexual ConditionsSkin ProblemsSleep DisordersUlcerative Colitis View All Drugs & Supplements Back Drugs & SupplementsDrugsSupplementsPill IdentifierInteraction CheckerWell-Being Back Well-Being View All Aging WellBabyBirth ControlChildren's HealthDiet & Weight ManagementFitness & ExerciseFood & RecipesHealthy BeautyMen's HealthParentingPet HealthPregnancySex & RelationshipsTeen HealthWomen's Health View All Symptom CheckerFind a DoctorMore Back MoreNewsBlogsPodcastsWebinarsNewslettersWebMD MagazineBest HospitalsSupport GroupsOrthopedics Privacy & More Subscribe Log In Search Subscribe MENU DRUGS AND MEDICATIONS CENTERFind a DrugMy MedicinePill IdentifierInteraction CheckerFind a VitaminFind a PharmacyVITAMINS & SUPPLEMENTS CENTERFind a Vitamin or SupplementVitamin Lifestyle GuideAssess Your Vitamin NeedsFIRST AID RESOURCESFirst Aid HomeFirst Aid Kit & Wound CareFirst Aid Mobile Drugs & Medications Paxlovid (EUA) 300 Mg (150 X 2)-100 Tablet Pharmacoenhancer - Cytochrome P450 InhibitorsPaxlovid (EUA) 300 Mg (150 X 2)-100 Tablet Pharmacoenhancer - Cytochrome P450 Inhibitors - Uses, Side Effects, and More Generic Name(S): nirmatrelvir-ritonavirUsesSide EffectsWarningsPrecautionsInteractionsOverdoseImages Reviews (805) Uses This combination of nirmatrelvir and ritonavir is used to treat coronavirus disease (COVID-19) in people who have mild to moderate symptoms and have a high risk for COVID-19 complications. It helps people who have COVID-19 to stay out of the hospital. It is not for use by people who are hospitalized due to COVID-19.Nirmatrelvir is a SARS-CoV-2 main protease inhibitor. It works by preventing the growth of the virus that causes COVID-19. Ritonavir increases ("boosts") the levels of nirmatrelvir. This helps nirmatrelvir work better.This medication works by stopping the coronavirus from growing. It cannot be used to prevent COVID-19. How to use Paxlovid (EUA) 300 Mg (150 X 2)-100 Tablet Pharmacoenhancer - Cytochrome P450 InhibitorsRead the Patient Information Leaflet if available from your pharmacist before you start taking this product and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually once in the morning and once in the evening for 5 days. Swallow the tablets whole. Do not chew, break, or crush the tablets. The dosage is based on your medical condition and response to treatment.This product works best if you start taking it within 5 days of when symptoms begin.For the best effect, take this product at evenly spaced times. To help you remember, take it at the same times every day.Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.Tell your doctor if your condition lasts or gets worse. Side Effects Changes in taste or diarrhea may occur. If either of these effects lasts or gets worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.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.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. Warnings This product contains a combination of nirmatrelvir tablets and ritonavir tablets. Ritonavir may interact with many different types of medications, in some cases causing severe (sometimes fatal) reactions. Before using nirmatrelvir and ritonavir, tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Also, before you start using any new product, ask your doctor and pharmacist if it could interact with nirmatrelvir and ritonavir. Consult your doctor or pharmacist about which medications should not be taken with this product (see also Drug Interactions section). Precautions Before taking this product, tell your doctor or pharmacist if you are allergic to nirmatrelvir or ritonavir; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, HIV infection.To avoid spreading the virus, you should continue to take precautions such as self-isolation, wearing a mask, social distancing (physical distancing), washing hands, and not sharing personal items.