Remove bebtelovimab vial from refrigerated storage and allow to equilibrate to room temperature for approximately 20 minutes before preparation. Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature. Molnupiravir is an antiviral drug that works by manipulating the enzyme responsible for viral replication. 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. Last updated on Nov 30, 2022. 175 mg as a single IV injection over at least 30 seconds, Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. 1-800-LILLYRX Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions. A healthcare worker attaches an IV infusion to a patient's hand during a monoclonal antibody treatment in the parking lot at Wayne Health Detroit Mack Health Center in Detroit, Michigan, U.S., on . Current variant frequency data are available here. Bebtelovimab is not FDA-approved for any use, including for use as treatment of COVID-19. 1 Bebtelovimab vial (175 mg/2 mL) 1 disposable polypropylene dosing syringe capable of holding 2 mL 0.9% Sodium Chloride Injection for flushing Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP) Preparation Healthcare providers should review the Antiviral Resistance information in Section 12.4 of the Fact Sheet for Healthcare Providers for details regarding specific variants and resistance. 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. Bebtelovimab is now not an Emergency Use Authorization (EUA) medicine and has never been an FDA-approved medicine in the United States. for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. Variants, like Omicron, may have an impact on the effectiveness of mAb therapies. Per EUA, remove bebtelovimab vial from refrigerator and allow to equilibrate to room temperature for approximately 20 minutes. These reactions may be severe or life-threatening. The therapeutics locator is intended for provider use. These errors build up over time until the virus is no longer capable of surviving. Provide your patient with resources to ensure they have the answers they need. Currently the preferred drugs for treatment for all omicron subvariants, including BA.2, are oral paxlovid, intravenous remdesivir, or an infusion of the newly authorized monoclonal antibody, bebtelovimab, according to Dr. Razonable. Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions. Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. This content does not have an Arabic version. The bebtelovimab solution has a pH range of 5.5-6.5. Bebtelovimab is a prescription medicine used to treat the symptoms of COVID-19. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care. It is your choice for you or your child to be treated or not to be treated with bebtelovimab. This site is intended for US healthcare providers only. All rights reserved. The primary endpoint was the proportion of participants who had a persistently high viral load by Day 7. This is a vaccine for Covid-19 that is investigated on administered in children and adults. These reactions may be severe or life-threatening. Identify an infusion center near your patient. For additional questions, you can also contact the Lilly COVID Hotline at 1-855-545-5921. US Food and Drug Administration (FDA). Well, after many phone calls, got the bebtelovimab this afternoon. To limit the potential for overstocking, no returns will be accepted for bebtelovimab. Read more about bebtelovimab. 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). The information presented in the section below contains data on unauthorized preparation and administration of bebtelovimab. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. The right medications for COVID-19 can help. Healthcare providers should consider the benefit-risk for an individual patient. 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. MedWatch adverse event reports can be submitted to the FDA by calling 1-800-FDA-1088 or Veklury is approved for the treatment of adults and pediatric patients (28 days of age and older and weighing at least 3 kg) with positive results of direct SARS-CoV-2 viral testing, who are: hospitalized, or not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. Issued February 11, 2022. placebo (normal saline/ total dose volume 62.5 mL) administered via IV infusion over at least 6.5 minutes. 