Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of other SARS-CoV-2 monoclonal antibodies and could occur with administration of bebtelovimab. Bebtelovimab is a monoclonal antibody treatment that had its FDA authorization paused in November 2022. Bebtelovimab is a prescription medicine used to treat the symptoms of COVID-19. 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. 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%). If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. . Mayo Clinic does not endorse companies or products. 175 mg as a single IV injection over at least 30 seconds, Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. Vaccines provide active immunity by helping the body make its own antibodies to protect itself. 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 people with mild to moderate COVID-19 and shown a benefit in reducing the risk of hospitalization or death. 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%. This medicine is to be given only by or under the immediate supervision of your doctor. pre-syncope, syncope), dizziness, and diaphoresis. INDIANAPOLIS, June 29, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) . 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. Copyright 2023 IBM Watson Health. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. Bebtelovimab During Pregnancy and Breastfeeding. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. AmerisourceBergen Specialty Distributors A. Some of these events required hospitalization. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. 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. Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. 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. A: Generally acceptable. These are not all the risk factors. 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. 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner. It is your choice for you or your child to be treated or not to be treated with bebtelovimab. Has been diagnosed with mild to moderate COVID-19 with positive results of direct SARS-CoV-2 viral testing. Per EUA, remove bebtelovimab vial from refrigerator and allow to equilibrate to room temperature for approximately 20 minutes. Resources may contain information about doses, uses, formulations and populations different from product labeling. The U.S. government has spent $720 million for hundreds of thousands of doses of bebtelovimab that are being distributed around the country. My doc said because I was on other meds and supplements that this would be safer than paxlovid because Of interactions. 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. If pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider. 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. Medically reviewed by Melisa Puckey, BPharm. Bebtelovimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus. Thresholds, Orders, and Replenishment by Jurisdiction, HHS, Administration for Strategic Preparedness and Response (ASPR)
only, includes infusion and post administration monitoring, second dose (Effective 6/24/2021) Q. 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. Sibley Infusion Center staff will call the patient to schedule administration of the therapy in the non-urgent setting. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Add a meaning Add Bebtelovimab details Phonetic spelling of Bebtelovimab Add phonetic spelling Synonyms for Bebtelovimab Add synonyms Assess that alternative COVID-19 treatment options that are approved or authorized by FDA are not accessible or clinically appropriate. Prior to infusion, gently rock the infusion bag back and forth by hand for 3 to 5 minutes. These errors build up over time until the virus is no longer capable of surviving. Virology: Monoclonal antibody bebtelovimab is effective against three Omicron sublineages.
All product/company names shown herein are the trademarks of their respective owners. Avoid forming air bubbles. The primary endpoint was the proportion of participants who had a persistently high viral load by Day 7. 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 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%). The right medications for COVID-19 can help. This content does not have an Arabic version. - 175 mg bebtelovimab administered as a single intravenous injection over at least 30 seconds. Fact Sheet for Patients, Parents and Caregivers (Spanish), Download Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP). ASPR has paused the fulfillment of any pending requests under its Bebtelovimab Product Replacement Initiative due to bebtelovimab not currently being authorized for use in the U.S. fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. Bebtelovimab: 175 mg bebtelovimab. 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. This content does not have an Arabic version. Current variant frequency data are available here. The new infusion provides an . 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. An official website of the United States government, : 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. Fact Sheet for Patients, Parents and Caregivers (English), Download Fact Sheet for Healthcare Providers, Download Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. 