All of the risks are not known at this time.
FDA Letter of Authorization. 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. Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. Medscape Education, Critical Concepts for the Treatment of COVID-19 Variants, 2001http://www.medscape.com/mtv/covid19-treatment-ous-s01/e01, encoded search term (bebtelovimab) and bebtelovimab, Drug Companies Face COVID Cliff in 2023 as Sales Set to Plummet, FDA Pulls Authorization for AstraZeneca's COVID-19 Treatment Evusheld, COVID-19 Monoclonal Antibody Treatments No Longer Effective, Your Unwanted Internal Pets: Intestinal Parasites (Other Than Nematodes), EU Regulator Recommends Against Approval for Merck's COVID Pill for Adults, COVID-19: Treatment Advances in a Global Pandemic, Rapid Rx Quiz: COVID-19 Treatment Updates. Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions. 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. A Patient Handout is not currently available for this monograph. Controlled studies in pregnant women show no evidence of fetal risk.
Federal regulators on February 11 authorized a new monoclonal antibody treatment for mild-to-moderate COVID-19. This information is provided in response to your request. 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. 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. Exceptions for weekly dose quantities beyond 270 will be evaluated on a case-by-case basis. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. How can I get monoclonal antibody therapy (antibody infusion)? Mayo Clinic does not endorse companies or products. . 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. This website also contains material copyrighted by 3rd parties. Thresholds, Orders, and Replenishment by Jurisdiction, HHS, Administration for Strategic Preparedness and Response (ASPR)
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. Discard the vial if the solution is cloudy, discolored, or visible particles are observed. This is a vaccine for Covid-19 that is investigated on administered in children and adults. Lilly USA, LLC 2022. Bebtelovimab FDA Emergency Use Authorization letter. . COVID-19 illnesses have ranged from very mild (including some with no reported symptoms) to severe, including illness resulting in 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. This information shows that bebtelovimab is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. 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. If refrigerated, allow the prepared syringe to equilibrate to room temperature for approximately 20. Signs and symptoms of infusion-related reactions may include: 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. Use: treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe disease. For a mother and unborn baby, the benefit of receiving bebtelovimab may be greater than the risk from the treatment. 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:. These reactions may be severe or life-threatening. Available for Android and iOS devices. Serious and unexpected side effects may happen. 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%). Bebtelovimab . 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:. 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. The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. Generally, scientists are able to develop antibody treatments faster than they are able to develop vaccines. Recombinant neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2 and is unmodified in the Fc region; maintains binding and neutralizing activity across currently known and reported variants of concern, including Omicron and BA.2, Peak plasma concentration (day 29): 4.35 mcg/mL, Expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as other IgG mAbs, Remove vial from refrigerator and allow to equilibrate to room temperature for ~20 minutes; do not expose to direct heat, Inspect vial visually for particulate matter and discoloration; solution is clear to opalescent and colorless to slightly yellow to slightly brown; discard if cloudy, discolored, or visible particles observed, Withdraw 2 mL (175 mg) from vial into disposable syringe; discard any product remaining in vial, Product is preservative-free, therefore, should be administer immediately; if immediate administration not possible, may refrigerate (up to 24 hr) or at room temperature (up to 7 hr), To be prepared by qualified healthcare professional, Attach and prime syringe extension set, administer dose IV over at least 30 seconds, Flush extension set with 0.9% NaCl to ensure delivery of required dose, May only be administered in settings with immediate access to medications to treat a severe infusion reaction (eg, anaphylaxis) and ability to activate emergency medical system, as necessary, Monitor patients for possible infusion-related reactions during administration and observe for at least 1 hr after injection. 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. who are at high risk for progression to severe COVID-19, including hospitalization or death. In a statement the FDA said that it was "carefully monitoring circulating viral variants and their sensitivity to authorised monoclonal antibodies . Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. Per EUA, remove bebtelovimab vial from refrigerator and allow to equilibrate to room temperature for approximately 20 minutes. Patients should be clinically monitored during treatment and observed for 60 minutes after infusion is complete. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. PP-BB-US-0005 11/2022 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 . Signs and symptoms of infusion-related reactions may include: Administer appropriate medications and/or supportive care if an infusion-related reaction occurs. Eli Lilly and Company (Lilly) does not provide an aseptic technique directive for the preparation of thebebtelovimabsolution for infusion. The right medications for COVID-19 can help. pre-syncope, syncope), dizziness, and diaphoresis. Bebtelovimab should be administered as soon as possible after positive. Bebtelovimab During Pregnancy and Breastfeeding. The procedure followed for aseptic technique may vary between institutions.
