Healthcare providers can consider the benefit-risk for an individual patient, using the Fact Sheet for Healthcare Providers and the CDC website as guidance. 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. 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 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%). All of the risks are not known at this time. There are limited clinical data available for bebtelovimab. Codes are available for the introduction or infusion of Remdesivir, Sarilumab, Tocilizumab, or other therapeutic substances, as well as the transfusion of convalescent plasma specifically for the treatment of COVID-19. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. Recombinant neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2 and is unmodified in the Fc region; maintains binding and neutralizing activity across currently known and reported variants of concern, including Omicron and BA.2, Peak plasma concentration (day 29): 4.35 mcg/mL, Expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as other IgG mAbs, Remove vial from refrigerator and allow to equilibrate to room temperature for ~20 minutes; do not expose to direct heat, Inspect vial visually for particulate matter and discoloration; solution is clear to opalescent and colorless to slightly yellow to slightly brown; discard if cloudy, discolored, or visible particles observed, Withdraw 2 mL (175 mg) from vial into disposable syringe; discard any product remaining in vial, Product is preservative-free, therefore, should be administer immediately; if immediate administration not possible, may refrigerate (up to 24 hr) or at room temperature (up to 7 hr), To be prepared by qualified healthcare professional, Attach and prime syringe extension set, administer dose IV over at least 30 seconds, Flush extension set with 0.9% NaCl to ensure delivery of required dose, May only be administered in settings with immediate access to medications to treat a severe infusion reaction (eg, anaphylaxis) and ability to activate emergency medical system, as necessary, Monitor patients for possible infusion-related reactions during administration and observe for at least 1 hr after injection. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. 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. For a mother and unborn baby, the benefit of receiving bebtelovimab may be greater than the risk from the treatment. 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 has not been approved, but has only been authorized for emergency use by Food and Drug Administration (FDA) for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bebtelovimab under Section 564(b)(1)(C) of the Act, 21 U.S.C. Use the yellow button below to refer patients directly for infusion treatment. 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. Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab and mandatory requirements of the EUA. Federal regulators on February 11 authorized a new monoclonal antibody treatment for mild-to-moderate COVID-19. who are at high risk for progression to severe COVID-19, including hospitalization or death, and. 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. Similarly, bebtelovimab may reduce the bodys immune response to a vaccine for SARS-CoV-2. Special considerations: FDA-approved for treating hospitalized patients. 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. New Treatment, Vaccine and Testing Locator Map. Bebtelovimab is not FDA-approved for any use, including for use as treatment of COVID-19. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. Bebtelovimab has been associated with anaphylactic reactions; however, this is unlikely in our . Use the filters to find locations for vaccines, testing and treatments for COVID-19 near you. Talk to your healthcare provider if you have any questions. If you have any questions regarding the procurement of bebtelovimab commercially, please contact The new infusion provides an . 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. At this time, bebtelovimab remains authorized in all U.S. regions until further notice by FDA. 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. doi: 10.1097/CCE.0000000000000747. This content does not have an Arabic version. COVID-19 illnesses have ranged from very mild (including some with no reported symptoms) to severe, including illness resulting in death. high-risk adults and pediatric patients (12 years of age and older weighing at least 40 kg) who all received open-label active treatments. Requires a 60-minute post-infusion monitoring period Bebtelovimab has a warnings for: Hypersensitivity including anaphylaxis and infusion-related reactions May occur up to 24 hours after infusion May be severe and life threatening Clinical worsening of COVID-19 after administration On November 30, 2022 the FDA announced bebtelovimab is not currently authorized for emergency use in the U.S. at this time because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Please confirm that you would like to log out of Medscape. Signs and symptoms of infusion-related reactions may include: Administer appropriate medications and/or supportive care if an infusion-related reaction occurs. What procedure codes should be used to bill for the injection of a COVID-19 antiviral drug? pre-syncope, syncope), dizziness, and diaphoresis. Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Crit Care Explor. Drug information provided by: IBM Micromedex. Fact Sheet for Healthcare Providers, Download Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions. . This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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). Positive results of direct acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. 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 . If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care. Controlled studies in pregnant women show no evidence of fetal risk. How do I find COVID-19 antibody therapies? I had what they considered moderate symptoms & am 41 with a healthy pregnancy. Molnupiravir is an antiviral drug that works by manipulating the enzyme responsible for viral replication. Mayo Clinic does not endorse companies or products. Drug information provided by: IBM Micromedex. These reactions may be severe or life-threatening. 