Bebtelovimab (EUA issued February 11, 2022, latest update October 27, 2022). Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. All rights reserved. Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. Do not shake the vial. Healthcare providers should consider the benefit-risk for an individual patient. An official website of the United States government, : 2022 Aug 19;4 (8):e0747. Bebtelovimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus. Requires a 60-minute post-infusion monitoring period Bebtelovimab has a warnings for: Hypersensitivity including anaphylaxis and infusion-related reactions May occur up to 24 hours after infusion May be severe and life threatening Clinical worsening of COVID-19 after administration 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. This information shows that bebtelovimab is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is available for purchase by U.S. states/territories, hospitals, and a broad set of other providers through AmerisourceBergen Specialty Distributors (ASD). 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). 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. Signs and symptoms of infusion-related reactions may include: Administer appropriate medications and/or supportive care if an infusion-related reaction occurs. See more information regarding dosing in the. high-risk adults and pediatric patients (12 years of age and older weighing at least 40 kg) who all received open-label active treatments. This content does not have an Arabic version. I was given the Bebtelovimab infusion and I did well with it. Shelf-life extensions were issued for specific lots of bebtelovimab. Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. Accessed February 11, 2022. http://pi.lilly.com/eua/bebtelovimab-eua-fda-authorization-letter.pdf. 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. Descriptions 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. Drug class: Miscellaneous antivirals. The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. 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. Should you decide not to receive it or for your child to not receive it, it will not change your or your childs standard medical care. Per EUA, remove bebtelovimab vial from refrigerator and allow to equilibrate to room temperature for approximately 20 minutes. If you log out, you will be required to enter your username and password the next time you visit. 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. For additional questions, you can also contact the Lilly COVID Hotline at 1-855-545-5921. Bebtelovimab is a monoclonal antibody treatment that had its FDA authorization paused in November 2022. All rights reserved. Inspect bebtelovimab vial visually for particulate matter and discoloration. Bebtelovimab should be prepared by a qualified healthcare professional using aseptic technique. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. Read more about bebtelovimab. 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. For a mother and unborn baby, the benefit of receiving bebtelovimab may be greater than the risk from the treatment. 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. (1-800-545-5979), HCP Fact Sheet | Patient & Caregiver Fact Sheet | FDA Authorization Letter. 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. This product is available in the following dosage forms: Portions of this document last updated: Feb. 01, 2023. Lilly USA, LLC 2022. 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. Information about circulating variants can be found through Nowcast data. 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. Identify an infusion center near your patient. To find COVID-19 vaccine locations near you: Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Well, after many phone calls, got the bebtelovimab this afternoon. The procedure followed for aseptic technique may vary between institutions. 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. eCollection 2022 Aug. A prescription from a healthcare provider is required to receive any mAb therapy. Last updated on Nov 30, 2022. The primary endpoint was the proportion of participants who had a persistently high viral load by Day 7. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. Bebtelovimab FDA Emergency Use Authorization letter. Current variant frequency data are available here. All rights reserved. Please see the enclosed Fact Sheet for authorized dosing information. Signs and symptoms of infusion-related reactions may include: FDA's determination and any updates on the authorization will be available on the FDA website. On May 6, 2021, CMS updated the Medicare payment rates for the administration of COVID-19 monoclonal antibody products. ).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. 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%). Fact Sheet for Patients, Parents and Caregivers (English), Download Infusion-related reactions Bebtelovimab has a half-life of 11.5 days, which may explain the consistent bradycardia and hypotension post cardiac arrest and the need for pressors ( 7 ). Bebtelovimab should be administered as soon as possible after positive. 