FDA Letter of Authorization. For patients, the infusion is free (for now). The drug, called bebtelovimab from Eli Lilly, is a monoclonal therapy meant for COVID-19 patients as young as 12 who are at high risk for getting severely ill and who were recently infected, to keep them from getting even sicker and keep them out of the hospital. . Individuals 12 and older who are considered high risk of getting very sick from COVID-19, with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom other COVID-19 treatment options approved or authorized by FDA are not available or clinically appropriate and may qualify for a monoclonal antibody treatment. This site is intended for US healthcare providers only. Please turn on JavaScript and try again. How do you prepare, administer, and monitor bebtelovimab for treatment of COVID-19? for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. The new infusion provides an . Like bebtelovimab, FDA may allow for the emergency use of other medicines to treat people with COVID-19. How do I get bebtelovimab? Lilly USA, LLC 2022. (1-800-545-5979), HCP Fact Sheet | Patient & Caregiver Fact Sheet | FDA Authorization Letter. Medscape Education, Critical Concepts for the Treatment of COVID-19 Variants, 2001http://www.medscape.com/mtv/covid19-treatment-ous-s01/e01, encoded search term (bebtelovimab) and bebtelovimab, Drug Companies Face COVID Cliff in 2023 as Sales Set to Plummet, FDA Pulls Authorization for AstraZeneca's COVID-19 Treatment Evusheld, COVID-19 Monoclonal Antibody Treatments No Longer Effective, Your Unwanted Internal Pets: Intestinal Parasites (Other Than Nematodes), EU Regulator Recommends Against Approval for Merck's COVID Pill for Adults, COVID-19: Treatment Advances in a Global Pandemic, Rapid Rx Quiz: COVID-19 Treatment Updates. When issuing an EUA under the COVID-19 public health emergency, the FDA determined, among other things, that based on the total amount of scientific evidence available, including data from adequate and well-controlled clinical trials, it is reasonable to believe that the product may be effective for diagnosing, treating, or preventing COVID-19, or a serious or life-threatening disease or condition caused by COVID-19; that the known and potential benefits of the product, when used to diagnose, treat, or prevent such disease or condition, outweigh the known and potential risks of such product; and that there are no adequate, approved and available alternatives. Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. Fact Sheet for Patients, Parents and Caregivers (Spanish), Download If pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider. Sometimes, these may be severe or life-threatening. You will be observed by your healthcare provider for at least 1 hour after you receive bebtelovimab. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. PP-BB-US-0005 11/2022 This product is available in the following dosage forms: Portions of this document last updated: Feb. 01, 2023. Current variant frequency data are available here. Bebtelovimab was not authorized for use in people who: The United States FDA had made bebtelovimab available under an emergency access mechanism called an Emergency Use Authorization (EUA). If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care. There is a code for the injectable antiviral drug as well . Hypersensitivity reactions occurring more than 24 hours after the injection have also been reported with the use of SARS-CoV-2 monoclonal antibodies under Emergency Use Authorization. More Information about Payment for Infusion & IV Injection at Home. Has been diagnosed with mild to moderate COVID-19 with positive results of direct SARS-CoV-2 viral testing. Bebtelovimab is available for purchase by U.S. states/territories, hospitals, and a broad set of other providers through AmerisourceBergen Specialty Distributors (ASD). Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. Clinical worsening of COVID-19 after administration of SARS-CoV-2 monoclonal antibody treatment has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmia (e.g., atrial fibrillation, sinus tachycardia, bradycardia), fatigue, and altered mental status. Identify an infusion center near your patient. pre-syncope, syncope), dizziness, and diaphoresis. Bebtelovimab: 175 mg bebtelovimab. Bebtelovimab is now not an Emergency Use Authorization (EUA) medicine and has never been an FDA-approved medicine in the United States. Fact Sheet for Healthcare Providers, Download Bebtelovimab (EUA issued February 11, 2022, latest update October 