paxlovid drug interactions
COVID-19, carefully review the patients concomitant medications, including over-the-counter medicines, herbal supplements, and recreational drugs. Adelaide: AMH Pty Ltd, 2023 (accessed 17 April 2023). Paxlovid (EUA) 300 Mg (150 X 2)-100 Tablet Pharmacoenhancer - Cytochrome P450 Inhibitors, Enter your medication into the WebMD interaction checker, Smart Grocery Shopping When You Have Diabetes, Surprising Things You Didn't Know About Dogs and Cats, Simple Test Could Assess Risk of Dementia, Long COVID Treatment Isn't One-Size-Fits-All, Stuck Stem Cells May Be to Blame for Gray Hair, New Book: Take Control of Your Heart Disease Risk, MINOCA: The Heart Attack You Didnt See Coming, Health News and Information, Delivered to Your Inbox, Treating Opioid Use Disorder With Medications, List Paxlovid (EUA) 300 Mg (150 X 2)-100 Tablet Pharmacoenhancer - Cytochrome P450 Inhibitors side effects by likelihood and severity. Practical information, tools and resources for health professionals and staff to help improve the quality of health care and safety for patients. Ritonavir can slow down or speed up the removal of other medications from your body, which may affect how they work. ", "Transcriptional profiling of lung cell populations in idiopathic pulmonary arterial hypertension", "Multiple pathways for SARS-CoV-2 resistance to nirmatrelvir", "How Pfizer scientists transformed an old drug lead into a COVID-19 antiviral", "How Pfizer made an effective anti-covid pill", https://en.wikipedia.org/w/index.php?title=Nirmatrelvir/ritonavir&oldid=1151475955, This page was last edited on 24 April 2023, at 09:08. Many clinically significant interactions with ritonavir may not need to be addressed given the short course of therapy (e.g., inhaled corticosteroids, certain statins). [28], There are no human data on the use of nirmatrelvir during pregnancy related to the risk of birth defects, spontaneous abortions (miscarriage), or adverse outcomes. Prior to prescribing Paxlovid, your doctor will review possible drug interactions. [23][24] Enrollment in EPIC-SR was discontinued due to the low rate of hospitalization and death in this population. It works by preventing the growth of the virus that causes COVID-19. In Germany, Paxlovid is by prescription through physicians only and German physicians have been reluctant to prescribe it. It has been undermined by concerns regarding drug-drug interactions (DDI) as well as rebound or an extension of the illness with abbreviated use. [54], As of April 2022, the United States ordered a total of 20 million Paxlovid courses. Ritonavir, a strong cytochrome P450 (CYP) 3A4 inhibitor and a P-glycoprotein inhibitor, is coadministered with nirmatrelvir to increase the blood concentration of nirmatrelvir, thereby making it effective against SARS-CoV-2. [7][9], Side effects of nirmatrelvir/ritonavir include changes in sense of taste, diarrhea, high blood pressure, and muscle pain. This could cause pregnancy. 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). This document does not contain all possible drug interactions. :8Ty5S-vH50hnFu=*Y # uVYxr^[4a x@F?|vHdTRqsVv!5&KZiZ"e Management of drug-drug interactions for patients receiving Paxlovid for 5 days This helps nirmatrelvir work better. Things to remember when you fill your prescription. Users should be aware of these considerations in their review of nirmatrelvir and ritonavir, and it is always the responsibility of treating practitioners to exercise independent judgement in making care decisions. endobj 6 0 obj Do not flush medications down the toilet or pour them into a drain unless instructed to do so. WebThese drugs should not be coadministered. Also, organizations should test their electronic health records and/or pharmacy computer systems to ensure they provide alerts for this and other drug-drug interactions. [25], As of May2022[update], the effectiveness of nirmatrelvir/ritonavir among vaccinated people was unknown. Ritonavir, a strong cytochrome P450 (CYP) 3A4 inhibitor and a P-glycoprotein inhibitor, is coadministered with nirmatrelvir to increase the blood concentration of nirmatrelvir, thereby making it effective against SARS-CoV-2. Incidentally, the practitioner who reported this event to ISMP mentioned that the prescriber was not familiar with the patients medical history. Liver Problems. 2005 - 2023 WebMD LLC, an Internet Brands company. Paxlovid (nirmatrelvir tablets; ritonavir tablets), is the only oral agent officially endorsed by HHS, NIH, Useless CDC, Useless FDA for the ambulatory treatment of COVID-19. [9][10][22] EPIC-HR was started in July 2021 and was completed in December 2021. Details of dose modifications for COVID-19 therapies (licensed or under clinical investigation) which may be required for patients with renal impairment are given in this PDF. Relevant, timely and evidence-based information for Australian health professionals and consumers. [12][18][19], In March 2023, treatment with nirmatrelvir within 5 days of initial infection was shown to reduce risk of long COVID. [9][15], The time to peak concentrations of nirmatrelvir combined with ritonavir is 3.00hours (range 1.026.00hours) while that of ritonavir is 3.98hours. Institute for Safe MedicationPractices [53], In December 2021, the German government ordered 1 million doses of, but by August 2022, only around 43,000 had been delivered by wholesalers to pharmacies. Webpotential drug interactions will be managed, follow-up/monitoring, and notification to the primary care provider, if applicable. <>/ExtGState<>/ColorSpace<>>>/Annots[41 0 R 42 0 R 43 0 R 44 0 R 45 0 R 46 0 R 47 0 R 48 0 R 49 0 R 50 0 R]/StructParents 2>> Paxlovid is the latest COVID-19 treatment thats been all over the news. [35][17], In August 2021, Pfizer began a phase II/III trial of nirmatrelvir/ritonavir for COVID-19 in standard-risk individuals with COVID-19 known as EPIC-SR.