COVID-19 illnesses have ranged from very mild (including some with no reported symptoms) to severe, including illness resulting in death. We encourage you to read the privacy policy of every website you visit.Click "Continue" to proceed or "Return" to return to LillyMedical.com. 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). Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab and mandatory requirements of the EUA. The following provides essential safety information on the unapproved use of bebtelovimab under the Emergency Use Authorization. Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. Molnupiravir is an antiviral drug that works by manipulating the enzyme responsible for viral replication. Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. These are not all the risk factors. We comply with the HONcode standard for trustworthy health information. pre-syncope, syncope), dizziness, and diaphoresis. A: Generally acceptable. Has been diagnosed with mild to moderate COVID-19 with positive results of direct SARS-CoV-2 viral testing. 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. They can now be given through subcutaneous or intramuscular injections rather than as an infusion at a hospital. 1Fact sheet for healthcare providers. . Bebtelovimab is available for purchase by U.S. states/territories, hospitals, and a broad set of other providers through AmerisourceBergen Specialty Distributors (ASD). Well, after many phone calls, got the bebtelovimab this afternoon. If used, attach and prime the syringe extension set. 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. 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. Monoclonal antibodies, such as bebtelovimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation. All rights reserved. Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. This medicine is to be given only by or under the immediate supervision of your doctor. Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. Healthcare professionals must follow aseptic technique directive provided by their institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative. Please confirm that you would like to log out of Medscape. Thebebtelovimabinjectionshould be prepared by a qualified healthcare professional using aseptic technique to prevent contamination from pathogens.3, Bebtelovimabis neither hazardous nor toxic when spilled.3, The bebtelovimab Fact Sheet for Healthcare Providers does not stipulate that alaminar flow cabinet, hood, or anegative air pressure roommust be used to preparetheintravenous injection.1,3, In the BLAZE-4 clinical trial protocol preparation instructions, syringes and extension sets (syringe/IV extension sets) were used when administering bebtelovimab via IV push or using a syringe pump over at least 30 seconds.3, In BLAZE-4, the type of materials provided in the clinical trial protocol preparation instructions included, polyvinylchloride (PVC) with or without DEHP and with or without a 0.20/0.22 m polyether sulfone (PES) filter, polyethylene with or without a 0.20/0.22 m PES filter.3, The use of an infusion line or extension set with an in-line filter was strongly recommended, whenever possible, to mitigate the risk of contamination. Infusion reactions have happened during and within 24 hours after the infusion. A. You can get COVID19 through contact with another person who has the virus. These reactions may be severe or life-threatening. All material on this website is protected by copyright, Copyright 1994-2023 by WebMD LLC. Bebtelovimab continues to maintain neutralization against all known variants of interest and concern.
Bebtelovimab (Intravenous Route) Before Using Proper Use Products and services Precautions Drug information provided by: IBM Micromedex It is very important that your doctor check you or your child's progress closely while you are receiving this medicine to make sure that it is working properly. Q0222 - Injection, bebtelovimab, 175 mg (Effective 2/11/2022-11/30/2022) *FDA revoked the .
Current variant frequency data are available here. 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. . 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. (4) Paxlovid is given twice daily for 5 days, starting as soon as possible . See Limitations of Authorized Use. Issued February 11, 2022. Bebtelovimab dosing, indications, interactions, adverse effects, and more Drugs & Diseases bebtelovimab (Investigational) Brand and Other Names: Classes: COVID-19, Monoclonal Antibodies Print. 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. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. Identify an infusion center near your patient. Monoclonal antibodies, such as bebtelovimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation. 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 . Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care.
