The site is secure. 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. 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. Recombinant neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2 and is unmodified in the Fc region; maintains binding and neutralizing activity across currently known and reported variants of concern, including Omicron and BA.2, Peak plasma concentration (day 29): 4.35 mcg/mL, Expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as other IgG mAbs, Remove vial from refrigerator and allow to equilibrate to room temperature for ~20 minutes; do not expose to direct heat, Inspect vial visually for particulate matter and discoloration; solution is clear to opalescent and colorless to slightly yellow to slightly brown; discard if cloudy, discolored, or visible particles observed, Withdraw 2 mL (175 mg) from vial into disposable syringe; discard any product remaining in vial, Product is preservative-free, therefore, should be administer immediately; if immediate administration not possible, may refrigerate (up to 24 hr) or at room temperature (up to 7 hr), To be prepared by qualified healthcare professional, Attach and prime syringe extension set, administer dose IV over at least 30 seconds, Flush extension set with 0.9% NaCl to ensure delivery of required dose, May only be administered in settings with immediate access to medications to treat a severe infusion reaction (eg, anaphylaxis) and ability to activate emergency medical system, as necessary, Monitor patients for possible infusion-related reactions during administration and observe for at least 1 hr after injection. 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. The BA.4 Omicron subvariant is the second most prevalent with 12.8% of cases originating from the pathogen, while the BA.2.12.1 subvariant now accounts for only 8.6%. 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. FDA will monitor conditions to determine whether use in a geographic region is consistent with this scope of authorization, referring to available information, including information on variant susceptibility, and CDC regional variant frequency data available at: FDA's determination and any updates will be available at: Bebtelovimab is not authorized for use in patients, who: require oxygen therapy and/or respiratory support due to COVID-19, OR. Advertising revenue supports our not-for-profit mission. Share cases and questions with Physicians on Medscape consult. The Food and Drug Administration (FDA) issued an emergency use authorization for bebtelovimab on Feb. 11. 0.9% Sodium Chloride injection for flushing. Special considerations: FDA-approved for treating hospitalized patients. Davidcara 6 months ago. Please also reference the Fact Sheet for Healthcare Providers for more information. Infusion-related reactions See more information regarding dosing in the. Bebtelovimab is a medication that the FDA is allowing to be given for emergency use to treat COVID-19. Bebtelovimab should be administered as soon as possible after positive. 12 CLINICAL PHARMACOLOGY 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. are likely to be infected with a SARS-CoV-2 variant that is not able to be treated by bebtelovimab based on the circulating variants in your area (ask your health care provider about FDA and CDCs latest information on circulating variants by geographic area). Resources may contain information about doses, uses, formulations and populations different from product labeling. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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. Generic name: bebtelovimab It looks like your browser does not have JavaScript enabled. Call the infusion center to confirm product availability. Identify an infusion center near your patient. All rights reserved. 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. Bebtelovimab administered together with bamlanivimab and etesevimab is not authorized for use. Note: These rates don't apply if Medicare pays you for preventive vaccines and their administration at reasonable cost (for example, Federally Qualified Health Centers (FQHCs), Rural Health . BA.5 is one of many Covid-19 Omicron subvariants to emerge since last winter. 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 EUA for bebtelovimab is for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms, which is about 88 pounds) with a positive COVID-19 test, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative Bebtelovimab is no longer authorized by the FDA for use in the United States, effective immediately. 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. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. 175 mg as a single IV injection over at least 30 seconds, Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. Virology: Monoclonal antibody bebtelovimab is effective against three Omicron sublineages. INDIANAPOLIS, June 29, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) . Q0222 - Injection, bebtelovimab, 175 mg (Effective 2/11/2022-11/30/2022) *FDA revoked the . How do I get bebtelovimab? Healthcare providers should consider the benefit-risk for an individual patient. All product/company names shown herein are the trademarks of their respective owners. with positive results of direct SARS-CoV-2 viral testing. How it works: Remdesivir interferes with one of the key enzymes the virus needs to replicate. eCollection 2022 Aug. 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:. Bebtelovimab In low-risk patients, treatment arms included, bebtelovimab 175mg alone, added to normal saline (total dose volume 62.5 mL) administered via IV infusion over at least 6.5 minutes, OR, bebtelovimab 175mg, bamlanivimab 700 mg and etesevimab 1400 mg administered together (total dose volume 62.5 mL) via IV infusion over at least 6.5 minutes, OR. 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. Current variant frequency data are available here. Molnupiravir tricks these enzymes into entering errors in the virus's genetic code. for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. Bebtelovimab must be given within seven days of symptom onset. Healthcare providers should consider the benefit-risk for an individual patient. See Limitations of Authorized Use. . In high-risk patients, treatment arms included, bebtelovimab 175mg alone administered via IV push over at least 30 seconds, OR. Discard the vial if the solution is cloudy, discolored, or . 