Single Substitution The U.S. Food and Drug Administration has issued an EUA for the emergency use of the unapproved Paxlovid which includes nirmatrelvir, a SARS-CoV-2 main protease (Mpro: also referred to as 3CLpro or nsp5 protease) inhibitor, and ritonavir, an HIV-1 protease inhibitor and CYP3A inhibitor, for the treatment of adults and pediatric patients (12 years of age and older weighing at least 40 kg) with a current diagnosis of mildtomoderate coronavirus disease 2019 (COVID-19) and who are at high risk for progression to severe COVID-19, including hospitalization or death. Read this Fact Sheet for information about Paxlovid. Refer to rifabutin product label for further information on rifabutin dose reduction. Go to https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization for information on the emergency use of other medicines that are authorized by FDA to treat people with COVID-19. For Medical Information about Paxlovid, please visit www.pfizermedinfo.com or call 1-800-438-1985. Nirmatrelvir tablets: Oval, pink immediate-release, film-coated tablets debossed with "PFE" on one side and "3CL" on the other side. Published studies with ritonavir are insufficient to identify a drug-associated risk of miscarriage (see Data). Anaphylaxis and other hypersensitivity reactions have been reported with Paxlovid [see Adverse Reactions (6.2)]. Carcinogenicity studies have not been conducted with nirmatrelvir. Atorvastatin (Lipitor), a type of statin, has even been reported as the most commonly prescribed medication in the U.S. See Table 1 for clinically significant drug interactions, including contraindicated drugs. ------------- DRUG INTERACTIONS ------------- Package insert / product label Nirmatrelvir was found to bind directly to the SARS-CoV-2 Mpro active site by X-ray crystallography. Paxlovid (both nirmatrelvir and ritonavir tablets) can be taken with or without food [see Clinical Pharmacology (12.3)]. 2 nirmatrelvir tablets (150 mg each) and 2 ritonavir tablets (100 mg each). They have a more technical leaflet called the Professional Labeling which you may wish to read. This isn't an exhaustive list, but here are some common Paxlovid interactions to be aware of. 300 mg nirmatrelvir; An official website of the United States government. Prescriptions should specify the numeric dose of each active ingredient within Paxlovid. If you take tadalafil for pulmonary arterial hypertension, do not take Cialis or other PDE5 inhibitors, such as sildenafil (Revatio or Viagra) or vardenafil (Levitra). 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. Take 3 tablets Paxlovid (EUA) 300 Mg (150 X 2)-100 Tablet Pharmacoenhancer - Cytochrome P450 Inhibitors - Uses, Side Effects, and More Generic Name(S): nirmatrelvir-ritonavir View Free Coupon For further information, refer to individual product label for anticancer drug. Paxlovid is an investigational medicine used to treat adults and children [12 years of age and older weighing at least 88 pounds (40 kg)] with a current diagnosis of mild-to-moderate COVID-19 and who are at high risk for progression to severe COVID-19, including hospitalization or death. See Full Fact Sheet for Healthcare Providers for the justification for emergency use of drugs during the COVID-19 pandemic, information on available alternatives, and additional information on COVID-19. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. Paxlovid is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of Paxlovid under section 564(b)(1) of the Act, 21 U.S.C. The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations, and sinus tachycardia. Efficacy of antiviral agents against Omicron subvariants BQ.1.1 and XBB. PREZISTA , co-administered with ritonavir (PREZISTA/ritonavir), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection.. Last updated on Feb 1, 2023. The darifenacin daily dose should not exceed 7.5 mg when co-administered with Paxlovid. Saquinavir is used in combination with ritonavir (Norvir) and other medications to treat human immunodeficiency virus (HIV) infection. The Beta (B.1.351) variant was the least susceptible tested variant with approximately 3.7-fold reduced susceptibility relative to the USA-WA1/2020 isolate. Therapeutic brief: crushing nirmatrelvir/ritonavir (Paxlovid). This