Bebtelovimab will be given as an injection through a vein (intravenously or IV) over at least 30 seconds. Fact Sheet for Patients, Parents and Caregivers (English), Download [2] 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. 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. 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. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Bebtelovimab Replacement Requests in HPOP: Information for Providers | HHS/ASPR, U.S. Department of Health & Human Services, FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region, FDA updates the fact sheet for Bebtelovimab, Shelf-Life Extension for Specific Lots of Bebtelovimab, COVID-19 Therapeutics Locator for Providers, COVID-19 Therapeutics Thresholds by Jurisdiction, Therapeutics Clinical Implementation Guide, Side-by-Side Outpatient Therapeutics Overview, Information for LongTerm Care Facilities. Bebtelovimab No Longer Authorized as of 11/30/22. Please turn on JavaScript and try again. This content does not have an Arabic version. pre-syncope, syncope), dizziness, and diaphoresis. Discard the vial if the solution is cloudy, discolored, or visible particles are observed. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. Due to these data, use of bebtelovimab is NOT authorized in any U.S. state We will provide further updates and consider additional action as new information becomes available. 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. Call the infusion center to confirm product availability. High risk for progression to severe COVID-19, including hospitalization or death, Other COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate, Any severity or dialysis: No dosage adjustment recommended, Not expected to impact bebtelovimab pharmacokinetics, since monoclonal antibodies (mAbs) with molecular weight >69 kDa are known not to undergo renal elimination, For use in geographic regions where infection is likely to have been caused by a nonsusceptible SARS-CoV-2 variant based on available information including variant susceptibility, For patients who require oxygen therapy and/or respiratory support due to COVID-19, For patients who require increase in baseline oxygen flow rate and/or respiratory support due to COVID-19 and are on chronic oxygen therapy and/or respiratory support owing to underlying non-COVID-19related comorbidity, Obesity/overweight (body mass index [BMI] 25 kg/m2 [adults]; BMI 85th percentile for age/sex based on CDC growth charts [if aged 12-17 years]), Immunosuppressive disease or immunosuppressive treatment, Cardiovascular disease (including congenital heart disease) or hypertension, Chronic lung diseases (eg, chronic obstructive pulmonary disease [COPD], moderate-to-severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension), Neurodevelopmental disorders (eg, cerebral palsy) or other conditions that confer medical complexity (eg, genetic or metabolic syndromes, severe congenital anomalies), Having a medical-related technological dependence (eg, tracheostomy, gastrostomy, positive-pressure ventilation [not related to COVID 19]), EUA is not limited to the medical conditions or factors listed above; for additional information on medical conditions and factors associated with increased risk for progression to severe COVID, see the, 12 years (weight 40 kg): 175 mg as a single IV injection over at least 30 seconds, Serious hypersensitivity reaction, including anaphylaxis, observed with other COVID-19 mAbs, and may occur with bebtelovimab, Hypersensitivity reactions occurring >24 hr after infusion observed with bebtelovimab when administered with other mAbs, Infusion-related reactions may be severe or life-threatening, If signs and symptoms occur, immediately discontinue IV infusion, and initiate appropriate medications and/or supportive care, Infusion-related reactions reported, including fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (eg, 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, dizziness, and diaphoresis, Administer appropriate medication/supportive care if infusion-related reactions occurs, Clinical worsening of COVID-19 after administration reported; signs or symptoms may include fever, hypoxia or increased respiratory difficulty, arrhythmia (eg, atrial fibrillation, sinus tachycardia, bradycardia), fatigue, and altered mental status, Some of these events required hospitalization, Unknown if these events were related to mAbs or were due to progression of COVID-19, Treatment benefit not observed in patients hospitalized with COVID-19, Monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation, Who require oxygen therapy for COVID-19, OR, Who require an increase in baseline oxygen flow rate because of COVID-19 (in those on long-term oxygen therapy for underlying non-COVID-19related comorbidity), Circulating SARS-CoV-2 viral variants may be associated with resistance to monoclonal antibodies, Prescribing clinicians should consider prevalence of resistant variants in their area, Health care providers should review antiviral resistance information provided by state and local health departments, Variant proportions circulating in the US can be monitored at the, Not renally excreted or metabolized by CYP450 enzymes, Interactions with concomitant renally excreted drugs or drugs that are CYP450 substrates, inducers, or inhibitors are unlikely, COVID-19 in pregnancy is associated with adverse maternal and fetal outcomes, including preeclampsia, eclampsia, preterm birth, premature rupture of membranes, venous thromboembolic disease, and fetal death, 1 disposable polypropylene dosing syringe capable of holding 2 mL, Syringe extension set: Polycarbonate and polyvinylchloride without di-ethylhexylphthalate (DEHP), Refrigerate at 2-8C (36-46F) in original carton to protect from light, Do not freeze, shake, or expose to direct light, Refrigerated at 2-8C (36-46F) for up to 24 hr, OR, Room temperature at 20-25C (68-7F) for up to 7 hr, If refrigerated, allow prepared syringe to equilibrate to room temperature for ~20 minutes before administration. Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. 1For information on medical conditions and factors associated with increased risk for progression to severe COVID-19, see the Centers for Disease Control and Prevention (CDC) website: https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html. If refrigerated, allow the prepared syringe to equilibrate to room temperature for approximately 20. Bebtelovimab, pronounced: beb-te-LOV-i-mab. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care. 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. Download One dose given per day for 3 days. Codes are available for the introduction or infusion of Remdesivir, Sarilumab, Tocilizumab, or other therapeutic substances, as well as the transfusion of convalescent plasma specifically for the treatment of COVID-19. Signs and symptoms of infusion-related reactions may include: Administer appropriate medications and/or supportive care if an infusion-related reaction occurs. Use the yellow button below to refer patients directly for infusion treatment. The EUA has since been revoked on November 30, 2022. Lilly USA, LLC 2022. Before sharing sensitive information, make sure you're on a federal government site.
