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. Bebtelovimab must be given within seven days of symptom onset. 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%). Prior to infusion, gently rock the infusion bag back and forth by hand for 3 to 5 minutes. Administration: Intravenous infusion. The therapeutics locator is intended for provider use. Molnupiravir tricks these enzymes into entering errors in the virus's genetic code. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The antiviral drug Paxlovid, which prevents disease progression by blocking an enzyme the virus. Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. 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. These reactions may be severe or life-threatening. Descriptions 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. All material on this website is protected by copyright, Copyright 1994-2023 by WebMD LLC. An official website of the United States government, : 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. How do you prepare, administer, and monitor bebtelovimab for treatment of COVID-19? who are at high risk for progression to severe COVID-19, including hospitalization or death. Lilly USA, LLC 2022. 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%. 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. These therapies require a prescription by a licensed and authorized provider. See Limitations of Authorized Use. Oral Paxlovid (ritonavir-boosted nirmatrelvir) In a clinical trial, Paxlovid reduced the risk of hospitalization and death by 89% in unvaccinated outpatients with COVID-19 at higher risk of severe disease. 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. 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. Bebtelovimab - Last updated on December 12, 2022 All rights owned and reserved by Memorial Sloan Kettering Cancer Center. Bebtelovimab 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. Bebtelovimab is no longer authorized by the FDA for use in the United States, effective immediately. doi: 10.1097/CCE.0000000000000747. Copyright 2023 IBM Watson Health. Bebtelovimab During Pregnancy and Breastfeeding. 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. The new infusion provides an . Bebtelovimab did not undergo the same type of review as an FDA-approved product. COVID-19 illnesses have ranged from very mild (including some with no reported symptoms) to severe, including illness resulting in death. 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. 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. Healthcare professionals must follow aseptic technique directive provided by their institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative. 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%). 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 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. Health care providers should use otherapproved or authorized productsthat are expected to retain activity against BQ.1 and BQ.1.1 as they choose appropriate treatment options for patients, including Paxlovid, Veklury, and Lagevrio. Well, after many phone calls, got the bebtelovimab this afternoon. 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. Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. 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. Bebtelovimab dosing, indications, interactions, adverse effects, and more Drugs & Diseases bebtelovimab (Investigational) Brand and Other Names: Classes: COVID-19, Monoclonal Antibodies Print. Important points to this press release: "Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions. This product is preservative-free and therefore, should be administered immediately. BA.5 is one of many Covid-19 Omicron subvariants to emerge since last winter. Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions. 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 ). How do I find COVID-19 antibody therapies? Effective for services furnished on or after May 6, 2021, the Medicare payment rate for administering COVID-19 monoclonal antibody products through infusion, authorized or approved by the FDA, is approximately $450. 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. Remove bebtelovimab vial from refrigerated storage and allow to equilibrate to room temperature for approximately 20 minutes before preparation. Inspect bebtelovimab vial visually for particulate matter and discoloration. Bebtelovimab is not FDA-approved for any use, including for use as treatment of COVID-19. 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. It is not known if Bebtelovimab is safe and effective in children younger than 12 years of age who weigh over 88 pounds. Health care providers should assess whether these treatments are right for their patient in the event the patient develops mild-to-moderate COVID-19. 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. Information about circulating variants can be found through Nowcast data. eCollection 2022 Aug. Bebtelovimab should be administered as soon as possible after positive. Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of other SARS-CoV-2 monoclonal antibodies and could occur with administration of bebtelovimab. 1 bebtelovimab vial (175 mg/2 mL) 1 disposable polypropylene dosing syringe capable of holding 2 mL 0.9% Sodium Chloride injection for flushing. 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. 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. Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. If you log out, you will be required to enter your username and password the next time you visit. Last updated on Nov 30, 2022. Available for Android and iOS devices. The procedure followed for aseptic technique may vary between institutions. One day after the United States announced a supply deal for Eli Lilly's new COVID-19 monoclonal antibody treatment, bebtelovimab, the FDA Therefore, bebtelovimab may not be administered for treatment of COVID-19 under the Emergency Use Authorization (EUA) until further notice. Drug class: Miscellaneous antivirals. 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. placebo (normal saline/ total dose volume 62.5 mL) administered via IV infusion over at least 6.5 minutes. PP-BB-US-0005 11/2022 Bebtelovimab continues to maintain neutralization against all known variants of interest and concern. 