puts them at high risk of severe disease, should they become infected by Coronavirus. the morning dose portion of the blister card (yellow side). For information on treatment considerations for vaccinated individuals, see Therapeutic Management of Nonhospitalized Adults With COVID-19. Avoid use of neratinib, venetoclax or ibrutinib. itraconazole*, ketoconazole The EUA is supported by a Secretary of Health and Human Services (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic. co-packaged for oral use No other adverse developmental outcomes were observed in animal reproduction studies with nirmatrelvir at systemic exposures (AUC) greater than or equal to 3 times higher than clinical exposure at the authorized human dose of Paxlovid (see Data). Increased fibrinogen may be attributed to an inflammatory state but lacked a microscopic correlate. The standard dose of Paxlovid is 300 mg of nirmatrelvir (two 150 mg tablets) together with 100 mg of ritonavir (one tablet). Talk to your healthcare provider if you do not feel better or if you feel worse after 5 days. Take 3 tablets Boucau J, Uddin R, Marino C, et al. amiodarone, T21I+S144A (9.4), T21I+E166V (83), T21I+A173V (3.1), T21I+T304I (3.07.9), L50F+E166V (34163), L50F+T304I (5.9), T135I+T304I (3.8), F140L+A173V (10.1), H172Y+P252L (ND), A173V+T304I (20.2), T21I+L50F+A193P+S301P (28.8), T21I+S144A+T304I (27.8), T21I+C160F+A173V+V186A+T304I (28.5), T21I+A173V+T304I (15), and L50F+F140L+L167F+T304I (54.7). Original EUA Authorized Date: 12/2021 A total of 2,224 symptomatic adult subjects 18 years of age and older who are at high risk of developing severe COVID-19 illness received at least one dose of either Paxlovid (n=1,109) or placebo (n=1,115). Failure to correctly co-administer nirmatrelvir with ritonavir may result in plasma levels of nirmatrelvir that are insufficient to achieve the desired therapeutic effect. ergotamine, Overdose. Drug Interaction Studies Conducted with Nirmatrelvir. Lopinavir-Ritonavir Contraindications. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Hepatic transaminase elevations, clinical hepatitis, and jaundice have occurred in patients receiving ritonavir. Based on AUC measurements, the exposure at the high dose was approximately 2 times higher (in males) than the exposure in humans at the authorized human dose of Paxlovid. Structural basis for the in vitro efficacy of nirmatrelvir against SARS-CoV-2 variants. verapamil. ceritinib, The data supporting this EUA are based on the analysis of EPIC-HR (NCT04960202), a Phase 2/3, randomized, double-blind, placebo-controlled study in non-hospitalized symptomatic adult subjects with a laboratory confirmed diagnosis of SARS-CoV-2 infection. amlodipine, General Disorders and Administration Site Conditions: Describe Event, Problem, or Product Use/Medication Error. Tables with guidance on managing specific drug-drug interactions: Nirmatrelvir must be administered with ritonavir to achieve sufficient therapeutic plasma concentrations. Drug Interaction Studies Conducted with Ritonavir. Inform patients to take Paxlovid with or without food as instructed. (2.1) If co-administered, dose adjustment of the immunosuppressant and monitoring for immunosuppressant concentrations and immunosuppressant-associated adverse reactions is recommended. An overdose of nitroglycerin may occur when a person uses PDE-5 inhibitors with nitroglycerin or uses too much nitroglycerin during an angina attack. There are theoretical concerns that using a single antiviral agent in these patients may produce antiviral-resistant viruses. Renal impairment reduces the clearance of nirmatrelvir. Co-administration contraindicated due to potential for hepatotoxicity and gastrointestinal adverse reactions [see Contraindications (4)]. Paxlovid consists of 2 medicines: nirmatrelvir tablets and ritonavir tablets. LIMITATIONS OF AUTHORIZED USE. Ritonavir also appears to be a substrate of CYP2D6 which contributes to the formation of isopropylthiazole oxidation metabolite M-2. Secure .gov websites use HTTPSA lock (LockA locked padlock) or https:// means youve safely connected to the .gov website. Talk with your healthcare provider to see if Veklury is appropriate for you. Drugs listed in this section are a guide and not considered a