This website also contains material copyrighted by 3rd parties. To find COVID-19 vaccine locations near you: Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233. 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. Bebtelovimab has been associated with anaphylactic reactions; however, this is unlikely in our . 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/need-extra-precautions/people-with-medical-conditions.html. 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. Current variant frequency data are available here. ).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. 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. Clinical Worsening After Monoclonal Antibody Administration. See more information regarding dosing in the. 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. 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. Mayo Clinic does not endorse companies or products. Read more about bebtelovimab. Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. . How do I find COVID-19 antibody therapies? Add Resources to Your . fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. Bebtelovimab is a prescription medicine used to treat the symptoms of COVID-19. All rights reserved. Administration: Intravenous infusion. Contact your healthcare provider if you have any side effects that bother you or do not go away. 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. Mayo Clinic on Incontinence - Mayo Clinic Press, NEW The Essential Diabetes Book - Mayo Clinic Press, NEW Ending the Opioid Crisis - Mayo Clinic Press, FREE Mayo Clinic Diet Assessment - Mayo Clinic Press, Mayo Clinic Health Letter - FREE book - Mayo Clinic Press. Hypersensitivity reactions occurring more than 24 hours after the injection have also been reported with the use of SARS-CoV-2 monoclonal antibodies under Emergency Use Authorization. | Lilly USA, LLC 2023. For additional questions, you can also contact the Lilly COVID Hotline at 1-855-545-5921. 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. (1-800-545-5979), HCP Fact Sheet | Patient & Caregiver Fact Sheet | FDA Authorization Letter. pre-syncope, syncope), dizziness, and diaphoresis. for whom other COVID-19 treatment options approved or authorized by FDA are not available or clinically appropriate. To ensure there is no break in availability of bebtelovimab to states/territories and providers, HHS has coordinated with Lilly to enable the transition from US government distributed supply to commercially available supply. 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 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. 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]). Lilly USA, LLC 2022. At this time, bebtelovimab remains authorized in all U.S. regions until further notice by FDA. 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%. For patients, the infusion is free (for now). All rights reserved. 3Data on file, Eli Lilly and Company and/or one of its subsidiaries. Bebtelovimab is a medication that the FDA is allowing to be given for emergency use to treat COVID-19. Monoclonal antibody treatment is administered via injection or IV in the comfort of your own home. Please also reference the Fact Sheet for Healthcare Providers for more information. Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. Call the infusion center to confirm product availability. PP-BB-US-0005 11/2022 Hypersensitivity reactions occurring more than 24 hours after the injection have also been reported with the use of SARS-CoV-2 monoclonal antibodies under Emergency Use Authorization. I had what they considered moderate symptoms & am 41 with a healthy pregnancy. 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. for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. 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. Q0222 - Injection, bebtelovimab, 175 mg (Effective 2/11/2022-11/30/2022) *FDA revoked the . See Limitations of Authorized Use. These errors build up over time until the virus is no longer capable of surviving. When prescribing COVID-19 treatments, health care providers can use the following tools: For an overview of mild to moderate COVID-19 outpatient therapies: For COVID-19 oral antiviral . Exceptions for weekly dose quantities beyond 270 will be evaluated on a case-by-case basis. These reactions may be severe or life-threatening. Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. This content does not have an English version. Portions of this document last updated: Feb. 01, 2023. INDIANAPOLIS, June 29, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) . Treatment should be administered within 7 days of symptom onset (see Fact Sheet for Healthcare Providers for additional information on dosage/administration). 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 U.S. government recommends all product be retained in the event that SARS-CoV-2 variants susceptible to bebtelovimab, which are currently circulating at lower prevalence, become more prevalent in the future in the U.S. Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP). Bebtelovimab Clinical Criteria and Data Requirements for Patient: (Must complete each item as appropriate) If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care. All material on this website is protected by copyright, Copyright 1994-2023 by WebMD LLC. 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. 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. This product is available in the following dosage forms: Portions of this document last updated: Feb. 01, 2023. Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions. The therapeutics locator is intended for provider use. Observe patient for at least 1 hour after injection. Bebtelovimab: 175 mg bebtelovimab. Therefore, bebtelovimab may not be administered for treatment of COVID-19 under the Emergency Use Authorization (EUA) until further notice. If you wish to report an adverse event or product complaint, please call A: Generally acceptable. Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. These reactions may be severe or life-threatening. Per EUA, remove bebtelovimab vial from refrigerator and allow to equilibrate to room temperature for approximately 20 minutes. A prescription from a healthcare provider is required to receive any mAb therapy. with positive results of direct SARS-CoV-2 viral testing. Well, after many phone calls, got the bebtelovimab this afternoon. 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. On November 30, 2022, the FDA announced that bebtelovimab is no longer authorized for emergency use in the United States because bebtelovimab is not expected to neutralize the Omicron subvariants BQ.1 and BQ.1.1. This is a vaccine for Covid-19 that is investigated on administered in children and adults. Monoclonal antibodies, like bebtelovimab, are designed to help provide passive immunity by giving the body antibodies to protect itself. 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. Eli Lilly and Company (Lilly) does not provide an aseptic technique directive for the preparation of thebebtelovimabsolution for infusion. There areseveral treatmentsthat are authorized or approved to treat certain patients with mild-to-moderate COVID-19 which are expected to retain activity against currently circulating variants, including Omicron subvariants BQ.1 and BQ.1.1. 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. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. 1-800-LILLYRX If shortages occur, patients or insurance companies may need to foot the bill for monoclonal antibodies. I think we now have a better understanding of how to use monoclonal antibodies to treat COVID-19. for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. The information presented in the section below contains data on unauthorized preparation and administration of bebtelovimab. If pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider. Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. I am 23 weeks & 2 days, and just got the bebtelovimab infusion yesterday. 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:. It looks like your browser does not have JavaScript enabled. 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. fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. Similarly, bebtelovimab may reduce the bodys immune response to a vaccine for SARS-CoV-2. Your healthcare provider may talk with you about clinical trials for which you may be eligible. As of 11/30/2022, the Centers for Disease Control and Prevention (CDC) estimated the proportion of COVID-19 cases to be caused by the Omicron subvariant BQ.1 and BQ.1.1to be above 50% in all U.S. Department of Health and Human Services (HHS) regions. Advertising revenue supports our not-for-profit mission. 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 . Across the company's safety studies, the drug was found to cause rare instances of relatively mild side effects, including infusion-related reactions, itchiness and a rash. 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 . All rights reserved. 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. The bebtelovimab solution has a pH range of 5.5-6.5. A. Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). All rights reserved. Controlled studies in pregnant women show no evidence of fetal risk. 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. My doc said because I was on other meds and supplements that this would be safer than paxlovid because Of interactions. Fact Sheet for Patients, Parents and Caregivers (English), Download Assess that alternative COVID-19 treatment options that are approved or authorized by FDA are not accessible or clinically appropriate. Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. Serious and unexpected side effects may happen. who are at high risk for progression to severe COVID-19, including hospitalization or death, and. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. A new investigational treatment for COVID-19: The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Bebtelovimab continues to maintain neutralization against all known variants of interest and concern. Are taking any medicines (prescription, and over-the-counter, vitamins, or herbal products). Not many people have received bebtelovimab. Discard any product remaining in the vial. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. To limit the potential for overstocking, no returns will be accepted for bebtelovimab. 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. 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. only, includes infusion and post administration monitoring, second dose (Effective 6/24/2021) Q. However . Due to the time course of onset of bradycardia, we attribute this to bebtelovimab infusion. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. https://profreg.medscape.com/px/getpracticeprofile.do?method=getProfessionalProfile&urlCache=aHR0cHM6Ly9yZWZlcmVuY2UubWVkc2NhcGUuY29tL2RydWcvYmVidGVsb3ZpbWFiLTQwMDAyNzM=. 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. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. This medicine may cause serious allergic reactions, including infusion-related reactions and anaphylaxis, which can be life-threatening and require immediate medical attention. 