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! 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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!