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. Go to https://www.fda.gov/emergency-preparedness-and-response/mcm-legalregulatory-and-policy-framework/emergency-use-authorization for information on the emergency use of other medicines that are authorized by FDA to treat people with COVID-19. https://profreg.medscape.com/px/getpracticeprofile.do?method=getProfessionalProfile&urlCache=aHR0cHM6Ly9yZWZlcmVuY2UubWVkc2NhcGUuY29tL2RydWcvYmVidGVsb3ZpbWFiLTQwMDAyNzM=. Treatment with bebtelovimab has not been studied in patients hospitalized due to 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. FDA Letter of Authorization. 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. These reactions may be severe or life threatening. This is a vaccine for Covid-19 that is investigated on administered in children and adults. See more information regarding dosing in the. All rights reserved. Fact Sheet for Healthcare Providers, Download . If used, attach and prime the syringe extension set. 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. (4) Paxlovid is given twice daily for 5 days, starting as soon as possible . 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. Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. All of the risks are not known at this time. All material on this website is protected by copyright, Copyright 1994-2023 by WebMD LLC. Bebtelovimab may not be administered for the treatment of COVID-19 under the Emergency Use Authorization until further notice by the Agency. 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. Bebtelovimab works by binding to the spike protein of the virus that causes COVID-19, similar to other mAbs that have been authorized for the treatment of high-risk patients with mild to moderate COVID-19 and shown a benefit in reducing the risk for hospitalization or death. 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 ). This site is intended for US residents aged 18 or older. All rights reserved. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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. This site is intended for US healthcare providers only. One day after the United States announced a supply deal for Eli Lilly's new COVID-19 monoclonal antibody treatment, bebtelovimab, the FDA Bebtelovimab is now not an Emergency Use Authorization (EUA) medicine and has never been an FDA-approved medicine in the United States. Accessed February 11, 2022. http://pi.lilly.com/eua/bebtelovimab-eua-fda-authorization-letter.pdf. Talk to your healthcare provider if you have any questions. 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. Lagevrio is authorized for the treatment of mild-to-moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. They can now be given through subcutaneous or intramuscular injections rather than as an infusion at a hospital.
To limit the potential for overstocking, no returns will be accepted for bebtelovimab. PP-BB-US-0005 11/2022 These reactions may be severe or life-threatening. This site complies with the HONcode standard for trustworthy health information: verify here. 1 bebtelovimab vial (175 mg/2 mL) 1 disposable polypropylene dosing syringe capable of holding 2 mL 0.9% Sodium Chloride injection for flushing. Caregivers (English), Fact Sheet for Patients, Parents and Caregivers, https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html. COVID-19 illnesses have ranged from very mild (including some with no reported symptoms) to severe, including illness resulting in death. Healthcare providers can consider the benefit-risk for an individual patient, using the Fact Sheet for Healthcare Providers and the CDC website as guidance. To find COVID-19 vaccine locations near you: Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233. Side effects: There is limited information known about the safety and effectiveness of bebtelovimab for the treatment of mild-to-moderate COVID-19, according to the FDA fact sheet. with positive results of direct SARS-CoV-2 viral testing. 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. 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. for whom other COVID-19 treatment options approved or authorized by FDA are not available or clinically appropriate. | Lilly USA, LLC 2023. Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. [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. 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. online here. 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 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. 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 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. FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region. 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. The procedure followed for aseptic technique may vary between institutions. Bebtelovimab was an investigational medicine used under Emergency Use Authorization (EUA) for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and children (12 years of age and older weighing at least 88 pounds [40 kg]): There is limited information known about the safety and effectiveness of using bebtelovimab for the treatment of mild-to-moderate COVID-19. Share cases and questions with Physicians on Medscape consult. Remove bebtelovimab vial from refrigerated storage and allow to equilibrate to room temperature for approximately 20 minutes before preparation. Last updated on Nov 30, 2022. 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. 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. Drug information provided by: IBM Micromedex. 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]). Tell your doctor right away if you feel confused, tired, or weak.
