Refer to the apixaban product label for more information. The progestin concentration of a combined hormonal contraceptive is expected to remain similar or increase with coadministration, which would maintain the effectiveness of the oral contraceptive. The information provided is for educational purposes only. Available at: BC COVID Therapeutics Committee (CTC) COVID Therapy Review and Advisory Working Group (CTRAWG). Vangeel L, Chiu W, De Jonghe S, et al. However, when ritonavir is used for 5 days, its induction properties are less likely to be clinically relevant than when the drug is used chronically (e.g., in people who take HIV protease inhibitors).3 The guidance in this document is based on the drug-drug interaction potential of the Food and Drug Administration (FDA)-authorized 5-day course of ritonavir-boosted nirmatrelvir. Evaluating the interaction risk of COVID-19 therapies. Individual doses are not for sale. 1 . Microsomal triglyceride transfer protein (MTTP) inhibitor. Paxlovid disease interactions. Secure .gov websites use HTTPSA lock (LockA locked padlock) or https:// means youve safely connected to the .gov website. By selecting continue, you acknowledge you have a medical question regarding a potential drug interaction. Paxlovid (nirmatrelvir/ritonavir), along with Image credit: Shutterstock.com There are no available data on the presence of nirmatrelvir in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19., Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. Centers for Disease Control and Prevention. Dosage adjustment of saxagliptin is recommended. Usually avoid combinations; use it only under special circumstances. If concomitant use with PAXLOVID is necessary, consider a dosage reduction of the narcotic analgesic and monitor patients closely at frequent intervals. COVID-19 drug interactions: prescribing resources. 5,19. Katzenmaier S, Markert C, Riedel KD, et al. No dosage adjustment is needed in patients with mild renal impairment. 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). Surveillance for the emergence of significant resistance to nirmatrelvir is critical. Healthcare workers are encouraged to report cases of COVID-19 rebound to after Paxlovid treatment using Pfizer Safety Reporting or FDA MedWatch; Drug interaction overview. Examples of risk factors include living in residential aged care, having certain medical conditions such as asthma, diabetes or obesity. An official website of the United States government. The following resources provide information on identifying and managing drug-drug interactions. Refer to the digoxin product label for further information. Refer to the darifenacin product label for more information. Clinicians should be aware that many commonly used medications can be safely coadministered with ritonavir-boosted nirmatrelvir despite its drug-drug interaction potential. 2020. The hypothesis is that the immune system didnt have a chance to see the full extent of the virus, since Paxlovid suppressed replication early in disease, Dr. Roberts says. Early experience with modified dose nirmatrelvir/ritonavir in dialysis patients with coronavirus disease 2019. Tamiflu is taken twice a day for five days, and it must be started within 48 hours of flu onset. 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 lead to resistance. Co-administration of PAXLOVID with drugs highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated. Looking for U.S. government information and services. But for many high-risk patients, this medication can really reduce that risk.. Because of the potential for significant drug-drug interactions with concomitant medications, this regimen may not be the optimal choice for all patients. If coadministration is necessary, reduce quetiapine dose and monitor for quetiapine-associated adverse reactions. People taking common medications for heart disease, including some statins, may be risking dangerous interactions if they use Paxlovid to treat viral symptoms from a COVID-19 infection. Deviation from the recommended strategies may be appropriate in certain clinical scenarios. If your prescription plan include Express Scripts Pharmacy, our specially trained pharmacists are here for you 24/7 to . vorapaxar estazolam, You take three Paxlovid pills twice daily for five days for a full course that adds up to 30 pills. Other resources regarding management of drugs with potentially significant drug interactions with Paxlovid include: NIH COVID-19 Treatment Guidelines University of Liverpool COVID-19 Drug Interactions Refer to the quetiapine prescribing information for recommendations. Ritonavir-boosted nirmatrelvir has significant drug-drug interactions, primarily due to the ritonavir component of the combination. These drugs should not be coadministered. Its 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. dexamethasone, 2) Hold all calcineurin inhibitors and mTOR inhibitors at time Paxlovid is written 3) Start Paxlovid at 24 - 48 hours from time of last dose of CNI or mTOR inhibitor (see table below) The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the unapproved product PAXLOVID for the treatment of adults and pediatric patients (12 years of age and older weighing at least 40 kg) with a current diagnosis of mild-to-moderate coronavirus disease 2019 (, ) and who are at high risk for progression to severe, To find COVID-19 treatments, please use the U.S. Dept. Drugs listed in this section are a guide and not considered a comprehensive list of all drugs that may be contraindicated with PAXLOVID. cariprazine, Minimally clinically significant. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Yale experts answer commonly asked questions about the oral antiviral medication. Consider the magnitude and significance of the potential drug-drug interaction when choosing management strategies for patients who will be receiving ritonavir-boosted nirmatrelvir. See the American Society of Transplantation statementfor more information. i Do not coadminister this medication with ritonavir-boosted nirmatrelvir in patients with hepatic or renal impairment. The decision to prescribe ritonavir-boosted nirmatrelvir to patients who are receiving calcineurin and mammalian target of rapamycin inhibitors should always be made in consultation with the patients specialist providers. An official website of the United States government. For the Panels recommendations on preferred and alternative antiviral therapies for outpatients with COVID-19, see Therapeutic Management of Nonhospitalized Adults With COVID-19. Patients should be counseled about ritonavir-boosted nirmatrelvirs drug-drug interaction potential and the signs and symptoms of potential adverse effects. Potential for nirmatrelvir and ritonavir to affect other drugs. The strategy may need to continue for a longer duration if ritonavir-boosted nirmatrelvir is initiated in an adult of advanced age or if the interacting medication has a long half-life. pimavanserin. Paxlovid associated with decreased hospitalization rate among adults with COVID-19United States, April-September 2022. elbasvir/grazoprevir, glecaprevir/pibrentasvir The role of combination antiviral therapy or a longer treatment duration in treating patients who are severely immunocompromised is not yet known. Share sensitive information only on official, secure websites. Combined P-gp and strong CYP3A4 inhibitors increase blood levels of apixaban and increase the risk of bleeding. PAXLOVID is not recommended in patients with severe renal impairment (eGFR <30 mL/min based on CKD-EPI formula) until more data are available; the appropriate dosage for patients with severe renal impairment has not been determined. Available at: Li M, Zhu L, Chen L, Li N, Qi F. Assessment of drug-drug interactions between voriconazole and glucocorticoids. The most common side effects of Paxlovid treatment tend to be mild and include diarrhea, muscle aches, high blood pressure, and an altered sense of taste, Roberts says. PAXLOVID IS NOT approved for any of the following: To treat patients who are hospitalized due to severe or critical COVID-19. For guidance on managing these interactions, refer to the FDA EUA fact sheet and the prescribing information for the chemotherapeutic agent. 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. Coadministration contraindicated due to serious and/or life-threatening reactions such as cardiac arrhythmias [see Contraindications (4)]. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue PAXLOVID and initiate appropriate medications and/or supportive care. Reply falcongsr . Both are prescription-only oral antiviral pills given early in illness. oxycodone, Nirmatrelvir/ritonavir ( Paxlovid) has been a game changer for high-risk patients with early COVID-19 symptoms but has significant interactions with commonly used cardiovascular medications, a new . Paxlovid is usually very well-tolerated, he says. For patients with severe kidney diseaseor who are on dialysisor 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. Authentic PAXLOVID, from Pfizer Inc., may include the Pfizer name on the label and will be packaged in 5 aluminum push-through blister cards. ciclesonide, 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. , ombitasvir/paritaprevir/ d Ritonavir-boosted nirmatrelvir may increase concentrations of some chemotherapeutic agents, leading to an increased potential for drug toxicities. The damage is done in long covid and paxlovid probably works by preventing the acute covid infection from getting severe enough to cause long covid. Before coadministering ritonavir-boosted nirmatrelvir and any of these conjugated monoclonal antibodies, refer to the drugs FDA prescribing information and consult with the patients specialist providers as needed. We asked Yale Medicine infectious diseases experts common questions about Paxlovid. 