By clicking this link, you will be redirected to Pfizer Medical Information. The University Health Network/Kingston Health Sciences Centre is an additional resource for evaluating drug-drug interactions for chemotherapeutic agents. 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 Combined P-gp and strong CYP3A4 inhibitors increase blood levels of apixaban and increase the risk of bleeding. Coadministration of eletriptan within at least 72 hours of PAXLOVID is contraindicated due to potential for serious adverse reactions including cardiovascular and cerebrovascular events [see Contraindications (4)]. Published observational studies on ritonavir use in pregnant women have not identified an increase in the risk of major birth defects. Rebound phenomenon after nirmatrelvir/ritonavir treatment of coronavirus disease 2019 (COVID-19) in high-risk persons. The 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. For General Product Inquiries call 1877C19PACK (18772197225). Find patient medical information for Paxlovid (EUA) oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. in the PAXLOVID group (1%) that occurred at a greater frequency (5 subject difference) than in the placebo group were dysgeusia (6% and <1%, respectively), diarrhea (3% and 2%), hypertension (1% and <1%), and myalgia (1% and <1%). fluticasone, No pharmacokinetic or safety data are available for this patient population. The usual apixaban treatment should be resumed 3 days after the last dose of nirmatrelvir/ritonavir. cariprazine Withhold these medications during ritonavir-boosted nirmatrelvir treatment and for at least 23 days after treatment completion. PAXLOVID TM (nirmatrelvir tablets; ritonavir tablets) has not been approved, but has been authorized for emergency use by FDA under an EUA, 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 (COVID-19) and who are at high risk for progression to severe COVID-19, including . Clinical trials are needed to determine whether combination therapy has a role in the treatment of COVID-19. 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). Vangeel L, Chiu W, De Jonghe S, et al. Additional resources include NIH recommendations for drug-drug interactions between PAXLOVID and UpToDate PAXLOVID drug information. felodipine, Patients with hypertension, coronary artery disease, atrial fibrillation, and hyperlipidemia should pay close attention to what follows if they are considering starting the drug as they likely will need to . When you give a patient Tamiflu beyond that, it doesnt really change the course of their flu, Dr. Roberts says. Avoid concomitant use Authentic PAXLOVID, from Pfizer Inc., may include the Pfizer name on the label and will be packaged in 5 aluminum push-through blister cards. Prescriptions should specify the numeric dose of each active ingredient within PAXLOVID. Therefore, concerns about the recurrence of symptoms should not be a reason to avoid using ritonavir-boosted nirmatrelvir.20,22,23. Refer to the clinical comments in the Paxlovid product information for each of the medicines listed below. 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. Modification of other medications is needed due to a potential drug interaction. Coadministration of ritonavir is required to . Do not use PAXLOVID with avanafil because a safe and effective avanafil dosage regimen has not been established. Coadministration contraindicated due to potential for myopathy including rhabdomyolysis [see Contraindications (4)]. Paxlovidan antiviral medicationis a tool we still have left. However, the lower ethinyl estradiol concentrations are not expected to be clinically significant during the 5 days of therapy. Drug interactions. (See also Liverpool's Quick Guide on Interactions with Outpatient Medicines and Paxlovid ) 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. Otherwise, an alternative therapy for COVID-19 should be considered. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. An additional, nonhormonal method of contraception should be considered during the 5 days of PAXLOVID treatment and until one menstrual cycle after stopping PAXLOVID. An official website of the United States government. Sufficient information is available, such as through access to health records, patient reporting of medical history, or consultation with a health care provider in an established provider-patient relationship with the individual patient, to obtain a comprehensive list of medications (prescribed and non-prescribed) that the patient is taking to assess for potential drug interaction. But this drug hits your liver pretty hard. The other is ritonavir, a drug that was once used to treat HIV/AIDS but is now used to boost levels of antiviral medicines. 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. for clearance and for which elevated concentrations are associated with serious and/or life-threatening reactions: Antiarrhythmic: amiodarone, dronedarone, flecainide, propafenone, quinidine, Benign prostatic hyperplasia agents: silodosin, Cardiovascular agents: eplerenone, ivabradine, HMG-CoA reductase inhibitors: lovastatin, simvastatin, Microsomal triglyceride transfer protein inhibitor: lomitapide, Migraine medications: eletriptan, ubrogepant, Mineralocorticoid receptor antagonists: finerenone, Sedative/hypnotics: triazolam, oral midazolam, Serotonin receptor 1A agonist/serotonin receptor 2A antagonist: flibanserin, Vasopressin receptor antagonists: tolvaptan, Anticonvulsant: carbamazepine, phenobarbital, primidone, phenytoin, Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor. If you suspect the product you have received may be counterfeit, contact us at 18004381985or visit www.pfizersafetyreporting.com. 2022. Its important to note that Paxlovid (the brand name for the drug, which is made up of two generic medicationsnirmatrelvir and ritonavir) isnt the only pill available to treat COVID-19. Molnupiravir for oral treatment of COVID-19 in nonhospitalized patients. Katzenmaier S, Markert C, Riedel KD, et al. In June, the CDC releasedguidance 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. 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. k Dexamethasone exposure is expected to increase 2.60-fold when dexamethasone is coadministered with ritonavir-boosted nirmatrelvir.5 Clinicians should weigh the risks and benefits of continuing the patients normal dose of dexamethasone (while monitoring for AEs) versus decreasing the dose. Refer to the individual product label for more information. oxycodone Longer treatment courses of ritonavir-boosted nirmatrelvir are not authorized by the current FDA Emergency Use Authorization (EUA), and there are insufficient data on the efficacy of administering a second treatment course in cases where SARS-CoV-2 viral rebound is suspected. Management of Drug Interactions With Nirmatrelvir/Ritonavir (Paxlovid): Resource for Clinicians Facebook Twitter LinkedIn Email. 