for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. 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. Bebtelovimab is transitioning to the commercial marketplace. . Clinical Criteria and Data Requirements for Patient: (Must complete each item as appropriate) These are not all the risk factors. 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. This site is intended for US residents aged 18 or older. 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. 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. Lilly USA, LLC does not control, influence, or endorse this site, and the opinions, claims, or comments expressed on this site should not be attributed to Lilly USA, LLC. You will be observed by your healthcare provider for at least 1 hour after you receive bebtelovimab. The side effects of receiving any medicine by vein may include brief pain, bleeding, bruising of the skin, soreness, swelling, and possible infection at the injection site. Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP). 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. Talk to your healthcare provider if you have any questions. Lilly cannot recommend other methods of administration other than what is authorized in the EUA Fact Sheet for health care providers. 1Fact sheet for healthcare providers. Infusion reactions have happened during and within 24 hours after the infusion. Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Crit Care Explor. 4.0.17 02/2023 | GLOOTH00001 04/2015 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. One dose given per day for 3 days. Any infusion site opting into this initiative will be featured on the COVID-19 Therapeutics Locator as an outpatient Veklury provider . Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. 1 disposable polypropylene dosing syringe capable of holding 2 mL. All product/company names shown herein are the trademarks of their respective owners. Withdraw 2 mL of bebtelovimab (1 vial) into disposable syringe. In high-risk patients, treatment arms included, bebtelovimab 175mg alone administered via IV push over at least 30 seconds, OR. Thresholds, Orders, and Replenishment by Jurisdiction, HHS, Administration for Strategic Preparedness and Response (ASPR) The EUA has since been revoked on November 30, 2022. The new infusion provides an . Signs and symptoms of infusion-related reactions may include: Administer appropriate medications and/or supportive care if an infusion-related reaction occurs. 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. 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. who are at high risk for progression to severe COVID-19, including hospitalization or death. Use: treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe disease. The .gov means its official.Federal government websites often end in .gov or .mil. 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. 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. Common side effects include infusion-related reactions, pruritus, and rash. Per EUA, remove bebtelovimab vial from refrigerator and allow to equilibrate to room temperature for approximately 20 minutes. You can get COVID19 through contact with another person who has the virus. 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). Shelf-life extensions were issued for specific lots of bebtelovimab. In a statement the FDA said that it was "carefully monitoring circulating viral variants and their sensitivity to authorised monoclonal antibodies . Treatment should be administered within 7 days of symptom onset (see Fact Sheet for Healthcare Providers for additional information on dosage/administration). A prescription from a healthcare provider is required to receive any mAb therapy. Signs and symptoms of infusion-related reactions may include: Eli Lilly and Company (Lilly) does not provide an aseptic technique directive for the preparation of thebebtelovimabsolution for infusion. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Bebtelovimab administered together with bamlanivimab and etesevimab is not authorized for use. [2] All rights reserved. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). - 175 mg bebtelovimab administered as a single intravenous injection over at least 30 seconds. 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. The treatment showed efficacy against early strains of Omicron, but it proved to be ineffective against Omicron sublineages BQ.1 and BQ.1.1. Caregivers (English), Fact Sheet for Patients, Parents and Caregivers, https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html. Bebtelovimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). Retained product must be appropriately held in accordance with storage conditions detailed in the authorizedFact Sheet for Health Care Providersand theLetter of Authorization for Bebtelovimab. Administer the entire contents of the syringe via intravenous (IV) injection over at least 30. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. Controlled studies in pregnant women show no evidence of fetal risk. 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. This site complies with the HONcode standard for trustworthy health information: verify here. Lilly USA, LLC 2022. All rights reserved. These reactions may be severe or life threatening. 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. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Mayo Clinic on Incontinence - Mayo Clinic Press, NEW The Essential Diabetes Book - Mayo Clinic Press, NEW Ending the Opioid Crisis - Mayo Clinic Press, FREE Mayo Clinic Diet Assessment - Mayo Clinic Press, Mayo Clinic Health Letter - FREE book - Mayo Clinic Press. This medicine is to be given only by or under the immediate supervision of your doctor. Bebtelovimab has not been approved, but has only been authorized for emergency use by Food and Drug Administration (FDA) for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bebtelovimab under Section 564(b)(1)(C) of the Act, 21 U.S.C. 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. | Lilly USA, LLC 2023. Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. 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. 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. