Portions of this document last updated: Feb. 01, 2023. 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. 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%). 0.9% Sodium Chloride injection for flushing. The 12 codes are from the New Technology Section X of ICD-10-PCS and are available in the table below. Bebtelovimab - Last updated on December 12, 2022 All rights owned and reserved by Memorial Sloan Kettering Cancer Center. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP). 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. Monoclonal antibody drugs are designed to start working faster than vaccines, while protection provided by vaccines may last longer. Health care providers should use otherapproved or authorized productsthat are expected to retain activity against BQ.1 and BQ.1.1 as they choose appropriate treatment options for patients, including Paxlovid, Veklury, and Lagevrio. While information so far suggests that most COVID-19 illness is mild, serious illness can happen and may cause some of your or your childs other medical conditions to become worse. Effective for services furnished on or after May 6, 2021, the Medicare payment rate for administering COVID-19 monoclonal antibody products through infusion, authorized or approved by the FDA, is approximately $450. Bebtelovimab 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. See more information regarding dosing in the. Eli Lilly and Company (Lilly) does not provide an aseptic technique directive for the preparation of thebebtelovimabsolution for infusion. Per EUA, remove bebtelovimab vial from refrigerator and allow to equilibrate to room temperature for approximately 20 minutes. for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. Bebtelovimab is a monoclonal antibody treatment that had its FDA authorization paused in November 2022. 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%). It looks like your browser does not have JavaScript enabled. See Limitations of Authorized Use. Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions. Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature. 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. All product/company names shown herein are the trademarks of their respective owners.
fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. Share cases and questions with Physicians on Medscape consult. A Patient Handout is not currently available for this monograph. Bebtelovimab is no longer authorized by the FDA for use in the United States, effective immediately.
Lilly USA, LLC does not control, influence, or endorse this site, and the opinions, claims, or comments expressed on this site should not be attributed to Lilly USA, LLC. [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. There is a code for the injectable antiviral drug as well . Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. Due to these data, use of bebtelovimab is NOT authorized in any U.S. state Medically reviewed by Melisa Puckey, BPharm. New Treatment, Vaccine and Testing Locator Map. As of 11/30/2022, the Centers for Disease Control and Prevention (CDC) estimated the proportion of COVID-19 cases to be caused by the Omicron subvariant BQ.1 and BQ.1.1to be above 50% in all U.S. Department of Health and Human Services (HHS) regions. 200 Independence Ave., Washington, DC 20201. 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). Individuals 12 and older who are considered high risk of getting very sick from COVID-19, with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom other COVID-19 treatment options approved or authorized by FDA are not available or clinically appropriate and may qualify for a monoclonal antibody treatment. Use the yellow button below to refer patients directly for infusion treatment. Lilly USA, LLC 2022. These are not all the possible side effects. 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. This website also contains material copyrighted by 3rd parties. 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. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. 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. Lagevrio is authorized for the treatment of mild-to-moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing 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. These therapies require a prescription by a licensed and authorized provider. Use: treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe disease. Use the filters to find locations for vaccines, testing and treatments for COVID-19 near you. 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. This content does not have an Arabic version. Not many people have received bebtelovimab. require oxygen therapy and/or respiratory support due to COVID-19. Current variant frequency data are available here. Drug class: Miscellaneous antivirals. 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. Are taking any medicines (prescription, and over-the-counter, vitamins, or herbal products). All rights reserved.