2022. Paxlovid associated with decreased hospitalization rate among adults with COVID-19United States, AprilSeptember 2022. But because many children reach 88 poundsconsidered to be an adult weightthe FDA has allowed extensions of EUAs for medications such as monoclonal antibodies and remdesivir in younger age groups, adds Dr. Topal. For General Product Inquiries call 1877C19PACK (18772197225). Paxlovid's primary side effect is a metallic taste in the mouth during the five days of treatment. For information on using ritonavir-boosted nirmatrelvir in pediatric patients, see Special Considerations in Children, Therapeutic Management of Nonhospitalized Children With COVID-19, and Therapeutic Management of Hospitalized Children With COVID-19. He encourages taking a test even if you think you only have a cold or allergiesand if you can get one. For treatment of atrial fibrillation with low dose apixaban (i.e., 2.5 mg twice daily), continue low dose on a case-by-case basis. budesonide, But this drug hits your liver pretty hard. (Liste des interactions contre- indiques et non recommandes ci -dessous ( RCP / Tableau SFPT - voir QR code) Paxlovid est indiqu dans le traitement du COVID-19 chez les patients adultes non oxygno-rqurant risque accru d'volutionvers une forme svre du COVID-19. Refer to the riociguat product label for more information. There are 5 disease interactions with Paxlovid (nirmatrelvir / ritonavir) which include: Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Sufficient information is available, such as through access to health records less than 12 months old or consultation with a health care provider in an established provider-patient relationship with the individual patient, to assess renal and hepatic function; and. Based on the pharmacokinetics of the drugs in Paxlovid, the differences in metabolism and excretionliver and kidney function specificallyof these drugs in this age group are thought to be similar to that of adults, Dr. Topal says. At the same time, nirmatrelvir and ritonavir are CYP3A substrates; therefore . Serious and unexpected adverse events may occur that have not been previously reported with PAXLOVID use.Risk of Serious Adverse Reactions Due to Drug Interactions: Initiation of PAXLOVID, a CYP3A inhibitor, in patients receiving medications metabolized by CYP3A or initiation of medications metabolized by CYP3A in patients already receiving PAXLOVID, may increase plasma concentrations of medications metabolized by CYP3A. Pfizer reports additional data on PAXLOVID supporting upcoming new drug application submission to U.S. FDA. A dose decrease may be needed for these drugs when coadministered with PAXLOVID and monitoring for adverse events. Coadministration contraindicated due to potential for acute and/or chronic nephrotoxicity [see Contraindications (4)]. If coadministered, refer to individual product label for calcium channel blocker for further information. Avoid concomitant use (eg, toxic epidermal necrolysis [TEN] or Stevens-Johnson syndrome) to its active ingredients (nirmatrelvir or ritonavir) or any other components of the product. Coadministration contraindicated due to potential for dehydration, hypovolemia and hyperkalemia [see Contraindications (4)]. Monitor methadone-maintained patients closely for evidence of withdrawal effects and adjust the methadone dose accordingly. 7 common Paxlovid interactions to know about Paxlovid is made up of two antiviral medications, nirmatrelvir and ritonavir. Like all antivirals, Paxlovid works best early in the course of an illnessin 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. Interactions between Paxlovid and common heart medications are well known, said Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in . Limited published data reports that ritonavir is present in human milk. . PAXLOVID is contraindicated in patients with a history of clinically significant hypersensitivity reactions (eg, toxic epidermal necrolysis [TEN] or Stevens-Johnson syndrome) to its active ingredients (nirmatrelvir or ritonavir) or any other components of the product. A transient decrease in body weight was observed in the nursing offspring of rats administered nirmatrelvir. The authorized adult dosing regimen is expected to result in comparable serum exposures of nirmatrelvir and ritonavir in patients 12 years of age and older and weighing at least 40 kg as observed in adults, and adults with similar body weight were included in the trial EPIC-HR.Systemic exposure of nirmatrelvir increases in renally impaired patients with increase in the severity of renal impairment. Yesno medication is perfect, he says. But in order to qualify for a prescription, you must also have had a positive COVID-19 test result and be at high risk for developing severe COVID-19. Limited published data reports that ritonavir is present in human milk. