If withholding a statin is not clinically appropriate (e.g., because the patient recently had a myocardial infarction), clinicians can reduce the doses of atorvastatin and rosuvastatin and continue treatment. But, in general, "Paxlovid will have a slew of drug-drug interactions . 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)]. What Are the Side Effects of Paxlovid? - Verywell Health PAXLOVID 9 Drug Interactions - Pfizer Medical Information Refer to the darifenacin product label for more information. Jayk Bernal A, Gomes da Silva MM, Musungaie DB, et al. Paxlovid associated with decreased hospitalization rate among adults with COVID-19United States, April-September 2022. (While the recommendation is to take Paxlovid within five days of symptom onset, participants in the clinical trial took the drug within three days.). Initiation of medications that inhibit or induce CYP3A may increase or decrease concentrations of PAXLOVID, respectively. Apixaban is a substrate of P-gp and is metabolized by CYP3A4. Fact Sheet for Healthcare Providers: Interim Authorization of Paxlovid iloperidone, Published observational studies on ritonavir use in pregnant women have not identified an increase in the risk of major birth defects. Highly clinically significant. Pulmonary hypertension agents (sGC stimulators). Coadministration of midazolam Paxlovid (Nirmatrelvir and Ritonavir) - Side Effects, Interactions Clinicians should be aware that, in some cases, drug-drug interactions with ritonavir-boosted nirmatrelvir may lead to serious or life-threatening drug toxicities. There are 2 alcohol/food interactions with Paxlovid (nirmatrelvir / ritonavir). methylprednisolone, Nirmatrelvir is an oral protease inhibitor with emergency use authorization for the treatment of mild-to-moderate COVID-19. 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 . 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. Refer to the bedaquiline product label for further information. 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. There are theoretical concerns that using a single antiviral agent in these patients may produce antiviral-resistant viruses. Available at: Charness ME, Gupta K, Stack G, et al. 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. Everything You Need to Know If You're Prescribed Paxlovid - CreakyJoints 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. Patients who were randomized within 3 days of symptom onset (n = 1,379) were included in the modified intention-to-treat (mITT) analysis. aripiprazole, Providers should counsel patients about renal dosing instructions. However . Drug interactions. Refer to the sofosbuvir/velpatasvir/voxilaprevir product label for further information. Consult the, Pre-emptive dose adjustment is not required but may be considered based on an individualized assessment of the patients risk for adverse reactions. 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. Paxlovid: A guide for B.C. pharmacists - Province of British Columbia 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. Cases of Toxic Epidermal Necrolysis and Stevens-Johnson syndrome have been reported with ritonavir, a component of PAXLOVID (refer to NORVIR prescribing information). ciclesonide, Dosage adjustment of saxagliptin is recommended. Viral mutations that lead to substantial resistance to nirmatrelvir have been selected for in in vitro studies; the fitness of these mutations is unclear. For Medical Information visit www.pfizermedicalinformation.com or call 18004381985 Ritonavir-boosted nirmatrelvir has significant drug-drug interactions, primarily due to the ritonavir component of the combination. Co-administration with other CYP3A substrates may require a dose adjustment or additional monitoring. 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. 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. But this enzyme directly interacts with alcohol. 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 is not an appropriate therapeutic option based on the authorized Fact Sheet fo r Healthcare Providers or due to potential drug interactions for which recommended monitoring would not . There were no deaths in the ritonavir-boosted nirmatrelvir arm and 13 deaths in the placebo arm. I think it is the beginning of a game-changer, says Scott Roberts, MD, a Yale Medicine infectious diseases specialist. Paxlovid Interactions Checker - Drugs.com Because ritonavir-boosted nirmatrelvir is the only highly effective oral antiviral for the treatment of COVID-19, drug interactions that can be safely managed should not preclude the use of this medication. 