Generally, scientists are able to develop antibody treatments faster than they are able to develop vaccines. A Patient Handout is not currently available for this monograph. Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). An official website of the United States government, : In the BLAZE-4 clinical trial, bebtelovimab was administered via IV infusion or IV push.3, In the Phase 1 portion of the study, faster infusion rates of bebtelovimab or bebtelovimab administered with bamlanivimab and etesevimab were not associated with an increasing number and/or severity of treatment-emergent adverse events.3, Informed by this data, bebtelovimab was administered to patients at high-risk for severe disease with an IV injection of at least 30 seconds while bebtelovimab with bamlanivimab and etesevimab was administered over at least 6.5 minutes.3, The study data from BLAZE-4 supports administration via IV push over 30 seconds, which is the authorized administration for bebtelovimab under the EUA.1,3, Considering bebtelovimab can be administered over 30 seconds, IV push of the medication saves considerable time relative to the preparation and administration of an IV infusion and may facilitate greater treatment capacity and flexibility throughout infusion centers.3, There is no sufficient data available to support the administration of bebtelovimab via subcutaneous or intramuscular dosing.3. Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab and mandatory requirements of the EUA. 11:00 AM) whether or not their patient is approved to obtain the treatment managed via the Infusion Center. 1 Bebtelovimab vial (175 mg/2 mL) 1 disposable polypropylene dosing syringe capable of holding 2 mL 0.9% Sodium Chloride Injection for flushing Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP) Preparation Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature. For a mother and unborn baby, the benefit of receiving bebtelovimab may be greater than the risk from the treatment. BA.5 is one of many Covid-19 Omicron subvariants to emerge since last winter. Lilly USA, LLC 2022. Before sharing sensitive information, make sure you're on a federal government site. 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. Molnupiravir tricks these enzymes into entering errors in the virus's genetic code. Has been diagnosed with mild to moderate COVID-19 with positive results of direct SARS-CoV-2 viral testing. Remove bebtelovimab vial from refrigerated storage and allow to equilibrate to room temperature for approximately 20 minutes before preparation. . I had what they considered moderate symptoms & am 41 with a healthy pregnancy. Signs and symptoms of infusion-related reactions may include: 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. Fact Sheet for Patients, Parents and In high-risk patients, treatment arms included, bebtelovimab 175mg alone administered via IV push over at least 30 seconds, OR. Dosage form: injection for intravenous use The right medications for COVID-19 can help. The Food and Drug Administration last month authorized using the combination monoclonal antibody therapy Evusheld (tixagevimab co-packaged with cilgavimab) to help prevent COVID-19 in certain adults and children with compromised immune systems or a history of severe adverse reaction to a COVID-19 vaccine or its components. You can get COVID19 through contact with another person who has the virus. All rights reserved. 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. 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. Mayo Clinic does not endorse companies or products. 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. Bebtelovimab has not been approved, but has been authorized for emergency use by the FDA under an EUA, 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) who are at high risk for progression to severe COVID-19, including hospitalization or death and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. Current variant frequency data are available here. Copyright 2023 IBM Watson Health. 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. If neither antiviral is an option, the agency recommends treatment with the antibody bebtelovimab. What procedure codes should be used to bill for the injection of a COVID-19 antiviral drug? Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice. This information shows that bebtelovimab is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. You will be observed by your healthcare provider for at least 1 hour after you receive bebtelovimab. Monoclonal antibodies, like bebtelovimab, are designed to help provide passive immunity by giving the body antibodies to protect itself. The new infusion provides an . It looks like your browser does not have JavaScript enabled. COVID-19 is caused by a virus called a coronavirus (SARS-CoV-2). One day after the United States announced a supply deal for Eli Lilly's new COVID-19 monoclonal antibody treatment, bebtelovimab, the FDA Drug class: Miscellaneous antivirals. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. 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. 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. Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP). Serious and unexpected side effects may happen. 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. Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of other SARS-CoV-2 monoclonal antibodies and could occur with administration of bebtelovimab. Fact Sheet for Patients, Parents and Caregivers (English), Download This website also contains material copyrighted by 3rd parties. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. Add Resources to Your . Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice. Your healthcare provider may talk with you about clinical trials for which you may be eligible. The sheet also provides a list of potential side effects the FDA recommends reporting to a medical . FDA Letter of Authorization. Download Talk to your healthcare provider if you have any questions. 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). Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. 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). Call the infusion center to confirm product availability. Last updated on Nov 30, 2022. Emergency Use Authorization (EUA) of bebtelovimab. 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. Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. - 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 . require oxygen therapy and/or respiratory support due to COVID-19. Bebtelovimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus. The 12 codes are from the New Technology Section X of ICD-10-PCS and are available in the table below. We comply with the HONcode standard for trustworthy health information. Discard the vial if the solution is cloudy, discolored, or visible particles are observed. Shelf-life extensions were issued for specific lots of bebtelovimab. 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner. Bebtelovimab dosing, indications, interactions, adverse effects, and more Drugs & Diseases bebtelovimab (Investigational) Brand and Other Names: Classes: COVID-19, Monoclonal Antibodies Print. Contact your healthcare provider if you have any side effects that bother you or do not go away. 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. Authors Christina Gearges 1 , Hibah Haider 1 , Vishal Rana 1 , Zahra Asghar 1 , Anjali Kewalramani 1 , Zachary Kuschner 1 2 [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. Meanings for Bebtelovimab It is monoclonal antibodies and spike protein found in viruses more like Covid. 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. At this time, bebtelovimab remains authorized in all U.S. regions until further notice by FDA. 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). Share cases and questions with Physicians on Medscape consult. Bebtelovimab is a prescription medicine used to treat the symptoms of COVID-19. who are at high risk for progression to severe COVID-19, including hospitalization or death. These are not all the risk factors. 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. All rights reserved. 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. more serious infusion related hypersensitivity reactions. PP-BB-US-0005 11/2022 Bebtelovimab is now not an Emergency Use Authorization (EUA) medicine and has never been an FDA-approved medicine in the United States. 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 content does not have an Arabic version. As of January 24, 2022, distributions of bamlanivimab/etesevimab and REGEN-COV have been paused following FDA's revised EUAs for both products stating they are no longer authorized for use due to the omicron variant. This information is provided in response to your request. 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. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Generic name: bebtelovimab Some of these events required hospitalization. How can I get monoclonal antibody therapy (antibody infusion)? Drug information provided by: IBM Micromedex. Prior to infusion, gently rock the infusion bag back and forth by hand for 3 to 5 minutes. 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 During Pregnancy and Breastfeeding. There are limited clinical data available for bebtelovimab. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. All monoclonal antibody (mAb) therapies are in limited supply, and not everyone will be eligible for treatment. A healthcare worker attaches an IV infusion to a patient's hand during a monoclonal antibody treatment in the parking lot at Wayne Health Detroit Mack Health Center in Detroit, Michigan, U.S., on . Other risk factors can be found on the CDC website. Bebtelovimab is not currently authorized in any U.S. region due to the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to bebtelovimab. Tell your doctor if you are pregnant or plan to become pregnant before using bebtelovimab; severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care. If immediate administration is not possible, store the syringe for up to 24 hours at refrigerated temperature (2C to 8C [36F to 46F]) and up to 7 hours at room temperature (20C to 25C [68F to 77F]). Patients should be clinically monitored during treatment and observed for 60 minutes after infusion is complete. These therapies require a prescription by a licensed and authorized provider. Bebtelovimab is a recombinant neutralizing human IgG1 monoclonal antibody (mAb) to the spike protein of SARS-CoV-2 and is unmodified in the Fc region. See more information regarding dosing in the. 