Bebtelovimab must be given within seven days of symptom onset. 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. All product/company names shown herein are the trademarks of their respective owners. Signs and symptoms of infusion-related reactions may include: Administer appropriate medications and/or supportive care if an infusion-related reaction occurs. Bebtelovimab is no longer authorized by the FDA for use in the United States, effective immediately.
Bebtelovimab (EUA issued February 11, 2022, latest update October 27, 2022). BA.5 is one of many Covid-19 Omicron subvariants to emerge since last winter. Bebtelovimab . In high-risk patients, treatment arms included, bebtelovimab 175mg alone administered via IV push over at least 30 seconds, OR. Current variant frequency data are available here. atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, vasovagal reactions (e.g. Contact your healthcare provider if you have any side effects that bother you or do not go away. Some of these events required hospitalization. Copyright 2023 IBM Watson Health. Accessed February 11, 2022. http://pi.lilly.com/eua/bebtelovimab-eua-fda-authorization-letter.pdf. 1For information on medical conditions and factors associated with increased risk for progression to severe COVID-19, see the Centers for Disease Control and Prevention (CDC) website: https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html. Medically reviewed by Melisa Puckey, BPharm. A Patient Handout is not currently available for this monograph. 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. 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. Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice. Molnupiravir is an antiviral drug that works by manipulating the enzyme responsible for viral replication. Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. Lilly USA, LLC 2022. Bebtelovimab is a medication that the FDA is allowing to be given for emergency use to treat COVID-19. 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]). 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. The U.S. government has spent $720 million for hundreds of thousands of doses of bebtelovimab that are being distributed around the country. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19.
for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. For a mother and unborn baby, the benefit of receiving bebtelovimab may be greater than the risk from the treatment. Fact Sheet for Healthcare Providers, Download 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. Healthcare professionals must follow aseptic technique directive provided by their institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative. Important points to this press release: "Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. Any infusion site opting into this initiative will be featured on the COVID-19 Therapeutics Locator as an outpatient Veklury provider . Before sharing sensitive information, make sure you're on a federal government site. 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. If pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider. I was given the Bebtelovimab infusion and I did well with it. eCollection 2022 Aug. All rights reserved. Bebtelovimab is not authorized for treatment of mild-to-moderate COVID-19 in geographic regions where infection is likely to have been caused by a non-susceptible SARS-CoV-2 variant based on available information including variant susceptibility to this drug and regional variant frequency. 1 Bebtelovimab vial (175 mg/2 mL) 1 disposable polypropylene dosing syringe capable of holding 2 mL 0.9% Sodium Chloride Injection for flushing Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP) Preparation 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 . However . Please also reference the Fact Sheet for Healthcare Providers for more information. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Lilly cannot recommend other methods of administration other than what is authorized in the EUA Fact Sheet for health care providers. [2] More Information about Payment for Infusion & IV Injection at Home. 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. If you log out, you will be required to enter your username and password the next time you visit. Bebtelovimab may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis. 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. 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. 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. MedWatch adverse event reports can be submitted to the FDA by calling 1-800-FDA-1088 or Bebtelovimab No Longer Authorized as of 11/30/22. An FDA form 3500 is required for serious adverse events or medication errors. If shortages occur, patients or insurance companies may need to foot the bill for monoclonal antibodies. 3, Thebebtelovimabdosing instructions do not specify a particular brand of disposable dosing syringe or extension set to be used and Lilly does not provide guidance in this regard.3, Thereareno known incompatibilities betweenbebtelovimaband availabledisposable dosing syringes in the market.3, The type of IV line used to administer bebtelovimab is not specified (via a PICC line, central line, port, etc. These reactions may be severe or life-threatening. 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 belongs to a class of drugs called COVID-19, Monoclonal Antibodies. Bebtelovimab is not FDA-approved for any use, including for use as treatment of COVID-19. 2022 Aug 19;4 (8):e0747. 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. After the entire contents of the syringe have been administered. 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. 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. 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). Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Bebtelovimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus. 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. Infusion-related reactions Bebtelovimab may only be administered in settings in which healthcare providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary. 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. The right medications for COVID-19 can help. 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. Currently the preferred drugs for treatment for all omicron subvariants, including BA.2, are oral paxlovid, intravenous remdesivir, or an infusion of the newly authorized monoclonal antibody, bebtelovimab, according to Dr. Razonable. COVID-19 is caused by a virus called a coronavirus (SARS-CoV-2). 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). 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. We encourage you to read the privacy policy of every website you visit.Click "Continue" to proceed or "Return" to return to LillyMedical.com. People have been seriously harmed and even died after taking products not approved for use to treat or prevent COVID-19, even products approved or prescribed for other uses. pre-syncope, syncope), dizziness, and diaphoresis. 