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. . with positive results of direct SARS-CoV-2 viral testing. 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. 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. COVID-19 illnesses have ranged from very mild (including some with no reported symptoms) to severe, including illness resulting in death. Well, after many phone calls, got the bebtelovimab this afternoon. 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. PP-BB-US-0005 11/2022 Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. Fact Sheet for Patients, Parents and Caregivers (English), Download Provide your patient with resources to ensure they have the answers they need. for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. 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. There are limited clinical data available for bebtelovimab. After the entire contents of the syringe have been administered. Molnupiravir is an antiviral drug that works by manipulating the enzyme responsible for viral replication. with positive results of direct SARS-CoV-2 viral testing. All rights reserved. BA.5 became the dominant subvariant in the US earlier this month, surpassing BA.2.12.1. Per EUA, remove bebtelovimab vial from refrigerator and allow to equilibrate to room temperature for approximately 20 minutes. Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Crit Care Explor.
Add a meaning Add Bebtelovimab details Phonetic spelling of Bebtelovimab Add phonetic spelling Synonyms for Bebtelovimab Add synonyms Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. Please see the enclosed Fact Sheet for authorized dosing information. 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. Withdraw 2 mL from the vial into the disposable syringe. 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. Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER).
Clinicians caring for COVID-19 patients should be aware of the availability of these important life-saving medications and consider use when clinically indicated. If pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider. mAbs are administered directly after exposure to COVID-19 with a positive test up to 7 days after onset of symptoms. Healthcare providers should consider the benefit-risk for an individual patient. Important points to this press release: "Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. If you have any questions regarding the procurement of bebtelovimab commercially, please contact 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. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. 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. Treatment should be administered within 7 days of symptom onset (see Fact Sheet for Healthcare Providers for additional information on dosage/administration). (1-800-545-5979), HCP Fact Sheet | Patient & Caregiver Fact Sheet | FDA Authorization Letter. Bebtelovimab is transitioning to the commercial marketplace. My doc said because I was on other meds and supplements that this would be safer than paxlovid because Of interactions. 1 Bebtelovimab vial (175 mg/2 mL) 1 disposable polypropylene dosing syringe capable of holding 2 mL 0.9% Sodium Chloride Injection for flushing Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP) Preparation Bebtelovimab belongs to a class of drugs called COVID-19, Monoclonal Antibodies.
who are at high risk for progression to severe COVID-19, including hospitalization or death.
Use the filters to find locations for vaccines, testing and treatments for COVID-19 near you. Details About the 2020 Codes 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. Common side effects include infusion-related reactions, pruritus, and rash. This medicine may cause serious allergic reactions, including infusion-related reactions and anaphylaxis, which can be life-threatening and require immediate medical attention. There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP). Bebtelovimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus. These therapies require a prescription by a licensed and authorized provider. [2] ).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. This website also contains material copyrighted by 3rd parties. 1For information on medical conditions and factors associated with increased risk for progression to severe COVID-19, see the Centers for Disease Control and Prevention (CDC) website: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html. Contact your healthcare provider if you have any side effects that bother you or do not go away. Drug information provided by: IBM Micromedex. 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. 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. 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. The 12 codes are from the New Technology Section X of ICD-10-PCS and are available in the table below. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Use the yellow button below to refer patients directly for infusion treatment. 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. Controlled studies in pregnant women show no evidence of fetal risk. Fact Sheet for Healthcare Providers, Download
The EUA for bebtelovimab was in effect until revoked due it not being expected to neutralize the current Omicron subvariants BQ.1 and BQ.1.1, therefore bebtelovimab can no longer be used under the EUA. To limit the potential for overstocking, no returns will be accepted for bebtelovimab. In the BLAZE-4 clinical trial, bebtelovimab was administered via IV infusion or IV push.3, In the Phase 1 portion of the study, faster infusion rates of bebtelovimab or bebtelovimab administered with bamlanivimab and etesevimab were not associated with an increasing number and/or severity of treatment-emergent adverse events.3, Informed by this data, bebtelovimab was administered to patients at high-risk for severe disease with an IV injection of at least 30 seconds while bebtelovimab with bamlanivimab and etesevimab was administered over at least 6.5 minutes.3, The study data from BLAZE-4 supports administration via IV push over 30 seconds, which is the authorized administration for bebtelovimab under the EUA.1,3, Considering bebtelovimab can be administered over 30 seconds, IV push of the medication saves considerable time relative to the preparation and administration of an IV infusion and may facilitate greater treatment capacity and flexibility throughout infusion centers.3, There is no sufficient data available to support the administration of bebtelovimab via subcutaneous or intramuscular dosing.3. Other risk factors can be found on the CDC website. 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 a monoclonal antibody treatment that had its FDA authorization paused in November 2022. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. We encourage you to read the privacy policy of every website you visit.Click "Continue" to proceed or "Return" to return to LillyMedical.com. Bebtelovimab may not be administered for the treatment of COVID-19 under the Emergency Use Authorization until further notice by the Agency. 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. Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions. To ensure there is no break in availability of bebtelovimab to states/territories and providers, HHS has coordinated with Lilly to enable the transition from US government distributed supply to commercially available supply. Lilly USA, LLC 2022. fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. Lilly USA, LLC 2022. All rights reserved. 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. Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab and mandatory requirements of the EUA. 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. Davidcara 6 months ago. The EUA has since been revoked on November 30, 2022. Bebtelovimab works by binding to the spike protein of the virus that causes COVID-19, similar to other mAbs that have been authorized for the treatment of high-risk patients with mild to moderate COVID-19 and shown a benefit in reducing the risk for hospitalization or death. This site complies with the HONcode standard for trustworthy health information: verify here. Tell your doctor right away if you feel confused, tired, or weak. It is very important that your doctor check you or your child's progress closely while you are receiving this medicine to make sure that it is working properly. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. 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 has not been approved, but has been authorized for emergency use by the FDA under an EUA, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. . 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Lilly cannot recommend other methods of administration other than what is authorized in the EUA Fact Sheet for health care providers. pre-syncope, syncope), dizziness, and diaphoresis. 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 This information is provided in response to your request. Remove bebtelovimab vial from refrigerated storage and allow to equilibrate to room temperature for approximately 20 minutes before preparation. