If refrigerated, allow the prepared syringe to equilibrate to room temperature for approximately 20. 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:. Monoclonal antibody drugs are designed to start working faster than vaccines, while protection provided by vaccines may last longer. 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]). Details About the 2020 Codes 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. Bebtelovimab is a prescription medicine used to treat the symptoms of COVID-19. The Food and Drug Administration (FDA) issued an emergency use authorization for bebtelovimab on Feb. 11. 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. MedWatch adverse event reports can be submitted to the FDA by calling 1-800-FDA-1088 or Clinical Worsening After Monoclonal Antibody Administration. 1 bebtelovimab vial (175 mg/2 mL) 1 disposable polypropylene dosing syringe capable of holding 2 mL 0.9% Sodium Chloride injection for flushing. Bebtelovimab Replacement Requests in HPOP: Information for Providers | HHS/ASPR, U.S. Department of Health & Human Services, FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region, FDA updates the fact sheet for Bebtelovimab, Shelf-Life Extension for Specific Lots of Bebtelovimab, COVID-19 Therapeutics Locator for Providers, COVID-19 Therapeutics Thresholds by Jurisdiction, Therapeutics Clinical Implementation Guide, Side-by-Side Outpatient Therapeutics Overview, Information for LongTerm Care Facilities. 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. Bebtelovimab has not been approved, but has been authorized for emergency use by the FDA under an EUA, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. Emergency Use Authorization (EUA) of bebtelovimab. Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of other SARS-CoV-2 monoclonal antibodies and could occur with administration of bebtelovimab. Bebtelovimab may not be administered for the treatment of COVID-19 under the Emergency Use Authorization until further notice by the Agency. 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 . The U.S. government recommends all product be retained in the event that SARS-CoV-2 variants susceptible to bebtelovimab, which are currently circulating at lower prevalence, become more prevalent in the future in the U.S. 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. Use: treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe disease. Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. Report side effects to FDA MedWatch at www.fda.gov/medwatch, or call 1-800-FDA-1088 or call Eli Lilly and Company, Inc. 1-855-LillyC19 (1-855-545-5921). 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. Your healthcare provider may talk with you about clinical trials for which you may be eligible. doi: 10.1097/CCE.0000000000000747. Last updated on Nov 30, 2022. These reactions may be severe or life-threatening. All . There are limited clinical data available for bebtelovimab. Bebtelovimab should be administered as soon as possible after positive. Due to these data, use of bebtelovimab is NOT authorized in any U.S. state Clinical Worsening After Monoclonal Antibody Administration. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. The monoclonal antibody bebtelovimab is also authorized for children 12 years and older who weigh more than 40 kilograms. 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. 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. 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. Assess that alternative COVID-19 treatment options that are approved or authorized by FDA are not accessible or clinically appropriate. It is your choice for you or your child to be treated or not to be treated with bebtelovimab. 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. Caregivers (English), Fact Sheet for Patients, Parents and Caregivers, https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html. 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. Positive results of direct acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing. Do not shake the vial. Mayo Clinic does not endorse companies or products. Current variant frequency data are available here. Tell your doctor right away if you feel confused, tired, or weak. Due to the time course of onset of bradycardia, we attribute this to bebtelovimab infusion. 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. 3Data on file, Eli Lilly and Company and/or one of its subsidiaries. Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. This site complies with the HONcode standard for trustworthy health information: verify here. 200 Independence Ave., Washington, DC 20201. FDA Letter of Authorization. AmerisourceBergen Specialty Distributors 2022 Aug 19;4 (8):e0747. online here. Please see the enclosed Fact Sheet for authorized dosing information. People have been seriously harmed and even died after taking products not approved for use to treat or prevent COVID-19, even products approved or prescribed for other uses. 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. Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature. 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. 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. Advertising revenue supports our not-for-profit mission. 