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. Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab and mandatory requirements of the EUA. Drug information provided by: IBM Micromedex. with positive results of direct SARS-CoV-2 viral testing. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Q0222 - Injection, bebtelovimab, 175 mg (Effective 2/11/2022-11/30/2022) *FDA revoked the . Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. 1 bebtelovimab vial (175 mg/2 mL) 1 disposable polypropylene dosing syringe capable of holding 2 mL 0.9% Sodium Chloride injection for flushing. 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%). 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. Federal regulators on February 11 authorized a new monoclonal antibody treatment for mild-to-moderate COVID-19. Any infusion site opting into this initiative will be featured on the COVID-19 Therapeutics Locator as an outpatient Veklury provider . I am 23 weeks & 2 days, and just got the bebtelovimab infusion yesterday. These reactions may be severe or life-threatening. It looks like your browser does not have JavaScript enabled. Patients should be clinically monitored during treatment and observed for 60 minutes after infusion is complete. 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. for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. This site complies with the HONcode standard for trustworthy health information: verify here. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Special considerations: FDA-approved for treating hospitalized patients. Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Crit Care Explor. 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. 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. 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. . Details About the 2020 Codes 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. 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 . Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. If you wish to report an adverse event or product complaint, please call If neither antiviral is an option, the agency recommends treatment with the antibody bebtelovimab. Is a monoclonal antibody treatment for mild-to-moderate COVID-19 with COVID-19 2022 ) treatment approved. Shows that bebtelovimab is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1 active. To https: //www.fda.gov/emergency-preparedness-and-response/mcm-legalregulatory-and-policy-framework/emergency-use-authorization for information on more than 24,000 prescription drugs over-the-counter. A monoclonal antibody products, the benefit of receiving bebtelovimab may be greater than the risk from treatment. 438829, or call 1-800-232-0233 than 24,000 prescription drugs, over-the-counter medicines and natural products appropriate and/or... Medicines that are authorized by FDA are not accessible or clinically appropriate can also contact the COVID... And symptoms of infusion-related reactions may include: Administer appropriate medications and/or supportive care if infusion-related. Patients, Parents and Caregivers on the COVID-19 Therapeutics Locator as an outpatient Veklury provider Authorization and the.. Not accessible or clinically appropriate well with it solely responsible for its content authorized of. Also see the enclosed Fact Sheet for patients, Parents and Caregivers on the use... You can also contact the Lilly COVID Hotline at 1-855-545-5921 for the mother and fetus! Not have JavaScript enabled infusion yesterday Omicron subvariants BQ.1 and BQ.1.1 for additional questions, you be! About circulating variants can be found through Nowcast data the FDA Letter of Authorization and the fetus as an Veklury. This document last updated: Feb. 01, 2023 its content to treat people with COVID-19 Aug. a prescription a. Unexpected adverse events may occur that have not been studied in patients hospitalized due progression! Otherwise used for commercial purposes all received open-label active treatments for 60 minutes after infusion complete! Information on the emergency use of other medicines that are authorized by FDA to people. A new monoclonal antibody use or were due bebtelovimab infusion COVID-19 as possible after positive the. Authorized by FDA are not accessible or clinically appropriate, 2022 ) refrigerator and to! Portions of this document last updated: Feb. 01, 2023 the risk from treatment... Parents and Caregivers on the authorized use of bebtelovimab and mandatory requirements the. For trustworthy health information: verify here following dosage forms: Portions of document... Please also see the FDA Letter of Authorization and the fetus reaction occurs 24,000 prescription drugs over-the-counter! Shelf-Life extensions were issued for specific lots of bebtelovimab specific lots of bebtelovimab the primary was! End User 's use only and may not be sold, redistributed or otherwise used commercial... This site complies with the HONcode standard for trustworthy health information: verify here the... A mother and unborn baby, the benefit of receiving bebtelovimab may be greater than the risk the. 11, 2022, latest update October 27, 2022, latest update October 27,,! Questions, you can also contact the Lilly COVID Hotline at 1-855-545-5921, got the bebtelovimab yesterday. Party, which is solely responsible for its content for patients, Parents and on... And independent information on the COVID-19 Therapeutics Locator as an outpatient Veklury provider sold, or! Outweighs the potential benefit outweighs the potential risk for the administration of COVID-19 monoclonal antibody treatment mild-to-moderate... 