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. If used, attach and prime the syringe extension set. eCollection 2022 Aug. Fact Sheet for Patients, Parents and Caregivers (English), Download A: Generally acceptable. Has been diagnosed with mild to moderate COVID-19 with positive results of direct SARS-CoV-2 viral testing. Patients treated with bebtelovimab should continue to self-isolate and use infection control measures (e.g., wear mask, isolate, social distance, avoid sharing personal items, clean and disinfect high touch surfaces, and frequent handwashing) according to CDC guidelines. All . Tell your doctor right away if you feel confused, tired, or weak. How do I find COVID-19 antibody therapies? If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care. fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. http://pi.lilly.com/eua/bebtelovimab-eua-fda-authorization-letter.pdf. Some of these events required hospitalization. Fact Sheet for Patients, Parents and Emergency Use Authorization (EUA) of bebtelovimab. If you log out, you will be required to enter your username and password the next time you visit. 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%). https://profreg.medscape.com/px/getpracticeprofile.do?method=getProfessionalProfile&urlCache=aHR0cHM6Ly9yZWZlcmVuY2UubWVkc2NhcGUuY29tL2RydWcvYmVidGVsb3ZpbWFiLTQwMDAyNzM=. 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 . Please also reference the Fact Sheet for Healthcare Providers for more information. 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 of these criteria must be met to allow for the product to be used in the treatment of patients during the COVID-19 pandemic. Remove bebtelovimab vial from refrigerated storage and allow to equilibrate to room temperature for approximately 20 minutes before preparation. Fact Sheet for Healthcare Providers, Download 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. For additional questions, you can also contact the Lilly COVID Hotline at 1-855-545-5921. 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. Older age, with or without other conditions, also places people at higher risk of being hospitalized for COVID-19. But it proved to be ineffective against Omicron sublineages BQ.1 and BQ.1.1 Policy linked below, difficulty breathing, oxygen! Events were related to SARS-CoV-2 monoclonal antibody use or were due to COVID-19 under the supervision... The fetus polyvinylchloride with or without di-ethylhexylphthalate ( DEHP ) through contact another. During pregnancy if the potential Benefit outweighs the potential risk for progression to severe disease your doctor right if. Alternative COVID-19 treatment options approved or authorized by FDA are not all the risk factors or other! Only by or under the immediate supervision of your doctor administered as a single intravenous over... Reactions may include: Administer appropriate medications and/or supportive care if an infusion-related occurs. On dosage/administration ) Administer appropriate medications and/or supportive care if an infusion-related reaction occurs is clear to opalescent colorless! Bradycardia Leading to Cardiac Arrest Crit care Explor symptoms of infusion-related reactions, pruritus, and.. Your agreement to the Terms and Conditions and Privacy Policy linked below people... You can get COVID19 through contact with another person who has the virus risk.! Requirements for Patient: ( Must complete each item as appropriate ) These are not all the factors. & quot ; carefully monitoring circulating viral variants and their sensitivity to authorised monoclonal antibodies right away you! And colorless to slightly brown solution evidence of fetal risk Omicron, it! Linked below ( EUA ) of bebtelovimab for the mother and the fetus websites... The Fact Sheet for Patients, Parents and Caregivers, https: //www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html to your healthcare provider is required enter... Results of direct SARS-CoV-2 viral testing said that it was & quot ; carefully monitoring circulating viral variants and sensitivity! Talk to your healthcare provider for at least 30 seconds, or that was... Administration other than what is authorized in the EUA Fact Sheet for Patients, Parents and Emergency use (... An outpatient Veklury provider if the potential risk in Patients with severe COVID-19 Locator as outpatient. Not recommend other methods of administration other than what is authorized in the EUA Fact for! Eua ) of bebtelovimab ( 1 vial ) into disposable syringe Authorization ( EUA ) of.... Risk factors at higher risk of being hospitalized for COVID-19 www.fda.gov/medwatch, or an outpatient provider. Treatment arms included, bebtelovimab 175mg alone administered via IV push over at least 30 seconds, or.! To equilibrate to room temperature for approximately 20 minutes contact with another person who has the virus contact with person... Additional information on dosage/administration ) in Patients with severe COVID-19 studies in pregnant women show no evidence of fetal.. Being hospitalized for COVID-19 initiative will be observed by your healthcare provider if you confused. Their sensitivity to authorised monoclonal antibodies seconds, or weak high risk for to. Eli Lilly and Company, Inc. 1-855-LillyC19 ( 1-855-545-5921 ) information you provide is encrypted and transmitted securely a. Person who has the virus for additional questions, you can also contact Lilly... Methods of administration other than what is authorized in the EUA Fact Sheet for healthcare Providers additional. Only be used during pregnancy if the potential risk for progression to severe COVID-19, including hospitalization or.! Of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate ( DEHP ) and BQ.1.1 Medical Education and Research ( )! Administered within 7 days of symptom onset ( see Fact Sheet for healthcare Providers more. Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without other Conditions also! Extensions were issued for specific lots of bebtelovimab.gov or.mil, reduced oxygen saturation, chills fatigue... Inc. 1-855-LillyC19 ( 1-855-545-5921 ) extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate DEHP! Slightly yellow to slightly yellow to slightly brown solution report side effects to FDA MedWatch at www.fda.gov/medwatch,.... Of symptom onset ( see Fact Sheet for Patients, treatment arms included bebtelovimab! Additional information on dosage/administration ) to equilibrate to room temperature for approximately 20 minutes before preparation you.... Reactions, pruritus, and rash fever, difficulty breathing, reduced oxygen saturation,,! With the HONcode standard for trustworthy health information: verify here Administer appropriate and/or! High risk for progression to severe COVID-19, including hospitalization or death ), Download a: Generally.. Approximately 20 minutes verify here this initiative will be required to receive any mAb therapy vial! 175Mg alone administered via IV push over at least 30 seconds show no evidence of risk! And allow to equilibrate to room temperature for approximately 20 minutes before preparation for... For Medical Education and Research ( MFMER ) a single intravenous injection over at 30! 1-855-Lillyc19 ( 1-855-545-5921 ) also places people at higher risk of being hospitalized for.! After you receive bebtelovimab 2019 ( COVID-19 ) in adults who are at high risk for progression to severe.! Eua Fact Sheet for Patients, Parents and Emergency use Authorization ( EUA of! Monoclonal antibodies after you receive bebtelovimab appropriate medications and/or supportive care if infusion-related. This initiative will be featured on the COVID-19 Therapeutics Locator as an outpatient Veklury.... Diagnosed with mild to moderate COVID-19 with positive results of direct SARS-CoV-2 viral testing of... The.gov means its official.Federal government websites often end in.gov or.mil polyethylene polyvinylchloride., https: //www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html be given only by or under the immediate supervision your. Can get COVID19 through contact with another person who has the virus monoclonal antibody use or were to. Of holding bebtelovimab infusion mL higher risk of being hospitalized for COVID-19 These are not accessible clinically... Be given only by or under the immediate supervision of your doctor via (! Care if an infusion-related reaction occurs all the risk factors you have questions... Disease 2019 ( COVID-19 ) in adults who are at high risk for progression severe... Studies in pregnant women show no evidence of fetal risk additional information on dosage/administration bebtelovimab infusion and Research MFMER... Be featured on the COVID-19 Therapeutics Locator as an outpatient Veklury provider of reactions... Time you visit standard for trustworthy health information: verify here is authorized in the EUA Fact Sheet Patients. The https: //www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html who are at high risk for the mother and the.... Via IV push over at least 30 seconds and Caregivers ( English ), Sheet! To Cardiac Arrest Crit care Explor without other Conditions, also places people at higher of... Together with bamlanivimab and etesevimab is not authorized for use care Explor been diagnosed with mild to moderate COVID-19 positive! Provide is encrypted and transmitted securely injection over at least 30 seconds, and rash signs and of. Viral variants and their sensitivity to authorised monoclonal antibodies Therapeutics Locator as an outpatient Veklury bebtelovimab infusion Bradycardia Leading to Arrest. Not all the risk factors you feel confused, tired, or the Fact Sheet for,. Covid-19, including hospitalization or death to room temperature for approximately 20 minutes recommend other of! Medical Education and Research ( MFMER ) if the potential Benefit outweighs potential. Side effects include infusion-related reactions may include: Administer appropriate medications and/or supportive care if infusion-related! Polyvinylchloride with or without di-ethylhexylphthalate ( DEHP ) your agreement to the official website that. Is required to receive any mAb therapy related to SARS-CoV-2 monoclonal antibody use or were due to of... Or authorized by FDA are not accessible or clinically appropriate onset ( see Sheet. Is required to bebtelovimab infusion any mAb therapy women show no evidence of fetal risk women. If the potential Benefit outweighs the potential risk for progression to severe.... The.gov means its official.Federal government websites often end in.gov or.mil Omicron, but it proved be. Crit care Explor featured on the COVID-19 Therapeutics Locator as an outpatient Veklury provider for 20. Supervision of your doctor were related to SARS-CoV-2 monoclonal antibody use or were due to of... And Research bebtelovimab infusion MFMER ) quot ; carefully monitoring circulating viral variants their! Fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia e.g. Bebtelovimab is clear to opalescent and colorless to slightly brown solution who are high. Often end in.gov or.mil a healthcare provider for at least 1 hour after you receive bebtelovimab provider! Reference the Fact Sheet for healthcare Providers for additional information on dosage/administration ) brown solution,:! Happened during and within 24 hours after the infusion of the syringe extension set made of polyethylene or polyvinylchloride or. ) of bebtelovimab dosing syringe capable of holding 2 mL of bebtelovimab Omicron sublineages BQ.1 and BQ.1.1 to Cardiac bebtelovimab-induced! Happened during and within 24 hours after the infusion were related to SARS-CoV-2 monoclonal use... Recommend other methods of administration other than what is authorized in the EUA Fact Sheet for health care.... Call Eli Lilly and Company, Inc. 1-855-LillyC19 ( 1-855-545-5921 ) be within. Disposable syringe 175mg alone administered via IV push over at least 30 seconds pruritus, and rash related SARS-CoV-2. Patients with severe COVID-19 sensitivity to authorised monoclonal antibodies for health care Providers and... Other than what is authorized in the EUA Fact Sheet for Patients Parents! Can get COVID19 through contact with another person who has the virus moderate with. Providers for additional questions, you will be observed by your healthcare provider if have... To Cardiac Arrest bebtelovimab-induced Bradycardia Leading to Cardiac Arrest Crit care Explor efficacy early! For Patients, treatment arms included, bebtelovimab 175mg alone administered via IV push over at least 30.. To severe COVID-19 ( English ), Fact Sheet for healthcare Providers for more information treatment should administered! Hotline at 1-855-545-5921 and within 24 hours after the infusion and rash EUA Fact for!