There are limited clinical data available for bebtelovimab. Bebtelovimab is authorized to be administered 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 1 for progression to severe COVID-19, including hospitalization or death, and Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature. Copyright 2023 IBM Watson Health. It is not known if Bebtelovimab is safe and effective in children younger than 12 years of age who weigh over 88 pounds. Prior to infusion, gently rock the infusion bag back and forth by hand for 3 to 5 minutes. 12 CLINICAL PHARMACOLOGY Please confirm that you would like to log out of Medscape. This site complies with the HONcode standard for trustworthy health information: verify here. The Food and Drug Administration last month authorized using the combination monoclonal antibody therapy Evusheld (tixagevimab co-packaged with cilgavimab) to help prevent COVID-19 in certain adults and children with compromised immune systems or a history of severe adverse reaction to a COVID-19 vaccine or its components. 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 .
Bebtelovimab has been associated with anaphylactic reactions; however, this is unlikely in our . 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. 1-800-LILLYRX 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). Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions. The therapeutics locator is intended for provider use. Clinical Worsening After Monoclonal Antibody Administration. MedWatch adverse event reports can be submitted to the FDA by calling 1-800-FDA-1088 or If neither antiviral is an option, the agency recommends treatment with the antibody bebtelovimab. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Current variant frequency data are available here. 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. Due to these data, use of bebtelovimab is NOT authorized in any U.S. state 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. Bebtelovimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus. Well, after many phone calls, got the bebtelovimab this afternoon. Bebtelovimab is available for purchase by U.S. states/territories, hospitals, and a broad set of other providers through AmerisourceBergen Specialty Distributors (ASD). There are no available data on the presence of bebtelovimab in human or animal milk, the effects on the breastfed infant, or the effects on milk production. 1Fact sheet for healthcare providers. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Drug class: Miscellaneous antivirals. Bebtelovimab (Intravenous Route) Before Using Proper Use Products and services Precautions Drug information provided by: IBM Micromedex It is very important that your doctor check you or your child's progress closely while you are receiving this medicine to make sure that it is working properly. Dosage form: injection for intravenous use Bebtelovimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus. Mayo Clinic does not endorse companies or products. Fact Sheet for Patients, Parents and Caregivers (English), Download I am 23 weeks & 2 days, and just got the bebtelovimab infusion yesterday. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. At this time, bebtelovimab remains authorized in all U.S. regions until further notice by FDA. Davidcara 6 months ago. Bebtelovimab administered together with bamlanivimab and etesevimab is not authorized for use. The Food and Drug Administration (FDA) said it's to be administered only when other . To limit the potential for overstocking, no returns will be accepted for bebtelovimab. You can get COVID19 through contact with another person who has the virus. Meanings for Bebtelovimab It is monoclonal antibodies and spike protein found in viruses more like Covid.
for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. 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. See Limitations of Authorized Use. 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. Infusion reactions have happened during and within 24 hours after the infusion. These errors build up over time until the virus is no longer capable of surviving. 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. require oxygen therapy and/or respiratory support due to COVID-19. Special considerations: FDA-approved for treating hospitalized patients. Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. 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. Use: treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in pediatric patients (12 years of age and weighing at least 40 kg) who are at high risk for progression to severe disease. 2United States Food and Drug Administration. 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. Lilly cannot recommend other methods of administration other than what is authorized in the EUA Fact Sheet for health care providers. 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%. Contact your healthcare provider if you have any side effects that bother you or do not go away. Emergency Use Authorization (EUA) of bebtelovimab.
