paxlovid interactions

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. Initiation of medications that inhibit or induce CYP3A may increase or decrease concentrations of PAXLOVID, respectively. These interactions may lead to: Consult Table 1 of the Fact Sheet for Healthcare Providers for clinically significant drug interactions, including contraindicated drugs. Stader F, Khoo S, Stoeckle M, et al. Clinicians should be aware that, in some cases, drug-drug interactions with ritonavir-boosted nirmatrelvir may lead to serious or life-threatening drug toxicities. co-administration of colchicine with PAXLOVID is contraindicated (see. Reply falcongsr . 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. Bottom line, a glass won't kill you.. immediately. i Do not coadminister this medication with ritonavir-boosted nirmatrelvir in patients with hepatic or renal impairment. Coadministration contraindicated due to serious and/or life-threatening reactions such as cardiac arrhythmias [see Contraindications (4)]. 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 . For anyone who experiences a rebound, the CDC advises people restart isolation for five days, following its isolation guidance. 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 providerpatient 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. [Originally published: March 10, 2022. Dosage reduction for midazolam should be considered, especially if more than a single dose of midazolam is administered. If concomitant use with PAXLOVID is necessary, consider a dosage reduction of the narcotic analgesic and monitor patients closely at frequent intervals. Ritonavir-boosted nirmatrelvir is contraindicated in this setting because the delayed offset of enzyme induction may reduce the concentrations of nirmatrelvir and ritonavir, rendering the treatment ineffective against SARS-CoV-2. Updated: Feb. 3, 2023]. For General Product Inquiries call 1877C19PACK (18772197225). Stopping lopinavir/ritonavir in COVID-19 patients: duration of the drug interacting effect. Paxlovids clinical trials took place before Omicron and later subvariants like BA.5 became predominant, but Pfizer says the drug works against the highly contagious variant. Concentrations of apixaban are expected to increase due to CYP3A4 and P-gp inhibition by ritonavir. atorvastatin, rosuvastatin. In some cases, the recommendation is to avoid co-administration. If coadministered, dose adjustment of the immunosuppressant and monitoring for immunosuppressant concentrations and immunosuppressant-associated adverse reactions is recommended. Shah MM, Joyce B, Plumb ID, et al. ritonavir (as Paxlovid), a strong cytochrome P450 (CYP) 3A4 inhibitor and pharmacokinetic boosting agent that has been used to boost HIV protease inhibitors. 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) can increase the risk of side effects from Xarelto: certain antiepileptic drugs Hammond J, Leister-Tebbe H, Gardner A, et al. Serious interactions with other medicines: Many medicines interact with PAXLOVID. 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. Because of the potential for significant drug-drug interactions with concomitant medications, this regimen may not be the optimal choice for all patients. By clicking this link, you will be redirected to Pfizer Medical Information. Published observational studies on ritonavir use in pregnant women have not identified an increase in the risk of major birth defects. The potential for drug interactions with Paxlovid is a significant concern, especially in older patients with multiple medical conditions. Moderately clinically significant. 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. Trazodone and Paxlovid interaction. Co-administration with other CYP3A substrates may require a dose adjustment or additional monitoring.Nirmatrelvir and ritonavir are CYP3A substrates; therefore, drugs that induce CYP3A may decrease nirmatrelvir and ritonavir plasma concentrations and reduce PAXLOVID therapeutic effect.Pregnancy: 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. Some chemotherapeutic agents may decrease the effectiveness of ritonavir-boosted nirmatrelvir. There are no data on combining ritonavir-boosted nirmatrelvir with other antiviral therapies to treat nonhospitalized patients with COVID-19. Patients on ritonavir-containing HCV regimens should continue their treatment as indicated. Symptom and viral reboundin untreated SARS-CoV-2 infection. The safety and effectiveness of PAXLOVID have not been established in pediatric patients. Paxlovid associated with decreased hospitalization rate among adults with COVID-19United States, April-September 2022. by clicking here. . . However, lovastatin and simvastatin should be switched to an alternative statin. Patients should be counseled about ritonavir-boosted nirmatrelvirs drug-drug interaction potential and the signs and symptoms of potential adverse effects. Studies outside of the laboratory have since confirmed Paxlovids effectivenessamong people who have been vaccinated. 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. You have to take Paxlovid within five days of developing symptoms. When you give a patient Tamiflu beyond that, it doesnt really change the course of their flu, Dr. Roberts says. 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. Systemic exposure of nirmatrelvir increases in renally impaired patients with increase in the severity of renal impairment. These medications may be coadministered without dose adjustment and without increased monitoring. Gottlieb RL, Vaca CE, Paredes R, et al. Withhold these medications during ritonavir-boosted nirmatrelvir treatment and for at least 23 days after treatment completion. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Consult the following resources for information on identifying and managing drug-drug interactions. Ritonavir-boosted nirmatrelvir may be used in patients who are hospitalized for a diagnosis other than COVID-19, provided they have mild to moderate COVID-19 (i.e., those who do not require supplemental oxygen), are at high risk of progressing to severe disease, and are within 5 days of symptom onset. Molnupiravir for oral treatment of COVID-19 in nonhospitalized patients. Paxlovid (nirmatrelvir/ritonavir), along with PAXLOVID must be prescribed by a licensed healthcare provider and supplied by a government-approved pharmacy or medical facility. 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. g Withhold lovastatin and simvastatin for at least 12 hours before initiating ritonavir-boosted nirmatrelvir, during treatment, and for 5 days after treatment completion. Yesno medication is perfect, he says. Therefore, concerns about the recurrence of symptoms should not be a reason to avoid using ritonavir-boosted nirmatrelvir.20,22,23. These interactions may lead to: Clinically significant adverse reactions, potentially leading to severe, life-threatening, or fatal events from greaterexposures of concomitant medications, Clinically significant adverse reactions from greater exposures of PAXLOVID, Loss of therapeutic effect of PAXLOVID and possible development of viral resistance. a Reduced effectiveness of clopidogrel is likely. Minimally clinically significant. A total of 2,246 patients enrolled in the trial. If coadministration is necessary, reduce quetiapine dose and monitor for quetiapine-associated adverse reactions. Refer to the sofosbuvir/velpatasvir/voxilaprevir product label for further information. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Available at: Ontario Health. PAXLOVID consists of tablets for a 5-day oral treatment regimen, with morning and evening doses. Published observational studies on ritonavir use in pregnant women have not identified an increase in the risk of major birth defects. Nirmatrelvir (PF-07321332) is an orally bioavailable 3C-like protease (3CL PRO) inhibitor that is the subject of clinical trial NCT04756531. Paxlovidan antiviral medicationis a tool we still have left. 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. f The use of another COVID-19 therapy may need to be considered. It's really our first efficacious oral antiviral pill for this virus. have been reported with PAXLOVID. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan. dexamethasone, A transient decrease in body weight was observed in the nursing offspring of rats administered nirmatrelvir. PDE5 inhibitors can be coadministered with ritonavir-boosted nirmatrelvir in patients with erectile dysfunction, though the dose of the PDE5 inhibitor should be adjusted. Submit adverse event and medication error reports to FDA MedWatch using one of the following methods: In addition, please provide a copy of all FDA MedWatch forms to: and may increase plasma concentrations of drugs that are primarily metabolized by CYP3A. a This list is primarily based on the most common medication searches by U.S. users on the Liverpool COVID-19 Drug Interactions website between January 1 and December 31, 2022 (internal communication, January 2023). Available at: BC COVID Therapeutics Committee (CTC) COVID Therapy Review and Advisory Working Group (CTRAWG). See the American Society of Transplantation statement for more information. 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. The emergency use of Paxlovid is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID- 19 pandemic under Section 564 (b) (1) of the Act, 21 U.S.C. Greasley SE, Noell S, Plotnikova O, et al. (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., Pharmacist Instruction Sheet for Patients with Moderate Renal Impairment, Important Prescribing & Dispensing Letter to Healthcare Professionals (Aug. 2022), Fact Sheet for Patients, Parents, and Caregivers, PAXLOVID is not authorized for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19, 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 providerpatient relationship with the individual patient, to assess renal and hepatic function; and. "There is a . The FDA EUA for ritonavir-boosted nirmatrelvir suggests that individuals who use these types of contraceptive products should consider using an additional nonhormonal contraceptive method. Refer to individual product labels for more information. 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. The usual apixaban treatment should be resumed 3 days after the last dose of nirmatrelvir/ritonavir. Published studies with ritonavir are insufficient to identify a drug-associated risk of miscarriage. 2022. No dosage adjustment is needed in patients with mild renal impairment. 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. Contact One of the Following Groups portal for adverse events associated with Paxlovid. 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. Paxlovid (nirmatrelvir and ritonavir) is a combination antiviral agent that has been shown to significantly reduce the risk of hospitalization or death from COVID in high-risk adults when administered within 5 days of symptom onset. Box 1 above lists select outpatient medications that are not expected to have clinically relevant interactions with ritonavir-boosted nirmatrelvir. Otherwise, an alternative therapy for COVID-19 should be considered. An official website of the United States government. Secure .gov websites use HTTPSA lock (LockA locked padlock) or https:// means youve safely connected to the .gov website. Enter other medications to view a detailed report. Clinically significant adverse reactions, potentially leading to severe, life-threatening, or fatal events from greater exposures of concomitant medications, Loss of therapeutic effect of PAXLOVID and possible development of resistance. felodipine, 2023. 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.