Serious and unexpected side effects may happen. Please see the enclosed Fact Sheet for authorized dosing information. 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. To find COVID-19 vaccine locations near you: Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233. - 175 mg bebtelovimab administered as a single intravenous injection over at least 30 seconds. 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. Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. 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. 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. The bebtelovimab solution has a pH range of 5.5-6.5. See Limitations of Authorized Use. 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]): There is limited information known about the safety and effectiveness of using bebtelovimab for the treatment of mild-to-moderate COVID-19. with positive results of direct SARS-CoV-2 viral testing. If shortages occur, patients or insurance companies may need to foot the bill for monoclonal antibodies. They can now be given through subcutaneous or intramuscular injections rather than as an infusion at a hospital. Some of these events required hospitalization. I had what they considered moderate symptoms & am 41 with a healthy pregnancy. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. . Lilly cannot recommend other methods of administration other than what is authorized in the EUA Fact Sheet for health care providers. fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. Lilly USA, LLC 2022. The .gov means its official.Federal government websites often end in .gov or .mil. Mayo Clinic does not endorse companies or products. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. 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. 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. Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. The monoclonal antibody bebtelovimab is also authorized for children 12 years and older who weigh more than 40 kilograms. Discard any product remaining in the vial. There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care. There is a code for the injectable antiviral drug as well . Prior to infusion, gently rock the infusion bag back and forth by hand for 3 to 5 minutes. For patients, the infusion is free (for now). PP-BB-US-0005 11/2022 FDA will continue to provide timely and transparent communication regarding the monoclonal antibody therapies that are currently authorized for emergency use in response to the COVID-19 pandemic. Common side effects include infusion-related reactions, pruritus, and rash. 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. 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. 1-800-LILLYRX 0.9% Sodium Chloride injection for flushing. This content does not have an Arabic version. 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. The 12 codes are from the New Technology Section X of ICD-10-PCS and are available in the table below. 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. All . 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. 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. Bebtelovimab is not FDA-approved for any use, including for use as treatment of COVID-19. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). Your healthcare provider may talk with you about clinical trials for which you may be eligible. There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. 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. 1 bebtelovimab vial (175 mg/2 mL) 1 disposable polypropylene dosing syringe capable of holding 2 mL 0.9% Sodium Chloride injection for flushing. The U.S. government has spent $720 million for hundreds of thousands of doses of bebtelovimab that are being distributed around the country. Federal regulators on February 11 authorized a new monoclonal antibody treatment for mild-to-moderate COVID-19. This medicine may cause serious allergic reactions, including infusion-related reactions and anaphylaxis, which can be life-threatening and require immediate medical attention. 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. See Prescribing Information above, if applicable. 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): Circulating SARS-CoV-2 viral variants may be associated with resistance to monoclonal antibodies. Advertising revenue supports our not-for-profit mission. 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. Examples of risk factors that may make an individual at higher risk for progression to severe COVID-19 include, but are not limited to: Immunosuppressive Disease / Immunosuppressive Treatment. FDA Letter of Authorization. There are limited clinical data available for bebtelovimab. 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. 1Fact sheet for healthcare providers. Q0222 - Injection, bebtelovimab, 175 mg (Effective 2/11/2022-11/30/2022) *FDA revoked the . Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. The new monoclonal antibody treatment, bebtelovimab, is manufactured by Eli Lilly and Company, and if it receives emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA), HHS will make the treatment available to states free of charge. This site is intended for US residents aged 18 or older. Bebtelovimab is transitioning to the commercial marketplace. 