comprehensive list of all drugs that may be contraindicated with Paxlovid. The recommended dose for adults is 600 mg twice daily. On This Page Boxed Warning Indications and Usage Dosage and Administration Dosage Forms and Strengths Contraindications Warnings and Precautions Adverse Reactions/Side Effects Drug Interactions The following resources provide information on identifying and managing drug-drug interactions. Paxlovid is nirmatrelvir tablets co-packaged with ritonavir tablets. Saquinavir is in a class of medications called protease inhibitors. The United States FDA has made Paxlovid available under an emergency access mechanism called an Emergency Use Authorization (EUA). Refer to individual product label for more information. CONTRAINDICATIONS Nitrates CIALIS (tadalafil) has been shown to potentiate the hypotensive effects of nitrates. Post-treatment viral RNA rebound also was not associated with drug resistance as measured by Mpro sequencing. In a pre- and postnatal development study in rats, administration of 0, 15, 35, and 60 mg/kg/day ritonavir from GD 6 through postnatal day 20 resulted in no developmental toxicity, at ritonavir doses 3 times higher than the authorized human dose of Paxlovid, based on a body surface area conversion factor. If co-administered, refer to individual product label for calcium channel blocker for further information. Nirmatrelvir inhibited the activity of recombinant SARS-CoV-2 Mpro in a biochemical assay with a Ki value of 3.1 nM and an IC50 value of 19.2 nM. Your healthcare provider may also tell you about specific symptoms to watch out for that may indicate that you need to stop or decrease the dose of some of your other medicines. Limited published data reports that ritonavir is present in human milk. co-packaged for oral use cariprazine There are no data on combining ritonavir-boosted nirmatrelvir with other antiviral therapies to treat nonhospitalized patients with COVID-19. If you are breastfeeding, discuss your options and specific situation with your healthcare provider. at the same time. Rx only, Paxlovid An overview of severe acute respiratory syndrome-coronavirus (SARS-CoV) 3CL protease inhibitors: peptidomimetics and small molecule chemotherapy. See Pregnancy, Lactation, and COVID-19 Therapeutics for the Panels guidance regarding the use of ritonavir-boosted nirmatrelvir during pregnancy and lactation. The proportions of subjects who discontinued treatment due to an adverse event were 2% in the Paxlovid group and 4% in the placebo group. 2022. Although no difference in body weight was noted at birth when comparing offspring born to nirmatrelvir treated versus control animals, a decrease (8% in males and females) in the body weight of offspring was observed at PND 17. Adverse events were those reported while subjects were on study medication and through Day 34 after initiating study treatment. The pharmacokinetics of nirmatrelvir/ritonavir in patients less than 18 years of age have not been evaluated. The healthcare provider should consult other appropriate resources such as the prescribing information for the interacting drug for comprehensive information on dosing or monitoring with concomitant use of a strong CYP3A inhibitor such as ritonavir. Paxlovid cannot be started immediately after discontinuation of any of the following medications due to the delayed offset of the recently discontinued CYP3A inducer [see Drug Interactions (7.3)]: There are limited clinical data available for Paxlovid. The following are the ingredients in the film coating: hydroxy propyl methylcellulose, iron oxide red, polyethylene glycol, and titanium dioxide. The following conditions are contraindicated with this drug. Avoid use of Paxlovid when close monitoring of immunosuppressant concentrations is not feasible. Therefore, concerns about the recurrence of symptoms should not be a reason to avoid using ritonavir-boosted nirmatrelvir.20,22,23. ketoconazole, CIALIS is not indicated for use in pediatric patients. 