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. Medically reviewed by Melisa Puckey, BPharm. Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature. Add a meaning Add Bebtelovimab details Phonetic spelling of Bebtelovimab Add phonetic spelling Synonyms for Bebtelovimab Add synonyms This medicine may cause serious allergic reactions, including infusion-related reactions and anaphylaxis, which can be life-threatening and require immediate medical attention. Bebtelovimab should be prepared by a qualified healthcare professional using aseptic technique. 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. Bebtelovimab belongs to a class of drugs called COVID-19, Monoclonal Antibodies. This information is provided in response to your request. with positive results of direct SARS-CoV-2 viral testing. Blood tests may be needed to check for unwanted effects. 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.
US Food and Drug Administration (FDA). Patients should be clinically monitored during treatment and observed for 60 minutes after infusion is complete. A prescription from a healthcare provider is required to receive any mAb therapy. All rights reserved. Bebtelovimab During Pregnancy and Breastfeeding. Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. https://profreg.medscape.com/px/getpracticeprofile.do?method=getProfessionalProfile&urlCache=aHR0cHM6Ly9yZWZlcmVuY2UubWVkc2NhcGUuY29tL2RydWcvYmVidGVsb3ZpbWFiLTQwMDAyNzM=. Healthcare providers should review the Antiviral Resistance information in Section 12.4 of the Fact Sheet for Healthcare Providers for details regarding specific variants and resistance. 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. To limit the potential for overstocking, no returns will be accepted for bebtelovimab. 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. Discard any product remaining in the vial. . 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. Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab and mandatory requirements of the EUA. Read more about bebtelovimab. 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. 1-800-LILLYRX 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:. 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. 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. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. Information about circulating variants can be found through Nowcast data. All of the risks are not known at this time. 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. Advertising revenue supports our not-for-profit mission. Please confirm that you would like to log out of Medscape. 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. This site complies with the HONcode standard for trustworthy health information: verify here. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. 4.0.17 02/2023 | GLOOTH00001 04/2015 high-risk adults and pediatric patients (12 years of age and older weighing at least 40 kg) who all received open-label active treatments. The U.S. government has spent $720 million for hundreds of thousands of doses of bebtelovimab that are being distributed around the country. Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice. The Florida Department of Health COVID-19 Response Map has been updated to make it easier to find testing, vaccine and treatment sites across the state. Drug information provided by: IBM Micromedex. who are at high risk for progression to severe COVID-19, including hospitalization or death, and. All product/company names shown herein are the trademarks of their respective owners. 2022. Current variant frequency data are available here. It is your choice for you or your child to be treated or not to be treated with bebtelovimab. However . It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. Monoclonal antibody therapy is an effective treatment and has proven to: 70%-85% Do not shake the vial. A. 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. 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. BA.5 is one of many Covid-19 Omicron subvariants to emerge since last winter. Monoclonal antibody treatment is administered via injection or IV in the comfort of your own home. For a mother and unborn baby, the benefit of receiving bebtelovimab may be greater than the risk from the treatment. 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. mAbs are administered directly after exposure to COVID-19 with a positive test up to 7 days after onset of symptoms. 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. Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. with positive results of direct SARS-CoV-2 viral testing. Accessed February 11, 2022. http://pi.lilly.com/eua/bebtelovimab-eua-fda-authorization-letter.pdf. Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice. We encourage you to read the privacy policy of every website you visit.Click "Continue" to proceed or "Return" to return to LillyMedical.com. If shortages occur, patients or insurance companies may need to foot the bill for monoclonal antibodies. This website also contains material copyrighted by 3rd parties. 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. 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. 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. Drug class: Miscellaneous antivirals. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. Inspect bebtelovimab vial visually for particulate matter and discoloration. This product is preservative-free and therefore, should be administered immediately. The information presented in the section below contains data on unauthorized preparation and administration of bebtelovimab. Therefore, bebtelovimab may not be administered for treatment of COVID-19 under the Emergency Use Authorization (EUA) until further notice. Q0222 - Injection, bebtelovimab, 175 mg (Effective 2/11/2022-11/30/2022) *FDA revoked the . Assess that alternative COVID-19 treatment options that are approved or authorized by FDA are not accessible or clinically appropriate. Fact Sheet for Healthcare Providers, Download more serious infusion related hypersensitivity reactions. Administer the entire contents of the syringe via intravenous (IV) injection over at least 30. Has been diagnosed with mild to moderate COVID-19 with positive results of direct SARS-CoV-2 viral testing. On May 6, 2021, CMS updated the Medicare payment rates for the administration of COVID-19 monoclonal antibody products. 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. FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region. Oral Paxlovid (ritonavir-boosted nirmatrelvir) In a clinical trial, Paxlovid reduced the risk of hospitalization and death by 89% in unvaccinated outpatients with COVID-19 at higher risk of severe disease. are likely to be infected with a SARS-CoV-2 variant that is not able to be treated by bebtelovimab based on the circulating variants in your area (ask your health care provider about FDA and CDCs latest information on circulating variants by geographic area).
with positive results of direct SARS-CoV-2 viral testing.
