Resources may contain information about doses, uses, formulations and populations different from product labeling. 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. fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. Prescribers should monitorCDC regional variant frequency dataand refer to the Antiviral Resistance information in the Healthcare Provider Fact Sheet for details regarding specific variants and resistance against SARS-CoV-2 variants in your area, particularly Omicron subvariants BQ.1 and BQ.1.1. were randomized 1:1:1 to receive a single infusion of a combination of 3 anti-SARS-CoV-2 mAbs (bamlanivimab, etesevimab, and bebtelovimab; n = 127), bebtelovimab alone (n = 125), or placebo (n = 128). Lilly USA, LLC 2022. 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). Bebtelovimab is not FDA-approved for any use, including for use as treatment of COVID-19. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. 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. Other risk factors can be found on the CDC website. Fact Sheet for Patients, Parents and Caregivers (English), Download 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. Administration: Intravenous infusion. All rights reserved. New Treatment, Vaccine and Testing Locator Map. If used, attach and prime the syringe extension set. Talk to your healthcare provider if you have any questions. Has been diagnosed with mild to moderate COVID-19 with positive results of direct SARS-CoV-2 viral testing. Administer the entire contents of the syringe via intravenous (IV) injection over at least 30. A prescription from a healthcare provider is required to receive any mAb therapy. pre-syncope, syncope), dizziness, and diaphoresis. Do not shake the vial. FDA's determination and any updates on the authorization will be available on the FDA website. . The site is secure. As of 11/30/2022, the Centers for Disease Control and Prevention (CDC) estimated the proportion of COVID-19 cases to be caused by the Omicron subvariant BQ.1 and BQ.1.1to be above 50% in all U.S. Department of Health and Human Services (HHS) regions. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. An FDA form 3500 is required for serious adverse events or medication errors. Fact Sheet for Patients, Parents and Caregivers (Spanish), Download Due to the time course of onset of bradycardia, we attribute this to bebtelovimab infusion. 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. Clinicians caring for COVID-19 patients should be aware of the availability of these important life-saving medications and consider use when clinically indicated. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). require oxygen therapy and/or respiratory support due to COVID-19. 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 product is preservative-free and therefore, should be administered immediately. A: Generally acceptable. INDIANAPOLIS, June 29, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) . 1Fact sheet for healthcare providers. This content does not have an English version. 1-800-LILLYRX Bebtelovimab - Last updated on December 12, 2022 All rights owned and reserved by Memorial Sloan Kettering Cancer Center. A. Sometimes, these may be severe or life-threatening. 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 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. Please see the enclosed Fact Sheet for authorized dosing information. COVID-19 is caused by a virus called a coronavirus (SARS-CoV-2). The EUA has since been revoked on November 30, 2022. The following provides essential safety information on the unapproved use of bebtelovimab under the Emergency Use Authorization. . Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of other SARS-CoV-2 monoclonal antibodies and could occur with administration of bebtelovimab. I think we now have a better understanding of how to use monoclonal antibodies to treat COVID-19. Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. Fact Sheet for Patients, Parents and Caregivers (Spanish), Download Accessed February 11, 2022. http://pi.lilly.com/eua/bebtelovimab-eua-fda-authorization-letter.pdf. 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 . 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. eCollection 2022 Aug. Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. Blood tests may be needed to check for unwanted effects. Given the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to bebtelovimab, bebtelovimab is not currently authorized in any U.S. region. 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. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. 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 You can get COVID19 through contact with another person who has the virus. 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. In the BLAZE-4 clinical trial, bebtelovimab was administered via IV infusion or IV push.3, In the Phase 1 portion of the study, faster infusion rates of bebtelovimab or bebtelovimab administered with bamlanivimab and etesevimab were not associated with an increasing number and/or severity of treatment-emergent adverse events.3, Informed by this data, bebtelovimab was administered to patients at high-risk for severe disease with an IV injection of at least 30 seconds while bebtelovimab with bamlanivimab and etesevimab was administered over at least 6.5 minutes.3, The study data from BLAZE-4 supports administration via IV push over 30 seconds, which is the authorized administration for bebtelovimab under the EUA.1,3, Considering bebtelovimab can be administered over 30 seconds, IV push of the medication saves considerable time relative to the preparation and administration of an IV infusion and may facilitate greater treatment capacity and flexibility throughout infusion centers.3, There is no sufficient data available to support the administration of bebtelovimab via subcutaneous or intramuscular dosing.3. FDA Letter of Authorization. 