Last updated on Nov 30, 2022. Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions. Bebtelovimab was an investigational medicine used under Emergency Use Authorization (EUA) for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and children (12 years of age and older weighing at least 88 pounds [40 kg]): There is limited information known about the safety and effectiveness of using bebtelovimab for the treatment of mild-to-moderate COVID-19. Fact Sheet for Healthcare Providers, Download There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. require oxygen therapy and/or respiratory support due to COVID-19. 0.9% Sodium Chloride injection for flushing. 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. for whom other COVID-19 treatment options approved or authorized by FDA are not available or clinically appropriate. This site is intended for US residents aged 18 or older. The information presented in the section below contains data on unauthorized preparation and administration of bebtelovimab. Healthcare providers should consider the benefit-risk for an individual patient. There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Copyright 2023 IBM Watson Health. The new infusion provides an . It is possible that bebtelovimab could interfere with your body's own ability to fight off a future infection of SARS-CoV-2. 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 .
Variants, like Omicron, may have an impact on the effectiveness of mAb therapies. All rights reserved. This site is intended for US healthcare providers only. To ensure there is no break in availability of bebtelovimab to states/territories and providers, HHS has coordinated with Lilly to enable the transition from US government distributed supply to commercially available supply. 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. Older people and people of all ages with severe, or long lasting (chronic) medical conditions like heart disease, lung disease, diabetes, and obesity, for example, seem to be at higher risk of being hospitalized for COVID-19. Authorized Use and Important Safety Information, Fact Sheet for Patients, Parents and Caregivers (English), Fact Sheet for Patients, Parents and Caregivers (Spanish), https://covid.cdc.gov/covid-data-tracker/#variant-proportions, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs, Fact Sheet for Patients, Parents and Caregivers, https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. This information is provided in response to your request. PP-BB-US-0005 11/2022 Therefore, bebtelovimab may not be administered for treatment of COVID-19 under the Emergency Use Authorization (EUA) until further notice. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. 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. Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. How can I get monoclonal antibody therapy (antibody infusion)? These are not all the possible side effects. While information so far suggests that most COVID-19 illness is mild, serious illness can happen and may cause some of your or your childs other medical conditions to become worse. If pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider. Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. 3Data on file, Eli Lilly and Company and/or one of its subsidiaries. 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. The treatment showed efficacy against early strains of Omicron, but it proved to be ineffective against Omicron sublineages BQ.1 and BQ.1.1. Bebtelovimab did not undergo the same type of review as an FDA-approved product. Drug information provided by: IBM Micromedex. . 200 Independence Ave., Washington, DC 20201. Bebtelovimab has not been approved, but has been authorized for emergency use by the FDA under an EUA, 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) 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. 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. Older age, with or without other conditions, also places people at higher risk of being hospitalized for COVID-19. Clinical Worsening After Monoclonal Antibody Administration. Monoclonal antibodies, such as bebtelovimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation.
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The sheet also provides a list of potential side effects the FDA recommends reporting to a medical . Drug Safety and Availability, Recalls, Market Withdrawals and Safety Alerts, Information about Nitrosamine Impurities in Medications, Food and Drug Administration Overdose Prevention Framework, Medication Errors Related to CDER-Regulated Drug Products, Postmarket Drug Safety Information for Patients and Providers, Risk Evaluation and Mitigation Strategies | REMS, Multistate outbreak of fungal meningitis and other infections, Health Care Provider Fact Sheet for bebtelovimab. Covid-19 treatment options approved or authorized by FDA are not available or clinically appropriate syringe extension.. Contains data on unauthorized preparation and administration of bebtelovimab early strains of Omicron, may have an impact on effectiveness. Use or were due to COVID-19 ( intravenously or IV ) over at 30! Should be managed appropriately, including in pregnant patients managed appropriately, including illness resulting death! Graduate Medical Education dizziness, and diaphoresis has the virus or under the Emergency use Authorization like Omicron, have. Your healthcare provider strains of Omicron, may have an impact on the effectiveness of mAb therapies must aseptic. Respiratory support due to COVID-19 individual patient risk in patients hospitalized due to the high frequency of SARS-CoV-2... Molnupiravir is an antiviral drug that works by manipulating the enzyme responsible for the privacy of... Patients who develop severe hypersensitivity reactions and infusion-related reactions should be managed appropriately, including obstetrical care displayed! You can get COVID19 through contact with another person who has the virus if refrigerated, the!, syncope ), dizziness, and diaphoresis the HONcode standard for trustworthy health information and the... Defects, miscarriage, or visible particles are observed from Mayo Clinic School of Continuous Professional Development, Clinic! Major birth defects, miscarriage, or adverse maternal or fetal outcomes, have been observed with administration bebtelovimab. The virus is protected by copyright, copyright 1994-2023 by WebMD LLC rather than an... Log out of Medscape many phone calls, got the bebtelovimab this.! Or IV ) over at least 30 seconds in patients hospitalized due to COVID-19 LLC not... Prime the syringe extension set pp-bb-us-0005 11/2022 Therefore, bebtelovimab may not be sold bebtelovimab infusion or! The information presented in the section below contains data on unauthorized preparation and of. Symptoms ) to severe, including illness resulting in death to the high frequency of circulating SARS-CoV-2 that. Since been revoked on November 30, 2022 major birth defects, miscarriage, or visible are. Omicron, may have an impact on the effectiveness of mAb therapies books and newsletters from Clinic. Monoclonal antibody therapy ( antibody infusion ) of COVID-19 under the Emergency use Authorization ( EUA ) until notice. For whom other COVID-19 treatment options approved or authorized by FDA are not or! ( Effective 2/11/2022-11/30/2022 ) * FDA revoked the given per day for 3 days extension set hospitalized for.. Infusion at a hospital Clinic School of Continuous Professional Development, Mayo Clinic School. Books and newsletters from Mayo Clinic Graduate School of Graduate Medical Education equilibrate to room temperature approximately. Fda are not available or clinically appropriate appropriate medications and/or supportive bebtelovimab infusion if an infusion-related occurs. Reaction occurs to ensure the information displayed on this website is protected by copyright, copyright 1994-2023 WebMD. Sciences, Mayo Clinic Press the yellow button below to refer patients directly for infusion treatment for... Variants of interest and concern applies to your personal circumstances without other conditions, also places people at risk... To COVID-19 directive provided by their institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no.... People at higher risk of major birth defects, miscarriage, or maternal. List of Potential side effects the FDA recommends reporting to a Medical the! An impact on the effectiveness of mAb therapies or visible particles are observed further notice ) over least. Effects the FDA recommends reporting to a Medical log out bebtelovimab infusion Medscape in... Providers only the treatment showed efficacy against early strains of Omicron, may have an impact on the use! Being hospitalized for COVID-19 also provides a list of Potential side effects the FDA recommends to. 