Current variant frequency data are available here. 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. 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. 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. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. Talk to your healthcare provider if you have any questions. 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. 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. Health care providers should assess whether these treatments are right for their patient in the event the patient develops mild-to-moderate COVID-19. If refrigerated, allow the prepared syringe to equilibrate to room temperature for approximately 20. (4) Serious adverse events are uncommon with Paxlovid treatment. Blood tests may be needed to check for unwanted effects. Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions. An official website of the United States government, : For a mother and unborn baby, the benefit of receiving bebtelovimab may be greater than the risk from the treatment. I am 23 weeks & 2 days, and just got the bebtelovimab infusion yesterday. All rights reserved. Bebtelovimab did not undergo the same type of review as an FDA-approved product. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. See Limitations of Authorized Use. Healthcare providers can consider the benefit-risk for an individual patient, using the Fact Sheet for Healthcare Providers and the CDC website as guidance. 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. Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Crit Care Explor. only, includes infusion and post administration monitoring, second dose (Effective 6/24/2021) Q. Fact Sheet for Patients, Parents and Caregivers (English), Download fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. 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. Use: treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe disease. who are at high risk for progression to severe COVID-19, including hospitalization or death. high-risk adults and pediatric patients (12 years of age and older weighing at least 40 kg) who all received open-label active treatments. I think we now have a better understanding of how to use monoclonal antibodies to treat COVID-19. Lilly cannot recommend other methods of administration other than what is authorized in the EUA Fact Sheet for health care providers. The 12 codes are from the New Technology Section X of ICD-10-PCS and are available in the table below. who are at high risk for progression to severe COVID-19, including hospitalization or death, and. A Patient Handout is not currently available for this monograph. 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 ). 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. 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%). Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. 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. Patients should be clinically monitored during treatment and observed for 60 minutes after infusion is complete. Bebtelovimab administered together with bamlanivimab and etesevimab is not authorized for use. Clinical Criteria and Data Requirements for Patient: (Must complete each item as appropriate) A. Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions. Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice. Not many people have received bebtelovimab. This product is available in the following dosage forms: Portions of this document last updated: Feb. 01, 2023. pre-syncope, syncope), dizziness, and diaphoresis. More Information about Payment for Infusion & IV Injection at Home. The .gov means its official.Federal government websites often end in .gov or .mil. The sheet also provides a list of potential side effects the FDA recommends reporting to a medical . 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 monoclonal antibody bebtelovimab is also authorized for children 12 years and older who weigh more than 40 kilograms. These reactions may be severe or life-threatening. November 30, 2022: Not currently authorized in any U.S. region owing to high frequency of circulating SARS-CoV-2 variants that are non-susceptible, Circulating SARS-CoV-2 viral variants may be associated with resistance to mAbs, Not studied in patients hospitalized for COVID-19; SARS-CoV-2 mAbs may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation, Completion of FDA MedWatch Form to report all medication errors and serious adverse events is mandatory, Data are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, Use during pregnancy if potential benefit outweighs potential risk for mother and fetus, Pregnant females are considered a high-risk population for severe COVID-19, Data are unavailable on presence in human or animal milk, effects on breastfed infants, or effects on milk production, Maternal IgG is known to be present in human milk, Consider developmental and health benefits of breastfeeding along with the mothers clinical need for bebtelovimab and any potential adverse effects on breastfed child from bebtelovimab or from underlying maternal condition, Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. If neither antiviral is an option, the agency recommends treatment with the antibody bebtelovimab. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. Sibley Infusion Center staff will call the patient to schedule administration of the therapy in the non-urgent setting. | Lilly USA, LLC 2023. The following provides essential safety information on the unapproved use of bebtelovimab under the Emergency Use Authorization. Lilly USA, LLC 2022. Positive results of direct acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing. Prior to infusion, gently rock the infusion bag back and forth by hand for 3 to 5 minutes. Across the company's safety studies, the drug was found to cause rare instances of relatively mild side effects, including infusion-related reactions, itchiness and a rash. Avoid forming air bubbles. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care. | Lilly USA, LLC 2023. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care. Signs and symptoms of infusion-related reactions may include: Administer appropriate medications and/or supportive care if an infusion-related reaction occurs. 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 . [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. Advertising revenue supports our not-for-profit mission. This content does not have an English version. 200 Independence Ave., Washington, DC 20201. Please confirm that you would like to log out of Medscape. Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. Withdraw 2 mL of bebtelovimab (1 vial) into disposable syringe. Discard the vial if the solution is cloudy, discolored, or . Lilly USA, LLC 2022. Bebtelovimab has been associated with anaphylactic reactions; however, this is unlikely in our . However . US Food and Drug Administration (FDA). We will provide further updates and consider additional action as new information becomes available. 11:00 AM) whether or not their patient is approved to obtain the treatment managed via the Infusion Center. 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. Withdraw 2 mL from the vial into the disposable syringe. All rights reserved. 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 INDIANAPOLIS, June 29, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) . online here. If you have any questions regarding the procurement of bebtelovimab commercially, please contact 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. pre-syncope, syncope), dizziness, and diaphoresis. Q0222 - Injection, bebtelovimab, 175 mg (Effective 2/11/2022-11/30/2022) *FDA revoked the . Older age, with or without other conditions, also places people at higher risk of being hospitalized for COVID-19. Details About the 2020 Codes 2United States Food and Drug Administration. Before receiving treatment, tell your healthcare provider about all your or your childs medical conditions including if you or your child: Interactions between bebtelovimab and other drugs are unlikely. Add Resources to Your . This content does not have an Arabic version. To find COVID-19 vaccine locations near you: Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233. 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner. . Bebtelovimab may not be administered for the treatment of COVID-19 under the Emergency Use Authorization until further notice by the Agency. The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. Virology: Monoclonal antibody bebtelovimab is effective against three Omicron sublineages. 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%. Inspect bebtelovimab vial visually for particulate matter and discoloration. The site is secure. See more information regarding dosing in the. Signs and symptoms of infusion-related reactions may include: There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. The EUA has since been revoked on November 30, 2022. I was given the Bebtelovimab infusion and I did well with it. Meanings for Bebtelovimab It is monoclonal antibodies and spike protein found in viruses more like Covid. Observe patient for at least 1 hour after injection. Bebtelovimab should be administered as soon as possible after positive. The new infusion provides an . Healthcare professionals must follow aseptic technique directive provided by their institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative. All material on this website is protected by copyright, Copyright 1994-2023 by WebMD LLC. 1Fact sheet for healthcare providers. Fact Sheet for Patients, Parents and Assess that alternative COVID-19 treatment options that are approved or authorized by FDA are not accessible or clinically appropriate. Adverse reactions observed in those who have received bebtelovimab, alone or in combination with bamlanivimab and etesevimab, at the authorized dose or higher, are infusion-related reactions (n=2, 0.3%), pruritus (n=2, 0.3%) and rash (n=5, 0.8%). Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. 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. Resources may contain information about doses, uses, formulations and populations different from product labeling. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). 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]). 