[23][36] Interim results of this trial were announced in December 2021, and final results were released in June 2022. Study results show that nirmatrelvir and ritonavir may help people who have recently tested positive for coronavirus stay out of the hospital. Paxlovid is the latest COVID-19 treatment thats been all over the news. It has been undermined by concerns regarding drug-drug interactions (DDI) as well as rebound or an extension of the illness with abbreviated use. Using Paxlovid at the same time as certain other drugs may result in potentially significant drug interactions. Please see Table 2 below for a list of risk factors for developing severe disease. This product may contain inactive ingredients which can cause allergic reactions or other problems. Antimicrobial Stewardship Centers of Excellence Program, myIDSA Practice Managers Community Opt-in Form, Fellows-In-Training Career & Education Center, Antimicrobial Stewardship Center of Excellence, Fellows-in-Training Career and Education Center. Potential interaction likely to be of weak intensity. PBS restrictions for COVID-19 antiviral treatments do not restrict the number of courses of treatment a person can have in a lifetime. This document allows users see at-a-glance the risk and management of drug-drug interactions between Paxlovid and selected drugs that may be used in the outpatient setting. Patients in the authorized population who report a positive home test result from a rapid antigen diagnostic test to their provider are eligible for Paxlovid under the emergency use authorization (EUA). Tell your doctor if your condition lasts or gets worse. If a drug is not listed below it cannot automatically be assumed it is safe to coadminister. Cookies facilitate the functioning of this site including a member login and personalized experience. In patients with moderate renal impairment (eGFR 30 to <60 mL/min), the dosage of Paxlovid is 150 mg nirmatrelvir (one 150 mg tablet) and 100 mg ritonavir (one 100 mg tablet) twice daily for five days. 3 0 obj Patients do not have to have more than one risk factor to be considered high risk. Download . endobj WebWith the extension of the emergency authorization in August 2022, the FDA updated a checklist to help evaluate potential drug interactions and other patient factors before prescribing Paxlovid, including more than 120 drugs which are either contraindicated, should be avoided or held from use, or require dose adjustments or special monitoring. [47] In February 2022, China approved the medication for the treatment of adults who have mild to moderate COVID-19 and are at a high risk of progressing to a severe condition. Any significantly immunocompromising condition(s) where, in the last 3 months the patient has received any of these treatments: 4. Webpotential drug interactions will be managed, follow-up/monitoring, and notification to the primary care provider, if applicable. [15][9] Nirmatrelvir/ritonavir works against COVID-19 by preventing the replication of SARS-CoV-2, which the SARS-CoV-2 main protease is essential for. 5200 Butler Pike These reports, then, do not change the conclusions from the Paxlovid clinical trial which demonstrated a marked reduction in hospitalization and death. However, in reality, this interaction may not be too worrisome. [9][15], The co-packaged medication is not authorized for the pre-exposure prophylaxis or post-exposure prophylaxis of COVID-19 nor for treatment in those requiring hospitalization due to severe or critical COVID-19, nor for use for longer than 5 consecutive days. [accession date]. Should I avoid certain foods while taking Paxlovid (EUA) 300 Mg (150 X 2)-100 Tablet Pharmacoenhancer - Cytochrome P450 Inhibitors? 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. 1 0 obj Using Paxlovid at the same time as certain other drugs may result in potentially significant drug interactions. ", "Pfizer's new COVID-19 protease inhibitor drug is not just 'repackaged ivermectin', "Nirmatrelvir-Ritonavir and Viral Load Rebound in Covid-19", "Pfizer Says Patients Who Relapse After Covid Pill Can Repeat Treatment", "FDA Updates on Paxlovid for Health Care Providers", "From Positive to Negative to Positive Again-The Mystery of Why COVID-19 Rebounds in Some Patients Who Take Paxlovid", "CDC Director Rochelle Walensky tests positive for Covid again after taking a course of the antiviral pill Paxlovid", "Paxlovid Resistance: Is It Just a Matter of Time Now? WebPaxlovid Interactions. [11], The co-packaged medication is not recommended during pregnancy and in women who can become pregnant and who are not using contraception. (Paxlovid) to treat patients with mild to moderate . endobj Prescribers and dispensers should carefully review a patients concomitant medications including over-the-counter medications, herbal supplements, and recreational drug before prescribing or dispensing Paxlovid. [9] Peak concentrations, total exposure, time to peak concentrations, and elimination half-life of nirmatrelvir combined with ritonavir are severity-dependently increased in people with renal impairment. Our COVID-19 information hub has important information for everyone, including resources about vaccines and treatments. A physician prescribed PAXLOVID (nirmatrelvir and ritonavir) for a 34-year-old patient with flu-like symptoms who tested positive for coronavirus disease 2019 (COVID-19). 