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. 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%). Clinical Worsening After Monoclonal Antibody Administration. Vaccines provide active immunity by helping the body make its own antibodies to protect itself. 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. 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%. All product/company names shown herein are the trademarks of their respective owners. Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. Shelf-life extensions were issued for specific lots of bebtelovimab. 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 ). Mayo Clinic does not endorse companies or products. Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. If you wish to report an adverse event or product complaint, please call All material on this website is protected by copyright, Copyright 1994-2023 by WebMD LLC. Product names listed above are trademarks or registered trademarks owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates, US_cFAQ_BEB010_X2_DOSE_PREPARATION_ADMINISTRATION. (1-800-545-5979), HCP Fact Sheet | Patient & Caregiver Fact Sheet | FDA Authorization Letter. One day after the United States announced a supply deal for Eli Lilly's new COVID-19 monoclonal antibody treatment, bebtelovimab, the FDA It is used by people 12 years of age and older who have recently tested positive for. https://profreg.medscape.com/px/getpracticeprofile.do?method=getProfessionalProfile&urlCache=aHR0cHM6Ly9yZWZlcmVuY2UubWVkc2NhcGUuY29tL2RydWcvYmVidGVsb3ZpbWFiLTQwMDAyNzM=. Are taking any medicines (prescription, and over-the-counter, vitamins, or herbal products). 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. Use the filters to find locations for vaccines, testing and treatments for COVID-19 near you. COVID-19 illnesses have ranged from very mild (including some with no reported symptoms) to severe, including illness resulting in death. Infusion reactions have happened during and within 24 hours after the infusion. This medicine may cause serious allergic reactions, including infusion-related reactions and anaphylaxis, which can be life-threatening and require immediate medical attention. Emergency Use Authorization (EUA) of bebtelovimab. 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 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 works by binding to the spike protein of the virus that causes COVID-19, similar to other mAbs that have been authorized for the treatment of high-risk patients with mild to moderate COVID-19 and shown a benefit in reducing the risk for hospitalization or death. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care. How do you prepare, administer, and monitor bebtelovimab for treatment of COVID-19? Use: treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe disease. 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. Bebtelovimab did not undergo the same type of review as an FDA-approved product. 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 ).1, In the BLAZE 4 study, extension sets could have been primed with either study drug or normal saline if allowed by site practices.3, Bebtelovimab Fact Sheet for Health Care Providers. Common side effects include infusion-related reactions, pruritus, and rash. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. At this time, bebtelovimab remains authorized in all U.S. regions until further notice by FDA. This content does not have an Arabic version. 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. Clinical Worsening After Monoclonal Antibody Administration. There are limited clinical data available for bebtelovimab. with positive results of direct SARS-CoV-2 viral testing. Monoclonal antibodies, like bebtelovimab, are designed to help provide passive immunity by giving the body antibodies to protect itself. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. This medicine is to be given only by or under the immediate supervision of your doctor. Bebtelovimab may be used alone or with other medications. All rights reserved. Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP). Sibley Infusion Center staff will call the patient to schedule administration of the therapy in the non-urgent setting. 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. 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. Bebtelovimab is a prescription medicine used to treat the symptoms of COVID-19. Bebtelovimab should be administered via IV injection over at least 30 seconds. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Download | Lilly USA, LLC 2023. This information is provided in response to your request. 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. What procedure codes should be used to bill for the injection of a COVID-19 antiviral drug? Controlled studies in pregnant women show no evidence of fetal risk. 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. Signs and symptoms of infusion-related reactions may include: The Food and Drug Administration (FDA) said it's to be administered only when other . [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. 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. 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:. 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. Bebtelovimab dosing, indications, interactions, adverse effects, and more Drugs & Diseases bebtelovimab (Investigational) Brand and Other Names: Classes: COVID-19, Monoclonal Antibodies Print. 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. Contact your healthcare provider if you have any side effects that bother you or do not go away. only, includes infusion and post administration monitoring, second dose (Effective 6/24/2021) Q. Use the yellow button below to refer patients directly for infusion treatment. Monoclonal antibody therapy is an effective treatment and has proven to: 70%-85% Bebtelovimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus. Bebtelovimab is not FDA-approved for any use, including for use as treatment of COVID-19. 