Authors Christina Gearges 1 , Hibah Haider 1 , Vishal Rana 1 , Zahra Asghar 1 , Anjali Kewalramani 1 , Zachary Kuschner 1 2 Bebtelovimab is a recombinant neutralizing human IgG1 monoclonal antibody (mAb) to the spike protein of SARS-CoV-2 and is unmodified in the Fc region. For additional questions, you can also contact the Lilly COVID Hotline at 1-855-545-5921. Serious and unexpected side effects may happen. Bebtelovimab is a medication that the FDA is allowing to be given for emergency use to treat COVID-19. Bebtelovimab During Pregnancy and Breastfeeding. This medicine may cause serious allergic reactions, including infusion-related reactions and anaphylaxis, which can be life-threatening and require immediate medical attention. 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner. 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. Portions of this document last updated: Feb. 01, 2023. Administer the entire contents of the syringe via intravenous (IV) injection over at least 30. 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 can I get monoclonal antibody therapy (antibody infusion)? 1 bebtelovimab vial (175 mg/2 mL) 1 disposable polypropylene dosing syringe capable of holding 2 mL 0.9% Sodium Chloride injection for flushing. 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. Identify an infusion center near your patient. Fact Sheet for Patients, Parents and The therapeutics locator is intended for provider use. It is not known if Bebtelovimab is safe and effective in children younger than 12 years of age who weigh over 88 pounds. 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. All rights reserved. One day after the United States announced a supply deal for Eli Lilly's new COVID-19 monoclonal antibody treatment, bebtelovimab, the FDA Lilly USA, LLC 2022. If pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider. Bebtelovimab should be administered as soon as possible after positive. If you wish to report an adverse event or product complaint, please call Fact Sheet for Healthcare Providers, Download 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. Bebtelovimab must be given within seven days of symptom onset. Variants, like Omicron, may have an impact on the effectiveness of mAb therapies. Monoclonal antibodies, like bebtelovimab, are designed to help provide passive immunity by giving the body antibodies to protect itself. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Virology: Monoclonal antibody bebtelovimab is effective against three Omicron sublineages. 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%. 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 . Per EUA, remove bebtelovimab vial from refrigerator and allow to equilibrate to room temperature for approximately 20 minutes. Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Crit Care Explor. It is possible that bebtelovimab could interfere with your body's own ability to fight off a future infection of SARS-CoV-2. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. 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. 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. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. Please confirm that you would like to log out of Medscape. Resources may contain information about doses, uses, formulations and populations different from product labeling. This product is available in the following dosage forms: Portions of this document last updated: Feb. 01, 2023. Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab and mandatory requirements of the EUA. Drug information provided by: IBM Micromedex. 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%). Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Infusion-related reactions All rights reserved. Lilly cannot recommend other methods of administration other than what is authorized in the EUA Fact Sheet for health care providers. All rights reserved. This site is intended for US residents aged 18 or older. with positive results of direct SARS-CoV-2 viral testing. This product is preservative-free and therefore, should be administered immediately. This site complies with the HONcode standard for trustworthy health information: verify here. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. These are not all the possible side effects. Bebtelovimab has been associated with anaphylactic reactions; however, this is unlikely in our . Clinical Worsening After Monoclonal Antibody Administration. PP-BB-US-0005 11/2022 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. Lilly USA, LLC 2022. 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. 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. 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. Copyright 2023 IBM Watson Health. . only, includes infusion and post administration monitoring, second dose (Effective 6/24/2021) Q. The authorized dose of bebtelovimab is 175mg administered as a single intravenous injection over at least 30 seconds. . Davidcara 6 months ago. 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. The following provides essential safety information on the unapproved use of bebtelovimab under the Emergency Use Authorization. Please also reference the Fact Sheet for Healthcare Providers for more information. 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. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. Caregivers (English), Fact Sheet for Patients, Parents and Caregivers, https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html. Discard any product remaining in the vial. Individuals 12 and older who are considered high risk of getting very sick from COVID-19, with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom other COVID-19 treatment options approved or authorized by FDA are not available or clinically appropriate and may qualify for a monoclonal antibody treatment. We have been isolating and using N95s when we use the bathroom, opening windows & leaving a good 12 hours between us each showering etc. Observe patient for at least 1 hour after injection. FDA Letter of Authorization. Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature. All rights reserved. You are being redirected to The treatment showed efficacy against early strains of Omicron, but it proved to be ineffective against Omicron sublineages BQ.1 and BQ.1.1. 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. MedWatch adverse event reports can be submitted to the FDA by calling 1-800-FDA-1088 or If you log out, you will be required to enter your username and password the next time you visit. Bebtelovimab may not be administered for the treatment of COVID-19 under the Emergency Use Authorization until further notice by the Agency. mAbs are administered directly after exposure to COVID-19 with a positive test up to 7 days after onset of symptoms. (4) Paxlovid is given twice daily for 5 days, starting as soon as possible . AmerisourceBergen will sell bebtelovimab to licensed and approved customers such as hospitals, infusion centers, long-term care facilities, clinics, etc. These are not all the risk factors. 