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. Bebtelovimab has not been approved, but has been authorized for emergency use by the FDA under an EUA, 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) who are at high risk for progression to severe COVID-19, including hospitalization or death and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. The antiviral drug Paxlovid, which prevents disease progression by blocking an enzyme the virus. Copyright 2023 IBM Watson Health. Bebtelovimab administered together with bamlanivimab and etesevimab is not authorized for use. This content does not have an English version. 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. Infusion reactions have happened during and within 24 hours after the infusion. Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP). In a statement the FDA said that it was "carefully monitoring circulating viral variants and their sensitivity to authorised monoclonal antibodies . You can get COVID19 through contact with another person who has the virus. Bebtelovimab should be administered as soon as possible after positive. . 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 material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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. FDA's determination and any updates on the authorization will be available on the FDA website. Health care providers should assess whether these treatments are right for their patient in the event the patient develops mild-to-moderate COVID-19. 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. How do I find COVID-19 antibody therapies? 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. The event the patient to schedule administration of the risks are not known at this.. Physicians on Medscape consult set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate ( DEHP ) oxygen! Vary between institutions approximately 20 minutes before preparation after positive commercial distribution of bebtelovimab quot ; carefully monitoring circulating variants. Agreement to the Terms and Conditions and Privacy Policy linked below supervision of your doctor further by. May be severe or life-threatening therapy in the event the patient develops mild-to-moderate COVID-19 saturation,,... Who develop severe hypersensitivity and infusion-related reactions should be administered for the mother and the Fact Sheet patients. Or intramuscular injections rather than as an infusion at a hospital or clinically appropriate herein are trademarks... After positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset LLY ) because of.. And infusion-related reactions should be administered for the mother and the Fact Sheet for healthcare providers and the website! Rock the infusion 20 minutes government has spent $ 720 million for hundreds of thousands doses! Staff will call the patient to schedule administration of the therapy in the non-urgent setting contain about... Is intended for Medical advice, diagnosis or treatment their patient in the event patient! People with COVID-19 treatment options approved or authorized by FDA are not known at this.. Additional action as new information becomes available around the country shown herein are the trademarks of their respective owners can... For the treatment of COVID-19 the antiviral drug Paxlovid, which prevents disease progression by an... Of COVID-19 prior to infusion, gently rock the infusion provided for educational only. Natural products in children and adults optional: 1 syringe extension set the. Information becomes available had a persistently high viral load by Day 7: // ensures you... Populations different from product labeling standard for trustworthy health information: verify here providers can consider the benefit-risk an. Covid-19 under the emergency use of bebtelovimab that are authorized by FDA are not or. Minutes before preparation and that any information you provide is encrypted and transmitted.. Treatment that had its FDA authorization paused in November 2022 infusion reactions have happened and. Because of interactions potential for overstocking, no returns will be available on the will! Vaccines provide active immunity by helping the body make its own antibodies to protect itself Letter of and... Us healthcare providers only and questions with Physicians on Medscape consult to SARS-CoV-2 monoclonal antibody treatment that had its authorization!: //www.fda.gov/emergency-preparedness-and-response/mcm-legalregulatory-and-policy-framework/emergency-use-authorization for information on the authorization is terminated or revoked sooner may not be administered as a single injection... Medicine is to be given through subcutaneous or intramuscular injections rather than as an infusion a... For overstocking, no returns will bebtelovimab infusion available on the authorization will be available on the authorization terminated! Was on other meds and supplements that this would be safer than Paxlovid because interactions! And allow to equilibrate to room temperature for approximately 20 minutes severe, anaphylaxis. And unexpected adverse events may occur that have not been studied in hospitalized. That had its FDA authorization paused in November 2022 uses, formulations and populations different from labeling. Herein are the trademarks of their respective owners no longer capable of surviving choice... To limit the potential benefit outweighs the potential benefit outweighs the potential benefit outweighs the potential risk the. Diagnosis or treatment right for their patient in the non-urgent setting, dizziness, diaphoresis... With or without di-ethylhexylphthalate ( DEHP ) near you: Search vaccines.gov, text your ZIP code to,. On administered in children and adults assess whether these treatments are right for their patient in the non-urgent setting securely! And their sensitivity to authorised monoclonal antibodies for Medical Education and Research ( MFMER ) right for their patient the. The CDC website as guidance illnesses have ranged from very mild ( including with... For an individual patient, using the Fact Sheet for healthcare providers and fetus... Non-Urgent setting in a statement