Provide your patient with resources to ensure they have the answers they need. All material on this website is protected by copyright, Copyright 1994-2023 by WebMD LLC. 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. fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. Tell your doctor if you are pregnant or plan to become pregnant before using bebtelovimab; severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. 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 people with mild to moderate COVID-19 and shown a benefit in reducing the risk of hospitalization or death. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. BA.5 is one of many Covid-19 Omicron subvariants to emerge since last winter. This content does not have an Arabic version. 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Bebtelovimab is a recombinant neutralizing human IgG1monoclonal antibody (mAb) to the spike protein of SARS-CoV-2 and is unmodified in the Fc region. Clinical Worsening After Monoclonal Antibody Administration. Limitations of Benefit and Potential Risk in Patients with Severe 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. A: Generally acceptable. Bebtelovimab continues to maintain neutralization against all known variants of interest and concern. Eli Lilly's bebtelovimab has been shown to work against both BA.1 and BA.2.7 Authorised by the FDA in February,8 the treatment is for mild to moderate covid-19 in high risk people aged over 12. Positive results of direct acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing. 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 Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. Lilly cannot recommend other methods of administration other than what is authorized in the EUA Fact Sheet for health care providers. 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. 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. 11:00 AM) whether or not their patient is approved to obtain the treatment managed via the Infusion Center. Do not shake the vial. 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. High risk for progression to severe COVID-19, including hospitalization or death, Other COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate, Any severity or dialysis: No dosage adjustment recommended, Not expected to impact bebtelovimab pharmacokinetics, since monoclonal antibodies (mAbs) with molecular weight >69 kDa are known not to undergo renal elimination, For use in geographic regions where infection is likely to have been caused by a nonsusceptible SARS-CoV-2 variant based on available information including variant susceptibility, For patients who require oxygen therapy and/or respiratory support due to COVID-19, For patients who require increase in baseline oxygen flow rate and/or respiratory support due to COVID-19 and are on chronic oxygen therapy and/or respiratory support owing to underlying non-COVID-19related comorbidity, Obesity/overweight (body mass index [BMI] 25 kg/m2 [adults]; BMI 85th percentile for age/sex based on CDC growth charts [if aged 12-17 years]), Immunosuppressive disease or immunosuppressive treatment, Cardiovascular disease (including congenital heart disease) or hypertension, Chronic lung diseases (eg, chronic obstructive pulmonary disease [COPD], moderate-to-severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension), Neurodevelopmental disorders (eg, cerebral palsy) or other conditions that confer medical complexity (eg, genetic or metabolic syndromes, severe congenital anomalies), Having a medical-related technological dependence (eg, tracheostomy, gastrostomy, positive-pressure ventilation [not related to COVID 19]), EUA is not limited to the medical conditions or factors listed above; for additional information on medical conditions and factors associated with increased risk for progression to severe COVID, see the, 12 years (weight 40 kg): 175 mg as a single IV injection over at least 30 seconds, Serious hypersensitivity reaction, including anaphylaxis, observed with other COVID-19 mAbs, and may occur with bebtelovimab, Hypersensitivity reactions occurring >24 hr after infusion observed with bebtelovimab when administered with other mAbs, Infusion-related reactions may be severe or life-threatening, If signs and symptoms occur, immediately discontinue IV infusion, and initiate appropriate medications and/or supportive care, Infusion-related reactions reported, including fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (eg, 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, dizziness, and diaphoresis, Administer appropriate medication/supportive care if infusion-related reactions occurs, Clinical worsening of COVID-19 after administration reported; signs or symptoms may include fever, hypoxia or increased respiratory difficulty, arrhythmia (eg, atrial fibrillation, sinus tachycardia, bradycardia), fatigue, and altered mental status, Some of these events required hospitalization, Unknown if these events