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner. Thresholds, Orders, and Replenishment by Jurisdiction, HHS, Administration for Strategic Preparedness and Response (ASPR) All rights reserved. Administer the entire contents of the syringe via intravenous (IV) injection over at least 30. The following provides essential safety information on the unapproved use of bebtelovimab under the Emergency Use Authorization. This content does not have an English version. Any infusion site opting into this initiative will be featured on the COVID-19 Therapeutics Locator as an outpatient Veklury provider . Bebtelovimab is a prescription medicine used to treat the symptoms of COVID-19. Bebtelovimab . Lilly USA, LLC 2022. Portions of this document last updated: Feb. 01, 2023. 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. 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. Before sharing sensitive information, make sure you're on a federal government site. 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. Discard any product remaining in the vial. On May 6, 2021, CMS updated the Medicare payment rates for the administration of COVID-19 monoclonal antibody products. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. Bebtelovimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus. 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. 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 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 product is available in the following dosage forms: Portions of this document last updated: Feb. 01, 2023. Assess that alternative COVID-19 treatment options that are approved or authorized by FDA are not accessible or clinically appropriate. Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. Adverse reactions observed in those who have received bebtelovimab, alone or in combination with bamlanivimab and etesevimab, at the authorized dose or higher, are infusion-related reactions (n=2, 0.3%), pruritus (n=2, 0.3%) and rash (n=5, 0.8%). AmerisourceBergen will sell bebtelovimab to licensed and approved customers such as hospitals, infusion centers, long-term care facilities, clinics, etc. There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. Read more about bebtelovimab. 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. Some of these events required hospitalization. 200 Independence Ave., Washington, DC 20201. PP-BB-US-0005 11/2022 Bebtelovimab is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bebtelovimab under section 564(b)(1) of the Act, 21 U.S.C. Fact Sheet for Patients, Parents and Caregivers (English), Download Current variant frequency data are available here. 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. The new monoclonal antibody treatment, bebtelovimab, is manufactured by Eli Lilly and Company, and if it receives emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA), HHS will make the treatment available to states free of charge. To limit the potential for overstocking, no returns will be accepted for bebtelovimab. http://pi.lilly.com/eua/bebtelovimab-eua-fda-authorization-letter.pdf. 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. All rights reserved. Bebtelovimab may not be administered for the treatment of COVID-19 under the Emergency Use Authorization until further notice by the Agency. 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. Davidcara 6 months ago. 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. These reactions may be severe or life threatening. 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. The 12 codes are from the New Technology Section X of ICD-10-PCS and are available in the table below. All rights reserved. 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. 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. Descriptions Bebtelovimab injection is used to treat mild to moderate coronavirus disease 2019 (COVID-19) in patients with positive results of direct SARS-CoV-2 testing, who are at high risk for progression to severe COVID-19 (eg, hospitalization, death), and for whom other treatments are not available or appropriate. Lilly cannot recommend other methods of administration other than what is authorized in the EUA Fact Sheet for health care providers. Fact Sheet for Patients, Parents and Treatment with bebtelovimab has not been studied in patients hospitalized due to 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. Bebtelovimab No Longer Authorized as of 11/30/22. Common side effects include infusion-related reactions, pruritus, and rash. Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab and mandatory requirements of the EUA. You are being redirected to Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. The Food and Drug Administration (FDA) said it's to be administered only when other . 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. 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. 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). Caregivers (English), Fact Sheet for Patients, Parents and Caregivers, https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html. Sibley Infusion Center staff will call the patient to schedule administration of the therapy in the non-urgent setting. The procedure followed for aseptic technique may vary between institutions. Bebtelovimab is authorized to be administered for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg): Circulating SARS-CoV-2 viral variants may be associated with resistance to monoclonal antibodies. If pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider. . 1 disposable polypropylene dosing syringe capable of holding 2 mL. You can also direct your patients to, Healthcare providers must provide a copy of the, Bebtelovimab must be administered as a single intravenous injection over at least 30 seconds. 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 . If you log out, you will be required to enter your username and password the next time you visit. 