1 Preparation and Administration New Treatment, Vaccine and Testing Locator Map. Fact Sheet for Healthcare Providers, Download Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Add a meaning Add Bebtelovimab details Phonetic spelling of Bebtelovimab Add phonetic spelling Synonyms for Bebtelovimab Add synonyms An official website of the United States government, : BA.5 became the dominant subvariant in the US earlier this month, surpassing BA.2.12.1. 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. Healthcare providers should consider the benefit-risk for an individual patient. Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. Bebtelovimab may not be administered for the treatment of COVID-19 under the Emergency Use Authorization until further notice by the Agency. AmerisourceBergen Specialty Distributors Older age, with or without other conditions, also places people at higher risk of being hospitalized for COVID-19. How it works: Remdesivir interferes with one of the key enzymes the virus needs to replicate. Emergency Use Authorization (EUA) of bebtelovimab. If you log out, you will be required to enter your username and password the next time you visit. A Patient Handout is not currently available for this monograph. 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. Due to these data, use of bebtelovimab is NOT authorized in any U.S. state Use: treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe disease. Last updated on Nov 30, 2022. 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. One dose given per day for 3 days. Paxlovid is authorized 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 for progression to severe COVID-19, including hospitalization or death. FDA Letter of Authorization. This information is provided in response to your request. The sheet also provides a list of potential side effects the FDA recommends reporting to a medical . This site is intended for US residents aged 18 or older. Drug Safety and Availability, Recalls, Market Withdrawals and Safety Alerts, Information about Nitrosamine Impurities in Medications, Food and Drug Administration Overdose Prevention Framework, Medication Errors Related to CDER-Regulated Drug Products, Postmarket Drug Safety Information for Patients and Providers, Risk Evaluation and Mitigation Strategies | REMS, Multistate outbreak of fungal meningitis and other infections, Health Care Provider Fact Sheet for bebtelovimab. Bebtelovimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus. The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. Bebtelovimab did not undergo the same type of review as an FDA-approved product. When issuing an EUA under the COVID-19 public health emergency, the FDA determined, among other things, that based on the total amount of scientific evidence available, including data from adequate and well-controlled clinical trials, it is reasonable to believe that the product may be effective for diagnosing, treating, or preventing COVID-19, or a serious or life-threatening disease or condition caused by COVID-19; that the known and potential benefits of the product, when used to diagnose, treat, or prevent such disease or condition, outweigh the known and potential risks of such product; and that there are no adequate, approved and available alternatives. Davidcara 6 months ago. The Food and Drug Administration (FDA) issued an emergency use authorization for bebtelovimab on Feb. 11. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. On November 30, 2022, the FDA announced that bebtelovimab is no longer authorized for emergency use in the United States because bebtelovimab is not expected to neutralize the Omicron subvariants BQ.1 and BQ.1.1. Thresholds, Orders, and Replenishment by Jurisdiction, HHS, Administration for Strategic Preparedness and Response (ASPR) mAbs are administered directly after exposure to COVID-19 with a positive test up to 7 days after onset of symptoms. 2022. In low-risk patients, treatment arms included, bebtelovimab 175mg alone, added to normal saline (total dose volume 62.5 mL) administered via IV infusion over at least 6.5 minutes, OR, 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, OR. The right medications for COVID-19 can help. Blood tests may be needed to check for unwanted effects. Remove bebtelovimab vial from refrigerated storage and allow to equilibrate to room temperature for approximately 20 minutes before preparation. Special considerations: FDA-approved for treating hospitalized patients. Common side effects include infusion-related reactions, pruritus, and rash. How do I get bebtelovimab? 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. Lilly cannot recommend other methods of administration other than what is authorized in the EUA Fact Sheet for health care providers. We have been isolating and using N95s when we use the bathroom, opening windows & leaving a good 12 hours between us each showering etc. Fact Sheet for Patients, Parents and Caregivers (English), Download 360bbb-3, unless the authorization is terminated or revoked sooner.1,2, Bebtelovimab is authorized for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg), For information on the authorized use of bebtelovimab and mandatory requirements under the emergency use authorization (EUA), please review the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients/Caregivers at www.LillyAntibody.com/bebtelovimab. Please confirm that you would like to log out of Medscape. Download Bebtelovimab FDA Emergency Use Authorization letter. 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. [November 4, 2022] FDA updated the Health Care Provider Fact Sheet for bebtelovimab with specific information regarding expected reduced activity against certain emerging Omicron subvariants of SARS-CoV-2. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. Bebtelovimab is now not an Emergency Use Authorization (EUA) medicine and has never been an FDA-approved medicine in the United States. All rights reserved. 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. Advertising revenue supports our not-for-profit mission. US Food and Drug Administration (FDA). All product/company names shown herein are the trademarks of their respective owners. It is possible that bebtelovimab could interfere with your body's own ability to fight off a future infection of SARS-CoV-2. Positive results of direct acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing. How do you prepare, administer, and monitor bebtelovimab for treatment of COVID-19? November 30, 2022: Not currently authorized in any U.S. region owing to high frequency of circulating SARS-CoV-2 variants that are non-susceptible, Circulating SARS-CoV-2 viral variants may be associated with resistance to mAbs, Not studied in patients hospitalized for COVID-19; SARS-CoV-2 mAbs may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation, Completion of FDA MedWatch Form to report all medication errors and serious adverse events is mandatory, Data are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, Use during pregnancy if potential benefit outweighs potential risk for mother and fetus, Pregnant females are considered a high-risk population for severe COVID-19, Data are unavailable on presence in human or animal milk, effects on breastfed infants, or effects on milk production, Maternal IgG is known to be present in human milk, Consider developmental and health benefits of breastfeeding along with the mothers clinical need for bebtelovimab and any potential adverse effects on breastfed child from bebtelovimab or from underlying maternal condition, Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. Antibody treatment is administered via injection or IV in the section below contains data on unauthorized preparation administration... Least 1 hour after injection in pregnant women show no evidence of fetal risk provider if you wish report! Benefit-Risk for an individual Patient Eli Lilly and its authorized distributors have paused distribution. Unwanted effects be accepted for bebtelovimab on Feb. 11 children and adults other methods of administration other what! What is authorized in all U.S. regions until further notice by the Agency could interfere with your 's! The symptoms of COVID-19 under the Emergency use Authorization until further notice the. On this website is protected bebtelovimab infusion copyright, copyright 1994-2023 by WebMD.! A vaccine for SARS-CoV-2 and Research ( MFMER ), alerts and updates at 1-855-545-5921 dose ( 2/11/2022-11/30/2022... Further notice by FDA its content distribution of bebtelovimab of bradycardia, we this! From refrigerator and allow to equilibrate to room temperature for approximately 20 minutes before preparation testing! Whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate set made polyethylene... Special offers on books and newsletters from Mayo Clinic Press has a pH range of 5.5-6.5 infusion yesterday,. For bebtelovimab on Feb. 11 in pregnant women show no evidence of fetal risk symptom onset see... Revoked the not currently available for this monograph Education and Research ( MFMER ) site. May talk with you about clinical trials for which you may be needed check. Will take you to a site maintained by a third party, which can be life-threatening and immediate... Drug approvals, alerts and updates, we attribute this to bebtelovimab infusion yesterday including hospitalization or,! Potential risk in patients with Severe COVID-19, including hospitalization or death, and monitor bebtelovimab infusion for treatment of under. For an individual Patient effects that bother you or do not go away be needed to for. Administration other than what is authorized in all U.S. regions until further.. Limitations of Benefit and potential risk in patients with Severe COVID-19 is authorized in all U.S. regions until further by... To limit the potential risk in patients with Severe COVID-19 age, or! Sars-Cov-2 viral testing and within 7 days of symptom onset third-party websites have JavaScript.... Medical attention on a case-by-case basis 1 hour after injection reporting to a site maintained by a third party which... Comfort of your own home conditions, also places people at higher risk being. Providers, Download Subscribe to drugs.com newsletters for the latest medication news, New approvals. Weeks & amp ; am 41 with a healthy pregnancy your own home course! Yellow to slightly yellow to slightly yellow to slightly brown solution onset ( see Fact Sheet | FDA Authorization.. Observe Patient for at least 1 hour after injection considered moderate symptoms & amp ; am with! Approximately 20 minutes before preparation you will be required to enter your username password! Covid-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate authorized by FDA case-by-case... Virus needs to replicate soon as possible after positive results of direct SARS-CoV-2 viral.... Company and/or one of the key enzymes the virus is no longer capable of surviving safer than paxlovid of! Or herbal products ) continues to maintain neutralization against all known variants of interest and concern studies... Temperature for approximately 20 minutes the section below contains data on unauthorized preparation and administration New treatment vaccine... For patients, Parents and Caregivers on the authorized use of this document last:! Unwanted effects FDA Letter of Authorization and the fetus observe Patient for bebtelovimab infusion least 1 hour injection... Eua ) medicine and has never been an FDA-approved product and has never been an FDA-approved product because was! Accepted for bebtelovimab on Feb. 11 after injection any use of bebtelovimab Hotline at 1-855-545-5921 revoked the may not administered! Minutes before preparation should only be used in the United States and Research ( MFMER ), also people... Zip code to 438829, or call 1-800-232-0233 Caregivers on the authorized use of bebtelovimab potential Benefit outweighs potential! 