Bebtelovimab . See more information regarding dosing in the. Sibley Infusion Center staff will call the patient to schedule administration of the therapy in the non-urgent setting. Prior to infusion, gently rock the infusion bag back and forth by hand for 3 to 5 minutes. Bebtelovimab works by binding to the spike protein of the virus that causes COVID-19, similar to other monoclonal antibodies that have been authorized for the treatment of high-risk patients with. You will be observed by your healthcare provider for at least 1 hour after you receive bebtelovimab. All rights reserved. The monoclonal antibody bebtelovimab is also authorized for children 12 years and older who weigh more than 40 kilograms. This site is intended for US residents aged 18 or older. 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%. Q0222 - Injection, bebtelovimab, 175 mg (Effective 2/11/2022-11/30/2022) *FDA revoked the . An FDA form 3500 is required for serious adverse events or medication errors. Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice. Add a meaning Add Bebtelovimab details Phonetic spelling of Bebtelovimab Add phonetic spelling Synonyms for Bebtelovimab Add synonyms 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 If you wish to report an adverse event or product complaint, please call What procedure codes should be used to bill for the injection of a COVID-19 antiviral drug? If pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider. Bebtelovimab dosing, indications, interactions, adverse effects, and more Drugs & Diseases bebtelovimab (Investigational) Brand and Other Names: Classes: COVID-19, Monoclonal Antibodies Print. All product/company names shown herein are the trademarks of their respective owners. 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner. Drug information provided by: IBM Micromedex. Fact Sheet for Patients, Parents and Caregivers (English), Download 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. All rights reserved. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. 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. AmerisourceBergen Specialty Distributors 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. 1 bebtelovimab vial (175 mg/2 mL) 1 disposable polypropylene dosing syringe capable of holding 2 mL 0.9% Sodium Chloride injection for flushing. Special considerations: FDA-approved for treating hospitalized patients. Infusion reactions have happened during and within 24 hours after the infusion. Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions. The treatment showed efficacy against early strains of Omicron, but it proved to be ineffective against Omicron sublineages BQ.1 and BQ.1.1. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. The authorized dose of bebtelovimab is 175mg administered as a single intravenous injection over at least 30 seconds. All rights reserved. The 12 codes are from the New Technology Section X of ICD-10-PCS and are available in the table below. Advertising revenue supports our not-for-profit mission. The drug, called bebtelovimab from Eli Lilly, is a monoclonal therapy meant for COVID-19 patients as young as 12 who are at high risk for getting severely ill and who were recently infected, to keep them from getting even sicker and keep them out of the hospital. Blood tests may be needed to check for unwanted effects. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. require an increase in baseline oxygen flow rate and/or respiratory support due to COVID19 and are on chronic oxygen therapy and/or respiratory support due to underlying non-COVID-19 related comorbidity. ASPR has paused the fulfillment of any pending requests under its Bebtelovimab Product Replacement Initiative due to bebtelovimab not currently being authorized for use in the U.S. 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. 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. There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. The right medications for COVID-19 can help. Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of other SARS-CoV-2 monoclonal antibodies and could occur with administration of bebtelovimab. The Food and Drug Administration (FDA) issued an emergency use authorization for bebtelovimab on Feb. 11. fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. The new infusion provides an . On May 6, 2021, CMS updated the Medicare payment rates for the administration of COVID-19 monoclonal antibody products. We encourage you to read the privacy policy of every website you visit.Click "Continue" to proceed or "Return" to return to LillyMedical.com. Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. . 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. Please also reference the Fact Sheet for Healthcare Providers for more information. Share cases and questions with Physicians on Medscape consult. 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. 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. Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Crit Care Explor. Positive results of direct acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing. After the entire contents of the syringe have been administered. Bebtelovimab did not undergo the same type of review as an FDA-approved product. 1,2, BLAZE-4 is a phase 2, randomized, single-dose clinical trial evaluating treatment of non-hospitalized patients with mild-to-moderate COVID-19.1, Bebtelovimab was among the treatment interventions studied in BLAZE-4. . These are not all the risk factors. placebo (normal saline/ total dose volume 62.5 mL) administered via IV infusion over at least 6.5 minutes. Read more about bebtelovimab. How can I get monoclonal antibody therapy (antibody infusion)? A Patient Handout is not currently available for this monograph. 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 Fact Sheet for Patients, Parents and Caregivers (Spanish), Download Treatment should be administered within 7 days of symptom onset (see Fact Sheet for Healthcare Providers for additional information on dosage/administration). 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. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. 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. Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. Bebtelovimab is designed as a treatment option for those newly diagnosed with COVID-19 who cannot take Paxlovid and are deemed at high risk of severe outcomes. 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 Controlled studies in pregnant women show no evidence of fetal risk. Other risk factors can be found on the CDC website. You can get COVID19 through contact with another person who has the virus. If you have any questions regarding the procurement of bebtelovimab commercially, please contact 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. On the CDC website Sheet for healthcare Providers for more information volume 62.5 mL ) administered IV! Bebtelovimab, including in pregnant patients who develop severe hypersensitivity and infusion-related reactions, including obstetrical.! 62.5 mL ) administered via IV infusion over at least 30 seconds older who weigh more than 40.. 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