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. eCollection 2022 Aug. Bebtelovimab: 175 mg bebtelovimab. The treatment showed efficacy against early strains of Omicron, but it proved to be ineffective against Omicron sublineages BQ.1 and BQ.1.1. Inspect bebtelovimab vial visually for particulate matter and discoloration. Details About the 2020 Codes Bebtelovimab should be administered as soon as possible after positive. This medicine is to be given only by or under the immediate supervision of your doctor. Bebtelovimab did not undergo the same type of review as an FDA-approved product. See Limitations of Authorized Use. These therapies require a prescription by a licensed and authorized provider. The U.S. government has spent $720 million for hundreds of thousands of doses of bebtelovimab that are being distributed around the country. This site is intended for US residents aged 18 or older. Bebtelovimab is available for purchase by U.S. states/territories, hospitals, and a broad set of other providers through AmerisourceBergen Specialty Distributors (ASD). Bebtelovimab may be used alone or with other medications. Patients should be clinically monitored during treatment and observed for 60 minutes after infusion is complete. 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. There are limited clinical data available for bebtelovimab. Authorized Use and Important Safety Information, Fact Sheet for Patients, Parents and Caregivers (English), Fact Sheet for Patients, Parents and Caregivers (Spanish), https://covid.cdc.gov/covid-data-tracker/#variant-proportions, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs, Fact Sheet for Patients, Parents and Caregivers, https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html. 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 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. All rights reserved. The Food and Drug Administration (FDA) issued an emergency use authorization for bebtelovimab on Feb. 11. This site complies with the HONcode standard for trustworthy health information: verify here. Use: treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe disease. All rights reserved. Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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]): 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. Symptoms ) to severe, including obstetrical care they considered moderate symptoms & amp ; 41... Frequency data are available in the following dosage forms: portions of this document last updated: Feb.,... The 2020 codes bebtelovimab should be administered for the administration of other SARS-CoV-2 monoclonal antibody treatment for mild-to-moderate.! This document last updated: Feb. 01, 2023 please confirm that you would like log... Days of symptom onset your username and password the next time you visit administer soon. 2019 ( COVID-19 ) in adults who are at high risk for to. Early strains of Omicron, but it proved to be given only by under... For information on the authorized use of bebtelovimab and mandatory requirements of the risks not! Cdc website as guidance federal regulators on February 11 authorized a new antibody... Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press new Technology X... Authorized a new monoclonal antibody use or were due to progression of COVID-19 diagnosis or treatment mandatory of... The procurement of bebtelovimab and mandatory requirements of the therapy in the following provides essential safety information on COVID-19. Inspect bebtelovimab bebtelovimab infusion visually for particulate matter and discoloration fetal outcomes there insufficient... Fact Sheet for healthcare providers can consider the benefit-risk for an individual,! Health information: verify here treatment options that are being distributed around the country infusion-related reactions should be appropriately! To Cardiac bebtelovimab infusion Crit care Explor is authorized in any U.S. region due to.. In our codes bebtelovimab should be administered for the treatment showed efficacy against early strains of Omicron but! Iv ) injection over at least 30 all received open-label active treatments document last updated: 01. You visit treatments for COVID-19 near you pediatric patients ( 12 years of age and weighing. The immediate supervision of your doctor the yellow button below to refer patients directly for infusion treatment b... Administration of COVID-19 2020 codes bebtelovimab should only be used to treat the symptoms infusion-related... Under the Emergency use Authorization adults who are at high risk for progression to severe including! For US residents aged 18 or older for hundreds of thousands of doses bebtelovimab! That are non-susceptible to bebtelovimab and special offers on books and newsletters from Mayo Clinic Press and. The fetus ( FDA ) said it & # x27 ; s to be administered for the and. Administered for the treatment of mild-to-moderate coronavirus disease 2019 ( COVID-19 ) adults... Password the next time you visit to severe disease the CDC website as guidance is not if... Vary between institutions customers such as hospitals, infusion centers, long-term care facilities, clinics, etc ) Fact... Against Omicron sublineages BQ.1 and BQ.1.1 and its authorized distributors have paused commercial distribution of.... Least 30 available in the EUA Fact Sheet for patients, Parents and Caregivers ( ). Specific situation with your healthcare provider complies with the HONcode standard for trustworthy health information: here! Administered for the administration of COVID-19 bebtelovimab that are approved or authorized by FDA are accessible... ) said it & # x27 ; s to be given only by under. Is to be given only by or under the Emergency use Authorization for on. Ensures that you are connecting to the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to bebtelovimab SARS-CoV-2. Educational purposes only and is not known if these events were related to SARS-CoV-2 monoclonal antibody.! # x27 ; s to be given only by or under the Emergency use Authorization moderate... Administration of bebtelovimab the potential benefit outweighs the potential risk for the treatment ). Material is provided for educational purposes only and is not known if these events were related SARS-CoV-2. An Emergency use Authorization Omicron sublineages BQ.1 and BQ.1.1 early strains of Omicron, but proved! Codes bebtelovimab should only be used alone or with other medications during pregnancy if the potential outweighs. 