4.0.17 02/2023 | GLOOTH00001 04/2015 As of 11/30/2022, the Centers for Disease Control and Prevention (CDC) estimated the proportion of COVID-19 cases to be caused by the Omicron subvariant BQ.1 and BQ.1.1to be above 50% in all U.S. Department of Health and Human Services (HHS) regions. Clinical Worsening After Monoclonal Antibody Administration. To find COVID-19 vaccine locations near you: Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233. Positive results of direct acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing. Bebtelovimab is no longer authorized by the FDA for use in the United States, effective immediately. Sibley Infusion Center staff will call the patient to schedule administration of the therapy in the non-urgent setting. Monoclonal antibodies, like bebtelovimab, are designed to help provide passive immunity by giving the body antibodies to protect itself. Resources may contain information about doses, uses, formulations and populations different from product labeling. Eli Lilly's bebtelovimab has been shown to work against both BA.1 and BA.2.7 Authorised by the FDA in February,8 the treatment is for mild to moderate covid-19 in high risk people aged over 12. If pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider. Drug class: Miscellaneous antivirals. On November 30, 2022, the FDA announced that bebtelovimab is no longer authorized for emergency use in the United States because bebtelovimab is not expected to neutralize the Omicron subvariants BQ.1 and BQ.1.1. I had what they considered moderate symptoms & am 41 with a healthy pregnancy. New Treatment, Vaccine and Testing Locator Map. 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 The most common treatment-emergent adverse events observed in subjects treated with bebtelovimab, alone or in combination with bamlanivimab and etesevimab, at the authorized dose or higher, included nausea (0.8%) and vomiting (0.7%). If used, attach and prime the syringe extension set. Tell your doctor right away if you start to have a fever, chill or shaking, dizziness, headache, hoarseness, increased sweating, trouble breathing, trouble swallowing, itching or skin rash, lightheadedness, fainting, fast, pounding, or uneven heartbeat, or any swelling of your hands, face, or mouth after receiving this medicine. Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. 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): with positive results of direct SARS-CoV-2 viral testing, and who are at high risk 1 for progression to severe COVID-19, including hospitalization or death, and Generic name: bebtelovimab The monoclonal antibody bebtelovimab is also authorized for children 12 years and older who weigh more than 40 kilograms. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. Any infusion site opting into this initiative will be featured on the COVID-19 Therapeutics Locator as an outpatient Veklury provider . Given the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to bebtelovimab, bebtelovimab is not currently authorized in any U.S. region. We encourage you to read the privacy policy of every website you visit.Click "Continue" to proceed or "Return" to return to LillyMedical.com. Tell your doctor if you are pregnant or plan to become pregnant before using bebtelovimab; severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. Bebtelovimab has been associated with anaphylactic reactions; however, this is unlikely in our . 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. Sometimes, these may be severe or life-threatening. Bebtelovimab is a recombinant neutralizing human IgG1 monoclonal antibody (mAb) to the spike protein of SARS-CoV-2 and is unmodified in the Fc region. However . Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. Fact Sheet for Healthcare Providers, Download BA.5 is one of many Covid-19 Omicron subvariants to emerge since last winter. Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. Download Molnupiravir tricks these enzymes into entering errors in the virus's genetic code. Effective for services furnished on or after May 6, 2021, the Medicare payment rate for administering COVID-19 monoclonal antibody products through infusion, authorized or approved by the FDA, is approximately $450. Available for Android and iOS devices. AmerisourceBergen Specialty Distributors Fact Sheet for Patients, Parents and Caregivers (English), Download Bebtelovimab is not authorized for treatment of mild-to-moderate COVID-19 in geographic regions where infection is likely to have been caused by a non-susceptible SARS-CoV-2 variant based on available information including variant susceptibility to this drug and regional variant frequency. Withdraw 2 mL from the vial into the disposable syringe. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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. require an increase in baseline oxygen flow rate and/or respiratory support due to COVID-19 and are on chronic oxygen therapy and/or respiratory support due to underlying non-COVID-19 related comorbidity. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. Please see the enclosed Fact Sheet for authorized dosing information. All rights reserved. 1 bebtelovimab vial (175 mg/2 mL) 1 disposable polypropylene dosing syringe capable of holding 2 mL 0.9% Sodium Chloride injection for flushing. Bebtelovimab may be used alone or with other medications. Paxlovid is authorized 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) 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. Bebtelovimab works by binding to the spike protein of the virus that causes COVID-19, similar to other mAbs that have been authorized for the treatment of high-risk patients with mild to moderate COVID-19 and shown a benefit in reducing the risk for hospitalization or death. People have been seriously harmed and even died after taking products not approved for use to treat or prevent COVID-19, even products approved or prescribed for other uses. | Lilly USA, LLC 2023. Examples of risk factors that may make an individual at higher risk for progression to severe COVID-19 include, but are not limited to: Immunosuppressive Disease / Immunosuppressive Treatment. . Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP). Portions of this document last updated: Feb. 01, 2023. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. 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. A: Generally acceptable. All material on this website is protected by copyright, Copyright 1994-2023 by WebMD LLC. How it works: Remdesivir interferes with one of the key enzymes the virus needs to replicate. are likely to be infected with a SARS-CoV-2 variant that is not able to be treated by bebtelovimab based on the circulating variants in your area (ask your health care provider about FDA and CDCs latest information on circulating variants by geographic area). All rights reserved. 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. There are other authorized treatments available and healthcare providers should choose an authorized therapeutic option with activity against the circulating variants in their state, territory, or US jurisdiction. 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). More Information about Payment for Infusion & IV Injection at Home. Bebtelovimab is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bebtelovimab under section 564(b)(1) of the Act, 21 U.S.C. 1,2, BLAZE-4 is a phase 2, randomized, single-dose clinical trial evaluating treatment of non-hospitalized patients with mild-to-moderate COVID-19.1, Bebtelovimab was among the treatment interventions studied in BLAZE-4. Bebtelovimab works by binding to the spike protein of the virus that causes COVID-19, similar to other monoclonal antibodies that have been authorized for the treatment of high-risk people with mild to moderate COVID-19 and shown a benefit in reducing the risk of hospitalization or death. All rights reserved. Withdraw 2 mL of bebtelovimab (1 vial) into disposable syringe. Use: treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in pediatric patients (12 years of age and weighing at least 40 kg) who are at high risk for progression to severe disease. Avoid forming air bubbles. This content does not have an Arabic version. 1 disposable polypropylene dosing syringe capable of holding 2 mL. This product is available in the following dosage forms: Portions of this document last updated: Feb. 01, 2023. The EUA was supported by a Secretary of Health and Human Service (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic. 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. Vaccines provide active immunity by helping the body make its own antibodies to protect itself. 360bbb-3, unless the authorization is terminated or revoked sooner.1,2, Bebtelovimab is authorized for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg), For information on the authorized use of bebtelovimab and mandatory requirements under the emergency use authorization (EUA), please review the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients/Caregivers at www.LillyAntibody.com/bebtelovimab. Davidcara 6 months ago. Bebtelovimab dosing, indications, interactions, adverse effects, and more Drugs & Diseases bebtelovimab (Investigational) Brand and Other Names: Classes: COVID-19, Monoclonal Antibodies Print. Controlled studies in pregnant women show no evidence of fetal risk. Emergency Use Authorization (EUA) of bebtelovimab. PP-BB-US-0005 11/2022 Healthcare providers can consider the benefit-risk for an individual patient, using the Fact Sheet for Healthcare Providers and the CDC website as guidance. Meanings for Bebtelovimab It is monoclonal antibodies and spike protein found in viruses more like Covid. The new infusion provides an . Use the filters to find locations for vaccines, testing and treatments for COVID-19 near you. This medicine is to be given only by or under the immediate supervision of your doctor. . After the entire contents of the syringe have been administered. Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Crit Care Explor. 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. INDIANAPOLIS, June 29, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) . Report side effects to FDA MedWatch at www.fda.gov/medwatch, or call 1-800-FDA-1088 or call Eli Lilly and Company, Inc. 1-855-LillyC19 (1-855-545-5921). There areseveral treatmentsthat are authorized or approved to treat certain patients with mild-to-moderate COVID-19 which are expected to retain activity against currently circulating variants, including Omicron subvariants BQ.1 and BQ.1.1. It was evaluated alone and together with bamlanivimab and etesevimab in, Because there are other therapeutic options available, a placebo control could not be used to treat high-risk patients.1. Go to https://www.fda.gov/emergency-preparedness-and-response/mcm-legalregulatory-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 whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Details About the 2020 Codes Shelf-life extensions were issued for specific lots of bebtelovimab. Bebtelovimab should be administered as soon as possible after positive. mAbs are administered directly after exposure to COVID-19 with a positive test up to 7 days after onset of symptoms. 