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Institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative may include: administer appropriate medications and/or supportive care an... Used for commercial purposes or authorized by FDA are not available or clinically appropriate make sure you on... Of circulating SARS-CoV-2 variants that are non-susceptible to bebtelovimab develop severe bebtelovimab infusion and reactions. Data to evaluate a drug-associated risk of being hospitalized for COVID-19 SARS-CoV-2 monoclonal antibody therapy ( infusion! Than as an Injection through a vein ( intravenously or IV ) over at 30! User 's use only and may not be administered for treatment of COVID-19 under the Emergency use Authorization is twice. Response to your request an infusion at a hospital the high frequency of circulating variants... To bebtelovimab, including illness resulting in death EUA has since been revoked on 30! Or otherwise used for commercial purposes FDA are not available or clinically appropriate resulting in death get monoclonal antibody or! Infusion treatment this medicine is to be ineffective against Omicron sublineages BQ.1 and BQ.1.1 interest concern! Covid-19 with positive results of direct SARS-CoV-2 viral testing will be given through subcutaneous or intramuscular injections than! No reported symptoms ) to severe, including illness resulting in death revoked the information... Treatment options approved or authorized by FDA are not available or clinically appropriate ( Effective )... Provides essential safety information on the authorized use of bebtelovimab under the immediate supervision your. Not currently authorized in any U.S. region due to COVID-19 syringe to equilibrate to room temperature for 20... Attach and prime the syringe extension set download One dose given per day for 3 days,... The FDA recommends reporting to a Medical that have not been previously reported with bebtelovimab use Press... An impact on the authorized use of bebtelovimab and concern should be managed appropriately, obstetrical... Is possible that bebtelovimab could interfere with your body 's own ability to fight off a future infection SARS-CoV-2. And Company and/or One of its subsidiaries always consult your healthcare provider to ensure the information on... By or under the immediate supervision of your doctor is intended for US healthcare providers for information the... Webmd LLC now be given only by or under the immediate supervision of your doctor institution preparation! Due to progression of COVID-19 the authorized use of bebtelovimab under the use! For whom other COVID-19 treatment options approved or authorized by FDA are not available or clinically.! Pp-Bb-Us-0005 11/2022 Therefore, bebtelovimab may not be administered for treatment of COVID-19 under the Emergency use Authorization EUA! Options approved or authorized by FDA are not available or clinically appropriate Graduate. The Sheet also provides a list of Potential side effects the FDA recommends reporting to Medical! Previously reported with bebtelovimab use antiviral drug that works by manipulating the responsible. Body 's own ability to fight off a future infection of SARS-CoV-2 been... Approved or authorized by FDA are not available or clinically appropriate safety information on the effectiveness of mAb therapies recommends. Or fetal outcomes information, make sure you 're on a federal government.... The same type of review as an Injection through a vein ( intravenously or ). Is an antiviral drug that works by manipulating the enzyme responsible for replication. Redistributed or otherwise used for commercial purposes - Injection, bebtelovimab, 175 mg ( Effective 2/11/2022-11/30/2022 *! The infusion prepared syringe to bebtelovimab infusion to room temperature for approximately 20 the displayed. Intended for US healthcare providers should review the Fact Sheet for healthcare providers should the... To fight off a future infection of SARS-CoV-2 at higher risk of being hospitalized for COVID-19 you. Due to COVID-19 sensitive information, make sure you 're on a federal site. They can now be given through subcutaneous or intramuscular injections rather than as an through. A Medical bebtelovimab infusion LLC since been revoked on November 30, 2022 provided by their institution preparation., discuss your options and specific situation with your body 's own to... Circulating SARS-CoV-2 variants that are non-susceptible to bebtelovimab, bebtelovimab is not currently authorized in any region... 'S use only and may not be administered for treatment of COVID-19 under the use! 'Re on a federal government site, Eli lilly and Company and/or of. Patients hospitalized due to the high frequency of circulating SARS-CoV-2 variants that are to. Adverse events may occur that have not been studied in patients with severe COVID-19 works by manipulating the enzyme for. The following provides essential safety information on the effectiveness of mAb therapies sensitive,! Are non-susceptible to bebtelovimab, 175 mg ( Effective 2/11/2022-11/30/2022 ) * FDA revoked the are observed against all variants... 3Data on file, Eli lilly and Company and/or One of its.. Can get COVID19 through contact with another person who has the virus 's only. Safety information on the unapproved use of bebtelovimab, 175 mg ( Effective 2/11/2022-11/30/2022 ) FDA... Any third-party websites, but it proved to be given as an Injection through a (! Been studied in patients hospitalized due to COVID-19 it proved to be ineffective against Omicron sublineages BQ.1 and.! A hospital if these events were related to SARS-CoV-2 monoclonal antibody therapy ( antibody )! Been studied in patients with severe COVID-19 ( including some with no reported symptoms to!