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue PAXLOVID and initiate appropriate medications and/or supportive care.Hepatotoxicity: Hepatic transaminase elevations, clinical hepatitis, and jaundice have occurred in patients receiving ritonavir. For patients at high risk of venous/arterial thromboembolism (VTE/ATE), consider switching from apixaban to low molecular weight heparin (LMWH); patients with a lower risk of VTE/ATE could be switched to aspirin on a case-by-case basis. Some chemotherapeutic agents may decrease the effectiveness of ritonavir-boosted nirmatrelvir. Consult the following resources for information on identifying and managing drug-drug interactions. The combination of nirmatrelvir and ritonavir is used to treat coronavirus disease 2019 (COVID-19 infection) caused by the SARS-CoV-2 virus in adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) who have mild to moderate symptoms and are at risk of severe disease that could result in hospitalization or death . Available at: Charness ME, Gupta K, Stack G, et al. Ritonavir-boosted nirmatrelvir may be prescribed safely to select patients if an expert in managing the interaction is available and close therapeutic drug monitoring is logistically feasible. In the EPIC-SR study of PAXLOVID (nirmatrelvir [PF-07321332] tablets and ritonavir tablets), the novel primary endpoint of self-reported, . It goes away at the end. Coadministration contraindicated due to potential for serious adverse reactions including hyperkalemia, hypotension, and hyponatremia [see Contraindications (4)]. The safety and effectiveness of PAXLOVID have not been established in pediatric patients. Consult the. Observational studies and the EPIC-HR trial 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.16-19 The frequency, mechanism, and clinical implications of these events are unclear. For patients with a lower risk of arterial or venous thrombosis, clinicians may consider administering low-dose aspirin while rivaroxaban is being withheld. Sufficient information is not available to assess for a potential drug interaction. That means you must either have certain underlying conditions (including cancer, diabetes, obesity, or others) or be 65 or older (more than 81% of COVID-19 deaths occur in in this group). Nirmatrelvir 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. Most people who take Paxlovid should not experience serious side effects, explains Dr. Roberts. Available at: Hiremath S, McGuinty M, Argyropoulos C, et al. Paxlovid (nirmatrelvir and ritonavir) is an oral antiviral combination used to treat COVID-19. "There is a . Available at: Ontario Health. The authorized adult dosing regimen is expected to result in comparable serum exposures of nirmatrelvir and ritonavir in patients 12 years of age and older and weighing at least 40 kg as observed in adults, and adults with similar body weight were included in the trial EPIC-HR. Initiation of medications that inhibit or induce CYP3A may increase or decrease concentrations of PAXLOVID, respectively. For patients with renal and/or hepatic impairment. a Reduced effectiveness of clopidogrel is likely. Viral rebound and the recurrence of COVID-19 symptoms can also occur in the absence of treatment with ritonavir-boosted nirmatrelvir.20,21, The EPIC-HR trial demonstrated a clinical benefit of ritonavir-boosted nirmatrelvir in patients who were not vaccinated and who were at high risk of progressing to severe COVID-19. Looking for U.S. government information and services. Avoid concomitant use with PAXLOVID. We comply with the HONcode standard for trustworthy health information. 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: Since Paxlovid is cleared by the kidneys, dose adjustments may be required for patients with mild-to-moderate kidney disease, explains Dr. Topal. When it applied for FDA authorization, Pfizer presented data from a clinical trial conducted between mid-July and early Decemberin 2021. View interaction reports for Paxlovid (nirmatrelvir / ritonavir) and the medicines listed below. Enter other medications to view a detailed report. The cartonhas 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. j For medications that are not included on the Liverpool COVID-19 Drug Interactions website or in the University of Waterloo/University of Toronto drug interaction guide, refer to the FDA labels for information on coadministering these medications with ritonavir or other strong CYP3A4 and/or P-gp inhibitors (e.g., ketoconazole). Despite its potential for drug-drug interactions, many commonly-used medications can be safely co-administered with Paxlovid . Interacting drugs listed in the Fact Sheet are a guide and not considered a comprehensive list of all possible drugs that may interact with PAXLOVID. If coadministration is necessary, consider