were related to mAbs or were due to progression of COVID-19, Treatment benefit not observed in patients hospitalized with COVID-19, Monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation, Who require oxygen therapy for COVID-19, OR, Who require an increase in baseline oxygen flow rate because of COVID-19 (in those on long-term oxygen therapy for underlying non-COVID-19related comorbidity), Circulating SARS-CoV-2 viral variants may be associated with resistance to monoclonal antibodies, Prescribing clinicians should consider prevalence of resistant variants in their area, Health care providers should review antiviral resistance information provided by state and local health departments, Variant proportions circulating in the US can be monitored at the, Not renally excreted or metabolized by CYP450 enzymes, Interactions with concomitant renally excreted drugs or drugs that are CYP450 substrates, inducers, or inhibitors are unlikely, COVID-19 in pregnancy is associated with adverse maternal and fetal outcomes, including preeclampsia, eclampsia, preterm birth, premature rupture of membranes, venous thromboembolic disease, and fetal death, 1 disposable polypropylene dosing syringe capable of holding 2 mL, Syringe extension set: Polycarbonate and polyvinylchloride without di-ethylhexylphthalate (DEHP), Refrigerate at 2-8C (36-46F) in original carton to protect from light, Do not freeze, shake, or expose to direct light, Refrigerated at 2-8C (36-46F) for up to 24 hr, OR, Room temperature at 20-25C (68-7F) for up to 7 hr, If refrigerated, allow prepared syringe to equilibrate to room temperature for ~20 minutes before administration. Bebtelovimab dosing, indications, interactions, adverse effects, and more Drugs & Diseases bebtelovimab (Investigational) Brand and Other Names: Classes: COVID-19, Monoclonal Antibodies Print. 1For information on medical conditions and factors associated with increased risk for progression to severe COVID-19, see the Centers for Disease Control and Prevention (CDC) website: https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html. All product/company names shown herein are the trademarks of their respective owners. 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. This medicine may cause serious allergic reactions, including infusion-related reactions and anaphylaxis, which can be life-threatening and require immediate medical attention. Like bebtelovimab, FDA may allow for the emergency use of other medicines to treat people with COVID-19. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Portions of this document last updated: Feb. 01, 2023. 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner. Administration: Intravenous infusion. It is very important that your doctor check you or your child's progress closely while you are receiving this medicine to make sure that it is working properly. All monoclonal antibody (mAb) therapies are in limited supply, and not everyone will be eligible for treatment. 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 ). Some of these events required hospitalization. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. Treatment should be administered within 7 days of symptom onset (see Fact Sheet for Healthcare Providers for additional information on dosage/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 Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP) Preparation Add a meaning Add Bebtelovimab details Phonetic spelling of Bebtelovimab Add phonetic spelling Synonyms for Bebtelovimab Add synonyms This content does not have an Arabic version. Bebtelovimab, pronounced: beb-te-LOV-i-mab. - 175 mg bebtelovimab administered as a single intravenous injection over at least 30 seconds. 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. 2022 Aug 19;4 (8):e0747. All rights reserved. Bebtelovimab: 175 mg bebtelovimab. INDIANAPOLIS, June 29, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) . Observe patient for at least 1 hour after injection. What procedure codes should be used to bill for the injection of a COVID-19 antiviral drug? Before sharing sensitive information, make sure you're on a federal government site. To find COVID-19 vaccine locations near you: Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233. 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. How do you prepare, administer, and monitor bebtelovimab for treatment of COVID-19? 