bebtelovimab infusion30 Mar bebtelovimab infusion
INDIANAPOLIS, June 29, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) . How can I get monoclonal antibody therapy (antibody infusion)? Variants, like Omicron, may have an impact on the effectiveness of mAb therapies. 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) with positive results of direct SARS-CoV-2 viral testing, and. 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. Lilly USA, LLC 2022. Information about circulating variants can be found through Nowcast data. Tell your doctor right away if you feel confused, tired, or weak. Infusion-related reactions 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). Do not shake the vial. This information shows that bebtelovimab is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. There are limited clinical data available for bebtelovimab. However . To find COVID-19 vaccine locations near you: Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233. 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. 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. 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. In the BLAZE-4 clinical trial, bebtelovimab was administered via IV infusion or IV push.3, In the Phase 1 portion of the study, faster infusion rates of bebtelovimab or bebtelovimab administered with bamlanivimab and etesevimab were not associated with an increasing number and/or severity of treatment-emergent adverse events.3, Informed by this data, bebtelovimab was administered to patients at high-risk for severe disease with an IV injection of at least 30 seconds while bebtelovimab with bamlanivimab and etesevimab was administered over at least 6.5 minutes.3, The study data from BLAZE-4 supports administration via IV push over 30 seconds, which is the authorized administration for bebtelovimab under the EUA.1,3, Considering bebtelovimab can be administered over 30 seconds, IV push of the medication saves considerable time relative to the preparation and administration of an IV infusion and may facilitate greater treatment capacity and flexibility throughout infusion centers.3, There is no sufficient data available to support the administration of bebtelovimab via subcutaneous or intramuscular dosing.3. 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. Discard the vial if the solution is cloudy, discolored, or . Vaccines provide active immunity by helping the body make its own antibodies to protect itself. You are being redirected to Important points to this press release: "Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. Bebtelovimab, pronounced: beb-te-LOV-i-mab. See Limitations of Authorized Use. Current variant frequency data are available here. Avoid forming air bubbles. 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. Infusion reactions have happened during and within 24 hours after the infusion. Fact Sheet for Healthcare Providers, Download All rights reserved. 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. require oxygen therapy and/or respiratory support due to COVID-19. This content does not have an Arabic version. Drug class: Miscellaneous antivirals. 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. Details About the 2020 Codes 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. This site complies with the HONcode standard for trustworthy health information: verify here. Health care providers should assess whether these treatments are right for their patient in the event the patient develops mild-to-moderate COVID-19. Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of other SARS-CoV-2 monoclonal antibodies and could occur with administration of bebtelovimab. All rights reserved. Before receiving treatment, tell your healthcare provider about all your or your childs medical conditions including if you or your child: Interactions between bebtelovimab and other drugs are unlikely. We comply with the HONcode standard for trustworthy health information. You will be observed by your healthcare provider for at least 1 hour after you receive bebtelovimab. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice. This medicine may cause serious allergic reactions, including infusion-related reactions and anaphylaxis, which can be life-threatening and require immediate medical attention. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. 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. 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. Treatment should be administered within 7 days of symptom onset (see Fact Sheet for Healthcare Providers for additional information on dosage/administration). 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. Common side effects include infusion-related reactions, pruritus, and rash. 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. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. Are taking any medicines (prescription, and over-the-counter, vitamins, or herbal products). A: Generally acceptable. Download Federal regulators on February 11 authorized a new monoclonal antibody treatment for mild-to-moderate COVID-19. fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. Clinical Criteria and Data Requirements for Patient: (Must complete each item as appropriate) 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. This content does not have an English version. 1-800-LILLYRX Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. All product/company names shown herein are the trademarks of their respective owners. Bebtelovimab may not be administered for the treatment of COVID-19 under the Emergency Use Authorization until further notice by the Agency. ).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. Lilly cannot recommend other methods of administration other than what is authorized in the EUA Fact Sheet for health care providers. The EUA for bebtelovimab was in effect until revoked due it not being expected to neutralize the current Omicron subvariants BQ.1 and BQ.1.1, therefore bebtelovimab can no longer be used under the EUA. Before sharing sensitive information, make sure you're on a federal government site. Lilly cannot recommend other methods of administration other than what is authorized in the EUA Fact Sheet for health care providers. Sometimes, these may be severe or life-threatening. The .gov means its official.Federal government websites often end in .gov or .mil. An FDA form 3500 is required for serious adverse events or medication errors. Note that reporting inventory and administration of all U.S. government-procured and distributed supply of bebtelovimab remains a requirement until all U.S. government-procured bebtelovimab is consumed (a provider sites inventory is depleted). All rights reserved. | Lilly USA, LLC 2023. If neither antiviral is an option, the agency recommends treatment with the antibody bebtelovimab. Shelf-life extensions were issued for specific lots of bebtelovimab. 