Sibley Infusion Center staff will call the patient to schedule administration of the therapy in the non-urgent setting. (1-800-545-5979), HCP Fact Sheet | Patient & Caregiver Fact Sheet | FDA Authorization Letter. There are other authorized treatments available and healthcare providers should choose an authorized therapeutic option with activity against the circulating variants in their state, territory, or US jurisdiction. Exceptions for weekly dose quantities beyond 270 will be evaluated on a case-by-case basis. Similarly, bebtelovimab may reduce the bodys immune response to a vaccine for SARS-CoV-2. There are limited clinical data available for bebtelovimab. Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. See more information regarding dosing in the. Current variant frequency data are available here. Please also reference the Fact Sheet for Healthcare Providers for more information. 4.0.17 02/2023 | GLOOTH00001 04/2015 Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. 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%). 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). Caregivers (English), Fact Sheet for Patients, Parents and Caregivers, https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html. 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. Bebtelovimab may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis. Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. Copyright 2023 IBM Watson Health. 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. 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. 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. 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 ). If you have any questions regarding the procurement of bebtelovimab commercially, please contact Bebtelovimab is a prescription medicine used to treat the symptoms of COVID-19. For additional questions, you can also contact the Lilly COVID Hotline at 1-855-545-5921. Bebtelovimab belongs to a class of drugs called COVID-19, Monoclonal Antibodies. 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. Mayo Clinic does not endorse companies or products. 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. Bebtelovimab binds the spike protein with a dissociation constant KD = 0.046 to 0.075 nM and blocks spike protein attachment to the human ACE2 receptor with an IC50 value of 0.39 nM (0.056 mcg/mL). Please see the enclosed Fact Sheet for authorized dosing information. One day after the United States announced a supply deal for Eli Lilly's new COVID-19 monoclonal antibody treatment, bebtelovimab, the FDA Variants, like Omicron, may have an impact on the effectiveness of mAb therapies. 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. This product is available in the following dosage forms: Portions of this document last updated: Feb. 01, 2023. On May 6, 2021, CMS updated the Medicare payment rates for the administration of COVID-19 monoclonal antibody products. Examples of risk factors that may make an individual at higher risk for progression to severe COVID-19 include, but are not limited to: Immunosuppressive Disease / Immunosuppressive Treatment. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. Monoclonal antibody drugs are designed to start working faster than vaccines, while protection provided by vaccines may last longer. Health care providers should use otherapproved or authorized productsthat are expected to retain activity against BQ.1 and BQ.1.1 as they choose appropriate treatment options for patients, including Paxlovid, Veklury, and Lagevrio. Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. 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. Emergency Use Authorization (EUA) of bebtelovimab. 2022 Aug 19;4 (8):e0747. The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. It looks like your browser does not have JavaScript enabled. The new infusion provides an . 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. 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. Currently the preferred drugs for treatment for all omicron subvariants, including BA.2, are oral paxlovid, intravenous remdesivir, or an infusion of the newly authorized monoclonal antibody, bebtelovimab, according to Dr. Razonable. 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. For patients, the infusion is free (for now). Are taking any medicines (prescription, and over-the-counter, vitamins, or herbal products). 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. These are not all the possible side effects. In a statement the FDA said that it was "carefully monitoring circulating viral variants and their sensitivity to authorised monoclonal antibodies . 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): Circulating SARS-CoV-2 viral variants may be associated with resistance to monoclonal antibodies. 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. Thresholds, Orders, and Replenishment by Jurisdiction, HHS, Administration for Strategic Preparedness and Response (ASPR) 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. 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. Lilly cannot recommend other methods of administration other than what is authorized in the EUA Fact Sheet for health care providers. 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. On Feb. 11, the FDA authorized the emergency use of the monoclonal antibody bebtelovimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients when all of these apply:. Fact Sheet for Patients, Parents and Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. Before sharing sensitive information, make sure you're on a federal government site. . Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab and mandatory requirements of the EUA. All rights reserved. This site is intended for US residents aged 18 or older. Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. 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. Bebtelovimab is a monoclonal antibody treatment that had its FDA authorization paused in November 2022. Per EUA, remove bebtelovimab vial from refrigerator and allow to equilibrate to room temperature for approximately 20 minutes. Signs and symptoms of infusion-related reactions may include: Administer appropriate medications and/or supportive care if an infusion-related reaction occurs. AmerisourceBergen will sell bebtelovimab to licensed and approved customers such as hospitals, infusion centers, long-term care facilities, clinics, etc. It is used by people 12 years of age and older who have recently tested positive for. These errors build up over time until the virus is no longer capable of surviving. 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. This is a vaccine for Covid-19 that is investigated on administered in children and adults. Q0222 - Injection, bebtelovimab, 175 mg (Effective 2/11/2022-11/30/2022) *FDA revoked the . 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Avoid forming air bubbles. Tell your doctor right away if you feel confused, tired, or weak. Resources may contain information about doses, uses, formulations and populations different from product labeling. It is not known if Bebtelovimab is safe and effective in children younger than 12 years of age who weigh over 88 pounds. Signs and symptoms of infusion-related reactions may include: Administer appropriate medications and/or supportive care if an infusion-related reaction occurs. 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. Remove bebtelovimab vial from refrigerated storage and allow to equilibrate to room temperature for approximately 20 minutes before preparation. Clinical Worsening After Monoclonal Antibody Administration. We comply with the HONcode standard for trustworthy health information. 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. Healthcare providers should consider the benefit-risk for an individual patient. Last updated on Nov 30, 2022. Dosage form: injection for intravenous use Download The U.S. government has spent $720 million for hundreds of thousands of doses of bebtelovimab that are being distributed around the country. PP-BB-US-0005 11/2022 Fact Sheet for Patients, Parents and Caregivers (Spanish), Download 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. At this time, bebtelovimab remains authorized in all U.S. regions until further notice by FDA. There are limited clinical data available for bebtelovimab. Bebtelovimab: 175 mg bebtelovimab. All of the risks are not known at this time. Drug information provided by: IBM Micromedex. Bebtelovimab No Longer Authorized as of 11/30/22. If used, attach and prime the syringe extension set. Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions. (4) Paxlovid is given twice daily for 5 days, starting as soon as possible . Please confirm that you would like to log out of Medscape. These reactions may be severe or life-threatening. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. Administer the entire contents of the syringe via intravenous (IV) injection over at least 30. 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. It is your choice for you or your child to be treated or not to be treated with bebtelovimab. Bebtelovimab did not undergo the same type of review as an FDA-approved product. Health care providers should assess whether these treatments are right for their patient in the event the patient develops mild-to-moderate COVID-19. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. 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. Use the yellow button below to refer patients directly for infusion treatment. Clinical Criteria and Data Requirements for Patient: (Must complete each item as appropriate) 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. To find COVID-19 vaccine locations near you: Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233. Important points to this press release: "Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. Like bebtelovimab, FDA may allow for the emergency use of other medicines to treat people with COVID-19. Talk to your healthcare provider if you have any questions. I think we now have a better understanding of how to use monoclonal antibodies to treat COVID-19. . There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. These reactions may be severe or life threatening. COVID-19 is caused by a virus called a coronavirus (SARS-CoV-2). 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). Bebtelovimab may be used alone or with other medications. New Treatment, Vaccine and Testing Locator Map. There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. See Limitations of Authorized Use. FDA Letter of Authorization. . Bebtelovimab is now not an Emergency Use Authorization (EUA) medicine and has never been an FDA-approved medicine in the United States. Healthcare providers should consider the benefit-risk for an individual patient. Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab and mandatory requirements of the EUA. Bebtelovimab 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. Whether these treatments are right for their patient in the non-urgent setting, the infusion is free ( now! Can not recommend other methods of administration other than what is authorized in the setting.: Search vaccines.gov, text your ZIP code to 438829, or call 1-800-FDA-1088 call. The FDA said that it was & quot ; carefully monitoring circulating viral variants their... 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