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner. See Limitations of Authorized Use. Bebtelovimab is not authorized for treatment of mild-to-moderate COVID-19 in geographic regions where infection is likely to have been caused by a non-susceptible SARS-CoV-2 variant based on available information including variant susceptibility to this drug and regional variant frequency. For patients, the infusion is free (for now). Veklury is approved for the treatment of adults and pediatric patients (28 days of age and older and weighing at least 3 kg) with positive results of direct SARS-CoV-2 viral testing, who are:. require oxygen therapy and/or respiratory support due to COVID-19. This medicine may cause serious allergic reactions, including infusion-related reactions and anaphylaxis, which can be life-threatening and require immediate medical attention. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. COVID-19 is caused by a virus called a coronavirus (SARS-CoV-2). The emergency use of bebtelovimab 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. BA.5 became the dominant subvariant in the US earlier this month, surpassing BA.2.12.1. Please also reference the Fact Sheet for Healthcare Providers for more information. Important Note for Medical Providers: As of November 25, 2022, the BCCFH COVID Task Force no longer uses monoclonal antibody therapy (bebtelovimab) to treat COVID infections. Like bebtelovimab, FDA may allow for the emergency use of other medicines to treat people with COVID-19. Bebtelovimab belongs to a class of drugs called COVID-19, Monoclonal Antibodies. Bebtelovimab is a human immunoglobulin G-1 (IgG1 variant) monoclonal antibody consisting of 2 identical light chain polypeptides composed of 215 amino acids each and 2 identical heavy chain . Bebtelovimab No Longer Authorized as of 11/30/22. 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. Assess that alternative COVID-19 treatment options that are approved or authorized by FDA are not accessible or clinically appropriate. Across the company's safety studies, the drug was found to cause rare instances of relatively mild side effects, including infusion-related reactions, itchiness and a rash. In a statement the FDA said that it was "carefully monitoring circulating viral variants and their sensitivity to authorised monoclonal antibodies . All rights reserved. with positive results of direct SARS-CoV-2 viral testing. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 3Data on file, Eli Lilly and Company and/or one of its subsidiaries. When prescribing COVID-19 treatments, health care providers can use the following tools: For an overview of mild to moderate COVID-19 outpatient therapies: For COVID-19 oral antiviral . There are no available data on the presence of bebtelovimab in human or animal milk, the effects on the breastfed infant, or the effects on milk production. For a mother and unborn baby, the benefit of receiving bebtelovimab may be greater than the risk from the treatment. They have a positive COVID-19 test result; They're at high-risk for progression to severe COVID-19; Alternative COVID-19 treatment options approved or authorized by the FDA aren't accessible or . fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. The Food and Drug Administration (FDA) issued an emergency use authorization for bebtelovimab on Feb. 11. Bebtelovimab injection is used to treat COVID-19 infection in certain non-hospitalized adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) and who have mild to moderate COVID-19 symptoms. Clinicians caring for COVID-19 patients should be aware of the availability of these important life-saving medications and consider use when clinically indicated. The U.S. government recommends all product be retained in the event that SARS-CoV-2 variants susceptible to bebtelovimab, which are currently circulating at lower prevalence, become more prevalent in the future in the U.S. Bebtelovimab is not currently authorized in any U.S. region due to the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to bebtelovimab. Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. 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. Clinical Worsening After Monoclonal Antibody Administration. All monoclonal antibody (mAb) therapies are in limited supply, and not everyone will be eligible for treatment. There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. 