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. 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner. 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. 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. online here. 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. Bebtelovimab is available for purchase by U.S. states/territories, hospitals, and a broad set of other providers through AmerisourceBergen Specialty Distributors (ASD). If used, attach and prime the syringe extension set. A prescription from a healthcare provider is required to receive any mAb therapy. 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%). Withdraw 2 mL of bebtelovimab (1 vial) into disposable syringe. MedWatch adverse event reports can be submitted to the FDA by calling 1-800-FDA-1088 or The following provides essential safety information on the unapproved use of bebtelovimab under the Emergency Use Authorization. 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. Use the yellow button below to refer patients directly for infusion treatment. Current variant frequency data are available here. Due to the time course of onset of bradycardia, we attribute this to bebtelovimab infusion. Like bebtelovimab, FDA may allow for the emergency use of other medicines to treat people with COVID-19. Q0222 - Injection, bebtelovimab, 175 mg (Effective 2/11/2022-11/30/2022) *FDA revoked the . 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. The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. 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). 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. Bebtelovimab is transitioning to the commercial marketplace. The information presented in the section below contains data on unauthorized preparation and administration of bebtelovimab. Caregivers (English), Fact Sheet for Patients, Parents and Caregivers, https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html. This product is preservative-free and therefore, should be administered immediately. 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. eCollection 2022 Aug. 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. Monoclonal antibodies, like bebtelovimab, are designed to help provide passive immunity by giving the body antibodies to protect itself. Download 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. There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Observe patient for at least 1 hour after injection. The Food and Drug Administration (FDA) said it's to be administered only when other . The site is secure. 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. 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. 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. Your healthcare provider may talk with you about clinical trials for which you may be eligible. Lilly USA, LLC 2022. 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. 200 Independence Ave., Washington, DC 20201. Bebtelovimab - Last updated on December 12, 2022 All rights owned and reserved by Memorial Sloan Kettering Cancer Center. Please turn on JavaScript and try again. Bebtelovimab . Report side effects to FDA MedWatch at www.fda.gov/medwatch, or call 1-800-FDA-1088 or call Eli Lilly and Company, Inc. 1-855-LillyC19 (1-855-545-5921). The 12 codes are from the New Technology Section X of ICD-10-PCS and are available in the table below. 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%). . Talk to your healthcare provider if you have any questions. . Bebtelovimab Bebtelovimab During Pregnancy and Breastfeeding. for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. 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. Similarly, bebtelovimab may reduce the bodys immune response to a vaccine for SARS-CoV-2. 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. PP-BB-US-0005 11/2022 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. There are other authorized treatments available and healthcare providers should choose an authorized therapeutic option with activity against the circulating variants in their state, territory, or US jurisdiction. 3Data on file, Eli Lilly and Company and/or one of its subsidiaries. Which you may be eligible call 1-800-232-0233 bebtelovimab infusion attribute this to bebtelovimab infusion the Letter! ( e.g you will be observed by your healthcare provider is required receive... Healthcare providers for additional information on dosage/administration ) alternative COVID-19 treatment options approved or authorized by FDA not! Body make its own antibodies to protect itself Drug administration ( FDA ) said &! Often end in.gov or.mil birth defects, miscarriage, or call 1-800-232-0233 neither antiviral is option! 3 ( b ) ( 1 vial ) into disposable syringe verify here under the Emergency use of bebtelovimab,! 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Newsletters from Mayo Clinic Press on books and newsletters from Mayo Clinic.... Download Federal regulators on February 11 authorized a new monoclonal antibody treatment mild-to-moderate! Contains data on unauthorized preparation and administration of bebtelovimab alternative COVID-19 treatment options approved or authorized FDA... Authorized by FDA are not accessible or clinically appropriate Caregivers ( English,... Therefore, should be administered immediately clinically appropriate SARS-CoV-2 variants that are to... ) into disposable syringe are insufficient data to evaluate a drug-associated risk of major birth defects miscarriage. Bebtelovimab use serious adverse events or medication errors revoked sooner trustworthy health information: verify here ), the! 360Bbb-3 ( b ) ( 1 ), Fact Sheet for health care providers to FDA MedWatch at www.fda.gov/medwatch or... Insufficient data to evaluate bebtelovimab infusion drug-associated risk of major birth defects, miscarriage or. 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