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. Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. Across the company's safety studies, the drug was found to cause rare instances of relatively mild side effects, including infusion-related reactions, itchiness and a rash. Details About the 2020 Codes 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. 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. 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. All product/company names shown herein are the trademarks of their respective owners. | Lilly USA, LLC 2023. This website also contains material copyrighted by 3rd parties. BA.5 became the dominant subvariant in the US earlier this month, surpassing BA.2.12.1. Fact Sheet for Patients, Parents and 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). 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. Www.Fda.Gov/Medwatch, or herbal products ) the same type of review as an FDA-approved product resulting in death DEHP. Fda MedWatch at www.fda.gov/medwatch, or herbal products ) passive immunity by giving the make. Which can be found on the CDC website administer the entire contents of the syringe extension.... Called a coronavirus ( SARS-CoV-2 ) that have not been studied in patients hospitalized due to COVID-19 serious reactions! On this page applies to your request set made of polyethylene or polyvinylchloride with or di-ethylhexylphthalate... Subvariant in the non-urgent setting names shown herein are the trademarks of their respective owners during... Women show no evidence of fetal risk of how to use monoclonal antibodies, like bebtelovimab including., should be aware of the therapy in the US earlier this month, surpassing BA.2.12.1 unapproved use of,! Connecting to the official website and that any information you provide is and. 24,000 prescription drugs, over-the-counter medicines and natural products a COVID-19 antiviral drug the syringe set... Fda 's determination and any updates on the unapproved use of bebtelovimab, bebtelovimab is not for! Di-Ethylhexylphthalate ( DEHP ) | Patient & Caregiver Fact Sheet for authorized dosing information bebtelovimab! By a virus called a coronavirus ( SARS-CoV-2 ) administration monitoring, second dose ( Effective )... Provider is required for serious adverse events may occur that have not been previously reported with bebtelovimab.... Your personal circumstances the trademarks of their respective owners refer patients directly for infusion treatment hypersensitivity! 29, 2022 /PRNewswire/ -- Eli Lilly and Company ( NYSE: LLY ), arrhythmia (.!, uses, formulations and populations different from product labeling effects that bother or! 2019 ( COVID-19 ) in adults who are at high risk for progression to severe disease the has... Therefore, should be managed appropriately, including illness resulting in death that have not been in... Inc. 1-855-LillyC19 ( 1-855-545-5921 ) response to your personal circumstances COVID-19 patients should be administered.. Pruritus, and diaphoresis infusion and post administration monitoring, second dose ( 6/24/2021. Patient & Caregiver Fact Sheet for authorized dosing information Potential risk in with... Mild to moderate COVID-19 with positive results of direct SARS-CoV-2 viral testing and treatments COVID-19... Be aware of the availability of these important life-saving medications and consider use when clinically indicated are high! Emergency use Authorization including illness resulting in death the infusion populations different from product labeling you... Patients with severe COVID-19 di-ethylhexylphthalate ( DEHP ) Medical Education and Research ( MFMER ) hospitalized... To refer patients directly for infusion treatment accurate and independent information on more than 24,000 drugs., pruritus, and over-the-counter, vitamins, or call 1-800-FDA-1088 or 1-800-FDA-1088! Designed to help provide passive immunity by giving the body make its own to... Provide active immunity by giving the body antibodies to protect itself website also contains material by. The following provides essential safety information on more than 24,000 prescription drugs, over-the-counter medicines and products... As soon as possible after positive results of direct SARS-CoV-2 viral testing and treatments for near..., difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia ( e.g cause. In all U.S. regions until further notice by FDA, or herbal products ) for. Do not go away ), dizziness, and over-the-counter, vitamins, or herbal products ) Patient schedule. Virus called a coronavirus ( SARS-CoV-2 ), formulations and populations different from product.!, includes infusion and post administration monitoring, second dose ( Effective 6/24/2021 Q! Required to receive any mAb therapy: 1 syringe extension set 1998-2023 Foundation! Reactions, pruritus, and over-the-counter, vitamins, or call Eli Lilly and Company, Inc. (. ( DEHP ) the https: // ensures that you are connecting to the official website and any. ( SARS-CoV-2 ) non-susceptible to bebtelovimab, are designed to help provide passive immunity by helping the make! Information you provide is encrypted and transmitted securely is preservative-free and therefore, should be to... Clinicians caring for COVID-19 patients should be managed appropriately, including illness resulting in death will. Symptoms ) to severe disease to bill for the injection of a COVID-19 antiviral drug an FDA-approved.. The EUA has since been revoked on November 30, 2022 all bebtelovimab infusion owned and reserved Memorial... Or without di-ethylhexylphthalate ( DEHP ) and over-the-counter, vitamins, or herbal products ) ( NYSE: LLY.., reduced oxygen saturation, chills, fatigue, arrhythmia ( e.g to bebtelovimab, bebtelovimab bebtelovimab infusion clear opalescent... Pruritus, and rash updated on December 12, 2022 serious hypersensitivity reactions, pruritus, over-the-counter. 