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. BA.5 is one of many Covid-19 Omicron subvariants to emerge since last winter. 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. 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. At this time, bebtelovimab remains authorized in all U.S. regions until further notice by FDA. Fact Sheet for Patients, Parents and Caregivers (English), Download Bebtelovimab FDA Emergency Use Authorization letter. These are not all the risk factors. [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 belongs to a class of drugs called COVID-19, Monoclonal Antibodies. 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]). Other risk factors can be found on the CDC website. Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. 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. 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner. Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions. Important points to this press release: "Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. Patients should be clinically monitored during treatment and observed for 60 minutes after infusion is complete. 2022 Aug 19;4 (8):e0747. 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. All rights reserved. Bebtelovimab continues to maintain neutralization against all known variants of interest and concern. Use: treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe disease. Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. Generally, scientists are able to develop antibody treatments faster than they are able to develop vaccines. 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. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. 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. A prescription from a healthcare provider is required to receive any mAb therapy. It is used by people 12 years of age and older who have recently tested positive for. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. 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%. There are limited clinical data available for bebtelovimab. 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). Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab and mandatory requirements of the EUA. 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). In a statement the FDA said that it was "carefully monitoring circulating viral variants and their sensitivity to authorised monoclonal antibodies . These reactions may be severe or life threatening. 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. | Lilly USA, LLC 2023. Advertising revenue supports our not-for-profit mission. Download Prescribers should monitorCDC regional variant frequency dataand refer to the Antiviral Resistance information in the Healthcare Provider Fact Sheet for details regarding specific variants and resistance against SARS-CoV-2 variants in your area, particularly Omicron subvariants BQ.1 and BQ.1.1. It is not known if Bebtelovimab is safe and effective in children younger than 12 years of age who weigh over 88 pounds. One day after the United States announced a supply deal for Eli Lilly's new COVID-19 monoclonal antibody treatment, bebtelovimab, the FDA The U.S. government has spent $720 million for hundreds of thousands of doses of bebtelovimab that are being distributed around the country. Discard any product remaining in the vial. 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. Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. Bebtelovimab has been associated with anaphylactic reactions; however, this is unlikely in our . The bebtelovimab solution has a pH range of 5.5-6.5. We will provide further updates and consider additional action as new information becomes available. The Food and Drug Administration (FDA) issued an emergency use authorization for bebtelovimab on Feb. 11. Tell your doctor right away if you start to have a fever, chill or shaking, dizziness, headache, hoarseness, increased sweating, trouble breathing, trouble swallowing, itching or skin rash, lightheadedness, fainting, fast, pounding, or uneven heartbeat, or any swelling of your hands, face, or mouth after receiving this medicine. Like bebtelovimab, FDA may allow for the emergency use of other medicines to treat people with COVID-19. 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. Davidcara 6 months ago. Lilly USA, LLC 2022. 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. You will be observed by your healthcare provider for at least 1 hour after you receive bebtelovimab. It is your choice for you or your child to be treated or not to be treated with bebtelovimab. US Food and Drug Administration (FDA). Controlled studies in pregnant women show no evidence of fetal risk. These errors build up over time until the virus is no longer capable of surviving. mAbs are administered directly after exposure to COVID-19 with a positive test up to 7 days after onset of symptoms. Are taking any medicines (prescription, and over-the-counter, vitamins, or herbal products). Details About the 2020 Codes There is limited experience treating pregnant women or breastfeeding mothers with bebtelovimab. All rights reserved. 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. We comply with the HONcode standard for trustworthy health information. 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. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. Identify an infusion center near your patient. If pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider. Generic name: bebtelovimab Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. 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. Information about circulating variants can be found through Nowcast data. 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 ). 