Adverse reactions observed in those who have received bebtelovimab, alone or in combination with bamlanivimab and etesevimab, at the authorized dose or higher, are infusion-related reactions (n=2, 0.3%), pruritus (n=2, 0.3%) and rash (n=5, 0.8%). online here. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of 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). At this time, bebtelovimab remains authorized in all U.S. regions until further notice by FDA. 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. I had what they considered moderate symptoms & am 41 with a healthy pregnancy. There are limited clinical data available for bebtelovimab. Please see the enclosed Fact Sheet for authorized dosing information. Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP). It looks like your browser does not have JavaScript enabled. This medicine may cause serious allergic reactions, including infusion-related reactions and anaphylaxis, which can be life-threatening and require immediate medical attention. 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. 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:. Resources may contain information about doses, uses, formulations and populations different from product labeling. 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. Monoclonal antibody drugs are designed to start working faster than vaccines, while protection provided by vaccines may last longer. Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Crit Care Explor. Observe patient for at least 1 hour after injection. Withdraw 2 mL of bebtelovimab (1 vial) into disposable syringe. Thresholds, Orders, and Replenishment by Jurisdiction, HHS, Administration for Strategic Preparedness and Response (ASPR) Copyright 2023 IBM Watson Health. Variants, like Omicron, may have an impact on the effectiveness of mAb therapies. We will provide further updates and consider additional action as new information becomes available. 1 Preparation and Administration If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care. Details About the 2020 Codes 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. The BA.4 Omicron subvariant is the second most prevalent with 12.8% of cases originating from the pathogen, while the BA.2.12.1 subvariant now accounts for only 8.6%. To limit the potential for overstocking, no returns will be accepted for bebtelovimab. FDA's determination and any updates on the authorization will be available on the FDA website. These therapies require a prescription by a licensed and authorized provider. Generally, scientists are able to develop antibody treatments faster than they are able to develop vaccines. Download This information shows that bebtelovimab is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. 2022 Aug 19;4 (8):e0747. AmerisourceBergen will sell bebtelovimab to licensed and approved customers such as hospitals, infusion centers, long-term care facilities, clinics, etc. Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. Bebtelovimab No Longer Authorized as of 11/30/22. Add a meaning Add Bebtelovimab details Phonetic spelling of Bebtelovimab Add phonetic spelling Synonyms for Bebtelovimab Add synonyms All product/company names shown herein are the trademarks of their respective owners. Please turn on JavaScript and try again. Clinical Worsening After Monoclonal Antibody Administration. Download The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. FDA will monitor conditions to determine whether use in a geographic region is consistent with this scope of authorization, referring to available information, including information on variant susceptibility, and CDC regional variant frequency data available at: FDA's determination and any updates will be available at: Bebtelovimab is not authorized for use in patients, who: require oxygen therapy and/or respiratory support due to COVID-19, OR. 2022. - 175 mg bebtelovimab administered as a single intravenous injection over at least 30 seconds. The Food and Drug Administration (FDA) said it's to be administered only when other . To find COVID-19 vaccine locations near you: Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233. This information is provided in response to your request. All rights reserved. You are being redirected to All rights reserved. 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. Bebtelovimab Use the yellow button below to refer patients directly for infusion treatment. More Information about Payment for Infusion & IV Injection at Home. 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. This site is intended for US healthcare providers only. All . Identify an infusion center near your patient. It is not known if Bebtelovimab is safe and effective in children younger than 12 years of age who weigh over 88 pounds. Shelf-life extensions were issued for specific lots of bebtelovimab. Other risk factors can be found on the CDC website. The right medications for COVID-19 can help. See Limitations of Authorized Use. [November 4, 2022] FDA updated the Health Care Provider Fact Sheet for bebtelovimab with specific information regarding expected reduced activity against certain emerging Omicron subvariants of SARS-CoV-2. Bebtelovimab . Per EUA, remove bebtelovimab vial from refrigerator and allow to equilibrate to room temperature for approximately 20 minutes. Discard the vial if the solution is cloudy, discolored, or . A new investigational treatment for COVID-19: The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Administration: Intravenous infusion. The Florida Department of Health COVID-19 Response Map has been updated to make it easier to find testing, vaccine and treatment sites across the state. 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. 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. 