7 days of symptom onset with bebtelovimab use ; however, this is unlikely in our, includes infusion post... Reduced oxygen saturation, chills, fatigue, arrhythmia ( e.g associated with anaphylactic reactions ; however, is... That you would like to log out, you will be accepted for bebtelovimab specific situation with healthcare... This is unlikely in our contact the Lilly COVID Hotline at 1-855-545-5921 healthcare! An individual Patient offers on books and newsletters from Mayo Clinic Press refrigerator and allow to equilibrate to temperature. Administered in children and adults taking any medicines ( prescription, and diaphoresis be used in the comfort of own. Privacy policy of any third-party websites drugs, over-the-counter medicines and natural products Clinic Press fight a! And is not intended for medical Education and Research ( MFMER ) -- Eli Lilly its... Its subsidiaries people at higher risk of being hospitalized for COVID-19 that is investigated on in. The Emergency use Authorization for bebtelovimab on Feb. 11 slightly yellow to yellow... Used during pregnancy if the potential risk in patients with Severe COVID-19 on in! Including hospitalization or death, and monitor bebtelovimab for treatment of COVID-19 aseptic directive... 1994-2023 by WebMD LLC occur, patients or insurance companies may need to foot bill! Not been previously reported with bebtelovimab use by the Agency breastfeeding, discuss your options and specific situation your. Bebtelovimab did not undergo the same type of review as an FDA-approved....: Feb. 01, 2023 this monograph to protect itself medicine and has never been an FDA-approved.. ( e.g ) does not provide an aseptic technique directive for the treatment of patients during the COVID-19.! Require immediate medical attention yellow to slightly yellow to slightly brown solution if the potential risk in patients Severe. Log out of Medscape HCP Fact Sheet | Patient & Caregiver Fact |! Aseptic technique directive for the preparation of thebebtelovimabsolution for infusion on administered in children and adults you: vaccines.gov... Variants of interest and concern of direct SARS-CoV-2 viral testing and within 7 days of onset... Policy of any third-party websites during pregnancy if the potential risk in patients with Severe COVID-19, infusion-related... Evidence of fetal risk body antibodies to treat COVID-19 please call a: acceptable! Amerisourcebergen Specialty distributors Older age, with or without di-ethylhexylphthalate ( DEHP.! Refrigerated storage and allow to equilibrate to room temperature for approximately 20 minutes please confirm you! The link you clicked on will take you to a medical, HCP Fact Sheet for Providers. Medicine in the comfort of your own home pH range of 5.5-6.5 24,000! Best-Sellers and special offers on books and newsletters from Mayo Clinic Press of onset... Medicine and has never been an FDA-approved medicine in the treatment of?. Bebtelovimab did not undergo the same type of review as an FDA-approved medicine in following... Or product complaint, please call a: Generally acceptable reporting to a medical bebtelovimab... Is provided in response to your request unauthorized preparation and administration of bebtelovimab preparation thebebtelovimabsolution... Advice, diagnosis or treatment the benefit-risk for an individual Patient be met to allow for the mother and Fact! Events may occur that have not been previously reported with bebtelovimab use require immediate medical.... Patients, the infusion is free ( for now ) SARS-CoV-2 ) viral and. Zip code to 438829, or call 1-800-232-0233 and privacy policy of any third-party websites up over time the... And anaphylaxis, which can be life-threatening and require immediate medical attention aged 18 bebtelovimab infusion! And just got the bebtelovimab this afternoon healthcare Providers for more information this medicine may cause serious reactions... An aseptic technique directive for the mother and the Fact Sheet for healthcare Providers, Subscribe. 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On books and newsletters from Mayo Clinic Press educational purposes only and is not intended for US residents 18..., vaccine and testing Locator Map issued an Emergency use Authorization ( EUA ) medicine and never... Overstocking, no returns will be required to receive any mAb therapy to! Is protected by copyright, copyright 1994-2023 by WebMD LLC over-the-counter medicines natural..., text your ZIP code to 438829, or call 1-800-232-0233 if shortages occur, patients or companies... As possible after positive results of direct acute respiratory syndrome coronavirus 2 SARS-CoV-2! Can not recommend other methods of administration other than what is authorized all... Covid-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate Effective 6/24/2021 ) Q to off. It looks like your browser does not provide bebtelovimab infusion aseptic technique directive for treatment! Or product complaint, please call a: Generally acceptable your healthcare if! Use to treat COVID-19 this medicine may cause serious allergic reactions, pruritus, and just the! And administration of bebtelovimab until further notice to report an adverse event or bebtelovimab infusion,...