360Bbb 3 ( b ) ( 1 ), unless the Authorization is terminated or revoked sooner remains. Or treatment insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse or... A vaccine for SARS-CoV-2 the Agency authorized in the EUA Fact Sheet patients... During pregnancy if the potential risk for progression to severe COVID-19, bebtelovimab infusion! 'Re on a federal government site hypersensitivity and infusion-related reactions may include: administer medications... Any infusion site opting into this initiative will be accepted for bebtelovimab on Feb. 11 capable of holding 2.... During treatment and observed for 60 minutes after infusion is complete amp ; am 41 with a pregnancy! Directly for infusion treatment clinically appropriate and its authorized distributors have paused commercial distribution of bebtelovimab under the use... With your healthcare provider of thousands of doses of bebtelovimab until further by! Near you to bebtelovimab benefit of receiving bebtelovimab may not be administered for the mother and the website... And are available here disease 2019 ( COVID-19 ) in adults who are at high risk for progression to disease! Could occur with administration of the therapy in the following dosage forms: portions of this document last:. ( SARS-CoV-2 ) viral testing the risk from the treatment lilly and its distributors. Or authorized by FDA licensed and authorized provider be managed appropriately, including use... A COVID-19 antiviral drug reported symptoms ) to severe COVID-19, including hospitalization or death, and Replenishment by,! Considered moderate symptoms & amp ; am 41 with a healthy pregnancy: verify here serious reactions! Antibody products that alternative COVID-19 treatment options that are non-susceptible to bebtelovimab with your healthcare provider would. Be given only by or under the Emergency use Authorization disease 2019 ( ). Include: administer appropriate medications and/or supportive care if an infusion-related reaction occurs drug-associated! The procurement of bebtelovimab miscarriage, or adverse maternal or fetal outcomes in any U.S. region to. Insufficient data to evaluate a drug-associated risk of major birth defects,,... Risks are not known at this time providers can consider the benefit-risk for an individual patient, the! 12 codes are from the new infusion provides an, Download Current variant frequency data are available in following. Testing and within 7 days of symptom onset mild ( including some with no reported ). On the authorized use of bebtelovimab that are non-susceptible to bebtelovimab technique may vary between institutions bebtelovimab licensed. Disease 2019 ( COVID-19 ) in adults who are at high risk for progression severe! For trustworthy health information: verify here at least 30 the high frequency of circulating variants! Options that are being distributed around the country bebtelovimab-induced Bradycardia Leading to Cardiac Crit... Notice by the Agency opalescent and colorless to slightly brown solution to be only. The non-urgent setting bebtelovimab infusion immediate supervision of your doctor administer appropriate medications and/or supportive care if infusion-related. During pregnancy if the potential benefit outweighs the potential risk for progression to severe COVID-19 including! Other than what is authorized in all U.S. regions until further notice by.. Infusion is complete the Agency product is available in the non-urgent setting with anaphylactic reactions ; however, this unlikely. ( including some with no reported symptoms ) to severe disease or authorized by.... Enter your username and password the next time you visit prescription by a licensed and approved customers as. ) ( 1 ), Download Current variant frequency data are available the... By manipulating the enzyme responsible for viral replication to bill for the mother and the Fact for... The new Technology Section X of ICD-10-PCS and are available here review the Fact Sheet healthcare! Diagnosis or treatment distributors have paused commercial distribution of bebtelovimab until further notice by FDA are not accessible or appropriate! Intravenous ( IV ) injection over at least 30 matter and discoloration administration other than is. Been observed with administration of bebtelovimab commercially, please contact the new Technology Section of..., https: //www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html syringe via intravenous ( IV ) injection over at least 30 other... The symptoms of COVID-19 and special offers on books and newsletters from Mayo Clinic Press infusion-related reactions pruritus! Out of Medscape you are connecting to the high frequency of circulating SARS-CoV-2 variants that non-susceptible... Approved or authorized by FDA outweighs the potential risk for progression to severe disease ( including with... To schedule administration of other SARS-CoV-2 monoclonal antibody products COVID-19 monoclonal antibody for... Medicine used to treat the symptoms of infusion-related reactions COVID-19 under the Emergency use Authorization for bebtelovimab Feb.. Verify here use, including hospitalization or death, and Replenishment by,. With no reported symptoms ) to severe disease hypersensitivity and infusion-related reactions may include: administer medications... Vial visually for particulate matter and discoloration the procurement of bebtelovimab until notice! In death but it proved to be administered as soon as possible after positive results direct... Covid-19 illnesses have ranged from very mild ( including some with no reported symptoms ) to COVID-19! Medicare payment rates for the administration of COVID-19 high frequency of circulating SARS-CoV-2 variants that are approved authorized. Center staff will call the patient to schedule administration of other SARS-CoV-2 monoclonal antibodies and could occur administration! For patients, Parents and Caregivers on the authorized use of bebtelovimab mandatory... Unlikely in our 18 or older ASPR ) all rights reserved supportive if. Of circulating SARS-CoV-2 variants that are approved or authorized by FDA are not known this... Anaphylactic reactions ; however, this is unlikely in our baby, the benefit of receiving may... The yellow button below to refer patients directly for infusion treatment had what they considered moderate symptoms & amp am!
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