US Food and Drug Administration (FDA). Patients should be clinically monitored during treatment and observed for 60 minutes after infusion is complete. Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. Fact Sheet for Healthcare Providers, Download (4) Paxlovid is given twice daily for 5 days, starting as soon as possible . If neither antiviral is an option, the agency recommends treatment with the antibody bebtelovimab. 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. Administer the entire contents of the syringe via intravenous (IV) injection over at least 30. There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. This site is intended for US healthcare providers only. How do you prepare, administer, and monitor bebtelovimab for treatment of COVID-19? 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. Identify an infusion center near your patient. 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. Fact Sheet for Patients, Parents and Caregivers (Spanish), 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. Infusion-related reactions Due to these data, use of bebtelovimab is NOT authorized in any U.S. state Shelf-life extensions were issued for specific lots of bebtelovimab. All rights reserved. Please also reference the Fact Sheet for Healthcare Providers for more information. ).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. How do I get bebtelovimab? Vaccines provide active immunity by helping the body make its own antibodies to protect itself. All rights reserved. Bebtelovimab injection is used to treat COVID-19 infection in certain non-hospitalized adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) and who have mild to moderate COVID-19 symptoms. It is used by people 12 years of age and older who have recently tested positive for. The primary endpoint was the proportion of participants who had a persistently high viral load by Day 7. FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region. Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP). PP-BB-US-0005 11/2022 A: Generally acceptable. The treatment showed efficacy against early strains of Omicron, but it proved to be ineffective against Omicron sublineages BQ.1 and BQ.1.1. The .gov means its official.Federal government websites often end in .gov or .mil. Clinicians caring for COVID-19 patients should be aware of the availability of these important life-saving medications and consider use when clinically indicated. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. 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. This medicine is to be given only by or under the immediate supervision of your doctor. Bebtelovimab is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bebtelovimab under section 564(b)(1) of the Act, 21 U.S.C. 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%). with positive results of direct SARS-CoV-2 viral testing. 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. Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions. 3Data on file, Eli Lilly and Company and/or one of its subsidiaries. To limit the potential for overstocking, no returns will be accepted for bebtelovimab. PP-BB-US-0005 11/2022 If you wish to report an adverse event or product complaint, please call In high-risk patients, treatment arms included, bebtelovimab 175mg alone administered via IV push over at least 30 seconds, OR. 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. 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. high-risk adults and pediatric patients (12 years of age and older weighing at least 40 kg) who all received open-label active treatments. 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. 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. This site is intended for US Healthcare Professionals only. Monoclonal antibody therapy is an effective treatment and has proven to: 70%-85% If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care. Monoclonal antibodies, like bebtelovimab, are designed to help provide passive immunity by giving the body antibodies to protect itself. They can now be given through subcutaneous or intramuscular injections rather than as an infusion at a hospital. 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. They have a positive COVID-19 test result; They're at high-risk for progression to severe COVID-19; Alternative COVID-19 treatment options approved or authorized by the FDA aren't accessible or . Download The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The sheet also provides a list of potential side effects the FDA recommends reporting to a medical . There are limited clinical data available for bebtelovimab. Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. Medically reviewed by Melisa Puckey, BPharm. 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 ). To find COVID-19 vaccine locations near you: Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233. Bebtelovimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus. Bebtelovimab belongs to a class of drugs called COVID-19, Monoclonal Antibodies. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. This website also contains material copyrighted by 3rd parties. Bebtelovimab is now not an Emergency Use Authorization (EUA) medicine and has never been an FDA-approved medicine in the United States. Side effects: There is limited information known about the safety and effectiveness of bebtelovimab for the treatment of mild-to-moderate COVID-19, according to the FDA fact sheet. Bebtelovimab is a medication that the FDA is allowing to be given for emergency use to treat COVID-19. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. This content does not have an English version. 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. FDA Letter of Authorization. It is your choice for you or your child to be treated or not to be treated with bebtelovimab. for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. Withdraw 2 mL from the vial into the disposable syringe. Discard the vial if the solution is cloudy, discolored, or . Avoid forming air bubbles. The EUA has since been revoked on November 30, 2022. Monoclonal antibody treatment is administered via injection or IV in the comfort of your own home. 12 CLINICAL PHARMACOLOGY Infusion reactions have happened during and within 24 hours after the infusion. Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice. 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). 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%. 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 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%). 2022. 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