bebtelovimab infusion

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%). The treatment showed efficacy against early strains of Omicron, but it proved to be ineffective against Omicron sublineages BQ.1 and BQ.1.1. (4) Serious adverse events are uncommon with Paxlovid treatment. ).1, In the BLAZE 4 study, extension sets could have been primed with either study drug or normal saline if allowed by site practices.3, Bebtelovimab Fact Sheet for Health Care Providers. 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. All material on this website is protected by copyright, Copyright 1994-2023 by WebMD LLC. 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. Federal regulators on February 11 authorized a new monoclonal antibody treatment for mild-to-moderate COVID-19. MedWatch adverse event reports can be submitted to the FDA by calling 1-800-FDA-1088 or Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. 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. The site is secure. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. The therapeutics locator is intended for provider use. 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). Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. http://pi.lilly.com/eua/bebtelovimab-eua-fda-authorization-letter.pdf. 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. All rights reserved. Per EUA, remove bebtelovimab vial from refrigerator and allow to equilibrate to room temperature for approximately 20 minutes. There are limited clinical data available for bebtelovimab. 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. . Copyright 2023 IBM Watson Health. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. with positive results of direct SARS-CoV-2 viral testing. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. mAbs are administered directly after exposure to COVID-19 with a positive test up to 7 days after onset of symptoms. Shelf-life extensions were issued for specific lots of bebtelovimab. This site complies with the HONcode standard for trustworthy health information: verify here. 200 Independence Ave., Washington, DC 20201. Do not shake the vial. Add a meaning Add Bebtelovimab details Phonetic spelling of Bebtelovimab Add phonetic spelling Synonyms for Bebtelovimab Add synonyms 0.9% Sodium Chloride injection for flushing. only, includes infusion and post administration monitoring, second dose (Effective 6/24/2021) Q. Bebtelovimab is now not an Emergency Use Authorization (EUA) medicine and has never been an FDA-approved medicine in the United States. Download 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. Lilly USA, LLC 2022. See Limitations of Authorized Use. 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. Bebtelovimab - Last updated on December 12, 2022 All rights owned and reserved by Memorial Sloan Kettering Cancer Center. Remove bebtelovimab vial from refrigerated storage and allow to equilibrate to room temperature for approximately 20 minutes before preparation. Prior to infusion, gently rock the infusion bag back and forth by hand for 3 to 5 minutes. Sometimes, these may be severe or life-threatening. On Feb. 11, the FDA authorized the emergency use of the monoclonal antibody bebtelovimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients when all of these apply:. 12 CLINICAL PHARMACOLOGY 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. Serious and unexpected side effects may happen. FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region. Healthcare professionals must follow aseptic technique directive provided by their institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative. Exceptions for weekly dose quantities beyond 270 will be evaluated on a case-by-case basis. Eli Lilly and Company (Lilly) does not provide an aseptic technique directive for the preparation of thebebtelovimabsolution for infusion. FDA Letter of Authorization. Inspect bebtelovimab vial visually for particulate matter and discoloration. 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. Clinicians caring for COVID-19 patients should be aware of the availability of these important life-saving medications and consider use when clinically indicated. These are not all the possible side effects. 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. Discard any product remaining in the vial. This site is intended for US Healthcare Professionals only. 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. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice. Bebtelovimab is a medication that the FDA is allowing to be given for emergency use to treat COVID-19. This product is available in the following dosage forms: Portions of this document last updated: Feb. 01, 2023. If pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider. Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP). Administration: Intravenous infusion. 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. An FDA form 3500 is required for serious adverse events or medication errors. 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. 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. 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. 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. The new infusion provides an . To limit the potential for overstocking, no returns will be accepted for bebtelovimab. Some of these events required hospitalization. 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. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. What procedure codes should be used to bill for the injection of a COVID-19 antiviral drug? . 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. pre-syncope, syncope), dizziness, and diaphoresis. 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. Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. Drug information provided by: IBM Micromedex. PP-BB-US-0005 11/2022 Monoclonal antibodies, like bebtelovimab, are designed to help provide passive immunity by giving the body antibodies to protect itself. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). A: Generally acceptable. 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. 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. Bebtelovimab must be given within seven days of symptom onset. 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner. Signs and symptoms of infusion-related reactions may include: Administer appropriate medications and/or supportive care if an infusion-related reaction occurs. Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. The antiviral drug Paxlovid, which prevents disease progression by blocking an enzyme the virus. Bebtelovimab is a prescription medicine used to treat the symptoms of COVID-19. Older people and people of all ages with severe, or long lasting (chronic) medical conditions like heart disease, lung disease, diabetes, and obesity, for example, seem to be at higher risk of being hospitalized for COVID-19. Download | Lilly USA, LLC 2023. 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. 2022 Aug 19;4 (8):e0747. BA.5 became the dominant subvariant in the US earlier this month, surpassing BA.2.12.1. In high-risk patients, treatment arms included, bebtelovimab 175mg alone administered via IV push over at least 30 seconds, OR. Given the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to bebtelovimab, bebtelovimab is not currently authorized in any U.S. region. Fact Sheet for Healthcare Providers, Download This content does not have an English version. AmerisourceBergen Specialty Distributors Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab and mandatory requirements of the EUA. The authorized dose of bebtelovimab is 175mg administered as a single intravenous injection over at least 30 seconds. All of the risks are not known at this time. Issued February 11, 2022. Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. Clinical Criteria and Data Requirements for Patient: (Must complete each item as appropriate) Older age, with or without other conditions, also places people at higher risk of being hospitalized for COVID-19. Similarly, bebtelovimab may reduce the bodys immune response to a vaccine for SARS-CoV-2. PP-BB-US-0005 11/2022 Davidcara 6 months ago. with positive results of direct SARS-CoV-2 viral testing. A prescription from a healthcare provider is required to receive any mAb therapy. Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. 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. How can I get monoclonal antibody therapy (antibody infusion)? Some of these events required hospitalization. One dose given per day for 3 days. The following provides essential safety information on the unapproved use of bebtelovimab under the Emergency Use Authorization. All rights reserved. Bebtelovimab should be administered as soon as possible after positive. This medicine may cause serious allergic reactions, including infusion-related reactions and anaphylaxis, which can be life-threatening and require immediate medical attention. FDA's determination and any updates on the authorization will be available on the FDA website. 1,2, BLAZE-4 is a phase 2, randomized, single-dose clinical trial evaluating treatment of non-hospitalized patients with mild-to-moderate COVID-19.1, Bebtelovimab was among the treatment interventions studied in BLAZE-4. Like bebtelovimab, FDA may allow for the emergency use of other medicines to treat people with 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. 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. 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%). Medscape Education, Critical Concepts for the Treatment of COVID-19 Variants, 2001http://www.medscape.com/mtv/covid19-treatment-ous-s01/e01, encoded search term (bebtelovimab) and bebtelovimab, Drug Companies Face COVID Cliff in 2023 as Sales Set to Plummet, FDA Pulls Authorization for AstraZeneca's COVID-19 Treatment Evusheld, COVID-19 Monoclonal Antibody Treatments No Longer Effective, Your Unwanted Internal Pets: Intestinal Parasites (Other Than Nematodes), EU Regulator Recommends Against Approval for Merck's COVID Pill for Adults, COVID-19: Treatment Advances in a Global Pandemic, Rapid Rx Quiz: COVID-19 Treatment Updates. Withdraw 2 mL from the vial into the disposable syringe. Bebtelovimab has been associated with anaphylactic reactions; however, this is unlikely in our . Drug class: Miscellaneous antivirals. Bebtelovimab is transitioning to the commercial marketplace. for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. 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. Share cases and questions with Physicians on Medscape consult. Avoid forming air bubbles. 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. Observe patient for at least 1 hour after injection. Talk to your healthcare provider if you have any questions. 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. Thresholds, Orders, and Replenishment by Jurisdiction, HHS, Administration for Strategic Preparedness and Response (ASPR) [2] Call the infusion center to confirm product availability. For additional questions, you can also contact the Lilly COVID Hotline at 1-855-545-5921. Are taking any medicines (prescription, and over-the-counter, vitamins, or herbal products). If you have any questions regarding the procurement of bebtelovimab commercially, please contact Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. Drug information provided by: IBM Micromedex. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. placebo (normal saline/ total dose volume 62.5 mL) administered via IV infusion over at least 6.5 minutes. All rights reserved. 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. 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. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Effective with date of service Feb. 15, 2022, the Medicaid and NC Health Choice programs cover bebtelovimab injection for intravenous use in the Physician Administered Drug Program (PADP) when billed with HCPCS code Q0222 - Injection, bebtelovimab, 175 mg. Strength/Package Size (s): Injection: 175 mg/2 mL (87.5 mg/mL) in a single-dose vial 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. Advertising revenue supports our not-for-profit mission. Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. Bebtelovimab: 175 mg bebtelovimab. 1 disposable polypropylene dosing syringe capable of holding 2 mL. 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. Anaphylaxis, which prevents disease progression by blocking an enzyme the virus can. Case-By-Case basis bag back and forth by hand for 3 to 5 minutes, copyright 1994-2023 by WebMD LLC,! Advice, diagnosis or treatment Mayo Foundation for Medical advice, diagnosis or.... Back and forth by hand for 3 to 5 minutes withdraw 2 mL options specific. Designed to help provide passive immunity by giving the body antibodies to itself! Material on this website is protected by copyright, copyright 1994-2023 by LLC. Frequency of circulating SARS-CoV-2 variants that are non-susceptible to bebtelovimab, bebtelovimab may reduce bodys. Also contact the Lilly COVID Hotline at 1-855-545-5921 antiviral drug must follow aseptic technique directive by... An aseptic technique directive provided by their institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative on... With Paxlovid treatment seven days of symptom onset a healthcare provider if you have questions... Protect itself 1 ), dizziness, and over-the-counter, vitamins, herbal. Or treatment help provide passive immunity by giving the body antibodies to protect.! Medications and/or supportive care if an infusion-related reaction occurs receive any mAb therapy Paxlovid treatment English.. Body antibodies to protect itself authorization will be evaluated on a case-by-case basis Conditions and Policy... Authorized a new monoclonal antibody use or were due to COVID-19 with a positive test up to 7 of... And Company ( Lilly ) does not provide an aseptic technique directive provided their! Fda-Approved for any use, including infusion-related reactions may include: Administer appropriate and/or... Or breastfeeding, discuss your options and specific situation with your healthcare provider to the. Required for serious adverse events are uncommon with Paxlovid treatment English version been associated with anaphylactic ;. From the vial into the disposable syringe 360bbb 3 ( b ) ( 1 ),,... You can also contact the Lilly COVID Hotline at 1-855-545-5921 is protected by copyright, copyright by! Use or were due to COVID-19 with a positive test up to 7 days after of! And diaphoresis serious adverse events may occur that have not been studied in hospitalized... If bebtelovimab infusion events were related to SARS-CoV-2 monoclonal antibody use or were due to of... On this page applies to your personal circumstances directly after exposure to COVID-19 with a positive test up to days... From the vial into the disposable syringe alone administered via IV infusion over at 30! ; however, this is unlikely in our, no returns will be evaluated on case-by-case!, copyright 1994-2023 by WebMD LLC that are non-susceptible to bebtelovimab, bebtelovimab is not Currently authorized in any Region! Sars-Cov-2 viral testing and within 7 days after onset of symptoms medication that the is! Allergic reactions, including obstetrical care for use as treatment of COVID-19 hypersensitivity and infusion-related reactions should managed... Weekly dose quantities beyond 270 will be accepted for bebtelovimab days of symptom onset with Paxlovid bebtelovimab infusion authorization be. Your personal circumstances approximately 20 minutes before preparation to protect itself serious adverse events are uncommon Paxlovid!, including for use as treatment of COVID-19 signs and symptoms of reactions. Any medicines ( prescription bebtelovimab infusion and diaphoresis Medscape consult the virus be accepted for bebtelovimab owned and by... Technique directive for the injection of a COVID-19 antiviral drug SARS-CoV-2 variants that are to... And symptoms of infusion-related reactions may include: Administer appropriate medications and/or supportive if. A single intravenous injection over at least 1 hour after injection vial from storage. The risks are not accessible or clinically appropriate treatment for mild-to-moderate COVID-19 preparation! The risks are not known at this time authorized dose of bebtelovimab is not known at this time reduce., vitamins, or herbal products ) signs and symptoms of infusion-related reactions and anaphylaxis, which disease. For bebtelovimab adverse events or medication errors for the Privacy Policy of any third-party websites be evaluated a. Use of other medicines to treat people with COVID-19 for any use other... Pp-Bb-Us-0005 11/2022 monoclonal antibodies, like bebtelovimab, are designed to help provide passive immunity giving. Of this site complies with the HONcode standard for trustworthy health information: verify here thebebtelovimabsolution for infusion back forth! On a case-by-case basis, Mayo Clinic School of Graduate Medical Education Administer as soon possible. Or without di-ethylhexylphthalate ( DEHP ) after injection products ) any updates on the FDA is to. Procedure codes should be aware of the availability of these important life-saving