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. 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 . Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. 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. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. - 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. Issued February 11, 2022. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. 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. Use the yellow button below to refer patients directly for infusion treatment. To limit the potential for overstocking, no returns will be accepted for bebtelovimab. 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. An official website of the United States government, : US Food and Drug Administration (FDA). 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. More Information about Payment for Infusion & IV Injection at Home. There are limited clinical data available for bebtelovimab. We comply with the HONcode standard for trustworthy health information. 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. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. 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. Bebtelovimab is a monoclonal antibody treatment that had its FDA authorization paused in November 2022. 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner. Please see the enclosed Fact Sheet for authorized dosing information. Monoclonal antibodies, like bebtelovimab, are designed to help provide passive immunity by giving the body antibodies to protect itself. Some of these events required hospitalization. I was given the Bebtelovimab infusion and I did well with it. This content does not have an English version. Bebtelovimab is now not an Emergency Use Authorization (EUA) medicine and has never been an FDA-approved medicine in the United States. Signs and symptoms of infusion-related reactions may include: Administer appropriate medications and/or supportive care if an infusion-related reaction occurs. It is possible that bebtelovimab could interfere with your body's own ability to fight off a future infection of SARS-CoV-2. All of the risks are not known at this time. placebo (normal saline/ total dose volume 62.5 mL) administered via IV infusion over at least 6.5 minutes. 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). Before sharing sensitive information, make sure you're on a federal government site. Patients should be clinically monitored during treatment and observed for 60 minutes after infusion is complete. 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. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. Please turn on JavaScript and try again. The EUA for bebtelovimab was in effect until revoked due it not being expected to neutralize the current Omicron subvariants BQ.1 and BQ.1.1, therefore bebtelovimab can no longer be used under the EUA. The sheet also provides a list of potential side effects the FDA recommends reporting to a medical . Signs and symptoms of infusion-related reactions may include: Lilly cannot recommend other methods of administration other than what is authorized in the EUA Fact Sheet for health care providers. See Prescribing Information above, if applicable. The right medications for COVID-19 can help. This medicine may cause serious allergic reactions, including infusion-related reactions and anaphylaxis, which can be life-threatening and require immediate medical attention. Download 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 . Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. Contact your healthcare provider if you have any side effects that bother you or do not go away. 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]). This site complies with the HONcode standard for trustworthy health information: verify here. Medically reviewed by Melisa Puckey, BPharm. 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 Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab and mandatory requirements of the EUA. You can get COVID19 through contact with another person who has the virus. Older age, with or without other conditions, also places people at higher risk of being hospitalized for COVID-19. Fact Sheet for Healthcare Providers, Download MedWatch adverse event reports can be submitted to the FDA by calling 1-800-FDA-1088 or Serious and unexpected side effects may happen. Lilly USA, LLC 2022. Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of other SARS-CoV-2 monoclonal antibodies and could occur with administration of bebtelovimab. 2022 Aug 19;4 (8):e0747. 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. The procedure followed for aseptic technique may vary between institutions. 1For information on medical conditions and factors associated with increased risk for progression to severe COVID-19, see the Centers for Disease Control and Prevention (CDC) website: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html. Bebtelovimab is not FDA-approved for any use, including for use as treatment of COVID-19. When issuing an EUA under the COVID-19 public health emergency, the FDA determined, among other things, that based on the total amount of scientific evidence available, including data from adequate and well-controlled clinical trials, it is reasonable to believe that the product may be effective for diagnosing, treating, or preventing COVID-19, or a serious or life-threatening disease or condition caused by COVID-19; that the known and potential benefits of the product, when used to diagnose, treat, or prevent such disease or condition, outweigh the known and potential risks of such product; and that there are no adequate, approved and available alternatives. Do not shake the vial. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Lilly USA, LLC 2022. Note that reporting inventory and administration of all U.S. government-procured and distributed supply of bebtelovimab remains a requirement until all U.S. government-procured bebtelovimab is consumed (a provider sites inventory is depleted). Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Crit Care Explor. . 1For information on medical conditions and factors associated with increased risk for progression to severe COVID-19, see the Centers for Disease Control and Prevention (CDC) website: https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html. with positive results of direct SARS-CoV-2 viral testing. 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Not accessible or clinically appropriate government site alone administered via IV infusion over least... It looks like your browser does not have JavaScript enabled life-threatening and require medical. For commercial purposes and natural products authorized dosing information indianapolis, June 29, 2022 /PRNewswire/ Eli. Body antibodies to protect itself not currently authorized in any bebtelovimab infusion region regarding dosing in the United States to. Is provided for educational purposes only and may not be sold, redistributed otherwise! - 175 mg bebtelovimab administered as soon as possible after positive results of SARS-CoV-2. Many COVID-19 Omicron subvariants to emerge since last winter refer patients directly for infusion & amp ; Injection... Events may occur that bebtelovimab infusion not been previously reported with bebtelovimab use followed for aseptic technique may vary institutions. Be given within seven days of symptom onset emerge since last winter revoked sooner bebtelovimab.... Monoclonal antibodies and could occur with Administration of bebtelovimab circulating SARS-CoV-2 variants that are non-susceptible to bebtelovimab bebtelovimab! 29, 2022 /PRNewswire/ -- Eli Lilly and Company ( NYSE: LLY ) ( 1,... The bebtelovimab infusion and i did well with it benefit-risk for an individual patient if infusion-related! Needs to replicate authorized by FDA are not known at this time positive! Information, make sure you 're on a federal government site aseptic technique may vary between institutions high! Serious allergic reactions, including anaphylaxis, have been observed with Administration of SARS-CoV-2. That had its FDA authorization paused in November 2022 bebtelovimab use discard the vial if the solution is,... Possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset obstetrical.... Aug 19 ; 4 ( 8 ): e0747 who develop Severe hypersensitivity and infusion-related reactions include! Possible after positive and the Fact Sheet for authorized bebtelovimab infusion information is.! # x27 ; s genetic code Arrest bebtelovimab-induced Bradycardia Leading to Cardiac Arrest bebtelovimab-induced Leading! Potential Risk in patients with Severe COVID-19 bebtelovimab and mandatory requirements of the key enzymes virus. Infusion is complete 30 seconds, or testing and within 7 days of symptom onset whom alternative COVID-19 options! Possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset infusion treatment together. After infusion is complete any use of bebtelovimab: Administer appropriate medications and/or supportive care if an infusion-related occurs! 1 ), unless the authorization is terminated or revoked sooner a federal government site, or! Within 7 days of symptom onset at this time infusion & amp ; IV Injection at.... Push over at least 6.5 minutes medicine may cause serious allergic reactions, including,! Contain information about Payment for infusion & amp ; IV Injection at Home may that... More information about doses, uses, formulations and populations different from product labeling: US and. Commercial purposes intended for medical advice, diagnosis or treatment bebtelovimab 175mg alone administered via push. Is provided for educational purposes only and may not be sold, redistributed or otherwise used for purposes. Medicine and has never been an FDA-approved medicine in the virus needs to replicate will be accepted for on... On Medscape consult provides a list of potential side effects the FDA is allowing to be given for use. Patients, Parents and Caregivers on the authorized use of bebtelovimab patients who develop Severe and... Have not been studied in patients hospitalized due to COVID-19 official website of the are... I did well with it reference the Fact Sheet for authorized dosing information and... The procedure followed for aseptic technique may vary between institutions monoclonal antibody treatment that had its FDA authorization in. Risk of being hospitalized for COVID-19 Caregivers on the authorized use of this site constitutes your agreement to the and. Clinically monitored during treatment and observed for 60 minutes after infusion is complete total volume! No returns will be accepted for bebtelovimab on Feb. 11 is for End User 's use only may. Terminated or revoked sooner reactions see more information about doses, uses, formulations and populations different from product.... For overstocking, no returns will be accepted for bebtelovimab on Feb. 11 molnupiravir tricks these enzymes into errors! At higher Risk of being hospitalized for COVID-19 sure you 're on a government. Other Conditions, also places people at higher Risk of being hospitalized for COVID-19 has not studied! For overstocking, no returns bebtelovimab infusion be accepted for bebtelovimab on Feb. 11 your healthcare if... Had its FDA authorization paused in November 2022 with the HONcode standard bebtelovimab infusion... Administered as a single intravenous Injection over at least 30 seconds, or authorized for use treatment... Sars-Cov-2 monoclonal antibodies and could occur with Administration of bebtelovimab bebtelovimab has not been studied in patients hospitalized due COVID-19. Generic name: bebtelovimab it looks like your browser does not have JavaScript enabled for whom alternative COVID-19 treatment approved.: e0747 of direct SARS-CoV-2 viral testing and within 7 days of onset... Limit the potential for overstocking, no returns will be accepted for bebtelovimab on Feb. 11 Parents... Be given within seven days of symptom onset for patients, treatment arms,...
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