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this product should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if nirmatrelvir passes into breast milk. Ritonavir does pass into breast milk. The risks of breast-feeding while infected with COVID-19 and while using this product should be discussed with the doctor. Interactions See also Warning section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.A product that may interact with this drug is: orlistat.Nirmatrelvir/ritonavir can slow down or speed up the removal of other medications from your body, which may affect how they work. Examples of affected drugs include alfuzosin, antiarrhythmics (such as amiodarone, flecainide, propafenone, quinidine), azole antifungals (such as voriconazole), certain benzodiazepines (midazolam, triazolam), certain "blood thinners" (such as rivaroxaban, warfarin), eletriptan, drugs to treat erectile dysfunction-ED or pulmonary hypertension (such as avanafil, sildenafil), ergot alkaloids (such as dihydroergotamine, ergonovine, ergotamine, methylergonovine), lurasidone, certain opioid pain medications (such as fentanyl, meperidine), pimozide, ranolazine, salmeterol, "statin" cholesterol drugs (such as simvastatin, lovastatin), among others.Other medications can affect the removal of nirmatrelvir/ritonavir from your body, which may affect how this medication works. Examples include apalutamide, lumacaftor, certain rifamycins (such as rifampin, rifapentine), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenobarbital, phenytoin), among others.This medication may decrease the effectiveness of hormonal birth control (containing ethinyl estradiol) such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use reliable backup birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well. Does Paxlovid (EUA) 300 Mg (150 X 2)-100 Tablet Pharmacoenhancer - Cytochrome P450 Inhibitors interact with other drugs you are taking? Enter your medication into the WebMD interaction checker Check Interaction Overdose If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.Notes Notes Do not share this medication with others.This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor tells you to.Missed Dose Missed Dose If you miss a dose, take it as soon as you remember. If it is more than 8 hours after the missed dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.Storage Storage Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. Images NextYou Might Also LikeCold or Flu? How to TellTreating and Managing Eczema PigmentationTreating Opioid Use Disorder With MedicationsTaking Prescription Opioids?Navigating Life With Migraine Search Drugs Related Drugs Common Searches AdderallCelexaCiproCymbaltaFlexerilHydrocodonePrilosecProzacSeroquelSynthroidTramadolTrazodoneLexaproLisinoprilMobicNaproxenNeurontinPradaxaPrednisoneVicodinWarfarinWellbutrinXanaxZocorZoloft Show More Show Less Select a condition to view a list of medication options COVID-19 Drug Survey Are you currently using Paxlovid (EUA) 300 Mg (150 X 2)-100 Tablet Pharmacoenhancer - Cytochrome P450 Inhibitors? YesNo This survey is being conducted by the WebMD marketing sciences department. Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use. CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment. 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About Paxlovid - NHS
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About Paxlovid
Paxlovid is an antiviral medicine that works by stopping the virus that causes COVID-19 from growing and spreading in the body.It's used to treat early COVID-19 infection and help to prevent more severe symptoms.Paxlovid is a combination of 2 medicines called nirmatrelvir and ritonavir. Nirmatrelvir stops the virus from growing and spreading, and ritonavir helps nirmatrelvir from being broken down in your body long enough to do its job.It comes as tablets. You'll need to start taking them as soon as possible after you have tested positive for COVID-19 and within 5 days of your symptoms starting.Paxlovid is only available on prescription. However, you will only be eligible to have the medicine if you're in the highest risk group.If you test positive for COVID-19 and are eligible, call your GP surgery, NHS 111 or hospital specialist as soon as possible. This is so they can consider referring you for an assessment for COVID-19 treatment.Find out more about how to get treatments for COVID-19.
Key facts
You will take 2 nirmatrelvir tablets and 1 ritonavir tablet twice a day for 5 days. Even if you start to feel better, it's important that you finish the course.It's important that you start taking Paxlovid within 5 days of getting COVID-19 symptoms.Paxlovid starts working soon after taking it.Side effects include diarrhoea, vomiting and a change in how food and drink tastes.There are lots of medicines that can affect the way Paxlovid works. Tell your doctor if you're taking any medicines.
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Page last reviewed: 10 May 2022
Next review due: 10 May 2025
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