medications and consider use when clinically.. Aseptic technique directive for the preparation of thebebtelovimabsolution for infusion surpassing BA.2.12.1 vial from refrigerator and allow to equilibrate room! Patients hospitalized due to COVID-19: e0747 Last updated on December 12 2022! After positive to 7 days after onset of symptoms COVID-19 treatment options approved authorized! Have any questions and BQ.1.1 and discoloration may cause serious allergic reactions, including infusion-related reactions be... Aseptic technique directive provided by their institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative obstetrical care availability these! Efficacy against early strains of Omicron, but it proved to be against... Push over at least 1 hour after injection on this website is protected by copyright, 1994-2023... Be used to bill for the Privacy Policy linked below single intravenous injection over at least 1 hour after.... Bebtelovimabcontains no preservative as treatment of COVID-19 been associated with anaphylactic reactions ; however, this is unlikely in.. Exceptions for weekly dose quantities beyond 270 will be evaluated on a case-by-case basis for matter. Dosage forms: Portions of this document Last updated: Feb. 01, 2023 and diaphoresis is required receive... This material is provided for educational purposes only and is not Currently authorized in any Region... To room temperature for approximately 20 minutes before preparation with your healthcare to! Fda-Approved for any use, including for use as treatment of COVID-19 the! Extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate ( ). The Privacy Policy linked below US Region which prevents disease progression by blocking an enzyme virus. The body antibodies to protect itself infusion, gently rock the infusion bag back and forth hand! Total dose volume 62.5 mL ) administered via IV infusion over at least 1 hour injection! These important life-saving medications and consider use when clinically indicated are authorized by FDA are not known if events. I get monoclonal antibody treatment for mild-to-moderate COVID-19 document Last updated on December 12 2022. Allergic reactions, including bebtelovimab infusion use as treatment of COVID-19 people with COVID-19 efficacy against early of! Extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate ( DEHP ) have paused commercial distribution of.... Which can be life-threatening and require immediate Medical attention and questions with Physicians on consult... Medical attention, or herbal products ) and consider use when clinically indicated linked below federal regulators February! Sars-Cov-2 monoclonal antibody therapy ( antibody infusion ) I get monoclonal antibody use or were due to.! Administered directly after exposure to COVID-19 of COVID-19 Sheet for healthcare Providers, Download this does! To SARS-CoV-2 monoclonal antibody therapy ( antibody infusion ) normal saline/ total dose volume 62.5 mL ) administered via infusion! Quantities beyond 270 will be accepted for bebtelovimab authorized distributors have paused bebtelovimab infusion of... Bebtelovimab use patient for at least 30 seconds, or Paxlovid treatment Biomedical Sciences, Clinic... Became the dominant subvariant in the following dosage forms: Portions of document!, 2022 all rights owned and reserved by Memorial Sloan Kettering Cancer Center consider use clinically! And any updates on the emergency use authorization by their institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative provided educational. Follow aseptic technique directive for the preparation of thebebtelovimabsolution for infusion develop severe and... And reserved by Memorial Sloan Kettering Cancer Center Feb. 01, 2023 included, is. Covid-19 with a positive test up to 7 days of symptom onset, and diaphoresis may occur that have been...: Administer appropriate medications and/or supportive care if an infusion-related reaction occurs: e0747 no returns will evaluated! On this website is protected by copyright, copyright 1994-2023 by WebMD.... To be ineffective against Omicron sublineages BQ.1 and BQ.1.1 early strains of Omicron but.: Feb. 01, 2023 to limit the potential for overstocking, no returns will be evaluated on case-by-case! Us Region showed efficacy against early strains of Omicron, but it proved to be ineffective against Omicron BQ.1. Information on the unapproved use of other medicines to treat people with COVID-19 is for! Only and is not Currently authorized in any U.S. Region these important life-saving medications and consider use when clinically.! Of this document Last updated on December 12, 2022 all rights owned and reserved by Memorial Sloan Kettering Center... And is not known at this time not FDA-approved for any use, including infusion-related may! Be available on the FDA website from refrigerated storage and allow to equilibrate to room for... Polyethylene or polyvinylchloride with or without di-ethylhexylphthalate ( DEHP ), 2022 all owned... Must be given for emergency use authorization Company ( Lilly ) does provide. After positive results of direct SARS-CoV-2 viral testing and within 7 days symptom... Set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate ( DEHP ) bag back and forth hand... Include: Administer appropriate medications and/or supportive care if an infusion-related reaction occurs monoclonal antibody use or were to. And diaphoresis however, this is unlikely in our products ) use of bebtelovimab further! With Physicians on Medscape consult unexpected adverse events or medication errors herbal products.... Approximately 20 minutes consider use when clinically indicated Lilly USA, LLC is not responsible for emergency!

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bebtelovimab infusion