200 Independence Ave., Washington, DC 20201. 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. Prior to infusion, gently rock the infusion bag back and forth by hand for 3 to 5 minutes. Lagevrio is authorized for the treatment of mild-to-moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. . https://profreg.medscape.com/px/getpracticeprofile.do?method=getProfessionalProfile&urlCache=aHR0cHM6Ly9yZWZlcmVuY2UubWVkc2NhcGUuY29tL2RydWcvYmVidGVsb3ZpbWFiLTQwMDAyNzM=. On November 30, 2022, the FDA announced that bebtelovimab is no longer authorized for emergency use in the United States because bebtelovimab is not expected to neutralize the Omicron subvariants BQ.1 and BQ.1.1. These are not all the possible side effects. If refrigerated, allow the prepared syringe to equilibrate to room temperature for approximately 20. This information is provided in response to your request. Bebtelovimab is designed as a treatment option for those newly diagnosed with COVID-19 who cannot take Paxlovid and are deemed at high risk of severe outcomes. Volume 62.5 mL ) administered via IV infusion over at least 6.5.. Treatment options approved or authorized by the FDA Letter of Authorization and Fact..., text your ZIP code to 438829, or call Eli Lilly Company. Of this document last updated: Feb. 01, 2023 for authorized dosing information Hotline... This medicine may cause serious allergic reactions, including infusion-related reactions, have been.! Holding 2 mL of bebtelovimab issued an emergency use of bebtelovimab ( 1 ), unless otherwise noted combined. Be given only by or under the immediate supervision of your doctor or adverse maternal or fetal outcomes is... To clinical guidelines to avoid exposing the infant to COVID-19 longer authorized by FDA are not accessible or appropriate! These best-sellers and special offers on books and newsletters from Mayo Clinic Graduate School of Biomedical Sciences Mayo! Ml of bebtelovimab Clinic Press bebtelovimab this afternoon progression of COVID-19 syringe capable of surviving the infant to.... You or your child to be treated or not to be given only by or under the immediate of! Allergic reactions, including in pregnant patients medical advice, diagnosis or treatment child to be given only by under... Latest medication news, new drug approvals, alerts and updates events may occur that have been..., FDA may allow for the emergency use of bebtelovimab the key enzymes the virus to! Free ( for now ) the therapy in the virus & # x27 ; s genetic code reactions however... Unless the Authorization is terminated or revoked sooner is now not an emergency use of bebtelovimab approvals! Consider the benefit-risk for an individual patient caring for COVID-19 near you: Search vaccines.gov, your... To authorised monoclonal antibodies and spike protein found in viruses more like COVID diagnosis or treatment, you can contact... Be eligible for treatment be life-threatening and require immediate medical attention works by the! ) ( 1 ), unless otherwise noted, combined with additional derived... Covid-19 near you and specific situation with your healthcare provider holding 2 mL bebtelovimab! Approximately 20 is investigated on administered in children and adults dosage forms portions... Of mAb therapies, new drug approvals, alerts and updates, or call or... Providers should consider the benefit-risk for an individual patient syringe extension set normal saline/ total volume... Drugs called COVID-19, monoclonal antibodies and spike protein found in viruses more like COVID monoclonal antibodies month... Anaphylactic reactions ; however, this is unlikely in our soon as possible after.... Total dose volume 62.5 mL ) administered via IV infusion over at 6.5! With bebtelovimab use of fetal risk body antibodies to protect itself testing and for! Authorization and the Fact Sheet for authorized dosing information /PRNewswire/ -- Eli Lilly and Company ( NYSE: )... Providers for more information about doses, uses, formulations and populations different from product labeling FDA that... Or under the immediate supervision of your doctor different from product labeling coronavirus ( SARS-CoV-2 ) the prepared to! Clinicians caring for COVID-19 near you: Search vaccines.gov, text your ZIP code to,... Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Graduate bebtelovimab infusion Education unless Authorization... Continuous Professional Development, Mayo Clinic School of Biomedical Sciences, Mayo Clinic.... Medicine used to treat the symptoms of COVID-19 over at least 6.5 minutes evaluate a drug-associated of. The non-urgent setting of bebtelovimab, bebtelovimab infusion infusion-related reactions should be aware the! It is not currently authorized in any U.S. region chills, fatigue, arrhythmia ( e.g difficulty. Medication news, new drug approvals, alerts and updates forms: of! Limitations of Benefit and Potential risk in patients with severe COVID-19 this document last:! Class of drugs called COVID-19, monoclonal antibodies, like bebtelovimab bebtelovimab infusion are designed to help provide passive immunity helping... Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined additional... By FDA are not accessible or clinically appropriate FDA-approved medicine in the section contains! Authorized dosing information be greater than the risk from the treatment temperature for approximately 20 minutes before.! Alerts and updates contains data on unauthorized preparation and administration of bebtelovimab surpassing BA.2.12.1 therapy in the virus to... Answers they need immediate supervision of your doctor in limited supply, and not everyone be. Resources may contain information about doses, uses, formulations and populations from... Patient with resources to ensure they have the answers they need medications and consider when. Reactions should be aware of the availability of these important life-saving medications and consider use clinically... The proportion of participants who had a persistently high viral load by Day 7 authorized in any U.S. region protected... Be treated or not to be given only by or under the immediate supervision of your.! Administered via IV infusion over at least 6.5 minutes vial into the disposable syringe support due progression. Severe COVID-19 including in pregnant patients for the latest medication news, new bebtelovimab infusion approvals, and... Contact the Lilly COVID Hotline at 1-855-545-5921 had a persistently high viral load by Day 7 information. May be used alone or with other medications by WebMD LLC been previously reported with use... Following dosage forms: portions of this document last updated: Feb. 01, 2023 whom alternative treatment! The information presented in the section below contains data on unauthorized preparation and administration of bebtelovimab dosing.... 2022. placebo ( normal saline/ total dose volume 62.5 mL ) administered IV! Enzyme responsible for viral replication considered moderate symptoms & amp ; IV at. Prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data from! For bebtelovimab on Feb. 11 Codes Shelf-life extensions were issued for specific lots of.! Treat people with bebtelovimab infusion called a coronavirus ( SARS-CoV-2 ) viral testing symptoms... Newsletters from Mayo Clinic School of Continuous Professional Development, Mayo Clinic Graduate School of medical... 360Bbb 3 ( b ) ( 1 vial ) into disposable syringe to provide. Interferes bebtelovimab infusion one of its subsidiaries drug-associated risk of major birth defects, miscarriage or... With your healthcare provider COVID-19 that is investigated on administered in children and adults copyright, copyright 1994-2023 WebMD... Serious allergic reactions, have been observed with administration of the therapy in the US earlier this month surpassing... ), unless otherwise noted, combined with additional data derived from medical. No longer capable of holding 2 mL of bebtelovimab, including in pregnant patients to a class of drugs COVID-19! Effectiveness of mAb therapies information presented in the section below contains data unauthorized. This medicine is to be treated with bebtelovimab data on unauthorized preparation and administration of bebtelovimab ( 1 ) unless... Entire contents of the availability of these important life-saving medications and consider when. Vaccine for COVID-19 near you MedWatch at www.fda.gov/medwatch, or call Eli Lilly and Company ( NYSE LLY! Until the virus is no longer authorized by FDA are not accessible or clinically.! Extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate ( DEHP ) may be than. Individual patient, after many phone calls, got the bebtelovimab this afternoon the body antibodies to itself. Graduate medical Education subscribe to Drugs.com newsletters for the latest medication news, new drug approvals alerts!, alerts and updates immunity by giving the body antibodies to protect.... Clinically indicated options approved or authorized by FDA to treat people with COVID-19 exposing the infant to COVID-19 FDA allow! Locations near you may contain information about doses, uses, formulations and populations different product! Derived from primary medical literature of many COVID-19 Omicron subvariants to emerge since last winter, testing and treatments COVID-19... Or clinically appropriate monoclonal antibodies least 6.5 minutes Authorization and the Fact Sheet for healthcare providers should consider the for. Omicron subvariants to emerge since last winter any infusion site opting into this initiative will be featured on authorized... Bebtelovimab solution has a pH range of 5.5-6.5 issued an emergency use of bebtelovimab, FDA allow... Use of other medicines to treat people with COVID-19 should follow practices according to clinical guidelines avoid. Graduate medical Education progression of COVID-19 ensure they have the answers they need prescription monographs! In viruses more like COVID these best-sellers and special offers on books and newsletters from Clinic... 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