Dosage form: injection for intravenous use 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 see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. Drug Safety and Availability, Recalls, Market Withdrawals and Safety Alerts, Information about Nitrosamine Impurities in Medications, Food and Drug Administration Overdose Prevention Framework, Medication Errors Related to CDER-Regulated Drug Products, Postmarket Drug Safety Information for Patients and Providers, Risk Evaluation and Mitigation Strategies | REMS, Multistate outbreak of fungal meningitis and other infections, Health Care Provider Fact Sheet for bebtelovimab. 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 Florida Department of Health COVID-19 Response Map has been updated to make it easier to find testing, vaccine and treatment sites across the state. 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. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. All rights reserved. doi: 10.1097/CCE.0000000000000747. require oxygen therapy and/or respiratory support due to COVID-19. | Lilly USA, LLC 2023. How do I get bebtelovimab? Current variant frequency data are available here. Add a meaning Add Bebtelovimab details Phonetic spelling of Bebtelovimab Add phonetic spelling Synonyms for Bebtelovimab Add synonyms Healthcare professionals must follow aseptic technique directive provided by their institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative. 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. Special considerations: FDA-approved for treating hospitalized patients. Lilly cannot recommend other methods of administration other than what is authorized in the EUA Fact Sheet for health care providers. Bebtelovimab - Last updated on December 12, 2022 All rights owned and reserved by Memorial Sloan Kettering Cancer Center. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, vasovagal reactions (e.g. Sibley Infusion Center staff will call the patient to schedule administration of the therapy in the non-urgent setting. See more information regarding dosing in the. Bebtelovimab is designed as a treatment option for those newly diagnosed with COVID-19 who cannot take Paxlovid and are deemed at high risk of severe outcomes. 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. Read more about bebtelovimab. Issued February 11, 2022. (1-800-545-5979), HCP Fact Sheet | Patient & Caregiver Fact Sheet | FDA Authorization Letter. This content does not have an English version. They have a positive COVID-19 test result; They're at high-risk for progression to severe COVID-19; Alternative COVID-19 treatment options approved or authorized by the FDA aren't accessible or . Therefore, bebtelovimab may not be administered for treatment of COVID-19 under the Emergency Use Authorization (EUA) until further notice. A: Generally acceptable. Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. 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. There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions. Variants, like Omicron, may have an impact on the effectiveness of mAb therapies. Use the yellow button below to refer patients directly for infusion treatment. Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. Details About the 2020 Codes Download 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%). AmerisourceBergen Specialty Distributors 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. who are at high risk for progression to severe COVID-19, including hospitalization or death, and. 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. The site is secure. 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 . Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. 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. high-risk adults and pediatric patients (12 years of age and older weighing at least 40 kg) who all received open-label active treatments. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Some of these events required hospitalization. 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]): with positive results of direct SARS-CoV-2 viral testing, and To find COVID-19 vaccine locations near you: Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233. Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab and mandatory requirements of the EUA. ).1, In the BLAZE 4 study, extension sets could have been primed with either study drug or normal saline if allowed by site practices.3, Bebtelovimab Fact Sheet for Health Care Providers. Inspect bebtelovimab vial visually for particulate matter and discoloration. Provide your patient with resources to ensure they have the answers they need. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. 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. These are not all the possible side effects. If you log out, you will be required to enter your username and password the next time you visit. 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. 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. 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. 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. All rights reserved. This site complies with the HONcode standard for trustworthy health information: verify here. only, includes infusion and post administration monitoring, second dose (Effective 6/24/2021) Q. Bebtelovimab dosing, indications, interactions, adverse effects, and more Drugs & Diseases bebtelovimab (Investigational) Brand and Other Names: Classes: COVID-19, Monoclonal Antibodies Print. Bebtelovimab belongs to a class of drugs called COVID-19, Monoclonal Antibodies. Healthcare providers should consider the benefit-risk for an individual patient. Serious and unexpected side effects may happen. US Food and Drug Administration (FDA). [2] 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, pronounced: beb-te-LOV-i-mab. Medically reviewed by Melisa Puckey, BPharm. Bebtelovimab did not undergo the same type of review as an FDA-approved product. All rights reserved. PP-BB-US-0005 11/2022 Similarly, bebtelovimab may reduce the bodys immune response to a vaccine for SARS-CoV-2. Patients should be clinically monitored during treatment and observed for 60 minutes after infusion is complete. 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. 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. Generic name: bebtelovimab What procedure codes should be used to bill for the injection of a COVID-19 antiviral drug? The following provides essential safety information on the unapproved use of bebtelovimab under the Emergency Use Authorization. There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. 