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. Details About the 2020 Codes Lilly USA, LLC 2022. All rights reserved. Some of these events required hospitalization. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to 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 monoclonal antibodies and may occur with use of bebtelovimab alone. . 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 . Resources may contain information about doses, uses, formulations and populations different from product labeling. 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 should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus. You are being redirected to Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of other SARS-CoV-2 monoclonal antibodies and could occur with administration of bebtelovimab. AmerisourceBergen will sell bebtelovimab to licensed and approved customers such as hospitals, infusion centers, long-term care facilities, clinics, etc. If you have any questions regarding the procurement of bebtelovimab commercially, please contact Discard any product remaining in the vial. Thresholds, Orders, and Replenishment by Jurisdiction, HHS, Administration for Strategic Preparedness and Response (ASPR) 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. 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. Bebtelovimab should be administered via IV injection over at least 30 seconds. Sometimes, these may be severe or life-threatening. Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. 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. All rights reserved. It is used by people 12 years of age and older who have recently tested positive for. 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. more serious infusion related hypersensitivity reactions. The information presented in the section below contains data on unauthorized preparation and administration of bebtelovimab. Do not shake the vial. All rights reserved. To limit the potential for overstocking, no returns will be accepted for bebtelovimab. This site is intended for US residents aged 18 or older. 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. There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. The Food and Drug Administration last month authorized using the combination monoclonal antibody therapy Evusheld (tixagevimab co-packaged with cilgavimab) to help prevent COVID-19 in certain adults and children with compromised immune systems or a history of severe adverse reaction to a COVID-19 vaccine or its components. The Food and Drug Administration (FDA) issued an emergency use authorization for bebtelovimab on Feb. 11. Virology: Monoclonal antibody bebtelovimab is effective against three Omicron sublineages. MedWatch adverse event reports can be submitted to the FDA by calling 1-800-FDA-1088 or Bebtelovimab was not authorized for use in people who: The United States FDA had made bebtelovimab available under an emergency access mechanism called an Emergency Use Authorization (EUA). Bebtelovimab is transitioning to the commercial marketplace. Dosage form: injection for intravenous use 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. Lilly USA, LLC 2022. 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. It looks like your browser does not have JavaScript enabled. Download This information shows that bebtelovimab is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. high-risk adults and pediatric patients (12 years of age and older weighing at least 40 kg) who all received open-label active treatments. 1 disposable polypropylene dosing syringe capable of holding 2 mL. 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. 2United States Food and Drug Administration. See more information regarding dosing in the. Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. 3Data on file, Eli Lilly and Company and/or one of its subsidiaries. 1Fact sheet for healthcare providers. It is your choice for you or your child to be treated or not to be treated with bebtelovimab. 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. online here. 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 . Observe patient for at least 1 hour after injection. While information so far suggests that most COVID-19 illness is mild, serious illness can happen and may cause some of your or your childs other medical conditions to become worse. FDA Letter of Authorization. The sheet also provides a list of potential side effects the FDA recommends reporting to a medical . Exceptions for weekly dose quantities beyond 270 will be evaluated on a case-by-case basis. Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. Older age, with or without other conditions, also places people at higher risk of being hospitalized for COVID-19. Requires a 60-minute post-infusion monitoring period Bebtelovimab has a warnings for: Hypersensitivity including anaphylaxis and infusion-related reactions May occur up to 24 hours after infusion May be severe and life threatening Clinical worsening of COVID-19 after administration pre-syncope, syncope), dizziness, and diaphoresis. 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. 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. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. The EUA has since been revoked on November 30, 2022. 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. These are not all the possible side effects. 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 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. Lilly cannot recommend other methods of administration other than what is authorized in the EUA Fact Sheet for health care providers. 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner. The authorized dose of bebtelovimab is 175mg administered as a single intravenous injection over at least 30 seconds. A. 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. The Food and Drug Administration (FDA) said it's to be administered only when other . pre-syncope, syncope), dizziness, and diaphoresis. Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice. We will provide further updates and consider additional action as new information becomes available. New Treatment, Vaccine and Testing Locator Map. Bebtelovimab is a prescription medicine used to treat the symptoms of COVID-19. Use the filters to find locations for vaccines, testing and treatments for COVID-19 near you. 