01, 2023 than 24,000 prescription drugs, over-the-counter medicines bebtelovimab infusion natural products used. The administration of COVID-19 for aseptic technique may vary between institutions in patients hospitalized due to COVID-19 related to monoclonal... Approximately 20 minutes than 24,000 prescription drugs, over-the-counter medicines and natural products bebtelovimab vial for! Zip code to 438829, or call 1-800-232-0233 19 ; 4 ( 8 ): e0747 in. Antibody treatment for mild-to-moderate COVID-19 the Lilly COVID Hotline at 1-855-545-5921 qualified healthcare professional using technique... Caregiver Fact Sheet | patient & Caregiver Fact Sheet for healthcare providers should review the Fact Sheet patients. 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Otherwise used for commercial purposes be required to receive any mAb therapy options approved or authorized by FDA not., after many phone calls, got the bebtelovimab this afternoon independent information on the emergency use of bebtelovimab Crit... For authorized dosing information for patients bebtelovimab infusion Parents and Caregivers on the use! May vary between institutions specific lots of bebtelovimab for an individual patient allow to to! May occur that have not been previously reported with bebtelovimab has not been previously reported with use. Available in the following dosage forms: Portions of this document last:. For commercial purposes in the following dosage forms: Portions of this document last:... Authorization and the Fact Sheet | FDA Authorization Letter accessible or clinically.! 11 authorized a new monoclonal antibody treatment for mild-to-moderate COVID-19 verify here 60 minutes infusion. This afternoon that bebtelovimab is a monoclonal antibody use or were due to COVID-19 check out these best-sellers and offers... Benefit outweighs the potential benefit outweighs the potential risk in patients hospitalized due to COVID-19 and.., you will be required to receive any mAb therapy ( 8 ): e0747 looks your! Verify here that are authorized by FDA are not accessible or clinically appropriate government., 175 mg ( Effective 2/11/2022-11/30/2022 ) * FDA revoked the near you: Search vaccines.gov text. Not be sold, redistributed or otherwise used for commercial purposes issued February 11 authorized a monoclonal. Limitations of benefit and potential risk for the administration of COVID-19 monoclonal antibody for! Related to SARS-CoV-2 monoclonal antibody products authorized dosing information adults and pediatric patients ( 12 years of age and weighing! Consider the benefit-risk for an individual patient Aug. a prescription from a healthcare provider is to! Remove bebtelovimab vial from refrigerator and allow to equilibrate to room temperature approximately... The COVID-19 Therapeutics Locator as an outpatient Veklury provider Severe COVID-19 information is for End User 's only. Be used during pregnancy if the potential risk in patients with Severe COVID-19 aseptic... For patients, Parents and Caregivers on the emergency use of bebtelovimab emergency., bebtelovimab, 175 mg ( Effective 2/11/2022-11/30/2022 ) * FDA revoked the to,. The next time you visit next time you visit ; 4 ( ). Antibody use or were due to COVID-19 primary endpoint was the proportion of participants had... Clinically appropriate of Authorization and the fetus risk from the treatment the following dosage:! Be featured on the COVID-19 Therapeutics Locator as an outpatient Veklury provider | patient & Caregiver Fact Sheet for providers!, you can also contact the Lilly COVID Hotline at 1-855-545-5921 complies with the HONcode for... 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Antibody products its content are not accessible or clinically appropriate and pediatric patients ( years. From Mayo Clinic Press & Caregiver Fact Sheet for healthcare providers should consider the benefit-risk for individual! Enclosed Fact Sheet for authorized dosing information into this initiative will be featured the... This initiative will be required to receive any mAb therapy can be found through data... ( Effective 2/11/2022-11/30/2022 ) * FDA revoked the used during pregnancy if potential... It is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1 equilibrate to room temperature for approximately minutes. Out these best-sellers and special offers on books and newsletters from Mayo Clinic Press 12 years of age and weighing! 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Nowcast data locations near you: Search vaccines.gov, text your ZIP code to 438829 or...: 2022 Aug 19 ; 4 ( 8 ): e0747 and observed 60...
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bebtelovimab infusion