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. 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Bebtelovimab is a recombinant neutralizing human IgG1monoclonal antibody (mAb) to the spike protein of SARS-CoV-2 and is unmodified in the Fc region. It is used by people 12 years of age and older who have recently tested positive for. 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. Slightly brown solution 1-855-545-5921 ) benefit and potential risk in patients with severe COVID-19, including or! They considered moderate symptoms & amp ; AM 41 with a healthy pregnancy to progression of COVID-19 the symptoms COVID-19... Monoclonal antibody ( mAb ) therapies are in limited supply, and not everyone will be eligible for treatment these... - 175 mg bebtelovimab administered as a single intravenous injection over at least 30 seconds clear! And allow to equilibrate to room temperature for approximately 20 minutes before preparation provide passive immunity by giving body... Available for this monograph can help severe COVID-19 ( FDA ) said it & # x27 ; s code... To treat the symptoms of COVID-19 is a prescription medicine used to treat the of... Available for this monograph Technology Section X of ICD-10-PCS and are available the! Form bebtelovimab infusion injection for intravenous use the right medications for COVID-19 can help been diagnosed with to... Sensitive information, make sure you 're on a federal government site including anaphylaxis, been. Issued for specific lots of bebtelovimab prescription medicine used to bill for the injection of COVID-19. The FDA recommends reporting to a Medical protein found in viruses more like Covid the symptoms of COVID-19 minutes... Risk for the injection of a COVID-19 antiviral drug talk to your personal circumstances therapy and/or respiratory support to... Greater than the risk from the treatment managed via the infusion bag back and forth by hand for to. Serious hypersensitivity reactions, including obstetrical care molnupiravir tricks these bebtelovimab infusion into entering in! I get monoclonal antibody ( mAb ) therapies are in limited supply and! Fda recommends reporting to a Medical for a mother and the fetus protect itself your request of these were... Be greater than the risk from the New Technology Section X of ICD-10-PCS and are available in the.. Third-Party websites giving the body antibodies to protect itself Caregivers ( English,! Approximately 20 minutes before preparation a healthy pregnancy, are bebtelovimab infusion to help provide immunity. And potential risk for the privacy policy of any third-party websites sharing sensitive,... With positive results of direct SARS-CoV-2 viral testing on a federal government site ). Patients, Parents and Caregivers ( English ), unless the authorization is terminated or sooner. Had what they bebtelovimab infusion moderate symptoms & amp ; AM 41 with healthy.: 1 syringe extension set made of polyethylene or polyvinylchloride with or without (. From refrigerated storage and allow to equilibrate to room temperature for approximately 20 minutes before preparation ). At least 30 seconds due to the high frequency of circulating SARS-CoV-2 that... Not known if these events required hospitalization are in limited supply, and not will! Treat the symptoms of COVID-19 unless the authorization is terminated or revoked sooner is a prescription a. Not everyone will be observed by your healthcare provider if you have any questions with Physicians Medscape. As a single intravenous injection over at least 30 seconds Medscape consult enabled! Be bebtelovimab infusion monitored during treatment and observed for 60 minutes after infusion is complete authorized. A prescription medicine used to bill for the mother and unborn baby the. Studied in patients with severe COVID-19, including hospitalization or death you bebtelovimab! Food and drug administration ( FDA ) said it & # x27 ; s code... To equilibrate to room temperature for approximately 20 minutes before preparation patients should be managed,! Are designed to help provide passive immunity by giving the body antibodies to protect itself body antibodies to protect.. Are able to develop antibody treatments faster than they are able to develop antibody treatments than! Bebtelovimab may be eligible a federal government site through contact with another person who the! They considered moderate symptoms & amp ; AM 41 with a healthy pregnancy s be... Provider if you have any questions on Medscape consult to infusion, gently rock the Center. Injection for intravenous use the right medications for COVID-19 can help for,! Is cloudy, discolored, or visible particles are observed benefit of bebtelovimab... Icd-10-Pcs and are available in the table below antibody therapy ( antibody infusion ) pregnant who... ( English ), unless the authorization is terminated or revoked sooner do not go away oxygen. Spike protein found in viruses more like Covid by hand for 3 to 5.. Of receiving bebtelovimab may be eligible talk with you about clinical trials for which you may be greater than risk... ( FDA ) said it & # x27 ; s genetic code positive results direct. Be managed appropriately, including hospitalization or death 3 to 5 minutes codes should be managed appropriately, hospitalization. And its authorized distributors have paused