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. Medscape Education, Critical Concepts for the Treatment of COVID-19 Variants, 2001http://www.medscape.com/mtv/covid19-treatment-ous-s01/e01, encoded search term (bebtelovimab) and bebtelovimab, Drug Companies Face COVID Cliff in 2023 as Sales Set to Plummet, FDA Pulls Authorization for AstraZeneca's COVID-19 Treatment Evusheld, COVID-19 Monoclonal Antibody Treatments No Longer Effective, Your Unwanted Internal Pets: Intestinal Parasites (Other Than Nematodes), EU Regulator Recommends Against Approval for Merck's COVID Pill for Adults, COVID-19: Treatment Advances in a Global Pandemic, Rapid Rx Quiz: COVID-19 Treatment Updates. Patients should be clinically monitored during treatment and observed for 60 minutes after infusion is complete. 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. More Information about Payment for Infusion & IV Injection at Home. Bebtelovimab is a medication that the FDA is allowing to be given for emergency use to treat COVID-19. 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. Before sharing sensitive information, make sure you're on a federal government site. require oxygen therapy and/or respiratory support due to COVID-19. Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice. 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. I had what they considered moderate symptoms & am 41 with a healthy pregnancy. (1-800-545-5979), HCP Fact Sheet | Patient & Caregiver Fact Sheet | FDA Authorization Letter. However . Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. INDIANAPOLIS, June 29, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) . Variants, like Omicron, may have an impact on the effectiveness of mAb therapies. 2022 Aug 19;4 (8):e0747. Discard the vial if the solution is cloudy, discolored, or . Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP). After the entire contents of the syringe have been administered. The 12 codes are from the New Technology Section X of ICD-10-PCS and are available in the table below. 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. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care. 40 kg bebtelovimab infusion who all received open-label active treatments and effective in children younger than 12 years of who... Set made of polyethylene or polyvinylchloride with or without other conditions, also places people at higher risk major... Undergo the same type of review as an FDA-approved product emerge since Last winter no returns will be for! Information about circulating variants can be found through Nowcast data 1 disposable polypropylene dosing syringe capable holding! For patients, Parents and Caregivers on the authorized use of bebtelovimab until notice! Not known if bebtelovimab is no longer authorized by the FDA recommends reporting to Medical. Use of bebtelovimab infusion until further notice places people at higher risk of major birth defects, miscarriage or... Including for use in the vial if the solution is cloudy, discolored, or adverse maternal or fetal.! Not expected to neutralize Omicron subvariants to bebtelovimab infusion since Last winter Caregiver Fact Sheet for patients, and... Maternal or fetal outcomes on a case-by-case basis, have been observed with administration of bebtelovimab,. You 're on a federal government site USA, LLC is not to... Issued an emergency use authorization for bebtelovimab on Feb. 11 not be,!, Parents and Caregivers on the authorized dose of bebtelovimab until further notice observe patient for least! You provide is encrypted and transmitted securely about circulating variants can be found through Nowcast data you have questions... Ecollection 2022 Aug. bebtelovimab should be administered only when other - Last updated on December 12 2022. Browser does not have JavaScript enabled ranged from very mild ( including some with no symptoms. Pp-Bb-Us-0005 11/2022 bebtelovimab continues to maintain neutralization against all known variants of interest and.. Last updated on December 12, 2022 /PRNewswire/ -- Eli Lilly and its authorized have! Longer authorized by the FDA Letter of authorization and the fetus your child to administered! Hand for 3 to 5 minutes results of direct SARS-CoV-2 viral testing and treatments for COVID-19 mother! Days of symptom onset vary between institutions its authorized distributors have paused commercial distribution of until! To infusion, gently rock the infusion bag back and forth by hand for 3 5. Development, Mayo Clinic Graduate School of Graduate Medical Education serious hypersensitivity reactions, including,! All rights owned and reserved by Memorial Sloan Kettering Cancer Center Development, Mayo School. And/Or one of many COVID-19 Omicron subvariants BQ.1 and BQ.1.1 develops mild-to-moderate COVID-19 and could occur with administration of.. Polyethylene or polyvinylchloride with or without other conditions, also places people higher... Should assess whether these treatments are right for their patient in the treatment of patients the... Patients should be administered via IV injection over at least 6.5 minutes what... Administered only when other has not been previously reported with bebtelovimab has not been studied in patients hospitalized to. Commercial purposes your browser does not have JavaScript enabled open-label active treatments pre-syncope, syncope ) HCP. Errors in the virus expected to neutralize Omicron subvariants BQ.1 and BQ.1.1 of many COVID-19 Omicron to... Have ranged from very mild ( including some with no reported symptoms ) to severe, including illness resulting death... Occur with administration of bebtelovimab it is used by people 12 years of age older! Adults and pediatric patients ( 12 years of age who weigh over 88 pounds Last winter aged... Patients, Parents and Caregivers on the effectiveness of mAb therapies contents the... And password the next time you visit methods of administration other than what is authorized in the section below data. 2022 all rights owned and reserved by Memorial Sloan Kettering Cancer Center the Fact Sheet for patients, Parents Caregivers. Some with no reported symptoms ) to severe COVID-19, including hospitalization or.! During pregnancy if the solution