27, 2022). This medicine is to be given only by or under the immediate supervision of your doctor. MedWatch adverse event reports can be submitted to the FDA by calling 1-800-FDA-1088 or Before receiving treatment, tell your healthcare provider about all your or your childs medical conditions including if you or your child: Interactions between bebtelovimab and other drugs are unlikely. On November 30, 2022 the FDA announced bebtelovimab is not currently authorized for emergency use in the U.S. at this time because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of other SARS-CoV-2 monoclonal antibodies and could occur with administration of bebtelovimab. Mayo Clinic on Incontinence - Mayo Clinic Press, NEW The Essential Diabetes Book - Mayo Clinic Press, NEW Ending the Opioid Crisis - Mayo Clinic Press, FREE Mayo Clinic Diet Assessment - Mayo Clinic Press, Mayo Clinic Health Letter - FREE book - Mayo Clinic Press. The Food and Drug Administration (FDA) issued an emergency use authorization for bebtelovimab on Feb. 11. Bebtelovimab may be used alone or with other medications. There are limited clinical data available for bebtelovimab. All rights reserved. In low-risk patients, treatment arms included, bebtelovimab 175mg alone, added to normal saline (total dose volume 62.5 mL) administered via IV infusion over at least 6.5 minutes, OR, bebtelovimab 175mg, bamlanivimab 700 mg and etesevimab 1400 mg administered together (total dose volume 62.5 mL) via IV infusion over at least 6.5 minutes, OR. All of these criteria must be met to allow for the product to be used in the treatment of patients during the COVID-19 pandemic. Prescribers should monitorCDC regional variant frequency dataand refer to the Antiviral Resistance information in the Healthcare Provider Fact Sheet for details regarding specific variants and resistance against SARS-CoV-2 variants in your area, particularly Omicron subvariants BQ.1 and BQ.1.1. This medicine may cause serious allergic reactions, including infusion-related reactions and anaphylaxis, which can be life-threatening and require immediate medical attention. Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. Bebtelovimab continues to maintain neutralization against all known variants of interest and concern. Bebtelovimab injection is used to treat mild to moderate coronavirus disease 2019 (COVID-19) in patients with positive results of direct SARS-CoV-2 testing, who are at high risk for progression to severe COVID-19 (eg, hospitalization, death), and for whom other treatments are not available or appropriate. Oral Paxlovid (ritonavir-boosted nirmatrelvir) In a clinical trial, Paxlovid reduced the risk of hospitalization and death by 89% in unvaccinated outpatients with COVID-19 at higher risk of severe disease. All rights reserved. The treatment showed efficacy against early strains of Omicron, but it proved to be ineffective against Omicron sublineages BQ.1 and BQ.1.1. The EUA for bebtelovimab is for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms, which is about 88 pounds) with a positive COVID-19 test, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. 1 bebtelovimab vial (175 mg/2 mL) 1 disposable polypropylene dosing syringe capable of holding 2 mL 0.9% Sodium Chloride injection for flushing. Note that reporting inventory and administration of all U.S. government-procured and distributed supply of bebtelovimab remains a requirement until all U.S. government-procured bebtelovimab is consumed (a provider sites inventory is depleted). Infusion-related reactions If used, attach and prime the syringe extension set. These errors build up over time until the virus is no longer capable of surviving. This website also contains material copyrighted by 3rd parties. Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. Meanings for Bebtelovimab It is monoclonal antibodies and spike protein found in viruses more like Covid. Bebtelovimab is authorized to be administered for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg): The following provides essential safety information on the unapproved use of bebtelovimab under the Emergency Use Authorization. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. The drug, bebtelovimab, is authorized for people 12 years and older who test positive for COVID-19 and are at high risk of hospitalization or death. require an increase in baseline oxygen flow rate and/or respiratory support due to COVID19 and are on chronic oxygen therapy and/or respiratory support due to underlying non-COVID-19 related comorbidity. Bebtelovimab may only be administered in settings in which healthcare providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary. Bebtelovimab belongs to a class of drugs called COVID-19, Monoclonal Antibodies. Bebtelovimab, pronounced: beb-te-LOV-i-mab. Dosage form: injection for intravenous use Infusion-related reactions, which may occur up to 24 hours after the injection, have been observed in clinical trials of bebtelovimab when administered with other monoclonal antibodies and may occur with use of bebtelovimab alone. Side effects: There is limited information known about the safety and effectiveness of bebtelovimab for the treatment of mild-to-moderate COVID-19, according to the FDA fact sheet. Infusion-related reactions, which may occur up to 24 hours after the injection, have been observed in clinical trials of bebtelovimab when administered with other monoclonal antibodies and may occur with use of bebtelovimab alone. 3, Thebebtelovimabdosing instructions do not specify a particular brand of disposable dosing syringe or extension set to be used and Lilly does not provide guidance in this regard.3, Thereareno known incompatibilities betweenbebtelovimaband availabledisposable dosing syringes in the market.3, The type of IV line used to administer bebtelovimab is not specified (via a PICC line, central line, port, etc. Common side effects include infusion-related reactions, pruritus, and rash. Generally, scientists are able to develop antibody treatments faster than they are able to develop vaccines. Similarly, bebtelovimab may reduce the bodys immune response to a vaccine for SARS-CoV-2. All rights reserved. were randomized 1:1:1 to receive a single infusion of a combination of 3 anti-SARS-CoV-2 mAbs (bamlanivimab, etesevimab, and bebtelovimab; n = 127), bebtelovimab alone (n = 125), or placebo (n = 128). My doc said because I was on other meds and supplements that this would be safer than paxlovid because Of interactions. atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, vasovagal reactions (e.g. The Food and Drug Administration (FDA) said it's to be administered only when other . Add a meaning Add Bebtelovimab details Phonetic spelling of Bebtelovimab Add phonetic spelling Synonyms for Bebtelovimab Add synonyms I think we now have a better understanding of how to use monoclonal antibodies to treat COVID-19. Bebtelovimab FDA Emergency Use Authorization letter. In the BLAZE-4 clinical trial, bebtelovimab was administered via IV infusion or IV push.3, In the Phase 1 portion of the study, faster infusion rates of bebtelovimab or bebtelovimab administered with bamlanivimab and etesevimab were not associated with an increasing number and/or severity of treatment-emergent adverse events.3, Informed by this data, bebtelovimab was administered to patients at high-risk for severe disease with an IV injection of at least 30 seconds while bebtelovimab with bamlanivimab and etesevimab was administered over at least 6.5 minutes.3, The study data from BLAZE-4 supports administration via IV push over 30 seconds, which is the authorized administration for bebtelovimab under the EUA.1,3, Considering bebtelovimab can be administered over 30 seconds, IV push of the medication saves considerable time relative to the preparation and administration of an IV infusion and may facilitate greater treatment capacity and flexibility throughout infusion centers.3, There is no sufficient data available to support the administration of bebtelovimab via subcutaneous or intramuscular dosing.3. Is for End User 's use only and may not be sold, redistributed or otherwise used commercial! Supplements that this would be safer than paxlovid because of interactions life-threatening and require immediate attention. Belongs to a vaccine for SARS-CoV-2, have been observed with administration of bebtelovimab, including pregnant... Other SARS-CoV-2 monoclonal antibodies and could occur with administration of bebtelovimab, including in pregnant patients side effects include reactions... Healthcare provider for at least 1 hour after you receive bebtelovimab ; IV Injection at Home these criteria must met. ; s to be administered only when other to be used alone or with other medications of. Or under the immediate supervision of your doctor up over time until the virus is no longer capable of.! I was on other meds and supplements that this would be safer than paxlovid because of.. By FDA are not accessible or clinically appropriate constitutes your agreement to Terms... 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