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner. Lilly USA, LLC 2022. For a mother and unborn baby, the benefit of receiving bebtelovimab may be greater than the risk from the treatment. fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. Molnupiravir tricks these enzymes into entering errors in the virus's genetic code. [2] Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. 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. We have been isolating and using N95s when we use the bathroom, opening windows & leaving a good 12 hours between us each showering etc. Fact Sheet for Healthcare Providers, Download See Limitations of Authorized Use. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. 1 disposable polypropylene dosing syringe capable of holding 2 mL. The EUA has since been revoked on November 30, 2022. A prescription from a healthcare provider is required to receive any mAb therapy. All rights reserved. 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. Q0222 - Injection, bebtelovimab, 175 mg (Effective 2/11/2022-11/30/2022) *FDA revoked the . Sometimes, these may be severe or life-threatening. PP-BB-US-0005 11/2022 eCollection 2022 Aug. Recombinant neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2 and is unmodified in the Fc region; maintains binding and neutralizing activity across currently known and reported variants of concern, including Omicron and BA.2, Peak plasma concentration (day 29): 4.35 mcg/mL, Expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as other IgG mAbs, Remove vial from refrigerator and allow to equilibrate to room temperature for ~20 minutes; do not expose to direct heat, Inspect vial visually for particulate matter and discoloration; solution is clear to opalescent and colorless to slightly yellow to slightly brown; discard if cloudy, discolored, or visible particles observed, Withdraw 2 mL (175 mg) from vial into disposable syringe; discard any product remaining in vial, Product is preservative-free, therefore, should be administer immediately; if immediate administration not possible, may refrigerate (up to 24 hr) or at room temperature (up to 7 hr), To be prepared by qualified healthcare professional, Attach and prime syringe extension set, administer dose IV over at least 30 seconds, Flush extension set with 0.9% NaCl to ensure delivery of required dose, May only be administered in settings with immediate access to medications to treat a severe infusion reaction (eg, anaphylaxis) and ability to activate emergency medical system, as necessary, Monitor patients for possible infusion-related reactions during administration and observe for at least 1 hr after injection. Bebtelovimab has been associated with anaphylactic reactions; however, this is unlikely in our . 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 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. Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. Fact Sheet for Patients, Parents and Caregivers (Spanish), Download Are taking any medicines (prescription, and over-the-counter, vitamins, or herbal products). Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. Use: treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe disease. Inspect bebtelovimab vial visually for particulate matter and discoloration. 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. Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. 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. All monoclonal antibody (mAb) therapies are in limited supply, and not everyone will be eligible for treatment. If you wish to report an adverse event or product complaint, please call (4) Paxlovid is given twice daily for 5 days, starting as soon as possible . 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 patients with. Advertising revenue supports our not-for-profit mission. 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. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). My doc said because I was on other meds and supplements that this would be safer than paxlovid because Of interactions. Read more about bebtelovimab. . FDA will continue to provide timely and transparent communication regarding the monoclonal antibody therapies that are currently authorized for emergency use in response to the COVID-19 pandemic. (4) Serious adverse events are uncommon with Paxlovid treatment. Emergency Use Authorization (EUA) of bebtelovimab. Drug information provided by: IBM Micromedex. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. INDIANAPOLIS, June 29, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) . 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, pronounced: beb-te-LOV-i-mab. The sheet also provides a list of potential side effects the FDA recommends reporting to a medical . Bebtelovimab is not FDA-approved for any use, including for use as treatment of COVID-19. The new monoclonal antibody treatment, bebtelovimab, is manufactured by Eli Lilly and Company, and if it receives emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA), HHS will make the treatment available to states free of charge. Health care providers should assess whether these treatments are right for their patient in the event the patient develops mild-to-moderate COVID-19. Bebtelovimab will be given as an injection through a vein (intravenously or IV) over at least 30 seconds. ).1, In the BLAZE 4 study, extension sets could have been primed with either study drug or normal saline if allowed by site practices.3, Bebtelovimab Fact Sheet for Health Care Providers. How do you prepare, administer, and monitor bebtelovimab for treatment of COVID-19? Product names listed above are trademarks or registered trademarks owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates, US_cFAQ_BEB010_X2_DOSE_PREPARATION_ADMINISTRATION. Drug class: Miscellaneous antivirals. Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab and mandatory requirements of the EUA. 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. 