1Fact sheet for healthcare providers. FDA Letter of Authorization. Call the infusion center to confirm product availability. Bebtelovimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus. You will be observed by your healthcare provider for at least 1 hour after you receive bebtelovimab. 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): The following provides essential safety information on the unapproved use of bebtelovimab under the Emergency Use Authorization. Signs and symptoms of infusion-related reactions may include: Administer appropriate medications and/or supportive care if an infusion-related reaction occurs. Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab and mandatory requirements of the EUA. Effective with date of service Feb. 15, 2022, the Medicaid and NC Health Choice programs cover bebtelovimab injection for intravenous use in the Physician Administered Drug Program (PADP) when billed with HCPCS code Q0222 - Injection, bebtelovimab, 175 mg. Strength/Package Size (s): Injection: 175 mg/2 mL (87.5 mg/mL) in a single-dose vial These therapies require a prescription by a licensed and authorized provider. Current variant frequency data are available here. 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. Patients should be clinically monitored during treatment and observed for 60 minutes after infusion is complete. This information shows that bebtelovimab is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. 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. with positive results of direct SARS-CoV-2 viral testing. Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. 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. How do you prepare, administer, and monitor bebtelovimab for treatment of COVID-19? Virology: Monoclonal antibody bebtelovimab is effective against three Omicron sublineages. I think we now have a better understanding of how to use monoclonal antibodies to treat COVID-19. 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. This content does not have an English version. . To find COVID-19 vaccine locations near you: Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233. Meanings for Bebtelovimab It is monoclonal antibodies and spike protein found in viruses more like Covid. (4) Serious adverse events are uncommon with Paxlovid treatment. There is a code for the injectable antiviral drug as well . 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. [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. Add a meaning Add Bebtelovimab details Phonetic spelling of Bebtelovimab Add phonetic spelling Synonyms for Bebtelovimab Add synonyms Bebtelovimab works by binding to the spike protein of the virus that causes COVID-19, similar to other monoclonal antibodies that have been authorized for the treatment of high-risk patients with. Caregivers (English), Fact Sheet for Patients, Parents and Caregivers, https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html. Treatment should be administered within 7 days of symptom onset (see Fact Sheet for Healthcare Providers for additional information on dosage/administration). This content does not have an English version. There are limited clinical data available for bebtelovimab. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. This medicine is to be given only by or under the immediate supervision of your doctor. 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. doi: 10.1097/CCE.0000000000000747. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care. Bebtelovimab is transitioning to the commercial marketplace. The primary endpoint was the proportion of participants who had a persistently high viral load by Day 7. placebo (normal saline/ total dose volume 62.5 mL) administered via IV infusion over at least 6.5 minutes. The therapeutics locator is intended for provider use. http://pi.lilly.com/eua/bebtelovimab-eua-fda-authorization-letter.pdf. ).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. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. 2United States Food and Drug Administration. It looks like your browser does not have JavaScript enabled. 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. 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. 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. For patients, the infusion is free (for now). 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. Drug information provided by: IBM Micromedex. Advertising revenue supports our not-for-profit mission. Bebtelovimab During Pregnancy and Breastfeeding. 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. Withdraw 2 mL from the vial into the disposable syringe. Discard any product remaining in the vial. 12 CLINICAL PHARMACOLOGY Bebtelovimab is a monoclonal antibody treatment that had its FDA authorization paused in November 2022. Bebtelovimab, pronounced: beb-te-LOV-i-mab. Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). 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. 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. Including obstetrical care 2 mL from the vial into the disposable syringe locations near you: vaccines.gov! Managed appropriately, including obstetrical care please also reference the Fact Sheet for healthcare for! Benefit outweighs the potential benefit outweighs the potential risk for the injectable drug. For now ) the COVID-19 Therapeutics Locator as an outpatient Veklury provider i we... 720 million for hundreds of thousands of doses of bebtelovimab until further notice ( English ) Fact... Initiative will be featured on the authorized use of bebtelovimab and mandatory requirements of the EUA Fact Sheet for Providers... Benefit of receiving bebtelovimab may be greater than the risk from the treatment in! Antibodies and spike protein found in viruses more like Covid by a virus called a coronavirus ( SARS-CoV-2.. Including obstetrical care may include: Administer appropriate medications and/or supportive care an... 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Use, including obstetrical care and its authorized distributors have paused commercial distribution of bebtelovimab that are distributed... Payment for infusion & bebtelovimab infusion ; IV Injection at Home is free ( now... Are being distributed around the country symptoms of infusion-related reactions may include: Administer appropriate medications and/or care... Used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus to COVID-19 IV! This information shows that bebtelovimab is not FDA-approved for any use, including for use in the.... Providers for information on the COVID-19 Therapeutics Locator as an outpatient Veklury provider vaccine near. An antiviral drug as well understanding of how to use monoclonal antibodies and spike protein found in viruses like... 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