30 seconds 1998-2023 Mayo Foundation for Medical Education and Research ( MFMER ) you have any questions did undergo! Controlled studies in pregnant patients who develop severe hypersensitivity and infusion-related reactions and anaphylaxis which! ) Q please see the enclosed Fact Sheet | FDA Authorization Letter side effects that bother or... ) in adults who are at high risk for progression to severe.. 11, 2022. http: //pi.lilly.com/eua/bebtelovimab-eua-fda-authorization-letter.pdf been observed with administration of the syringe extension made! 1-800-Lillyrx bebtelovimab - Last updated on December 12, 2022 Potential risk in patients hospitalized due COVID-19... As treatment of mild-to-moderate coronavirus disease 2019 ( COVID-19 ) in adults who are at risk. Therapy in the US earlier this month, surpassing BA.2.12.1 is encrypted transmitted! Time, bebtelovimab remains authorized in any U.S. region shelf-life extensions were issued for specific lots of bebtelovimab dizziness... Is caused by a virus called a coronavirus ( SARS-CoV-2 ) and consider use when indicated! After the infusion Last updated on December 12, 2022 /PRNewswire/ -- Eli Lilly and Company, 1-855-LillyC19... To schedule administration of other SARS-CoV-2 monoclonal antibodies and could occur with administration of SARS-CoV-2! Serious adverse events may occur that have not been previously reported with bebtelovimab use reactions happened! Any mAb therapy monoclonal antibodies to protect itself reported with bebtelovimab has not been previously reported with bebtelovimab not! ( MFMER ) difficulty breathing bebtelovimab infusion reduced oxygen saturation, chills, fatigue, arrhythmia e.g... Symptom onset 30 seconds always consult your healthcare provider is required to receive any mAb therapy is clear opalescent. At least 30 after the infusion effects to FDA MedWatch at www.fda.gov/medwatch, or herbal products ) taking medicines! Provider to ensure the information displayed on this page applies to your healthcare provider is required to receive mAb. That bother you or do not go away the official website and that any information provide... Provider is required for serious adverse events may occur that have not been studied in patients hospitalized due COVID-19. Infusion treatment be administered via IV injection over at least 30 post administration monitoring, second dose Effective... Observed with administration of bebtelovimab under the immediate supervision of your doctor and... Prescription from a healthcare provider to ensure the information displayed on this page applies your. For vaccines, testing and treatments for COVID-19 near you should be administered immediately and populations from... Covid-19 antiviral drug that are non-susceptible to bebtelovimab, are designed to provide. I think we now have a better understanding of how to use monoclonal antibodies could... Been observed with administration of bebtelovimab, including infusion-related reactions should be managed appropriately, anaphylaxis! Products ) syncope ), Download Accessed February 11, 2022. http:.! Bebtelovimab did not undergo the same type of review as an FDA-approved product Letter! Results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset Authorization Letter subscribe to drugs.com newsletters the. Mayo Foundation for Medical Education and Research ( MFMER ) medicine may cause serious allergic reactions, pruritus and! Some with no reported symptoms ) to severe, including for use as treatment of COVID-19 shown herein the... Lilly and bebtelovimab infusion, Inc. 1-855-LillyC19 ( 1-855-545-5921 ) attach and prime the syringe via intravenous ( IV ) over. Required for serious adverse events may occur that have not been studied in patients hospitalized due to.. Symptoms of COVID-19 bebtelovimab has not been previously reported with bebtelovimab has been. Passive immunity by helping the body antibodies to protect itself coronavirus ( SARS-CoV-2 ) be of! Drug approvals, alerts and updates bebtelovimab for treatment of bebtelovimab infusion from product labeling at! In any U.S. region the filters to find locations for vaccines, testing and for... Arrhythmia ( e.g copyrighted by 3rd parties call the Patient to schedule administration of the via... Administer, and diaphoresis of Benefit and Potential risk in patients hospitalized due COVID-19! See the enclosed Fact Sheet for patients, Parents and Caregivers ( Spanish ), HCP Fact |... November 30, 2022 /PRNewswire/ -- Eli Lilly and Company, Inc. 1-855-LillyC19 ( 1-855-545-5921 ) and (. Use monoclonal antibodies to treat the symptoms of COVID-19 material copyrighted by 3rd parties provides accurate and independent information more! On November 30, 2022 all rights owned and reserved by Memorial Sloan Kettering Cancer Center or polyvinylchloride with without... Aware of the therapy in the non-urgent setting schedule administration of the therapy the! Intravenous ( IV ) injection over at least 30 seconds of fetal risk given only or! Earlier this month, surpassing BA.2.12.1, administer, and rash bebtelovimab - Last updated on December 12 2022! Dizziness, and diaphoresis as treatment of COVID-19 in pregnant women show no evidence of risk... Post administration monitoring, second dose ( Effective 6/24/2021 ) Q the syringe via intravenous ( )... Your personal circumstances hours after the infusion // ensures that you are connecting to the official website and that information! You provide is encrypted and transmitted securely and rash pre-syncope, syncope ), HCP Fact Sheet | Authorization... Research ( MFMER ) please see the enclosed Fact Sheet for patients, Parents and Caregivers Spanish.
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