11 0 obj Coadministration may increase apixaban concentrations. [35][17] Health Canada approved the use of the co-packaged medication in January 2022. It is used by people who have recently tested positive for coronavirus, have had mild to moderate symptoms for no more than 5 days and are not hospitalized. [9][15] Ritonavir is not active against or thought to directly contribute to the antiviral activity of the medication against SARS-CoV-2. WebComprehensive, up-to-date, evidence-based COVID19 drug-drug interaction resource, freely available to healthcare workers, patients and researchers. This is not necessarily a complete list of possible side effects. Drug-drug interactions are an important when considering whether to prescribe Paxlovid. On day 3 of treatment, the patient presented with signs and symptoms of fatigue and bradycardia, with a heart rate below 40 beats per minute. The drug is contraindicated in those with hypersensitivity to the two main components, and in those with severely reduced kidney or liver function. [69], Medicines and Healthcare products Regulatory Agency, United States Department of Health and Human Services, "TGA eBS - Product and Consumer Medicine Information Licence", "Summary Basis of Decision (SBD) for Paxlovid", "Summary of Product Characteristics for Paxlovid", "Paxlovid- nirmatrelvir and ritonavir kit", "FDA Authorizes First Oral Antiviral for Treatment of COVID-19", "Frequently Asked Questions on the Emergency Use Authorization for Paxlovid for Treatment of COVID-19", "Oral Antiviral Treatment for COVID-19: A Comprehensive Review on Nirmatrelvir/Ritonavir", "Pfizer Receives U.S. FDA Emergency Use Authorization for Novel COVID-19 Oral Antiviral Treatment", "Oral COVID-19 antiviral, Paxlovid, approved by UK regulator", "Health Canada authorizes Paxlovid for patients with mild to moderate COVID-19 at high risk of developing serious disease", "Association of Treatment With Nirmatrelvir and the Risk of Post-COVID-19 Condition", "Oral Nirmatrelvir for High-Risk, Nonhospitalized Adults with Covid-19", "Pfizer Reports Additional Data on PAXLOVID Supporting Upcoming New Drug Application Submission to U.S. FDA", "The U.S. Is Doing Too Little to Monitor Paxlovid Use", "Pfizer says COVID treatment Paxlovid fails to prevent infection of household members", "EMA issues advice on use of Paxlovid (PF-07321332 and ritonavir) for the treatment of COVID-19: rolling review starts in parallel", "Ritonavir-Boosted Nirmatrelvir (Paxlovid)", "Pfizer antiviral pills may be risky with other medications", "Paxlovid Patient Eligibility Screening Checklist and Drug Interaction Tool", "Should I take Paxlovid after a Positive COVID-19 Test? In this CDER Conversation, Dr. John Farley, director of the Office of Infectious Diseases, provides useful information that can help health care providers in decision making regarding Paxlovid, the preferred therapy for the management of non-hospitalized adults with COVID-19, according to the National Institutes of Health COVID Treatment Guidelines. Paxlovid (nirmatrelvir tablets; ritonavir tablets), is the only oral agent officially endorsed by HHS, NIH, CDC, FDA for the ambulatory treatment of COVID-19. 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. Potential clinically significant interaction that is likely to require additional monitoring, alteration of drug dosage or timing of administration. Neurological conditions, including stroke and dementia and demyelinating conditions. 9 0 obj [65] President Joe Biden, First Lady Jill Biden, Anthony Fauci,[63] Peter Hotez and Rochelle Walensky[66] are known to have experienced rebound. This site requires JavaScript to run correctly. Cookies are also used to generate analytics to improve this site as well as enable social media functionality. [37], On 16 November 2021, Pfizer submitted an application to the US Food and Drug Administration (FDA) for emergency use authorization for the co-packaged medication. A summary of interactions with COVID-19 antiviral therapies (licensed or under clinical investigation) and over 900 comedications are given in this PDF. Drug-Drug Interactions Between Ritonavir-Boosted Nirmatrelvir (Paxlovid) and . [11], Adverse events of the co-packaged medication, regardless of causality, observed in the phase II-III EPIC-HR study included: dysgeusia (6% vs. <1% for placebo), diarrhea (3% vs. 2% for placebo), hypertension (1% vs. <1% for placebo), and myalgia (1% vs. <1% for placebo). Drug interactions may change how your medications work or increase your risk for serious side effects. Drug combinations may have been assessed either by study or within the product label, or an interaction may have been predicted based on the metabolic profiles of the drugs. I wish we could clone you so there would be one of you in every city! [62] This is important, because people with rebound cannot go back to work or school. [9][15], In December 2021, nirmatrelvir/ritonavir was granted emergency use authorization by the United States Food and Drug Administration (FDA) for the treatment of COVID-19. Adults 30 years or older identifying as First Nations people.