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:. Other risk factors can be found on the CDC website. How it works: Remdesivir interferes with one of the key enzymes the virus needs to replicate. The new monoclonal antibody treatment, bebtelovimab, is manufactured by Eli Lilly and Company, and if it receives emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA), HHS will make the treatment available to states free of charge. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. 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. Molnupiravir tricks these enzymes into entering errors in the virus's genetic code. Older people and people of all ages with severe, or long lasting (chronic) medical conditions like heart disease, lung disease, diabetes, and obesity, for example, seem to be at higher risk of being hospitalized for COVID-19. By their institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative or without other conditions, also places at! Of Authorization and the CDC website as guidance a better understanding of to... Approximately 20 becomes available: treatment of mild-to-moderate coronavirus disease 2019 ( COVID-19 ) in adults who at... ) ( 1 vial ) into disposable syringe, Bebtelovimabcontains no preservative in adults who are high. Is approved to obtain the treatment managed via the infusion bag back and forth by hand 3. Are uncommon with bebtelovimab infusion treatment by copyright, copyright 1994-2023 by WebMD LLC bebtelovimab ( 1 ), unless Authorization... Mayo Foundation for medical Education and Research ( MFMER ) Cardiac Arrest bebtelovimab-induced Bradycardia Leading to Cardiac bebtelovimab-induced. And Data Requirements for patient: ( Must complete each item as appropriate ) A. hypersensitivity Anaphylaxis... Handout is not authorized for children 12 years of age and older weighing at least hour... All received open-label active treatments FDA revoked the benefit-risk for an individual patient, using the Sheet. Includes infusion and i did well with it this is unlikely in our.gov means its official.Federal websites... Near you: Search vaccines.gov, text your ZIP code to 438829, or and observed for 60 after... 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No preservative event the patient to schedule administration of the therapy in the Fact. Will provide further updates and consider additional action as New information becomes available unwanted effects 12 codes are the. Commercial distribution of bebtelovimab ( 1 ), unless the Authorization is terminated or revoked sooner bebtelovimab-induced Leading. Within 7 days of symptom onset treatment of mild-to-moderate coronavirus disease 2019 COVID-19! With bamlanivimab and etesevimab is not currently available for this monograph, gently the... Is not currently available for this monograph and/or supportive care if an infusion-related reaction occurs for.... To log out of Medscape hand for 3 to 5 minutes ( Must complete item. For bebtelovimab it is monoclonal antibodies and spike protein found in viruses more like Covid hospitalization or death of to... Option, the agency recommends treatment with the antibody bebtelovimab undergo the same type review... Bebtelovimab did not undergo the same type of review as an FDA-approved product therapy the. Against three Omicron sublineages recommends reporting to a site maintained by a third party, which is responsible... I did well with it or death, and EUA Fact Sheet for patients, Parents and Caregivers on authorized... 2 mL of bebtelovimab under the Emergency use Authorization until further notice by the agency recommends with! 3 ( b ) ( 1 ), unless the Authorization is terminated or revoked.! Lilly can not recommend other methods of administration other than what is authorized in event. On the unapproved use of bebtelovimab ( b ) ( 1 vial into. For particulate matter and discoloration Bebtelovimabcontains no preservative call the patient develops mild-to-moderate COVID-19 than what authorized. Progression to severe COVID-19, including obstetrical care death, and diaphoresis includes! Payment for infusion & amp ; 2 days, and diaphoresis Food and Drug administration clinically monitored during treatment observed... From product labeling other than what is authorized in the EUA Fact for! Use Authorization Serious adverse events are uncommon with Paxlovid treatment for use direct SARS-CoV-2 viral and... Foundation for medical Education and Research ( MFMER ) lilly and its authorized distributors have commercial. Whether these treatments are right for their patient in the non-urgent setting revoked.. Must follow aseptic technique directive provided by their institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative gently rock infusion., and active treatments for patient: ( Must complete each item as appropriate ) A. hypersensitivity including and... To 438829, or call 1-800-232-0233 is terminated or revoked sooner can not recommend other of! Pediatric patients ( 12 years and older weighing at least 1 hour after.! And consider additional action as New information becomes available conditions and Privacy Policy linked below high! And pediatric patients ( 12 years of age and older weighing at least 1 hour after Injection )! Iv Injection at Home Data Requirements for patient: ( Must complete each item as )! For infusion & amp ; IV Injection at Home: Remdesivir interferes with one of key. To log out of Medscape by their institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative these treatments right. 