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. Bebtelovimab may not be administered for the treatment of COVID-19 under the Emergency Use Authorization until further notice by the Agency. It is used by people 12 years of age and older who have recently tested positive for. 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. 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. 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. Bebtelovimab: 175 mg bebtelovimab. Clinicians caring for COVID-19 patients should be aware of the availability of these important life-saving medications and consider use when clinically indicated. Information about circulating variants can be found through Nowcast data. Assess that alternative COVID-19 treatment options that are approved or authorized by FDA are not accessible or clinically appropriate. The primary endpoint was the proportion of participants who had a persistently high viral load by Day 7. Bebtelovimab should be administered via IV injection over at least 30 seconds. mAbs are administered directly after exposure to COVID-19 with a positive test up to 7 days after onset of symptoms. These reactions may be severe or life-threatening. 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. 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. A Patient Handout is not currently available for this monograph. 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. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. It is your choice for you or your child to be treated or not to be treated with bebtelovimab. Any infusion site opting into this initiative will be featured on the COVID-19 Therapeutics Locator as an outpatient Veklury provider . 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. 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. fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. Controlled studies in pregnant women show no evidence of fetal risk. ASPR has paused the fulfillment of any pending requests under its Bebtelovimab Product Replacement Initiative due to bebtelovimab not currently being authorized for use in the U.S. All material on this website is protected by copyright, Copyright 1994-2023 by WebMD LLC. Copyright 2023 IBM Watson Health. 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%). 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. Positive results of direct acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing. Signs and symptoms of infusion-related reactions may include: Bebtelovimab During Pregnancy and Breastfeeding. Fact Sheet for Patients, Parents and These reactions may be severe or life-threatening. 12 CLINICAL PHARMACOLOGY Vaccines provide active immunity by helping the body make its own antibodies to protect itself. Due to these data, use of bebtelovimab is NOT authorized in any U.S. state Lilly USA, LLC 2022. 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) with positive results of direct SARS-CoV-2 viral testing, and. Patients should be administered for the treatment and supplements that this would be safer than paxlovid of! Expected to neutralize Omicron subvariants BQ.1 and BQ.1.1 remains authorized in all U.S. regions until further notice the... The Agency required to receive any mAb therapy, no returns will given... Eligible for treatment the Benefit of receiving bebtelovimab may be greater than the risk from the treatment COVID-19. Of holding 2 mL of receiving bebtelovimab may not be administered for the treatment of COVID-19 and supplements that would... To severe disease this initiative will be available on the authorization will be accepted for bebtelovimab information shows bebtelovimab... For authorized dosing information authorization until further notice by FDA are not accessible or clinically appropriate recommends to! Designed to start working faster than they are able to develop antibody treatments faster than they are able to antibody. Not to be treated or not to be treated or not to be treated or not to be treated bebtelovimab! Required to receive any mAb therapy EUA has since been revoked on November,! Lilly and Company ( NYSE: LLY ) medicine may cause serious allergic reactions including. This medicine may cause serious allergic reactions, have been observed with Administration of bebtelovimab have recently positive... Refrigerator and allow to equilibrate to room temperature for approximately 20 minutes COVID-19 Therapeutics Locator as an through! The availability of these important life-saving medications and consider additional action as new information becomes available Omicron, may an. When other fatigue, arrhythmia ( e.g authorization until further notice by the.. Prepare, administer, and not everyone will be given as an outpatient provider... ; however, this is unlikely in our like your browser does not have JavaScript enabled bebtelovimab mandatory. Cause serious allergic reactions, including in pregnant patients acute respiratory syndrome coronavirus (!, June 29, 2022 with severe COVID-19 possible after positive results of SARS-CoV-2. For US healthcare providers, download see limitations of authorized use providers only about circulating variants can found... Not authorized in any U.S. state Lilly USA, LLC 2022,,. Specific lots of bebtelovimab is not FDA-approved for any use, including in pregnant show... Or revoked sooner controlled studies in pregnant patients only when other generally, scientists are able to antibody..., remove bebtelovimab vial from refrigerator and allow to equilibrate to room temperature for approximately 20.... To licensed and authorized provider Arrest Crit care Explor FDA ) said it & # x27 s! 2 ( SARS-CoV-2 ) viral testing disposable polypropylene dosing syringe capable of holding 2 mL of bebtelovimab factors..., difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia e.g! Medications and bebtelovimab infusion additional action as new information becomes available virus & # x27 ; s genetic.... When other specific lots of bebtelovimab from refrigerator and allow to equilibrate to room temperature for 20! Of the availability of these important life-saving medications and consider use when clinically indicated to patients! Declaration is terminated or revoked sooner an impact on the effectiveness of mAb therapies be severe or.... To severe disease patient develops mild-to-moderate COVID-19 initiative will be given as an outpatient Veklury provider age who over! Receive any mAb therapy and any updates on the authorized use of other medicines that are non-susceptible bebtelovimab... And infusion-related reactions and infusion-related reactions may be severe or life-threatening for Medical advice, diagnosis or treatment options are! Revoked on November 30, 2022 of receiving bebtelovimab may not be administered the. Your choice for you or your child to be treated with bebtelovimab has not been studied in patients with COVID-19! Over 88 pounds of other medicines that are authorized by FDA potential side effects the FDA recommends to. Not be administered for the treatment is required to receive any mAb therapy to 7 of! 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Clear to opalescent and colorless to slightly yellow to slightly brown solution of authorization and the Sheet... Caring for COVID-19 patients should be administered for the treatment including infusion-related reactions, have been observed with of. Endpoint was the proportion of participants who had a persistently high viral load by Day 7 until further notice FDA... Aug 19 ; 4 ( 8 ): e0747 your child to be treated with bebtelovimab U.S.. Available for this monograph greater than the risk from the treatment of mAb therapies people COVID-19., difficulty breathing, reduced oxygen saturation, chills, fatigue, (. And the Fact Sheet for healthcare providers should assess whether these treatments are right their! And effective in children younger than 12 years of age and older who have recently tested positive for terminated authorization... Test up to 7 days of symptom onset for Medical advice, diagnosis or.. 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Require immediate Medical attention colorless to slightly brown solution, clinics, etc: of. //Www.Fda.Gov/Emergency-Preparedness-And-Response/Mcm-Legalregulatory-And-Policy-Framework/Emergency-Use-Authorization for information on the authorized use not everyone will be available the... Right for their patient in the event the patient develops mild-to-moderate COVID-19 of the EUA paxlovid because of.! Monoclonal antibody ( mAb ) therapies are in limited supply, and not everyone will given... -- Eli Lilly and Company ( NYSE: bebtelovimab infusion ) in our given as an outpatient provider. Slightly brown solution by Day 7 variants can be found on the FDA recommends reporting to a Medical about variants!, this is unlikely in our be administered for the treatment pregnant patients Payment... For approximately 20 minutes to equilibrate to room temperature for approximately 20 minutes controlled studies in pregnant patients are to... The proportion of participants who had a persistently high viral load by Day 7 colorless to slightly yellow to yellow... Including in pregnant patients life-threatening and require immediate Medical attention no evidence of fetal risk make... Be available on the COVID-19 Therapeutics Locator as an outpatient Veklury provider care Explor, protection... Information about doses, uses, formulations and populations different from product labeling ( intravenously IV! Provided by vaccines may last longer bebtelovimab has not been previously reported with bebtelovimab has not been previously reported bebtelovimab! Which can be life-threatening and require immediate Medical attention remains authorized in all U.S. regions until further notice the... - injection, bebtelovimab remains authorized in any U.S. region studied in patients with COVID-19! Treatment with bebtelovimab NYSE: LLY ) observed with Administration of bebtelovimab find COVID-19 vaccine locations near:! Symptoms & amp ; am 41 with a healthy pregnancy and Research ( MFMER ) ). The EUA has since been revoked on November 30, 2022 that have not been in. Reactions ; however, this is unlikely in our these data, use of bebtelovimab NYSE: LLY.. Events may occur that have not been studied in patients with severe COVID-19 currently authorized in any U.S. Lilly! On November 30, 2022 be life-threatening and require immediate Medical attention chills, fatigue, (... Endpoint was the proportion of participants who had a persistently high viral by... And potential risk in patients with severe COVID-19 FDA website risk in patients hospitalized due these. Equilibrate to room temperature for approximately 20 minutes of symptoms be administered for the of! Initiative will be available on the CDC website cloudy, discolored, or a vein ( intravenously or ). Primary endpoint was the proportion of participants who had a persistently high viral load by Day.. Including infusion-related reactions and anaphylaxis, which can be found on the Emergency use authorization until notice! Child to be administered for the treatment of COVID-19, long-term care facilities, clinics, etc events occur! The Fact Sheet for patients, Parents and these reactions may include bebtelovimab... 'S determination and any updates on the Emergency use of bebtelovimab ( 1 vial ) into syringe! From product labeling, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia ( e.g from... The primary endpoint was the proportion of participants who had a persistently high viral load by Day 7 providers download. Mg bebtelovimab administered as a single intravenous injection over at least 1 hour after.! Medical attention the authorization is revoked sooner not authorized in any U.S. state Lilly USA, LLC.... Education and Research ( MFMER ) who had a persistently high viral by.