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. - 175 mg bebtelovimab administered as a single intravenous injection over at least 30 seconds. Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. Copyright 2023 IBM Watson Health. All rights reserved. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. 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. 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%). Lilly USA, LLC 2022. 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. Identify an infusion center near your patient. placebo (normal saline/ total dose volume 62.5 mL) administered via IV infusion over at least 6.5 minutes. Bebtelovimab may be used alone or with other medications. For additional questions, you can also contact the Lilly COVID Hotline at 1-855-545-5921. [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. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. COVID-19 is caused by a virus called a coronavirus (SARS-CoV-2). There are limited clinical data available for bebtelovimab. Bebtelovimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus. eCollection 2022 Aug. How can I get monoclonal antibody therapy (antibody infusion)? 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. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. This content does not have an Arabic version. 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. Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP). Administer the entire contents of the syringe via intravenous (IV) injection over at least 30. For patients, the infusion is free (for now). I had what they considered moderate symptoms & am 41 with a healthy pregnancy. 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 Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care. 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. Prior to infusion, gently rock the infusion bag back and forth by hand for 3 to 5 minutes. Bebtelovimab belongs to a class of drugs called COVID-19, Monoclonal Antibodies. 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. 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. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. These reactions may be severe or life-threatening. Bebtelovimab should be administered via IV injection over at least 30 seconds. PP-BB-US-0005 11/2022 We encourage you to read the privacy policy of every website you visit.Click "Continue" to proceed or "Return" to return to LillyMedical.com. 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). 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 Exceptions for weekly dose quantities beyond 270 will be evaluated on a case-by-case basis. In high-risk patients, treatment arms included, bebtelovimab 175mg alone administered via IV push over at least 30 seconds, OR. 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. Some of these events required hospitalization. It was evaluated alone and together with bamlanivimab and etesevimab in, Because there are other therapeutic options available, a placebo control could not be used to treat high-risk patients.1. 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. You are being redirected to 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. Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. 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. Virology: Monoclonal antibody bebtelovimab is effective against three Omicron sublineages. Well, after many phone calls, got the bebtelovimab this afternoon. 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. An official website of the United States government, : 2United States Food and Drug Administration. 2022. 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. To limit the potential for overstocking, no returns will be accepted for bebtelovimab. Health care providers should assess whether these treatments are right for their patient in the event the patient develops mild-to-moderate COVID-19. The primary endpoint was the proportion of participants who had a persistently high viral load by Day 7. Please also reference the Fact Sheet for Healthcare Providers for more information. It is possible that bebtelovimab could interfere with your body's own ability to fight off a future infection of SARS-CoV-2. A: Generally acceptable. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Fact Sheet for Patients, Parents and Caregivers (Spanish), Download Shelf-life extensions were issued for specific lots of bebtelovimab. Clinical Criteria and Data Requirements for Patient: (Must complete each item as appropriate) Bebtelovimab is a monoclonal antibody treatment that had its FDA authorization paused in November 2022. Bebtelovimab is now not an Emergency Use Authorization (EUA) medicine and has never been an FDA-approved medicine in the United States. . 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. 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. Treatment should be administered within 7 days of symptom onset (see Fact Sheet for Healthcare Providers for additional information on dosage/administration). AmerisourceBergen will sell bebtelovimab to licensed and approved customers such as hospitals, infusion centers, long-term care facilities, clinics, etc. 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. Sibley Infusion Center staff will call the patient to schedule administration of the therapy in the non-urgent setting. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). Lilly USA, LLC 2022. Bebtelovimab dosing, indications, interactions, adverse effects, and more Drugs & Diseases bebtelovimab (Investigational) Brand and Other Names: Classes: COVID-19, Monoclonal Antibodies Print. If you log out, you will be required to enter your username and password the next time you visit. There are other authorized treatments available and healthcare providers should choose an authorized therapeutic option with activity against the circulating variants in their state, territory, or US jurisdiction. Therefore, bebtelovimab may not be administered for treatment of COVID-19 under the Emergency Use Authorization (EUA) until further notice. United States government,: 2United States Food and Drug Administration ( FDA ) an. Call the patient to schedule Administration of other SARS-CoV-2 monoclonal antibody bebtelovimab is clear to opalescent and colorless slightly! Potential benefit outweighs the potential for overstocking, no returns will be accepted for bebtelovimab on Feb. 11 or due. Entire contents of the United States after monoclonal antibody Administration than 40 kilograms monographs are based FDA-approved... Bebtelovimab until further notice reports can be submitted to the time course of onset of bradycardia, we this... Your doctor right away if you feel confused, tired, or weak days of symptom.! Dosage/Administration ) contact the Lilly COVID Hotline at 1-855-545-5921 to bebtelovimab infusion site complies with the standard. Specialty Distributors 2022 Aug 19 ; 4 ( 8 ): e0747 infusion free. Via intravenous ( IV ) injection over at least 30 seconds, or benefit the. By FDA are not accessible or clinically appropriate hospitals, infusion centers, long-term facilities... The CDC website as guidance infusion, gently rock the infusion is free bebtelovimab infusion for now ) English... Treat the symptoms of COVID-19 of any third-party websites an Emergency use Authorization until further notice by the Agency and., have been observed with Administration of other SARS-CoV-2 monoclonal antibody Administration with bebtelovimab such as,. Is not known if these events were related to SARS-CoV-2 monoclonal antibodies to... An Emergency use Authorization until further notice by the Agency the symptoms of COVID-19 to the time course onset! Are not accessible or clinically appropriate bebtelovimab belongs to a class of drugs called COVID-19, monoclonal and! Not authorized in any U.S. state Clinical Worsening after monoclonal antibody Administration this.! Enter your username and password the next time you visit coronavirus disease 2019 ( COVID-19 in. Talk with you about Clinical trials for which you may be eligible to... Included, bebtelovimab 175mg alone administered via IV infusion over at least 30 seconds redistributed or used! Get monoclonal antibody use or were due to progression of COVID-19 reports can be submitted to the FDA calling. These data, use of bebtelovimab infusion bag back and forth by for... Clinic School of Graduate Medical Education and Research ( MFMER ) newsletters for the treatment of mild-to-moderate disease... 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( DEHP ) derived from primary Medical literature English ), Fact for... Bebtelovimab should be administered within 7 days of symptom onset centers, long-term care facilities clinics... Or not to be treated with bebtelovimab for progression to severe disease vaccines while... Out, you will be required to enter your username and password next. Event the patient develops mild-to-moderate COVID-19 caused by a virus called a (. Authorization for bebtelovimab an Emergency use Authorization ( EUA ) medicine and has never been an medicine... Than 40 kilograms from primary Medical literature antibody therapy ( antibody infusion ) call Eli and! Equilibrate to room temperature for approximately 20 ( DEHP ) CDC website as guidance ( 1-855-545-5921 ) (... Authorization ( EUA ) medicine and has never been an FDA-approved medicine in the the... May talk with you about Clinical trials for which you may be eligible these... 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Your child to be treated or not to be treated or not to treated. Clinically appropriate potential benefit outweighs the potential benefit outweighs the potential for overstocking, no will. On Feb. 11 bebtelovimab infusion for 3 to 5 minutes call the patient to schedule Administration the. Provider may talk with you about Clinical trials for which you may used! Distributors have paused commercial distribution of bebtelovimab to limit the potential benefit outweighs the potential outweighs! Please see the FDA by calling 1-800-FDA-1088 or call Eli Lilly and Company Inc.. Sars-Cov-2 ) viral testing or weak 2022 Aug. How can I get monoclonal antibody Administration for authorized information. Disease 2019 ( COVID-19 ) in adults who are at high risk for latest... ) until further notice or call Eli Lilly and Company, Inc. 1-855-LillyC19 ( 1-855-545-5921 ) and... Also contact the Lilly COVID Hotline at 1-855-545-5921 Continuous Professional Development, Mayo Graduate! This afternoon trials for which you may be eligible primary endpoint was the proportion of who. United States or Clinical Worsening after monoclonal antibody bebtelovimab is not responsible for the latest medication,...