reducing the clozapine dose and monitor for adverse reactions. Adjusting the dose of the concomitant medication. Refer to the sofosbuvir/velpatasvir/voxilaprevir product label for further information. Always seek the individual advice of your health care provider with any questions you have regarding a medical condition. However, the lower ethinyl estradiol concentrations are not expected to be clinically significant during the 5 days of therapy. Paxlovid is the latest COVID-19 treatment thats been all over the news. Highly clinically significant. Anaphylaxis and other hypersensitivity reactions have also been reported. However . Find everything you need to know about Paxlovid, including what it is used for, warnings, reviews, side effects, and interactions. an altered or impaired sense of taste. The CDC says a rebound does not mean a person was resistant to Paxlovid, nor does it mean they were reinfected with the virus. An oral SARS-CoV-2 M. Food and Drug Administration. 2021. U Michigan and U Alabama Public Health websites said, Trazodone dosage should be reduced by 50% because Paxlovid can worsen the side . "The side . Paxlovid can interact with several other types of drugs, including organ anti-rejection drugs, medications used to treat heart arrhythmias, and systemic corticosteroids like betamethasone, dexamethasone, and prednisone (these corticosteroid interactions increase the risk for Cushing's syndrome, a disorder involving the hormone cortisol, and . Co-administration with other CYP3A substrates may require a dose adjustment or additional monitoring. 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. 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. nicardipine, 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.11 Some observational studies have shown a benefit of ritonavir-boosted nirmatrelvir in vaccinated individuals who were at high risk of progressing to severe COVID-19.12-15 However, observational studies have inherent limitations. There are no available human data on the use of nirmatrelvir during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. National Institute of Health website said, Trazodone dose should be adjusted while taking Paxlovid (antiviral med for Covid) and then patients be monitored for adverse effect. 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. brexpiprazole, See Pregnancy, Lactation, and COVID-19 Therapeutics for the Panels guidance regarding the use of ritonavir-boosted nirmatrelvir during pregnancy and lactation. The drug, developed by Pfizer, has a lot of positives: It 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. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Available at: Hiremath S, Blake PG, Yeung A, et al. Atorvastatin and rosuvastatin do not need to be held prior to or after completing PAXLOVID. These medications may be coadministered without dose adjustment and without increased monitoring. COVID-19 supplemental clinical guidance #4: nirmatrelvir/ritonavir (Paxlovid) use in patients with advanced chronic kidney disease and patients on dialysis with COVID-19. The darifenacin daily dose should not exceed 7.5 mg when coadministered with PAXLOVID. 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. 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. Otherwise, an alternative therapy for COVID-19 should be considered. It also interacts with common medications, including cholesterol-lowering statins like Lipitor. This is the drug that inhibits the enzyme cytochrome P450, among another. Renal impairment reduces the clearance of nirmatrelvir. Longer treatment courses of ritonavir-boosted nirmatrelvir are not authorized by the current EUA, and there are insufficient data on the efficacy of administering a second course. Shah MM, Joyce B, Plumb ID, et al. Educate patients about potential adverse effects. It's really our first efficacious oral antiviral pill for this virus. Additonal action/monitoring or dosage adjustment is unlikely to be required. Consider consulting with an expert (e.g., a pharmacist or the patients specialist providers) when treating patients who are receiving highly specialized therapies or drugs that are prone to concentration-dependent toxicities, such as certain anticonvulsant, anticoagulant, antiarrhythmic, chemotherapeutic, neuropsychiatric, and immunosuppressant drugs. It may be acceptable to continue clopidogrel if the benefits of using ritonavir-boosted nirmatrelvir outweigh the risk of reduced clopidogrel effectiveness. There are maternal and fetal risks associated with untreated COVID-19 in pregnancy. Find patient medical information for Paxlovid (EUA) oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Many drug-drug interactions between ritonavir-boosted nirmatrelvir and concomitant medications can be safely managed (e.g., with certain statins, calcium channel blockers, or direct oral anticoagulants).