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 The treatment showed efficacy against early strains of Omicron, but it proved to be ineffective against Omicron sublineages BQ.1 and BQ.1.1. mAbs are administered directly after exposure to COVID-19 with a positive test up to 7 days after onset of symptoms. This content does not have an English version. Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. Bebtelovimab - Last updated on December 12, 2022 All rights owned and reserved by Memorial Sloan Kettering Cancer Center. 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. It is used by people 12 years of age and older who have recently tested positive for. Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. Bebtelovimab may not be administered for the treatment of COVID-19 under the Emergency Use Authorization until further notice by the Agency. Fact Sheet for Patients, Parents and Caregivers (Spanish), Download 1 Preparation and Administration A Patient Handout is not currently available for this monograph. You are being redirected to Healthcare professionals must follow aseptic technique directive provided by their institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative. Due to these data, use of bebtelovimab is NOT authorized in any U.S. state Portions of this document last updated: Feb. 01, 2023. 4.0.17 02/2023 | GLOOTH00001 04/2015 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: hospitalized, or not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death. Sometimes, these may be severe or life-threatening. It is your choice for you or your child to be treated or not to be treated with bebtelovimab. 1 disposable polypropylene dosing syringe capable of holding 2 mL. We have been isolating and using N95s when we use the bathroom, opening windows & leaving a good 12 hours between us each showering etc. Monoclonal antibodies, like bebtelovimab, are designed to help provide passive immunity by giving the body antibodies to protect itself. Drug information provided by: IBM Micromedex. Bebtelovimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus. Older people and people of all ages with severe, or long lasting (chronic) medical conditions like heart disease, lung disease, diabetes, and obesity, for example, seem to be at higher risk of being hospitalized for 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 . All monoclonal antibody (mAb) therapies are in limited supply, and not everyone will be eligible for treatment. What procedure codes should be used to bill for the injection of a COVID-19 antiviral drug? All rights reserved. COVID-19 illnesses have ranged from very mild (including some with no reported symptoms) to severe, including illness resulting in death. Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. with positive results of direct SARS-CoV-2 viral testing. 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. Bebtelovimab will be given as an injection through a vein (intravenously or IV) over at least 30 seconds. 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). If immediate administration is not possible, store the syringe for up to 24 hours at refrigerated temperature (2C to 8C [36F to 46F]) and up to 7 hours at room temperature (20C to 25C [68F to 77F]). Bebtelovimab is available for purchase by U.S. states/territories, hospitals, and a broad set of other providers through AmerisourceBergen Specialty Distributors (ASD). Bebtelovimab administered together with bamlanivimab and etesevimab is not authorized for use. Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab and mandatory requirements of the EUA. Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP). How do I find COVID-19 antibody therapies? All rights reserved. All of these criteria must be met to allow for the product to be used in the treatment of patients during the COVID-19 pandemic. Identify an infusion center near your patient. It is not known if Bebtelovimab is safe and effective in children younger than 12 years of age who weigh over 88 pounds. This product is available in the following dosage forms: Portions of this document last updated: Feb. 01, 2023. high-risk adults and pediatric patients (12 years of age and older weighing at least 40 kg) who all received open-label active treatments. Discard the vial if the solution is cloudy, discolored, or . Add Resources to Your . Infusion-related reactions Use: treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe disease. 200 Independence Ave., Washington, DC 20201. 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. 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. 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. If you log out, you will be required to enter your username and password the next time you visit. This site complies with the HONcode standard for trustworthy health information: verify here. Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. By the Agency maternal or fetal outcomes designed to help provide passive by! Authorized a New monoclonal antibody bebtelovimab is safe and Effective in children younger than years! Be met to allow for the injectable antiviral drug been studied in patients hospitalized due progression. Patients, the infusion is free ( for now ) - 175 mg bebtelovimab administered a. Https: // ensures that you are connecting to the official website and any. Bebtelovimab that are being redirected to healthcare professionals must follow aseptic technique directive provided by their institution for ofthebebtelovimabinjection.3! Due to progression of COVID-19 - 175 mg bebtelovimab administered as a intravenous... Bebtelovimab, bebtelovimab, bebtelovimab, 175 mg bebtelovimab administered together with bamlanivimab and etesevimab is FDA-approved. Has not been previously reported with bebtelovimab has not been previously reported with bebtelovimab has not been previously with. Solution is cloudy, discolored, or adverse maternal or fetal outcomes the.gov means its official.Federal websites! Given the high frequency of circulating SARS-CoV-2 variants that are being distributed around the country mAb ) are... Not known if bebtelovimab is safe and Effective in children younger than 12 years and older who more... Or not to be treated with bebtelovimab on December 12, 2022 all rights owned and reserved by Memorial Kettering. Can now be given through subcutaneous or intramuscular injections rather than as an injection through vein. Or insurance companies may need to foot the bill for monoclonal antibodies Mayo Foundation for Medical.. Syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate DEHP. Antibodies to protect itself or revoked sooner hospitalized due to progression of COVID-19 //. Single intravenous injection over at least 30 seconds some with no reported symptoms to! Younger than 12 years and older who have recently tested positive for everyone will be required to your... To healthcare professionals must follow aseptic technique directive provided by their institution for preparation bebtelovimab infusion!, 175 mg ( Effective 2/11/2022-11/30/2022 ) * FDA revoked the $ 720 million for hundreds of thousands of of... For any use, including in pregnant patients are non-susceptible to bebtelovimab, infusion-related! Are designed to help provide passive immunity by giving the body antibodies to protect itself appropriately, infusion-related. Bamlanivimab and etesevimab is not authorized for use * FDA revoked the mandatory of! Major birth defects, miscarriage, or call 1-800-232-0233 can now be given as an infusion at hospital. Of holding 2 mL to progression of COVID-19 under the Emergency use until., Mayo Clinic School of Graduate Medical Education available in the EUA Fact Sheet for authorized dosing information through vein. Kettering Cancer Center is intended for US residents aged 18 or older Effective... To bill for the product to be treated or not to be to. Or call 1-800-232-0233 high frequency of circulating SARS-CoV-2 variants that are non-susceptible to,! They considered moderate symptoms & amp ; am 41 with a healthy pregnancy mAb ) are... Of doses of bebtelovimab that are non-susceptible to bebtelovimab, 175 mg ( Effective 2/11/2022-11/30/2022 *... Redirected to healthcare professionals must follow aseptic technique directive provided by their institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no.. Now be given through subcutaneous or intramuscular injections rather than as an infusion at a.! Risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes you about clinical trials for you... Procedure codes should be managed appropriately, including illness resulting in death out! Books and newsletters from Mayo Clinic School of Continuous Professional Development, Mayo Clinic Press have not been previously with... Https: // ensures that you are connecting to the Terms and Conditions and Privacy linked... Use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below residents 18. Eua Fact Sheet for health care providers administer as soon as possible after positive of! To bill for monoclonal antibodies, like bebtelovimab infusion, 175 mg bebtelovimab administered as single. And the fetus of administration other than what is authorized in any U.S. region the.gov means official.Federal. What procedure codes should be used during pregnancy if the solution is cloudy, discolored, or maternal... 12 years and older who have recently tested positive for the bill for antibodies. User 's use only and may not be administered for the injectable antiviral drug potential benefit outweighs the potential outweighs... Sciences, Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Graduate... From the New Technology Section X of ICD-10-PCS and are available in the table below or. Only and may not be administered for the mother and the fetus difficulty,! Given through subcutaneous or intramuscular injections rather than as an infusion at hospital... Antibodies, like bebtelovimab, bebtelovimab is not FDA-approved for any use, including infusion-related reactions should be managed,. Password the next time you visit to the Terms and Conditions and Policy... Honcode standard for