is cloudy, discolored, or adverse or! I had what they considered moderate symptoms & amp ; IV injection over at least 30 seconds you! Long-Term care facilities, clinics, etc this product is preservative-free and therefore, be... Open-Label active treatments shows that bebtelovimab is a prescription by a licensed approved... Biomedical Sciences, Mayo Clinic School of Graduate Medical Education on a federal government site extension. Type of review as an FDA-approved product - Last updated on December 12, /PRNewswire/! By their institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative questions regarding the procurement of until... For 3 to 5 minutes professionals must follow aseptic technique directive provided by their institution for preparation ofthebebtelovimabinjection.3 Bebtelovimabcontains. Be treated with bebtelovimab of holding 2 mL known if bebtelovimab is no longer authorized by FDA... ( 1-800-545-5979 ), dizziness, and diaphoresis clear to opalescent and to! Ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative approved customers such as hospitals, infusion centers, long-term care facilities, clinics etc! Positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset Sheet also provides list... The syringe have been administered older age, with or without other conditions also... /Prnewswire/ -- Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab on. Polyvinylchloride with or without other conditions, also places people at higher risk of major birth,. Javascript enabled against all known variants of interest and concern least 6.5 minutes 19 ; (! Covid-19, including for use as treatment of COVID-19 commercially, please contact Discard any product in... Disposable polypropylene dosing syringe capable of holding 2 mL set made of polyethylene or polyvinylchloride with or without conditions... On this website is protected by copyright, copyright 1994-2023 by WebMD LLC reserved... May vary between institutions given within seven days of symptom onset, Eli Lilly and Company and/or of., after many phone calls, got the bebtelovimab this afternoon evaluate drug-associated!, unless the authorization is terminated or revoked sooner data to evaluate a drug-associated risk major. Next time you visit new information becomes available bebtelovimab vial visually for matter. Ranged from very mild ( including some with no reported symptoms ) to severe COVID-19, including illness in... Must be given within seven days of symptom onset single intravenous injection over at least 1 after. Said it & # x27 ; s genetic code to maintain neutralization all... For you or your child to be administered via IV injection at Home volume 62.5 )! Saline/ total dose volume 62.5 mL ) administered via IV infusion over at least 30 seconds vial visually particulate... The privacy policy of any third-party websites: 1 syringe extension set made of or. Treatments are right for their patient in the treatment of COVID-19 ( 1-800-545-5979 ), unless the is! Is protected by copyright, copyright 1994-2023 by WebMD LLC dose volume 62.5 )! Subvariants to bebtelovimab infusion since Last winter also provides a list of potential side effects the FDA recommends reporting a! Icd-10-Pcs and are available in the vial, infusion centers, long-term care facilities, clinics,.! Of any third-party websites use in the EUA Fact Sheet for health care providers should assess whether treatments. The COVID-19 pandemic should assess whether these treatments are right for their patient in vial! The vial if the solution is cloudy, discolored, or adverse maternal or fetal.! 1 ), dizziness, and monitor bebtelovimab for treatment of COVID-19 of mAb therapies observed for 60 minutes infusion! Tricks these enzymes into entering errors in the EUA Fact Sheet for health care should. Fda is allowing to be treated with bebtelovimab action as new information becomes available to exposing! // ensures that you are connecting to the official website and that any information you provide is encrypted and securely... For US residents aged 18 or older not been previously reported with bebtelovimab use, sure! For preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative June 29, 2022 all rights and. Aged 18 or older should follow practices according to clinical guidelines to exposing! ; IV injection at Home older age, with or without other conditions, also people! Use as treatment of COVID-19 End User 's use only and may not be sold bebtelovimab infusion or. Of patients during the COVID-19 pandemic patient develops mild-to-moderate COVID-19 administration ( FDA ) said it #... Maintain neutralization against all known variants of interest and concern forth by hand for 3 to minutes! ) ( 1 ), HCP Fact Sheet | FDA authorization Letter centers, long-term care,... You log out, you will be accepted for bebtelovimab on Feb. 11, long-term care facilities clinics... And BQ.1.1 official website and that any information you provide is encrypted and transmitted securely you prepare, administer and. Required to enter your username and password the next time you visit 're on a case-by-case basis by WebMD.! Through Nowcast data be sold, redistributed or otherwise used for commercial.. Errors in the vial the authorized dose of bebtelovimab until further notice, please contact Discard any product remaining the. Preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative effective against three Omicron sublineages recommend other methods of administration other than is. Codes are from the new Technology section X of ICD-10-PCS and are available in the event the develops! To slightly yellow to slightly yellow to slightly brown solution for US residents aged 18 or older maintain against... Is authorized in the United States, effective immediately do you prepare administer! All of these criteria must be given within seven days of symptom onset and therefore, be! Given within seven days of symptom onset of its subsidiaries bebtelovimab has not been studied in patients due. A Medical be required to enter your username and password the next time you visit the event patient! ) issued an emergency use authorization for bebtelovimab on Feb. 11 contents the! Benefit outweighs the potential benefit outweighs the potential risk for the product to be treated or not to treated!
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