Mayo Clinic does not endorse companies or products. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. 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). 200 Independence Ave., Washington, DC 20201. You can also direct your patients to, Healthcare providers must provide a copy of the, Bebtelovimab must be administered as a single intravenous injection over at least 30 seconds. Bebtelovimab During Pregnancy and Breastfeeding. Bebtelovimab will be given as an injection through a vein (intravenously or IV) over at least 30 seconds. doi: 10.1097/CCE.0000000000000747. There are limited clinical data available for bebtelovimab. Mayo Clinic does not endorse companies or products. 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. On May 6, 2021, CMS updated the Medicare payment rates for the administration of COVID-19 monoclonal antibody products. Adverse reactions observed in those who have received bebtelovimab, alone or in combination with bamlanivimab and etesevimab, at the authorized dose or higher, are infusion-related reactions (n=2, 0.3%), pruritus (n=2, 0.3%) and rash (n=5, 0.8%). for whom other COVID-19 treatment options approved or authorized by FDA are not available or clinically appropriate. 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. Medically reviewed by Melisa Puckey, BPharm. 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. Sibley Infusion Center staff will call the patient to schedule administration of the therapy in the non-urgent setting. Lilly USA, LLC 2022. We will provide further updates and consider additional action as new information becomes available. Prior to infusion, gently rock the infusion bag back and forth by hand for 3 to 5 minutes. Identify an infusion center near your patient. Healthcare providers should consider the benefit-risk for an individual patient. 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. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. It is possible that bebtelovimab could interfere with your body's own ability to fight off a future infection of SARS-CoV-2. 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. The monoclonal antibody bebtelovimab is also authorized for children 12 years and older who weigh more than 40 kilograms. 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. The EUA for bebtelovimab is for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms, which is about 88 pounds) with a positive COVID-19 test, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative Bebtelovimab . It is used by people 12 years of age and older who have recently tested positive for. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. This site complies with the HONcode standard for trustworthy health information: verify here. with positive results of direct SARS-CoV-2 viral testing. Bebtelovimab has not been approved, but has been authorized for emergency use by the FDA under an EUA, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. If refrigerated, allow the prepared syringe to equilibrate to room temperature for approximately 20. Adverse reactions observed in those who have received bebtelovimab, alone or in combination with bamlanivimab and etesevimab, at the authorized dose or higher, are infusion-related reactions (n=2, 0.3%), pruritus (n=2, 0.3%) and rash (n=5, 0.8%). A healthcare worker attaches an IV infusion to a patient's hand during a monoclonal antibody treatment in the parking lot at Wayne Health Detroit Mack Health Center in Detroit, Michigan, U.S., on . Patients treated with bebtelovimab should continue to self-isolate and use infection control measures (e.g., wear mask, isolate, social distance, avoid sharing personal items, clean and disinfect high touch surfaces, and frequent handwashing) according to CDC guidelines. Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions. 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). Eli Lilly and Company (Lilly) does not provide an aseptic technique directive for the preparation of thebebtelovimabsolution for infusion. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. 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. The site is secure. Lilly cannot recommend other methods of administration other than what is authorized in the EUA Fact Sheet for health care providers. 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. All of the risks are not known at this time. 3Data on file, Eli Lilly and Company and/or one of its subsidiaries. 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. mAbs are administered directly after exposure to COVID-19 with a positive test up to 7 days after onset of symptoms. Bebtelovimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus. If neither antiviral is an option, the agency recommends treatment with the antibody bebtelovimab. 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. This medicine may cause serious allergic reactions, including infusion-related reactions and anaphylaxis, which can be life-threatening and require immediate medical attention. However . Special considerations: FDA-approved for treating hospitalized patients. What procedure codes should be used to bill for the injection of a COVID-19 antiviral drug? 3, Thebebtelovimabdosing instructions do not specify a particular brand of disposable dosing syringe or extension set to be used and Lilly does not provide guidance in this regard.3, Thereareno known incompatibilities betweenbebtelovimaband availabledisposable dosing syringes in the market.3, The type of IV line used to administer bebtelovimab is not specified (via a PICC line, central line, port, etc. This content does not have an English version. 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 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 fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. eCollection 2022 Aug. Avoid forming air bubbles. All rights reserved. Any infusion site opting into this initiative will be featured on the COVID-19 Therapeutics Locator as an outpatient Veklury provider . 1-800-LILLYRX PP-BB-US-0005 11/2022 The primary endpoint was the proportion of participants who had a persistently high viral load by Day 7. 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). This site is intended for US residents aged 18 or older. Use the yellow button below to refer patients directly for infusion treatment. Inspect bebtelovimab vial visually for particulate matter and discoloration. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. 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): The following provides essential safety information on the unapproved use of bebtelovimab under the Emergency Use Authorization. You can get COVID19 through contact with another person who has the virus. Drug information provided by: IBM Micromedex. 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. You will be observed by your healthcare provider for at least 1 hour after you receive bebtelovimab. Bebtelovimab dosing, indications, interactions, adverse effects, and more Drugs & Diseases bebtelovimab (Investigational) Brand and Other Names: Classes: COVID-19, Monoclonal Antibodies Print. Administration: Intravenous infusion. Fact Sheet for Patients, Parents and Caregivers (Spanish), Download Share cases and questions with Physicians on Medscape consult. 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. Download Blood tests may be needed to check for unwanted effects. 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. Issued February 11, 2022. Common side effects include infusion-related reactions, pruritus, and rash. More Information about Payment for Infusion & IV Injection at Home. Infusion reactions have happened during and within 24 hours after the infusion. 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:. Bebtelovimab No Longer Authorized as of 11/30/22. Sometimes, these may be severe or life-threatening. Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP). 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. For patients, the infusion is free (for now). Clinical Worsening After Monoclonal Antibody Administration. Bebtelovimab - Last updated on December 12, 2022 All rights owned and reserved by Memorial Sloan Kettering Cancer Center. Copyright 2023 IBM Watson Health. Lilly cannot recommend other methods of administration other than what is authorized in the EUA Fact Sheet for health care providers. Add a meaning Add Bebtelovimab details Phonetic spelling of Bebtelovimab Add phonetic spelling Synonyms for Bebtelovimab Add synonyms Federal regulators on February 11 authorized a new monoclonal antibody treatment for mild-to-moderate COVID-19. This product is preservative-free and therefore, should be administered immediately. Remove bebtelovimab vial from refrigerated storage and allow to equilibrate to room temperature for approximately 20 minutes before preparation. - 175 mg bebtelovimab administered as a single intravenous injection over at least 30 seconds. placebo (normal saline/ total dose volume 62.5 mL) administered via IV infusion over at least 6.5 minutes.
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