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. Available at: Takashita E, Kinoshita N, Yamayoshi S, et al. 2022. Clinicians should be aware that, in some cases, drug-drug interactions with ritonavir-boosted nirmatrelvir may lead to serious or life-threatening drug toxicities. Sufficient information is not available to assess renal and hepatic function. Copyright 2023 The University of Liverpool. It's used when there are contraindications for Paxlovid, such as liver/kidney issues, allergies, or medication interactions. Most people who take Paxlovid should not experience serious side effects, explains Dr. Roberts. After looking closely at the drug-drug interactions listed for the new oral COVID-19 drug, Paxlovid, I realized that a large percentage of my patients are taking medications on the list.. Providers should counsel patients about renal dosing instructions. To prevent COVID-19. The FDA authorized Paxlovid for people ages 12 and older who weigh at least 88 pounds. Coadministration contraindicated due to potential for hepatotoxicity and gastrointestinal adverse reactions [see Contraindications (4)]. clopidogrel active metabolite. dihydroergotamine,ergotamine,methylergonovine, dihydroergotamine ergotamine methylergonovine. 2023. (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. 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. This guide to COVID-19 medications and drug-drug interactions contains a helpful interaction checker, which provides a recommendation for management of DDIs in addition to a description of the primary data. Drug-Drug Interactions Between Ritonavir-Boosted Nirmatrelvir (Paxlovid) and Concomitant Medications. CYP3A4 inhibition occurs rapidly, with maximum inhibition occurring within 48 hours of ritonavir initiation.1 After treatment is completed and ritonavir is discontinued, 70% to 90% of CYP3A4 inhibition resolves within 2 to 3 days.2 The time to resolution of inhibition varies based on factors such as the patients age; therefore, resolution may take longer in some individuals, such as in adults of advanced age. Paxlovid associated with decreased hospitalization rate among adults with COVID-19United States, April-September 2022. Soares H, Baniecki ML, Cardin R, et al. Looking for U.S. government information and services. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for PAXLOVID and any potential adverse effects on the breastfed infant from PAXLOVID or from the underlying maternal condition. amlodipine, Refer to the sofosbuvir/velpatasvir/voxilaprevir product label for further information. University of Liverpool. Imai M, Ito M, Kiso M, et al. When it applied for FDA authorization, Pfizer presented data from a clinical trial conducted between mid-July and early Decemberin 2021. Please refer to the FDA EUA fact sheet for ritonavir-boosted nirmatrelvir and the prescribing information for the chemotherapeutic agent and consult the patients specialist provider. Published studies with ritonavir are insufficient to identify a drug-associated risk of miscarriage. Determining the time course of CYP3A inhibition by potent reversible and irreversible CYP3A inhibitors using a limited sampling strategy. By selecting continue, you acknowledge you have a medical question regarding a potential drug interaction. Pfizer recommends reporting it to them on its portal for adverse events associated with Paxlovid. Enter other medications to view a detailed report. PAXLOVID Fact Sheet for Healthcare Providers. Jayk Bernal A, Gomes da Silva MM, Musungaie DB, et al. 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. Studies outside of the laboratory have since confirmed Paxlovids effectivenessamong people who have been vaccinated. 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. Available at: Food and Drug Administration. l Patients should take ritonavir-boosted nirmatrelvir at least 3 hours after receipt of brincidofovir. Coadministration of sildenafil with PAXLOVID is contraindicated due to the potential for sildenafil associated adverse events, including visual abnormalities, hypotension, prolonged erection, and syncope [see Contraindications (4)]. Share sensitive information only on official, secure websites. Deviation from the recommended strategies may be appropriate in certain clinical scenarios. Drug-Drug Interactions. Coadministration of ubrogepant with PAXLOVID is contraindicated due to potential for serious adverse reactions [see Contraindications (4)]. The mean age was 46 years, 51% of the patients were men, and 72% were White. 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. Therapeutic brief: crushing nirmatrelvir/ritonavir (Paxlovid). PAXLOVID TM (nirmatrelvir tablets; ritonavir tablets) has not been approved, but has been authorized for emergency use by FDA under an EUA, 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 (COVID-19) and who are at high risk for progression to severe COVID-19, including . If coadministered, dose adjustment of the immunosuppressant and monitoring for immunosuppressant concentrations and immunosuppressant-associated adverse reactions is recommended. . Symptom and viral reboundin untreated SARS-CoV-2 infection. Its always been the Achilles heel of these antiviral drugs that most people dont get testedor they dont have access to testing.. There are 5 disease interactions with Paxlovid (nirmatrelvir / ritonavir) which include: hemophilia. Nirmatrelvir and ritonavir is an inhibitor of CYP3A and may increase drugs primarily metabolized by CYP3A 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. An overview of severe acute respiratory syndrome-coronavirus (SARS-CoV) 3CL protease inhibitors: peptidomimetics and small molecule chemotherapy. Refer to the quetiapine prescribing information for recommendations. 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). elexacaftor/tezacaftor/ivacaftor The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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. University of Liverpool. ticagrelor, 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. 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. 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. Monitor for increased PAXLOVID or HCV drug adverse events with concomitant use [see Dosage and Administration (2.4)]. These medications may be coadministered without dose adjustment and without increased monitoring. 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).