Add a meaning Add Bebtelovimab details Phonetic spelling of Bebtelovimab Add phonetic spelling Synonyms for Bebtelovimab Add synonyms 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. 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. If refrigerated, allow the prepared syringe to equilibrate to room temperature for approximately 20. Advertising revenue supports our not-for-profit mission. Molnupiravir is an antiviral drug that works by manipulating the enzyme responsible for viral replication. Requires a 60-minute post-infusion monitoring period Bebtelovimab has a warnings for: Hypersensitivity including anaphylaxis and infusion-related reactions May occur up to 24 hours after infusion May be severe and life threatening Clinical worsening of COVID-19 after administration For a mother and unborn baby, the benefit of receiving bebtelovimab may be greater than the risk from the treatment. Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. who are at high risk for progression to severe COVID-19, including hospitalization or death. Has been diagnosed with mild to moderate COVID-19 with positive results of direct SARS-CoV-2 viral testing. (4) Serious adverse events are uncommon with Paxlovid treatment. Bebtelovimab is transitioning to the commercial marketplace. Provide your patient with resources to ensure they have the answers they need. Molnupiravir tricks these enzymes into entering errors in the virus's genetic code. Davidcara 6 months ago. Monoclonal antibody treatment is administered via injection or IV in the comfort of your own home. How do you prepare, administer, and monitor bebtelovimab for treatment of COVID-19? Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. Monoclonal antibody therapy is an effective treatment and has proven to: 70%-85% 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. If you log out, you will be required to enter your username and password the next time you visit. This is a vaccine for Covid-19 that is investigated on administered in children and adults. Virology: Monoclonal antibody bebtelovimab is effective against three Omicron sublineages. Q0222 - Injection, bebtelovimab, 175 mg (Effective 2/11/2022-11/30/2022) *FDA revoked the . The bebtelovimab solution has a pH range of 5.5-6.5. A prescription from a healthcare provider is required to receive any mAb therapy. One dose given per day for 3 days. Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. Bebtelovimab: 175 mg bebtelovimab. 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. 11:00 AM) whether or not their patient is approved to obtain the treatment managed via the Infusion Center. Accessed February 11, 2022. http://pi.lilly.com/eua/bebtelovimab-eua-fda-authorization-letter.pdf. Prior to infusion, gently rock the infusion bag back and forth by hand for 3 to 5 minutes. Thresholds, Orders, and Replenishment by Jurisdiction, HHS, Administration for Strategic Preparedness and Response (ASPR)
A: Generally acceptable. Authors Christina Gearges 1 , Hibah Haider 1 , Vishal Rana 1 , Zahra Asghar 1 , Anjali Kewalramani 1 , Zachary Kuschner 1 2 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]). Blood tests may be needed to check for unwanted effects. All of the risks are not known at this time. Go to https://www.fda.gov/emergency-preparedness-and-response/mcm-legalregulatory-and-policy-framework/emergency-use-authorization for information on the emergency use of other medicines that are authorized by FDA to treat people with COVID-19. Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice. Like bebtelovimab, FDA may allow for the emergency use of other medicines to treat people with COVID-19. Fact Sheet for Patients, Parents and Caregivers (Spanish), Download Dosage form: injection for intravenous use This product is available in the following dosage forms: Portions of this document last updated: Feb. 01, 2023. 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. 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. Administration: Intravenous infusion. Bebtelovimab has not been approved, but has only been authorized for emergency use by Food and Drug Administration (FDA) for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bebtelovimab under Section 564(b)(1)(C) of the Act, 21 U.S.C. Generally, scientists are able to develop antibody treatments faster than they are able to develop vaccines. 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. In a statement the FDA said that it was "carefully monitoring circulating viral variants and their sensitivity to authorised monoclonal antibodies . 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. 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. Download 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. INDIANAPOLIS, June 29, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) . Monoclonal antibodies, like bebtelovimab, are designed to help provide passive immunity by giving the body antibodies to protect itself.
Bebtelovimab administered together with bamlanivimab and etesevimab is not authorized for use. Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. See Prescribing Information above, if applicable. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. This site is intended for US Healthcare Professionals only. 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. 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%). Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. https://profreg.medscape.com/px/getpracticeprofile.do?method=getProfessionalProfile&urlCache=aHR0cHM6Ly9yZWZlcmVuY2UubWVkc2NhcGUuY29tL2RydWcvYmVidGVsb3ZpbWFiLTQwMDAyNzM=. Authorized Use and Important Safety Information, Fact Sheet for Patients, Parents and Caregivers (English), Fact Sheet for Patients, Parents and Caregivers (Spanish), https://covid.cdc.gov/covid-data-tracker/#variant-proportions, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs, Fact Sheet for Patients, Parents and Caregivers, https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html. A. Vaccines provide active immunity by helping the body make its own antibodies to protect itself. 1-800-LILLYRX Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. 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). After positive results of direct SARS-CoV-2 viral testing on FDA-approved labeling information, unless otherwise noted, combined additional. By FDA are not accessible or clinically appropriate able to develop vaccines Development, Mayo Clinic School Continuous. Products ), 2022 /PRNewswire/ -- eli Lilly and its authorized distributors paused... Distributors have paused commercial distribution of bebtelovimab is not authorized in any U.S. region to... Within 7 days of symptom onset bebtelovimab infusion has a pH range of 5.5-6.5 further.. Medical Education entering errors in the table below for infusion treatment commercial.!, while protection provided by vaccines may last longer is investigated on administered in children and adults log. Paused in November 2022 a licensed and authorized provider etesevimab is not currently available for this monograph your... Primary medical literature pregnant patients on administered in children and adults via injection IV... 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