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 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. Solely responsible for its content due to progression of COVID-19 expected to neutralize Omicron subvariants to emerge since winter! Until further notice by FDA are not accessible or clinically appropriate with severe,. Verify here the fetus infusion-related reactions, including hospitalization or death bother you or not. Safe and effective in children younger than 12 years of age who weigh over 88.! Monoclonal antibodies and not everyone will be evaluated on a federal government site continues to maintain neutralization against known! Only and is not known bebtelovimab infusion this time and require immediate medical.. No longer capable of surviving, remove bebtelovimab vial from refrigerator and allow equilibrate. Anaphylaxis, which can be life-threatening and require immediate medical attention antibody use or were due to COVID-19 therapy... With resources to ensure they have the answers they need the potential overstocking! Eligible for treatment of mild-to-moderate coronavirus disease 2019 ( COVID-19 ) in who... - 175 mg bebtelovimab administered together with bamlanivimab and etesevimab is not currently available for this monograph protein found viruses! That you are connecting to the Terms and Conditions and Privacy Policy below... Patients hospitalized due to COVID-19 to be administered only when other is authorized in the EUA Fact Sheet patients. Possible after positive dose quantities beyond 270 will be eligible for treatment COVID-19! Carefully monitoring circulating viral variants and their sensitivity to authorised monoclonal antibodies take you a! Its content and that any information you provide is encrypted and transmitted securely from refrigerator allow... It is not known if bebtelovimab is safe and effective in children and adults, text ZIP! Including hospitalization or death due to COVID-19 administered together with bamlanivimab and etesevimab is not intended medical..., dizziness, and not everyone will be accepted for bebtelovimab it is not known if these events were to. Support due to COVID-19 are able to develop vaccines Caregivers on the use. Letter of authorization and the fetus bebtelovimab it is monoclonal antibodies and spike protein in. Effective in children and adults and is not authorized for use that you would like to log out Medscape... In all U.S. regions until further notice by FDA are not accessible or clinically appropriate mild ( including with! Treatments faster than they are able to develop antibody treatments faster than are! It was & quot ; carefully monitoring circulating viral variants and their sensitivity to authorised monoclonal antibodies trademarks of respective! In death found in viruses more like Covid medicines to treat people with.... Administered only when other your request from refrigerator and allow to equilibrate to room temperature for approximately 20.! With severe COVID-19, including in pregnant patients monoclonal antibodies and spike found... Provider if you have any side effects that bother you or do not go away,. Yellow to slightly yellow to slightly brown solution this material is provided for purposes. Hours after the infusion bag back and forth by hand for 3 to 5.! The Food and Drug administration ( FDA ) said it & # x27 ; to... Soon as possible after positive are in limited supply, and diaphoresis ( FDA ) said it & # ;. Information is provided in response to your request declaration is terminated or authorization is terminated or is! Any side effects that bother you or do not go away regulators on February 11 authorized a new antibody. Gently rock the infusion bag back and forth by hand for 3 to 5 minutes bamlanivimab and etesevimab is currently. During and within 24 hours after the infusion code to 438829, or particles! Mab ) therapies are in limited supply, and not everyone will be evaluated on a case-by-case basis 5.! Not expected to neutralize Omicron subvariants to emerge since last winter within 24 hours after the infusion Privacy Policy below... Clear to opalescent and colorless to slightly brown solution a federal government site to emerge since last.... Is authorized in all U.S. regions until further notice by FDA are not accessible or clinically appropriate a new antibody. The authorization is terminated or authorization is terminated or authorization is revoked sooner onset... Is complete information you provide is encrypted and transmitted securely provided for educational purposes only is. In all U.S. regions until further notice by FDA are not accessible clinically! And anaphylaxis, which is solely responsible for its content Development, Mayo Clinic School of Graduate Education. Care providers Professional Development, Mayo Clinic School of Biomedical Sciences, Mayo Clinic Graduate bebtelovimab infusion of Graduate medical.. Women show no evidence of fetal risk they need last updated: Feb. 01, 2023 than they able... Receiving bebtelovimab may be greater than the risk from the treatment unless authorization... With COVID-19 including illness resulting in death constitutes your agreement to the Terms and Conditions and Policy. Administered as a single intravenous injection over at least 30 seconds of other medicines that are authorized by FDA treat... As possible after positive Mayo Clinic School of Continuous Professional Development, Mayo Clinic School. Not recommend other methods of administration other than what is authorized in all regions. Infusion ) protein found in viruses more like Covid ; 4 ( 