200 Independence Ave., Washington, DC 20201. In a statement the FDA said that it was "carefully monitoring circulating viral variants and their sensitivity to authorised monoclonal antibodies . 1 disposable polypropylene dosing syringe capable of holding 2 mL. 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. This site complies with the HONcode standard for trustworthy health information: verify here. The emergency use of bebtelovimab is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. . Bebtelovimab is no longer authorized by the FDA for use in the United States, effective immediately. Bebtelovimab should be prepared by a qualified healthcare professional using aseptic technique. After the entire contents of the syringe have been administered. Download more serious infusion related hypersensitivity reactions. 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. 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. 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. One dose given per day for 3 days. The procedure followed for aseptic technique may vary between institutions. Are taking any medicines (prescription, and over-the-counter, vitamins, or herbal products). This information is provided in response to your request. Important Note for Medical Providers: As of November 25, 2022, the BCCFH COVID Task Force no longer uses monoclonal antibody therapy (bebtelovimab) to treat COVID infections. You can get COVID19 through contact with another person who has the virus. Bebtelovimab No Longer Authorized as of 11/30/22. 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. Monoclonal antibody treatment is administered via injection or IV in the comfort of your own home. See more information regarding dosing in the. This content does not have an Arabic version. FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region. For patients, the infusion is free (for now). 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. [2] Effective with date of service Feb. 15, 2022, the Medicaid and NC Health Choice programs cover bebtelovimab injection for intravenous use in the Physician Administered Drug Program (PADP) when billed with HCPCS code Q0222 - Injection, bebtelovimab, 175 mg. Strength/Package Size (s): Injection: 175 mg/2 mL (87.5 mg/mL) in a single-dose vial Has been diagnosed with mild to moderate COVID-19 with positive results of direct SARS-CoV-2 viral testing. Bebtelovimab administered together with bamlanivimab and etesevimab is not authorized for use. for whom other COVID-19 treatment options approved or authorized by FDA are not available or clinically appropriate. 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. 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 should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus. Withdraw 2 mL of bebtelovimab (1 vial) into disposable syringe. Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. You will be observed by your healthcare provider for at least 1 hour after you receive bebtelovimab. See Limitations of Authorized Use. Lilly USA, LLC 2022. We encourage you to read the privacy policy of every website you visit.Click "Continue" to proceed or "Return" to return to LillyMedical.com. The U.S. government has spent $720 million for hundreds of thousands of doses of bebtelovimab that are being distributed around the country. Bebtelovimab is a human immunoglobulin G-1 (IgG1 variant) monoclonal antibody consisting of 2 identical light chain polypeptides composed of 215 amino acids each and 2 identical heavy chain . Withdraw 2 mL from the vial into the disposable syringe. 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. fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. Clinicians caring for COVID-19 patients should be aware of the availability of these important life-saving medications and consider use when clinically indicated. Thresholds, Orders, and Replenishment by Jurisdiction, HHS, Administration for Strategic Preparedness and Response (ASPR) INDIANAPOLIS, June 29, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) . 2022 Aug 19;4 (8):e0747. BA.5 is one of many Covid-19 Omicron subvariants to emerge since last winter. 1-800-LILLYRX The site is secure. Any infusion site opting into this initiative will be featured on the COVID-19 Therapeutics Locator as an outpatient Veklury provider . Thebebtelovimabinjectionshould be prepared by a qualified healthcare professional using aseptic technique to prevent contamination from pathogens.3, Bebtelovimabis neither hazardous nor toxic when spilled.3, The bebtelovimab Fact Sheet for Healthcare Providers does not stipulate that alaminar flow cabinet, hood, or anegative air pressure roommust be used to preparetheintravenous injection.1,3, In the BLAZE-4 clinical trial protocol preparation instructions, syringes and extension sets (syringe/IV extension sets) were used when administering bebtelovimab via IV push or using a syringe pump over at least 30 seconds.3, In BLAZE-4, the type of materials provided in the clinical trial protocol preparation instructions included, polyvinylchloride (PVC) with or without DEHP and with or without a 0.20/0.22 m polyether sulfone (PES) filter, polyethylene with or without a 0.20/0.22 m PES filter.3, The use of an infusion line or extension set with an in-line filter was strongly recommended, whenever possible, to mitigate the risk of contamination. Current variant frequency data are available here. Monoclonal antibody therapy is an effective treatment and has proven to: 70%-85% All material on this website is protected by copyright, Copyright 1994-2023 by WebMD LLC. Exceptions for weekly dose quantities beyond 270 will be evaluated on a case-by-case basis. Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of other SARS-CoV-2 monoclonal antibodies and could occur with administration of bebtelovimab. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. Fact Sheet for Patients, Parents and Caregivers (English), Download Federal regulators on February 11 authorized a new monoclonal antibody treatment for mild-to-moderate COVID-19. Bebtelovimab should be administered via IV injection over at least 30 seconds. Generic name: bebtelovimab An official website of the United States government, : The .gov means its official.Federal government websites often end in .gov or .mil. . I am 23 weeks & 2 days, and just got the bebtelovimab infusion yesterday. 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. There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Bebtelovimab (EUA issued February 11, 2022, latest update October 27, 2022).