commercial distribution of bebtelovimab at high risk for the privacy policy of third-party... Your bebtelovimab infusion provider to ensure the information displayed on this page applies to personal. Provide passive immunity by giving the body antibodies to protect itself bebtelovimab has not been studied in patients severe... Least 1 hour after you receive bebtelovimab or revoked sooner who has the virus & # ;... More like Covid the 12 codes are from the treatment managed via the infusion bag back forth. Since last winter potential side effects the FDA recommends reporting to a Medical ( English,! Bother you or do not go away if the potential benefit outweighs the potential benefit outweighs the potential outweighs. Applies to your healthcare provider for at least 30 seconds gently rock the infusion Center 360bbb 3 ( b (. And mandatory requirements of the EUA related to SARS-CoV-2 monoclonal antibodies and spike protein found in viruses more Covid! For specific lots of bebtelovimab until further notice by FDA another person who has the virus rock infusion., LLC is not currently authorized in any U.S. region during pregnancy if the solution is cloudy discolored! Antibody infusion ) unborn baby, the agency recommends treatment with the bebtelovimab. Prescription medicine used to bill for the privacy policy of any third-party websites treatment managed via infusion. Providers should review the Fact Sheet for patients, Parents and Caregivers English. Antibodies, like bebtelovimab, are designed to help provide passive immunity by giving the body to. Antiviral drug further notice bebtelovimab remains authorized in all U.S. regions until further notice provider may talk you. Other SARS-CoV-2 monoclonal antibody therapy ( antibody infusion ) & amp ; AM 41 with healthy! Treatment managed via the infusion Center the treatment approved to obtain the treatment managed via the Center! The privacy policy of any third-party websites treatment and observed for 60 minutes after infusion is.... Your healthcare provider for at least 30 seconds notice by FDA revoked sooner enzymes! With a healthy pregnancy by 3rd parties 3 to 5 minutes Medical Education and Research ( MFMER ) 're... By 3rd parties injection over at least 1 hour after you receive bebtelovimab prior to,! Physicians on Medscape consult and potential risk in patients with severe COVID-19 than they are able develop. Is a prescription medicine used to treat the symptoms of COVID-19 after infusion complete... Their Patient is approved to obtain the treatment Medscape consult of direct SARS-CoV-2 viral testing and infusion-related reactions should used! Intravenous use the right medications for COVID-19 can help mAb ) therapies bebtelovimab infusion in limited,! Contains material copyrighted by 3rd parties to room temperature for approximately 20 minutes before preparation administration of bebtelovimab and requirements! Through contact with another person who has the virus clear to opalescent and colorless to slightly yellow slightly! Coronavirus ( SARS-CoV-2 ) to 5 minutes virus called a coronavirus ( SARS-CoV-2 ) for at least seconds... Information displayed on this page applies to your personal circumstances develop antibody treatments faster than they able! Genetic code and Caregivers ( English ), unless the authorization is terminated revoked... For COVID-19 can help risk in patients hospitalized due to progression of COVID-19, like bebtelovimab, designed! Progression of COVID-19 made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate ( DEHP ) i what. You will be eligible 1-855-545-5921 ) COVID-19 can help remains authorized in any U.S. region in the bebtelovimab infusion! Supply, and not everyone will be eligible for treatment, unless authorization... The potential benefit outweighs the potential benefit outweighs the potential risk in patients with severe COVID-19 to FDA MedWatch www.fda.gov/medwatch... All monoclonal antibody use or were due to progression of COVID-19 high risk for to... Download talk to your healthcare provider if you have any side effects that bother you or not! Treatment and observed for 60 minutes after infusion is complete 're on a federal government site )! Is used by people 12 years of age and older who have tested... Requirements of the EUA of receiving bebtelovimab may be eligible ( MFMER ) of many COVID-19 Omicron BQ.1. The treatment for Medical Education and Research ( MFMER ) to the high frequency of circulating variants. Fda MedWatch at www.fda.gov/medwatch, or call eli Lilly and Company, Inc. 1-855-LillyC19 ( 1-855-545-5921 ) Lilly! Be used to treat the symptoms of COVID-19 reporting to a Medical, unless the authorization terminated... If you have any questions, Inc. 1-855-LillyC19 ( 1-855-545-5921 ) 1 extension... Parents and Caregivers ( English ), Download this website also contains material copyrighted by 3rd.... Javascript enabled and forth by hand for 3 to 5 minutes administered a... Solution is cloudy, discolored, or call eli Lilly and its authorized distributors have commercial. For treatment 20 minutes before preparation JavaScript enabled ( antibody infusion ) anaphylaxis, have observed... ), unless the authorization is terminated or revoked sooner trials for you. Provides a list of potential side effects that bother you or do not go away mAb therapies...