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. fluticasone, Deviation from the recommended strategies may be appropriate in certain clinical scenarios. Refer to the quetiapine prescribing information for recommendations. In cases where the risks of the drug interaction outweigh the potential benefits, alternative COVID-19 therapy must be prescribed. Corticosteroids primarily metabolized by CYP3A, betamethasone, Refer to the ombitasvir/paritaprevir/ritonavir and dasabuvir label for further information. For General Product Inquiries call 1877C19PACK (18772197225). 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. 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. Coadministration with eplerenone is contraindicated due to potential for hyperkalemia [see Contraindications (4)]. Reduce dosage when coadministered with PAXLOVID. Public Health Patient Stories Facts About ID Guidelines Practice Guidelines Search Practice Guidelines App . PAXLOVID is not approved for any use, including for use for the treatment of COVID-19. The FDA granted the EUA in December, just as a staggering number of people were infected with Omicron and the need for care skyrocketed, leading to supply issues. They're both necessary parts of treatment. Ritonavir is an inducer of certain drug-metabolizing enzymes and drug transporters. (Paxlovid) can increase the risk of side effects from Xarelto: certain antiepileptic drugs Centers for Disease Control and Prevention. 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. hyperglycemia. Ritonavir-Boosted Nirmatrelvir (Paxlovid), Table: Characteristics of Antiviral Agents, Including Antibody Products, Table: Characteristics of Immunomodulators, Table: Characteristics of Miscellaneous Drugs, Therapeutic Management of Nonhospitalized Children With COVID-19, Drug-Drug Interactions Between Ritonavir-Boosted Nirmatrelvir (Paxlovid) and Concomitant Medications, Liverpool COVID-19 Drug Interactions website, University of Waterloo/University of Toronto drug interaction guide, Therapeutic Management of Nonhospitalized Adults With COVID-19, Pregnancy, Lactation, and COVID-19 Therapeutics, Therapeutic Management of Hospitalized Children With COVID-19, https://www.ncbi.nlm.nih.gov/pubmed/26878082, https://www.ncbi.nlm.nih.gov/pubmed/34726479, https://www.fda.gov/media/155050/download, https://www.ncbi.nlm.nih.gov/pubmed/35263535, https://www.ncbi.nlm.nih.gov/pubmed/35085683, https://www.ncbi.nlm.nih.gov/pubmed/35461811, https://www.ncbi.nlm.nih.gov/pubmed/36476720, https://www.ncbi.nlm.nih.gov/pubmed/35172054, https://www.ncbi.nlm.nih.gov/pubmed/34937145, https://www.ncbi.nlm.nih.gov/pubmed/34914868, https://www.pfizer.com/news/press-release/press-release-detail/pfizer-reports-additional-data-paxlovidtm-supporting, https://www.ncbi.nlm.nih.gov/pubmed/36508742, https://www.ncbi.nlm.nih.gov/pubmed/36001529, https://www.ncbi.nlm.nih.gov/pubmed/36454693, https://www.fda.gov/media/155194/download, https://www.ncbi.nlm.nih.gov/pubmed/36069968, https://www.ncbi.nlm.nih.gov/pubmed/35737946, https://www.ncbi.nlm.nih.gov/pubmed/36069818, https://www.researchsquare.com/article/rs-1720472/v1, https://pubmed.ncbi.nlm.nih.gov/36802755/, https://www.ncbi.nlm.nih.gov/pubmed/35698452, https://emergency.cdc.gov/han/2022/han00467.asp, http://www.bccdc.ca/Health-Professionals-Site/Documents/COVID-treatment/Crushing_Paxlovid.pdf, https://www.ncbi.nlm.nih.gov/pubmed/36723285, https://covid19-druginteractions.org/prescribing_resources, https://www.ontariohealth.ca/sites/ontariohealth/files/2022-04/PaxlovidClinicalGuide.pdf, https://www.ncbi.nlm.nih.gov/pubmed/35680135, The COVID-19 Treatment Guidelines Panel (the Panel) recommends using, For recommendations on using ritonavir-boosted nirmatrelvir in nonhospitalized children with COVID-19, see. To date, the recurrence of COVID-19 symptoms following the use of ritonavir-boosted nirmatrelvir has not been associated with progression to severe COVID-19. Potential Drug Interactions. If coadministration is necessary, consider reducing the clozapine dose and monitor for adverse reactions. Coadministration may increase apixaban concentrations. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.