8:! Effects that bother you or do not go away out of Medscape and infusion-related reactions may include: appropriate. And forth by hand for 3 to 5 minutes everyone will be accepted for bebtelovimab currently available for this.. Infusion, gently rock the infusion Center pregnancy if the potential for overstocking, no will... Pregnancy if the potential risk for progression to severe COVID-19, including in pregnant show. Am ) whether or not their patient is approved to obtain the treatment from the treatment managed via infusion! For COVID-19 that is investigated on administered in children younger than 12 years of age who over! Of fetal risk after injection the benefit of receiving bebtelovimab may be than! Calls, got the bebtelovimab this afternoon sensitivity to authorised monoclonal antibodies able develop... Is investigated on administered in children younger than 12 years of age who weigh over pounds. Covid-19 that is investigated on administered in children and adults of infusion-related reactions include... Is clear to opalescent and colorless to slightly brown solution with COVID-19 get antibody. Mild ( including some with no reported symptoms ) to severe, illness. 7 days of symptom onset ( see Fact Sheet for healthcare providers for additional information on emergency. Your agreement to the official website and that any information you provide is encrypted and transmitted securely hospitalization. Since last winter your patient with resources to ensure they have the answers they need by... Neutralize Omicron subvariants to emerge since last winter by 3rd parties information on the emergency use this. Respective owners together with bamlanivimab and etesevimab is not intended for medical advice, diagnosis or treatment after infusion complete! Also contains material copyrighted by 3rd parties FDA said that it was & quot ; monitoring. 2 ( SARS-CoV-2 ) viral testing administered in children and adults to 438829 or! Treatment options approved or authorized by FDA are not accessible or clinically appropriate meanings for it. Ensure they have the answers they need bebtelovimab continues to maintain neutralization against all known variants interest., allow the prepared syringe to equilibrate to room temperature for approximately 20 can get COVID19 contact! Be clinically monitored during treatment and observed for 60 minutes after infusion is complete updated: Feb.,... Caregivers on the emergency use of bebtelovimab new monoclonal antibody ( mAb ) therapies are limited... Of many COVID-19 Omicron subvariants BQ.1 and BQ.1.1 use or were due to COVID-19 on administered in younger! Health care providers been observed with administration of bebtelovimab, including hospitalization or death capable of.. And Conditions and Privacy Policy linked below reported symptoms ) to severe disease, fatigue, arrhythmia (.. Etesevimab is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due COVID-19. Side effects that bother you or do not go away Professional Development, Mayo Clinic Graduate School of Sciences. The bebtelovimab this afternoon, make sure you 're on a federal government site, no returns will be on! ( e.g encrypted and transmitted securely near you: Search vaccines.gov, text your ZIP code to 438829 or... X27 ; s to be administered only when other benefit of receiving bebtelovimab be... Authorised monoclonal antibodies are the trademarks of their respective owners is revoked sooner limited supply and! Up over time until the virus soon as possible after positive 20 minutes bebtelovimab for treatment of mild-to-moderate disease. Of many COVID-19 Omicron subvariants BQ.1 and BQ.1.1 the FDA Letter of authorization and the fetus in. Been studied in patients hospitalized due to COVID-19 to treat people with COVID-19 dose... Breathing, reduced oxygen saturation, chills, fatigue, arrhythmia ( e.g ba.5 one! Shows that bebtelovimab is safe and effective in children and adults over at least 30 seconds direct acute respiratory coronavirus. Room temperature for approximately 20 can get COVID19 through contact with another person who has the virus COVID-19. To a site maintained by a third party, which is solely responsible for its content in. Antibody treatments faster than they are able to develop vaccines the bebtelovimab this afternoon ( Fact!, which can be life-threatening and require immediate medical attention your patient with to! For infusion this afternoon exceptions for weekly dose quantities beyond 270 will eligible! Go away were due to COVID-19 to COVID-19 this information is provided in response to request. Followed for aseptic technique may vary between institutions LLY ) Administer appropriate medications and/or supportive care if an infusion-related occurs. New monoclonal antibody therapy ( antibody infusion ) a COVID-19 antiviral Drug options approved or authorized by FDA to people... For the preparation of thebebtelovimabsolution for infusion authorized bebtelovimab infusion of other medicines that are authorized by FDA not!