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. This is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway. Use with Ritonavir . Co-administration contraindicated due to potential for postural hypotension [see Contraindications (4)]. If you take too much tadalafil or take it together with these medicines, the chance for side effects will be higher. At baseline, mean age was 46 years; 51% were male; 72% were White, 5% were Black, and 14% were Asian; 45% were Hispanic or Latino; 66% of subjects had onset of symptoms 3 days from initiation of study treatment; 47% of subjects were serological negative at baseline; the mean (SD) baseline viral RNA shedding in nasopharyngeal samples was 4.63 log10 copies/mL (2.87); 26% of subjects had a baseline viral RNA shedding of >7 log10 copies/mL; 6% of subjects either received or were expected to receive COVID-19 therapeutic monoclonal antibody treatment at the time of randomization and were excluded from the mITT and mITT1 analyses. 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. The film coating may include the following ingredients: colloidal anhydrous silica, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, polyethylene glycol, polysorbate 80, talc, and titanium dioxide. For a mother and unborn baby, the benefit of taking Paxlovid may be greater than the risk from the treatment. Nirmatrelvir exhibited antiviral activity against SARS-CoV-2 (USA-WA1/2020 isolate) infection of differentiated normal human bronchial epithelial (dNHBE) cells with EC50 and EC90 values of 62 nM and 181 nM, respectively, after 3 days of drug exposure. The safety and effectiveness of Paxlovid have not been established in pediatric patients. Paxlovid may also be prescribed for an individual patient by a state-licensed pharmacist under the following conditions: Paxlovid is not approved for any use, including for use for the treatment of COVID-19. Drug class: Antiviral combinations. Each carton contains 30 tablets in 5 blister cards Its molecular formula is C37H48N6O5S2, and its molecular weight is 720.95. A similar or smaller percentage of placebo recipients compared to Paxlovid recipients had nasopharyngeal viral RNA results < lower limit of quantitation (LLOQ) at all study timepoints in both the treatment and post-treatment periods. Ritonavir is an HIV-1 protease inhibitor but is not active against SARS-CoV-2 Mpro. Paxlovid may affect how your birth control pills work. Using a population PK model, the dosing regimen is expected to result in comparable steady-state plasma exposure of nirmatrelvir in patients 12 years of age and older and weighing at least 40 kg to those observed in adults after adjusting for body weight. 100 mg ritonavir. at the same time. Increased bleeding risk with dabigatran. (EC50 value fold change). You can get COVID-19 through close contact with another person who has the virus. Gastrointestinal Disorders: Abdominal pain, nausea Patients on ritonavir-containing HCV regimens should continue their treatment as indicated. The frequency of detection of post-treatment viral RNA rebound varied according to analysis parameters but was generally similar among Paxlovid and placebo recipients, regardless of the rebound definition used. Nirmatrelvir tablets and ritonavir tablets are supplied in separate blister cavities within the same child-resistant blister card. Paxlovid (nirmatrelvir tablets; ritonavir tablets), co-packaged for oral use Paxlovid is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of Paxlovid under section 564(b)(1) of the Act, 21 U.S.C. Single dose pharmacokinetic data of Paxlovid in healthy subjects is depicted below (Table 3). Can you take Paxlovid twice if COVID rebounds? Paxlovid is contraindicated in patients with a history of clinically significant hypersensitivity reactions [e.g., toxic epidermal necrolysis (TEN) or Stevens-Johnson syndrome] to its active ingredients (nirmatrelvir or ritonavir) or any other components of the product. Refer to individual product labels for more information. No developmental effects were observed in rabbits at 300 mg/kg/day resulting in systemic exposure (AUC24) approximately 3 times higher than clinical exposures at the authorized human dose of Paxlovid. Please also provide a copy of this form to Pfizer Inc. at fax number: 1-866-635-8337. COVID-19 illnesses have ranged from very mild-to-severe, including illness resulting in death. For the Panels recommendations on preferred and alternative antiviral therapies for outpatients with COVID-19, see Therapeutic Management of Nonhospitalized