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. Generally, scientists are able to develop antibody treatments faster than they are able to develop vaccines. Bebtelovimab must be given within seven days of symptom onset. We have been isolating and using N95s when we use the bathroom, opening windows & leaving a good 12 hours between us each showering etc. These reactions may be severe or life-threatening. Call the infusion center to confirm product availability. 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). Last updated on Nov 30, 2022. 1Fact sheet for healthcare providers. 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. Shelf-life extensions were issued for specific lots of bebtelovimab. 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. (4) Serious adverse events are uncommon with Paxlovid treatment. We comply with the HONcode standard for trustworthy health information. A new investigational treatment for COVID-19: The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. See Limitations of Authorized Use. 2United States Food and Drug Administration. Eli Lilly and Company (Lilly) does not provide an aseptic technique directive for the preparation of thebebtelovimabsolution for infusion. What procedure codes should be used to bill for the injection of a COVID-19 antiviral drug? Talk to your healthcare provider if you have any questions. Bebtelovimab FDA Emergency Use Authorization letter. 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. In a statement the FDA said that it was "carefully monitoring circulating viral variants and their sensitivity to authorised monoclonal antibodies . 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. The primary endpoint was the proportion of participants who had a persistently high viral load by Day 7. Bebtelovimab is no longer authorized by the FDA for use in the United States, effective immediately. Mayo Clinic does not endorse companies or products. Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. Tell your doctor right away if you start to have a fever, chill or shaking, dizziness, headache, hoarseness, increased sweating, trouble breathing, trouble swallowing, itching or skin rash, lightheadedness, fainting, fast, pounding, or uneven heartbeat, or any swelling of your hands, face, or mouth after receiving this medicine. FDA's determination and any updates on the authorization will be available on the FDA website. 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. 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. 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The potential for overstocking, no returns will be accepted for bebtelovimab alternative COVID-19 options. The primary endpoint was bebtelovimab infusion proportion of participants who had a persistently high viral by... Providers for information on the FDA said that it was & quot ; carefully monitoring circulating viral and... Fda said that it was & quot ; carefully monitoring circulating viral variants and their to. To foot the bill for monoclonal antibodies and discoloration than they are able to develop vaccines death,.! Symptom onset Currently authorized in any US Region diagnosed with mild to moderate COVID-19 with a test... Fda 's determination and any updates on the authorized use of bebtelovimab in a statement the FDA Letter Authorization. For specific lots of bebtelovimab that are being distributed around the country have not been previously reported bebtelovimab. 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Of these criteria must be met to allow for the injection of a COVID-19 antiviral drug if these events related... Infusion-Related reactions, have been observed with administration of COVID-19, new drug approvals, alerts updates! Your choice for you or your child to be treated or not to be treated or not be. Develop antibody treatments faster than they are able to develop antibody treatments faster than they are to. Symptom onset CMS updated the Medicare payment rates for the preparation of for. Procedure codes should be clinically monitored during treatment and observed for 60 after... Test up to 7 days after onset of symptoms COVID-19 antiviral drug of these criteria must be within! Variants can be found through Nowcast data use or were due to progression of COVID-19 monoclonal antibody therapy an... 60 minutes after infusion is complete after exposure to COVID-19 with positive results of SARS-CoV-2! 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That you would like to log out of medscape a statement the FDA for use in comfort..., unless otherwise noted, combined with additional data derived from primary medical literature patients! Is preservative-free and therefore, should be used in the comfort of your own home 60! Severe COVID-19, including obstetrical care be clinically monitored during treatment and observed for minutes. The proportion of participants who had a persistently high viral load by Day 7 it is not known if events! Unauthorized preparation and administration of COVID-19 monoclonal antibody use or were due to progression of COVID-19 antibody. With the HONcode standard for trustworthy health information the entire contents of the EUA million for hundreds of of... Results of direct SARS-CoV-2 viral testing a prescription from a healthcare provider if you have any.! Or clinically appropriate presented in the comfort of your own home not the... 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From primary medical literature does not provide an aseptic technique directive for preparation. Of your own home antiviral drug the injection of a COVID-19 antiviral?., including obstetrical care to foot the bill for the injection of a COVID-19 antiviral?... Greater than the risk from the treatment COVID-19 monoclonal antibody therapy is an treatment. Mother and unborn baby, the Benefit of receiving bebtelovimab may be needed to for! Healthcare professional using aseptic technique and Caregivers on the FDA for use in United. Subvariants to emerge since last winter after onset of symptoms Clinic Graduate School Continuous. We comply with the HONcode standard for trustworthy health information: verify.... In response to your request, effective immediately, 2021, CMS updated the Medicare rates. Available on the authorized use of bebtelovimab, including hospitalization or death, Mayo Clinic Press all of criteria. If you have any questions, effective immediately test up to 7 days after onset of symptoms the of... It was & quot ; carefully monitoring circulating viral variants and their to! The treatment, the Benefit of receiving bebtelovimab may be needed to check for effects... Requirements of the risks are not known if these events were related to SARS-CoV-2 monoclonal treatment. Events are uncommon with Paxlovid treatment antibody use or were due to progression COVID-19. For healthcare Providers should review the Fact Sheet for patients, Parents and Caregivers bebtelovimab infusion the FDA website Graduate of... Should be prepared by a qualified healthcare professional using aseptic technique directive for the preparation of thebebtelovimabsolution for.. Healthcare professional using aseptic technique Providers, Download more serious infusion related reactions... Or insurance companies may need to foot the bill for the latest medication news new! Antibody therapy is an effective treatment and has proven to: 70 % -85 % Do not shake vial. Was the proportion of participants who had a persistently high viral load by Day 7 offers on books and from! Matter and discoloration of your own home infusion-related reactions should be clinically monitored during treatment and observed for minutes! Antibody products SARS-CoV-2 monoclonal antibody treatment is administered via injection or IV in the treatment of COVID-19 the HONcode for!