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. How it works: Remdesivir interferes with one of the key enzymes the virus needs to replicate. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. Clinicians caring for COVID-19 patients should be aware of the availability of these important life-saving medications and consider use when clinically indicated. The U.S. government has spent $720 million for hundreds of thousands of doses of bebtelovimab that are being distributed around the country. 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. 1 Preparation and Administration The sheet also provides a list of potential side effects the FDA recommends reporting to a medical . The drug, bebtelovimab, is authorized for people 12 years and older who test positive for COVID-19 and are at high risk of hospitalization or death. A prescription from a healthcare provider is required to receive any mAb therapy. 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. All rights reserved. 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner. Infusion reactions have happened during and within 24 hours after the infusion. 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. An official website of the United States government, : All material on this website is protected by copyright, Copyright 1994-2023 by WebMD LLC. 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. atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, vasovagal reactions (e.g. Bebtelovimab is not FDA-approved for any use, including for use as treatment of COVID-19. FDA will continue to provide timely and transparent communication regarding the monoclonal antibody therapies that are currently authorized for emergency use in response to the COVID-19 pandemic. . 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. 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. Add Resources to Your . We have been isolating and using N95s when we use the bathroom, opening windows & leaving a good 12 hours between us each showering etc. 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). These are not all the risk factors. Bebtelovimab works by binding to the spike protein of the virus that causes COVID-19, similar to other mAbs that have been authorized for the treatment of high-risk patients with mild to moderate COVID-19 and shown a benefit in reducing the risk for hospitalization or death. 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. 1Fact sheet for healthcare providers. require an increase in baseline oxygen flow rate and/or respiratory support due to COVID19 and are on chronic oxygen therapy and/or respiratory support due to underlying non-COVID-19 related comorbidity. Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. How do you prepare, administer, and monitor bebtelovimab for treatment of COVID-19? Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Assess that alternative COVID-19 treatment options that are approved or authorized by FDA are not accessible or clinically appropriate. In laboratory experiments involving 19 monoclonal antibodies, only the recently authorized bebtelovimab was found to be capable of neutralizing all three sublineages of the Omicron variant, according to a study published in Nature. Bebtelovimab No Longer Authorized as of 11/30/22. Bebtelovimab injection is used to treat COVID-19 infection in certain non-hospitalized adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) and who have mild to moderate COVID-19 symptoms. 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. Exceptions for weekly dose quantities beyond 270 will be evaluated on a case-by-case basis. It is not known if Bebtelovimab is safe and effective in children younger than 12 years of age who weigh over 88 pounds. Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. 1 bebtelovimab vial (175 mg/2 mL) 1 disposable polypropylene dosing syringe capable of holding 2 mL 0.9% Sodium Chloride injection for flushing. 4.0.17 02/2023 | GLOOTH00001 04/2015 If used, attach and prime the syringe extension set. 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. Bebtelovimab works by binding to the spike protein of the virus that causes COVID-19, similar to other monoclonal antibodies that have been authorized for the treatment of high-risk patients with. Before sharing sensitive information, make sure you're on a federal government site. [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. This product is preservative-free and therefore, should be administered immediately. This content does not have an Arabic version. 3Data on file, Eli Lilly and Company and/or one of its subsidiaries. These errors build up over time until the virus is no longer capable of surviving. pre-syncope, syncope), dizziness, and diaphoresis. Withdraw 2 mL from the vial into the disposable syringe. This medicine is to be given only by or under the immediate supervision of your doctor. Talk to your healthcare provider if you have any questions. The authorized dose of bebtelovimab is 175mg administered as a single intravenous injection over at least 30 seconds. You are being redirected to 360bbb-3, unless the authorization is terminated or revoked sooner.1,2, Bebtelovimab is authorized for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg), For information on the authorized use of bebtelovimab and mandatory requirements under the emergency use authorization (EUA), please review the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients/Caregivers at www.LillyAntibody.com/bebtelovimab. (4) Paxlovid is given twice daily for 5 days, starting as soon as possible . Use: treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe disease. Bebtelovimab should be administered via IV injection over at least 30 seconds. 1 disposable polypropylene dosing syringe capable of holding 2 mL. All of the risks are not known at this time. 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. Well, after many phone calls, got the bebtelovimab this afternoon. There areseveral treatmentsthat are authorized or approved to treat certain patients with mild-to-moderate COVID-19 which are expected to retain activity against currently circulating variants, including Omicron subvariants BQ.1 and BQ.1.1. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Fact Sheet for Healthcare Providers, Download Authors Christina Gearges 1 , Hibah Haider 1 , Vishal Rana 1 , Zahra Asghar 1 , Anjali Kewalramani 1 , Zachary Kuschner 1 2 Infusion-related reactions Signs and symptoms of infusion-related reactions may include: Administer appropriate medications and/or supportive care if an infusion-related reaction occurs. Health care providers should assess whether these treatments are right for their patient in the event the patient develops mild-to-moderate COVID-19. 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. 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. INDIANAPOLIS, June 29, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) . This site complies with the HONcode standard for trustworthy health information: verify here. Call the infusion center to confirm product availability. FDA Letter of Authorization. The right medications for COVID-19 can help. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. Product names listed above are trademarks or registered trademarks owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates, US_cFAQ_BEB010_X2_DOSE_PREPARATION_ADMINISTRATION. The .gov means its official.Federal government websites often end in .gov or .mil. 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. There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage or! Product is preservative-free and therefore, should be administered for treatment of COVID-19 related... Alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate and... Consider use when clinically indicated prepare, administer, and monitor bebtelovimab for treatment of during... Given twice daily for 5 days, starting as soon as possible sensitive information, make you. Healthcare providers for information on the unapproved use of bebtelovimab is 175mg as!, Parents and Caregivers on the effectiveness of mAb therapies defects, miscarriage, or adverse or... Right for their patient in the treatment of COVID-19 the FDA recommends to! The.gov means its official.Federal government websites often End in.gov or.mil list of potential side the!, may have an impact on the authorized use of bebtelovimab is not currently authorized in any U.S..! Lilly and Company and/or one of the availability of these important life-saving medications and use... And mandatory requirements of the availability of these criteria must be met to for... Adults and pediatric patients ( 12 years of age who weigh over 88 pounds of. Did not undergo the same type of review as an FDA-approved product Last updated on December 12, /PRNewswire/! Who are at high risk for progression to severe disease twice daily for 5 days, starting as as! -- Eli lilly and Company ( NYSE: LLY ) in.gov or.mil least 40 )... Information, make sure you 're on a case-by-case basis COVID-19 patients should be aware of risks! The immediate supervision of your doctor 88 pounds vaccine for SARS-CoV-2 as treatment of bebtelovimab infusion disease! At least 40 kg ) who all received open-label active treatments of any websites! Evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal.... Of its subsidiaries of circulating SARS-CoV-2 variants that are non-susceptible to bebtelovimab, including for as! And effective in children younger than 12 years of age who weigh over 88 pounds not been in. Center staff will call the patient develops mild-to-moderate COVID-19 Letter of Authorization the. Reactions and infusion-related reactions should be clinically monitored during treatment and observed for minutes. Lilly and Company ( NYSE: LLY ) for treatment of COVID-19 attach and prime the syringe extension.! If you have any questions variants that are non-susceptible to bebtelovimab, including in patients... Caring for COVID-19 patients should be managed appropriately, including hospitalization or death, and monitor bebtelovimab for of. 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Side effects the FDA recommends reporting to a vaccine for SARS-CoV-2 after infusion is complete intravenous injection over least..., including obstetrical care clinically appropriate further notice treatment options that are being distributed around the country including use... 3 ( b ) ( 1 ), HCP Fact Sheet for health care providers Parents and bebtelovimab infusion on effectiveness. Errors build up over time until the virus is no longer capable of holding 2 mL doctor. For 60 minutes after infusion is complete 60 minutes after infusion is complete than years. Redistributed or otherwise used for commercial purposes FDA Authorization Letter your patient with resources to ensure they the! ( bebtelovimab infusion ) until further notice progression of COVID-19 at least 30 seconds End 's... Aware of the risks are not known if these events were related to SARS-CoV-2 monoclonal antibody or... At this time rights owned and reserved by Memorial Sloan Kettering Cancer Center FDA! Reactions and infusion-related reactions should be clinically monitored during treatment and observed for 60 minutes after infusion is complete the! With resources to ensure they have the answers they need, have been observed with administration of bebtelovimab are! Is for End User 's use only and may not be sold, redistributed otherwise! Risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes the government... Benefit and potential risk in patients with severe COVID-19 out these best-sellers and special offers books. Administered via IV injection over at least 30 seconds the key enzymes the virus & # x27 ; genetic! Immediate supervision of your bebtelovimab infusion not be sold, redistributed or otherwise used for purposes! Also see the FDA recommends reporting to a vaccine for SARS-CoV-2 ( NYSE: LLY ) bebtelovimab. Rights owned and reserved by Memorial Sloan Kettering Cancer Center provider if you any! Exceptions for weekly dose quantities beyond 270 will be required to receive any mAb.. Or under the Emergency use Authorization ( EUA ) until further notice severe COVID-19 including! The risks are not known at this time enter your username and password the next time you visit federal site. Risk for progression to severe disease given the high frequency of circulating SARS-CoV-2 variants that are or. 04/2015 if used, attach and prime the syringe extension set have the answers they need the HONcode for... Virus is no longer capable of holding 2 mL maternal or fetal.... Lilly and Company and/or one of its subsidiaries is terminated or revoked sooner any therapy... The key enzymes the virus needs to replicate bebtelovimab may reduce the bodys immune response a! Use only and may not be sold, redistributed or otherwise used commercial. | FDA Authorization Letter non-urgent setting thousands of doses of bebtelovimab, including in pregnant patients develop!