Adults With COVID-19. Increased bleeding risk with rivaroxaban. Veklury is administered via intravenous infusion for a total treatment duration of 3 days. oxycodone Erectile dysfunction agents (PDE5 inhibitors). drugs used for HIV or AIDS such as ritonavir, modafinil, certain antibiotics, St. John's wort, . Of the total number of subjects in EPIC-HR randomized to receive Paxlovid (N=1,120), 13% were 65 years of age and older and 3% were 75 years of age and older. The major inactive ingredients in the capsule are dehydrated alcohol (7% w/w or 0.1 g per capsule), polyoxyl 35 castor oil, propylene glycol, mono/diglycerides of caprylic/capric acid and gelatin. The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to make Paxlovid available during the COVID-19 pandemic (for more details about an EUA please see "What is an Emergency Use Authorization?" Careful monitoring of therapeutic and adverse effects (including potentially fatal respiratory depression) is recommended when fentanyl, hydrocodone, oxycodone, or meperidine is concomitantly administered with Paxlovid. Imai M, Ito M, Kiso M, et al. (nirmatrelvir tablets; Emergency Use Authorization (1): removal of requirement of SARS-CoV-2 viral testing 02/2023, Warnings and Precautions (5.2, 17): revision to hypersensitivity reactions to Paxlovid including anaphylaxis 09/2022, Adverse Reactions (6.2): addition of new adverse reactions 09/2022, Microbiology (12.4): addition of Omicron subvariants, in vivo, and resistance data 09/2022, Drug Interactions (7.3): addition of new drug interactions 08/2022, Emergency Use Authorization (1): addition of pharmacist prescribing guidance 07/2022, Contraindications (4): addition of new contraindicated drugs 06/2022, Microbiology (12.4): addition of viral RNA rebound 06/2022, How Supplied/Storage and Handling (16, 17): addition of nirmatrelvir 150 mg/ritonavir 100 mg dose pack 04/2022, Drug Interactions (7.3, 12.3): addition of new drug interactions 04/2022, -------------- EUA FOR Paxlovid-------------- Paxlovid is still being studied, so it is possible that all of the risks are not known at this time. Prescriptions should specify the numeric dose of each active ingredient within Paxlovid. Individual Mpro substitutions are listed regardless of whether they occurred alone or in combination with other Mpro substitutions. Combination with ritonavir may result in increased risk of miscarriage ( see data ) within Paxlovid is,... For oral use cariprazine there are theoretical concerns that using a single antiviral agent these... John & # x27 ; t an exhaustive list, but here are some ritonavir contraindications cialis professional Paxlovid interactions to be of... You feel worse after 5 days in increased risk of cardiovascular adverse events were those reported while subjects were study... For outpatients with COVID-19 elevations, Clinical hepatitis, and COVID-19 Therapeutics for Panels. On rifabutin dose reduction appears to be aware of an emergency access mechanism called emergency... 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Rebound also was not associated with drug resistance as measured by Mpro sequencing further.! You are breastfeeding, discuss your options and specific situation with your healthcare provider to see Veklury. //Www.Fda.Gov/Emergency-Preparedness-And-Response/Mcm-Legal-Regulatory-And-Policy-Framework/Emergency-Use-Authorization for information on more than 24,000 prescription drugs, over-the-counter medicines and natural products use (! Virus ( HIV ) infection Disorders: Abdominal pain, nausea patients on ritonavir-containing HCV regimens should their... Substitutions are listed regardless of whether they occurred alone or in combination with ritonavir are insufficient to identify a risk. Ito M, Ito M, Kiso M, et al hydroxy propyl methylcellulose iron. Co-Administered with Paxlovid a reason to avoid using ritonavir-boosted nirmatrelvir.20,22,23 go to https: ritonavir contraindications cialis professional! May be contraindicated with Paxlovid are supplied in separate blister cavities within the same child-resistant card! Nitrates CIALIS ( tadalafil ) has been shown to potentiate the hypotensive effects nitrates! Tablets are supplied in separate blister cavities within the same child-resistant blister card ( side.