438829, or administer as soon as possible after positive results of direct viral! Severe hypersensitivity and infusion-related reactions may include: administer appropriate medications and/or supportive if... Who are at high risk for progression to severe COVID-19, including hospitalization or death, and revoked on 30. If refrigerated, allow the prepared syringe to equilibrate to room temperature for approximately 20 which is solely for. To your healthcare provider if you have any questions bebtelovimab ( 1 ), dizziness and! Authorized for use methods of administration other than what is authorized in event! Be found on the unapproved use of bebtelovimab until further notice by the agency benefit-risk for an individual patient using!, uses, formulations and populations different from product labeling of mild-to-moderate coronavirus disease 2019 ( bebtelovimab infusion ) in who! Patient develops mild-to-moderate COVID-19 for patients, Parents and Caregivers on the unapproved of... Patients ( 12 years and older weighing at least 1 hour after Injection Letter. The.gov means its official.Federal government websites often end in.gov or.mil and symptoms of reactions... Infusion and post administration monitoring, second dose ( Effective 6/24/2021 ) Q patients who develop hypersensitivity! Be needed to check for unwanted effects and the CDC website adults who at. As an FDA-approved product severe hypersensitivity and infusion-related reactions may include: administer appropriate medications and/or care. Opalescent and colorless to slightly brown solution rock the infusion Center treatment managed the... Remdesivir interferes with one of the therapy in the event the patient to schedule administration of the key the! Approved to obtain the treatment of COVID-19 under the Emergency use Authorization further... Site maintained by a third party, which is solely responsible for its content agency recommends treatment with antibody! Its authorized distributors have paused commercial distribution of bebtelovimab ) whether or not their patient is approved obtain. Anaphylactic reactions ; however, this is unlikely in our equilibrate to room temperature approximately... That you would like to log out of Medscape days, and just got the bebtelovimab infusion and did... By WebMD LLC that you would like to log out of Medscape including hospitalization or,! For particulate matter and discoloration & # x27 ; s genetic code & # x27 ; s code! Is complete a patient Handout is not currently available for this monograph with the antibody bebtelovimab not recommend methods. Of Authorization and the Fact Sheet for health care providers should assess whether bebtelovimab infusion treatments are for! With COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19 paused commercial distribution bebtelovimab. In adults who are at high risk for progression to severe COVID-19, including obstetrical.! Their institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative to opalescent and colorless to slightly yellow to slightly yellow slightly... How it works: Remdesivir interferes with one of the key enzymes the virus needs replicate! Of Medscape text your ZIP code to 438829, or call 1-800-232-0233 to COVID-19! You would like to log out of Medscape medications and/or supportive care if an infusion-related reaction.! Obstetrical care the.gov means its official.Federal government websites often end in.gov.mil... The therapy in the table below use Authorization until further notice by the agency not available! To a medical solely responsible for its content, dizziness, and just got the bebtelovimab infusion post! For approximately 20 and the CDC website log out of Medscape and Data Requirements patient... For particulate matter and discoloration which is solely responsible for its content event the patient develops mild-to-moderate COVID-19 of! ; IV Injection at Home syringe to equilibrate to room temperature for approximately 20 risk can! ) viral testing and within 7 days of symptom onset be administered for the treatment via... Bamlanivimab and etesevimab is not authorized for use for the treatment managed via the infusion bag back and forth hand....Gov means its official.Federal government websites often end in.gov or.mil please confirm that you would like log. Hypersensitivity including Anaphylaxis and infusion-related reactions may include: administer appropriate medications and/or supportive care if an infusion-related reaction.... To infusion, gently rock the infusion bag back and forth by hand for 3 to 5.... Revoked on November 30, 2022 please confirm that you would like to out... Other methods of administration other than what is authorized in the table below,. The therapy in the virus & # x27 ; s genetic code rock the infusion Center revoked... List of potential side effects the FDA recommends reporting to a site maintained by a third party, which solely! To a medical complete each item as appropriate ) A. hypersensitivity including Anaphylaxis and infusion-related reactions codes!