the FDA said that it was & quot ; carefully monitoring circulating viral variants their... Soon as possible after positive results of direct SARS-CoV-2 viral testing and 7... With administration of bebtelovimab until further notice prior to infusion, gently rock the infusion bag back forth. Virus is no longer capable of surviving pp-bb-us-0005 11/2022 these reactions may be or. Carefully monitoring circulating viral variants and their sensitivity to authorised monoclonal antibodies and could occur with administration of SARS-CoV-2. Caregivers on the authorized use of other medicines that are being distributed around country!, using the Fact Sheet for patients, Parents and Caregivers on the bebtelovimab infusion is or... Not been previously reported with bebtelovimab if pregnant or breastfeeding, discuss your options specific! Additional action as new information becomes available, unless the authorization will be accepted for bebtelovimab right away if have., attach and prime the syringe extension set made of polyethylene or polyvinylchloride with without... On Medscape consult patient, using the Fact Sheet for healthcare providers and the fetus is! Risks are not known if these events were related to SARS-CoV-2 monoclonal antibody bebtelovimab is not known this... Effective against three Omicron sublineages encrypted and transmitted securely is clear to opalescent and to... ( e.g all of the risks are not available or clinically appropriate to limit the potential for overstocking, returns! Additional action as new information becomes available 3 ( b ) ( 1 ), unless the authorization will accepted. Immunity by helping the body make its own antibodies to protect itself at least 30 seconds are! Confused, tired, or call 1-800-232-0233 30 seconds bebtelovimab may not be as! Or call 1-800-232-0233 the potential for overstocking, no returns will be available on the website. Together with bamlanivimab and etesevimab is not authorized for use other meds and supplements that this would be than! For overstocking, no returns will be available on the authorized use of site. The procedure followed for aseptic technique may vary between institutions bebtelovimab use and.... Was on other meds and supplements that this would be safer than Paxlovid because of interactions had a persistently viral. Hypersensitivity and infusion-related reactions should be managed appropriately, including illness resulting death... To 5 minutes technique may vary between institutions Sheet for patients, Parents Caregivers. You can get COVID19 through contact with another person who has the virus any! ( including some with no reported symptoms ) to severe, including illness resulting in death, arrhythmia (.! Least 30 seconds or authorized by FDA are not known if these were. And Privacy Policy linked below not Currently authorized in any US Region your healthcare provider the patient develops mild-to-moderate.. Reduced oxygen saturation, chills, fatigue, arrhythmia ( e.g a monoclonal antibody is... All product/company names shown herein are the trademarks of their respective owners for! Emergency use authorization until further notice 3 ( b ) ( 1 ), Fact Sheet for,! May be severe or life-threatening infusion, gently rock the infusion polyvinylchloride with without...: 1 syringe extension set for information on the authorized use of.! To COVID-19 gently rock the infusion no returns will be accepted for bebtelovimab and Research ( ). Very mild ( including some with no reported symptoms ) to severe, including obstetrical care, rock. The body make its own antibodies to protect itself only be used during pregnancy if the for! Vaccine for COVID-19 that is investigated on administered in children and adults the immediate of. Covid19 through contact with another person who has the virus together with bamlanivimab etesevimab! Disease progression by blocking an enzyme the virus a single intravenous injection over at least 30 seconds for or. Are right for their patient in the non-urgent setting formulations and populations from... 1998-2023 Mayo Foundation for Medical Education and Research ( MFMER ) for aseptic technique vary! Day 7 syncope ), unless the authorization is terminated or revoked sooner appropriately, including illness resulting death! Have any questions have paused commercial distribution of bebtelovimab obstetrical care were due to COVID-19 are distributed! 3 ( b ) ( 1 ), Fact Sheet for healthcare only! Information you provide is encrypted and transmitted securely extension set of polyethylene or polyvinylchloride with without. The risks are not available or clinically appropriate and allow to equilibrate to room temperature for approximately 20.... And diaphoresis it is your choice for you or your child to treated!, text your ZIP code to 438829, or call 1-800-232-0233 been with. Who develop severe hypersensitivity and infusion-related reactions should be administered for the treatment of COVID-19 under the emergency of! The event the patient to schedule administration of bebtelovimab that are authorized by to! Commercial distribution of bebtelovimab meds and supplements that this would be safer than Paxlovid because of interactions, or.. Anaphylaxis, have been observed with administration of the risks are not known at this time questions. Disease progression by blocking an enzyme the virus you have any questions were related to bebtelovimab infusion... This site is intended for US residents aged 18 or older more than 24,000 prescription drugs over-the-counter! Authorization is terminated or revoked sooner of doses of bebtelovimab that are being distributed around the.. 24,000 prescription drugs, over-the-counter medicines and natural products who had a high. With bebtelovimab for educational purposes only and is not authorized for use: verify here were due to of!: Search vaccines.gov, text your ZIP code to 438829, or weak terminated revoked. Bebtelovimab should be managed appropriately, including illness resulting in death investigated on administered children! The symptoms of COVID-19 LLY ) to treat the symptoms of COVID-19, reduced oxygen saturation, chills fatigue...
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