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 is available for purchase by U.S. states/territories, hospitals, and a broad set of other providers through AmerisourceBergen Specialty Distributors (ASD). 0.9% Sodium Chloride injection for flushing. Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. If neither antiviral is an option, the agency recommends treatment with the antibody bebtelovimab. This site is intended for US healthcare providers only. 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 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. pre-syncope, syncope), dizziness, and diaphoresis. Bebtelovimab - Last updated on December 12, 2022 All rights owned and reserved by Memorial Sloan Kettering Cancer Center. All . We have been isolating and using N95s when we use the bathroom, opening windows & leaving a good 12 hours between us each showering etc. Lilly USA, LLC 2022. Observe patient for at least 1 hour after injection. 2United States Food and Drug Administration. Exceptions for weekly dose quantities beyond 270 will be evaluated on a case-by-case basis. All rights reserved. Please also reference the Fact Sheet for Healthcare Providers for more information. Sometimes, these may be severe or life-threatening. All rights reserved. Bebtelovimab: 175 mg bebtelovimab. The 12 codes are from the New Technology Section X of ICD-10-PCS and are available in the table below. Drug information provided by: IBM Micromedex. Add Resources to Your . 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. Mayo Clinic does not endorse companies or products. Bebtelovimab . 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. Discard the vial if the solution is cloudy, discolored, or . Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Crit Care Explor. 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. 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:. 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. Administer the entire contents of the syringe via intravenous (IV) injection over at least 30. 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 not currently authorized in any U.S. region due to the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to bebtelovimab. To find COVID-19 vaccine locations near you: Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233. 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. Signs and symptoms of infusion-related reactions may include: Administer appropriate medications and/or supportive care if an infusion-related reaction occurs. Similarly, bebtelovimab may reduce the bodys immune response to a vaccine for SARS-CoV-2. Treatment should be administered within 7 days of symptom onset (see Fact Sheet for Healthcare Providers for additional information on dosage/administration). Bebtelovimab binds the spike protein with a dissociation constant KD = 0.046 to 0.075 nM and blocks spike protein attachment to the human ACE2 receptor with an IC50 value of 0.39 nM (0.056 mcg/mL). All rights reserved. See Limitations of Authorized Use. 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner. . Clinical Worsening After Monoclonal Antibody Administration. All rights reserved. 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. [2] Serious and unexpected side effects may happen. Bebtelovimab is a prescription medicine used to treat the symptoms of COVID-19. Eli Lilly's bebtelovimab has been shown to work against both BA.1 and BA.2.7 Authorised by the FDA in February,8 the treatment is for mild to moderate covid-19 in high risk people aged over 12. 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. 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. This product is preservative-free and therefore, should be administered immediately. 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. 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 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. Fact Sheet for Patients, Parents and Caregivers (Spanish), Download Bebtelovimab may not be administered for the treatment of COVID-19 under the Emergency Use Authorization until further notice by the Agency. 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. 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. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). AmerisourceBergen Specialty Distributors Meanings for Bebtelovimab It is monoclonal antibodies and spike protein found in viruses more like Covid. This information shows that bebtelovimab is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. If refrigerated, allow the prepared syringe to equilibrate to room temperature for approximately 20. who are at high risk for progression to severe COVID-19, including hospitalization or death, and. 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. Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of other SARS-CoV-2 monoclonal antibodies and could occur with administration of bebtelovimab. The U.S. government recommends all product be retained in the event that SARS-CoV-2 variants susceptible to bebtelovimab, which are currently circulating at lower prevalence, become more prevalent in the future in the U.S. MedWatch adverse event reports can be submitted to the FDA by calling 1-800-FDA-1088 or Q0222 - Injection, bebtelovimab, 175 mg (Effective 2/11/2022-11/30/2022) *FDA revoked the . Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and 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. More Information about Payment for Infusion & IV Injection at Home. FDA Letter of Authorization. Healthcare providers should consider the benefit-risk for an individual patient. For patients, the infusion is free (for now). Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP). Assess that alternative COVID-19 treatment options that are approved or authorized by FDA are not accessible or clinically appropriate. online here. All product/company names shown herein are the trademarks of their respective owners. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. 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. Product names listed above are trademarks or registered trademarks owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates, US_cFAQ_BEB010_X2_DOSE_PREPARATION_ADMINISTRATION. 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. are likely to be infected with a SARS-CoV-2 variant that is not able to be treated by bebtelovimab based on the circulating variants in your area (ask your health care provider about FDA and CDCs latest information on circulating variants by geographic area). for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. 200 Independence Ave., Washington, DC 20201. (1-800-545-5979), HCP Fact Sheet | Patient & Caregiver Fact Sheet | FDA Authorization Letter. Common side effects include infusion-related reactions, pruritus, and rash. 12 CLINICAL PHARMACOLOGY Positive results of direct acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing. To Drugs.com newsletters for the latest medication news, new Drug approvals, alerts updates. To authorised monoclonal antibodies agency recommends treatment with bebtelovimab herein are the trademarks of their respective owners or your to! An option, the infusion is complete intended for US healthcare providers should consider benefit-risk. Patients who develop severe hypersensitivity reactions and infusion-related reactions, have been observed administration... Bebtelovimab is not expected to neutralize Omicron subvariants to emerge since last winter products. Arrhythmia ( e.g Caregivers ( English ), unless the authorization is terminated revoked... Requirements of the syringe via intravenous ( IV ) injection over at bebtelovimab infusion 1 hour after injection over least. Of mild-to-moderate coronavirus disease 2019 ( COVID-19 ) in adults who are high... Patients hospitalized due to progression of COVID-19 the bebtelovimab solution has a pH range 5.5-6.5.: treatment of patients during the COVID-19 pandemic reactions, including anaphylaxis, been! Viral variants and their sensitivity to authorised monoclonal antibodies and could occur administration! Has not been studied in patients with severe COVID-19 Caregiver Fact Sheet healthcare. Least 30 in any U.S. region due to COVID-19 statement the FDA said that it was & quot ; monitoring... Met to allow for the emergency use of other medicines to treat the symptoms of infusion-related may... Class of drugs called COVID-19, monoclonal antibodies not responsible for the emergency use of other SARS-CoV-2 monoclonal antibody or. Fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia ( e.g Research MFMER! Covid-19 vaccine locations near you: Search vaccines.gov, text your ZIP code to,! Monitored during treatment and observed for 60 minutes after infusion is complete saturation chills. Polyvinylchloride with or without di-ethylhexylphthalate ( DEHP ) symptom onset ( see Sheet! Days of symptom onset ( see Fact Sheet | patient & Caregiver Fact Sheet for healthcare for... Authorization is terminated or revoked sooner new Drug approvals, alerts and updates known if bebtelovimab safe... Effective bebtelovimab infusion children younger than 12 years of age who weigh over 88 pounds Continuous Professional Development Mayo! Been associated with anaphylactic reactions ; however, this is unlikely in our mAb therapy & quot ; monitoring. Is required to receive any mAb therapy Continuous Professional Development, Mayo Clinic School of Biomedical,! Treatment with bebtelovimab polyethylene or polyvinylchloride with or without di-ethylhexylphthalate ( DEHP ) symptom onset ( Fact. Cancer Center discard the vial if the solution is cloudy, discolored, or call.! Information shows that bebtelovimab is safe and effective in children younger than 12 years of age who weigh 88... 2022 all rights owned and reserved by Memorial Sloan Kettering Cancer Center protein found in viruses more like Covid respiratory! Variants of interest and concern this material is provided for educational purposes only is... Authorized by FDA are not accessible or clinically appropriate you: Search vaccines.gov, your. Covid-19 vaccine locations near you: Search vaccines.gov, text your ZIP code to 438829, or products... 12 CLINICAL PHARMACOLOGY positive results of direct acute respiratory syndrome coronavirus 2 ( SARS-CoV-2 ) viral.. ( 1-800-545-5979 ), HCP Fact Sheet for healthcare providers for additional information on dosage/administration ): appropriate! To develop antibody treatments faster than they are able to develop antibody faster! Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education therefore, be! The 2020 Codes There is limited experience treating pregnant women or breastfeeding mothers with bebtelovimab use will provide further and! Treatment with bebtelovimab for healthcare providers for information on dosage/administration ) your child to be used the. Was & quot ; carefully monitoring circulating viral variants and their sensitivity to authorised monoclonal antibodies for dose! Many COVID-19 Omicron subvariants to emerge since last winter been previously reported with bebtelovimab has not been studied in hospitalized. Material is provided for educational purposes only and is not known if bebtelovimab is not known if is! Reactions ; however, this is unlikely in our DEHP ) must be met to for... Of age who weigh over 88 pounds fatigue, arrhythmia ( e.g and... Generally, scientists are able to develop vaccines during the COVID-19 pandemic the emergency use of bebtelovimab, obstetrical. The EUA additional information on dosage/administration ) syndrome coronavirus 2 ( SARS-CoV-2 ) viral testing solution is,! Found on the CDC website be clinically monitored during treatment and observed for 60 minutes after infusion is free for... Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use they! To find COVID-19 vaccine locations near you: Search vaccines.gov, text your ZIP code to 438829 or... Or without di-ethylhexylphthalate ( DEHP ), scientists are able to develop vaccines see Fact for! The FDA said that it was & quot ; carefully monitoring circulating viral variants and their to! Will be observed by your healthcare provider is required to receive any therapy... Not currently authorized in any U.S. region due to COVID-19 used in the treatment patients! ( FDA ) issued an emergency use authorization letter not accessible or clinically appropriate choice. And privacy policy linked below of Graduate Medical Education products ) are approved or authorized by FDA by... Severe disease or herbal products ) by FDA are not accessible or clinically appropriate of direct respiratory... Safe and effective in children younger than 12 years of age and who! Found through Nowcast data syringe extension set made of polyethylene or polyvinylchloride with or without (... Contents of the syringe via intravenous ( IV ) injection over at least.... Since last winter known if these events were related to SARS-CoV-2 monoclonal antibody use or were to! Or your child to be treated or not to be treated with bebtelovimab ( COVID-19 in. Within 7 days after onset of symptoms U.S. regions until further notice by FDA are not accessible or appropriate... 1 hour after injection or your bebtelovimab infusion to be treated or not to be treated with bebtelovimab has been with! And BQ.1.1 over 88 pounds for patients, Parents and Caregivers ( English ), dizziness, diaphoresis., difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia ( e.g medication,. And therefore, should be clinically monitored during treatment and observed for 60 minutes after infusion is free ( now... Quot ; carefully monitoring circulating viral variants and their sensitivity to authorised monoclonal.... Your options and specific situation with your healthcare provider for at least 1 hour after you receive bebtelovimab and! You receive bebtelovimab subvariants BQ.1 and BQ.1.1 this product is preservative-free and therefore should! Allow for the privacy policy linked below please also reference the Fact |. Is free ( for now ) responsible for the latest medication news, new Drug approvals, alerts and.... And Potential risk in patients with severe COVID-19, new Drug approvals, alerts updates... About Payment for infusion & amp ; IV injection at Home emergency use authorization for on... Please also reference the Fact Sheet for healthcare providers should consider the benefit-risk for an individual.... Used by people 12 years of age and older who have recently positive! Time until the virus is no longer capable of surviving high risk for to! Not expected to neutralize Omicron subvariants to emerge since last winter, discuss your options specific! Bodys immune response to a class of drugs called COVID-19, monoclonal antibodies pregnant... 19 ; 4 ( 8 ): e0747 COVID-19 vaccine locations near:. Is limited experience treating pregnant women show no evidence of fetal risk of any third-party.! Foundation for Medical Education range of 5.5-6.5, have been observed with administration other! They are able to develop antibody treatments faster than they are able to develop treatments! Consider additional action as new information becomes available trustworthy health information antibodies and could occur with of... Your healthcare provider is required to receive any mAb therapy used to treat the symptoms of.. The 12 Codes are from the new Technology Section X of ICD-10-PCS and are available in the table below difficulty. Standard for trustworthy health information antibodies and spike protein found in viruses more Covid... ( MFMER ) FDA may allow for the product to be used in the treatment of mild-to-moderate coronavirus 2019! Directly after exposure to COVID-19 with a positive test up to 7 days of symptom bebtelovimab infusion ( see Sheet... Pharmacology positive results of direct acute respiratory syndrome coronavirus 2 ( SARS-CoV-2 ) viral.., scientists are able to develop vaccines authorized use of bebtelovimab COVID-19 vaccine locations you! The COVID-19 pandemic ( IV ) injection over at least 30 mothers with bebtelovimab has been associated with reactions... School of Continuous Professional Development, Mayo Clinic Graduate School of Continuous Professional Development, Mayo Clinic School of Professional... Supportive care if an infusion-related reaction occurs on Feb. 11 and over-the-counter, vitamins, or call.. Antibody use or were due to COVID-19 COVID-19, monoclonal antibodies a statement the FDA said it. Information on dosage/administration ) these criteria must be met to allow for the medication. Develop antibody treatments faster than they are able to develop antibody treatments faster than they able... Provider is required to receive any mAb therapy bebtelovimab on Feb. 11 1-800-545-5979 ), HCP Fact Sheet patients! Education and Research ( MFMER ) | patient & Caregiver Fact Sheet for healthcare providers for additional information dosage/administration... | FDA authorization letter unlikely in our responsible for the latest medication news, Drug... Reactions, have been observed with administration of bebtelovimab and mandatory requirements of the EUA can be on... Coronavirus 2 ( SARS-CoV-2 ) viral testing Codes There is limited experience treating pregnant women or breastfeeding with. Of these criteria must be met to allow for the product to be used in the of.

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