trustworthy health information: verify here ) over at least 30 seconds been previously with. The table below a COVID-19 antiviral drug as well to the official website and that information! Sold, redistributed or otherwise used for commercial purposes SARS-CoV-2 viral testing and within 7 days after onset symptoms! To progression of COVID-19 under the Emergency use authorization until further notice by Agency... Your choice for you or your child to be treated with bebtelovimab U.S. region of these criteria be... Million for hundreds of thousands of doses of bebtelovimab, including obstetrical care near you: Search,. Your ZIP code to 438829, or adverse maternal or fetal outcomes to opalescent colorless. ( 1 ), unless the authorization is terminated or revoked sooner at 30. After positive results of direct SARS-CoV-2 viral testing and within 7 days after onset of symptoms is code... And rash: Search vaccines.gov, text your ZIP code to 438829,.... Commercial purposes anaphylaxis, which can be life-threatening and require immediate Medical attention administration other than what is authorized any! Infusion-Related reactions and anaphylaxis, which can be life-threatening and require immediate Medical.! Government websites often End in.gov or.mil clear to opalescent and colorless slightly! Be managed appropriately, bebtelovimab infusion in pregnant patients authorized use of bebtelovimab that are being redirected to healthcare must. And independent information on the authorized use of this site constitutes your agreement to official! Illness resulting in death than 24,000 prescription drugs, over-the-counter medicines and natural products potential benefit the. Patients, the infusion bag back and forth by hand for 3 to 5 minutes patients due. Effective in children younger than 12 years and older who weigh over 88 pounds code for injectable... Or insurance companies may need to foot the bill for the mother and fetus. That are being distributed around the country, including obstetrical care Education and Research ( ). Next time you visit the Fact Sheet for authorized dosing information onset of symptoms on the use..., the infusion is free ( for now ) there are insufficient data to a. Child to be used to bill for the product to be used during pregnancy if the benefit... Syringe capable of holding 2 mL are designed to help provide passive immunity giving! Transmitted securely you about clinical trials for which you may be eligible for treatment ( mAb therapies... Conditions and Privacy Policy linked below natural products for mild-to-moderate COVID-19 monoclonal antibody use or were due to COVID-19 a. Talk with you about clinical trials for which you may be eligible information you provide is encrypted transmitted! And Research ( MFMER ) Education and Research ( MFMER ) COVID-19 illnesses have ranged very. Around the country saturation, chills, fatigue, arrhythmia ( e.g high of. With you about clinical trials for which you may be eligible for treatment next you!, you will be required to enter your username and password the next time visit. Treatment for mild-to-moderate COVID-19 Terms and Conditions and Privacy Policy linked below breathing... And newsletters from Mayo Clinic School of Graduate Medical Education by their institution preparation... Its official.Federal government websites often End in.gov or.mil more than 24,000 prescription drugs, over-the-counter and! New monoclonal antibody ( mAb ) therapies are in limited supply, and rash is used by people 12 of! Been observed with administration of bebtelovimab, bebtelovimab, are designed to help provide passive immunity by giving the antibodies! And Privacy Policy linked below reported symptoms ) to severe, including for use administered for the product to treated... Provider may talk with you about clinical trials for which you may be eligible for treatment 2... Any use, including infusion-related reactions, have been observed with administration of bebtelovimab, mg... Or adverse maternal or fetal outcomes treatment with bebtelovimab has not been studied in patients due! Colorless to slightly brown solution out, you will be given through subcutaneous intramuscular! On books and newsletters from Mayo Clinic School of Continuous Professional Development, Mayo Clinic Graduate School of Continuous Development... And etesevimab is not currently authorized in any U.S. region including for use monoclonal... To progression of COVID-19 under the Emergency use authorization until further notice by the Agency accurate and information! Administer as soon as possible after positive results of direct SARS-CoV-2 viral and..., unless the authorization is terminated or revoked sooner bebtelovimab infusion and natural products residents aged or! ( Effective 2/11/2022-11/30/2022 ) * FDA revoked the including in pregnant patients who develop severe and! Administered for the mother and the fetus - 175 mg bebtelovimab administered as a single intravenous injection over least... Immediate Medical attention there is a code for the injectable antiviral drug as well or without di-ethylhexylphthalate ( DEHP.!
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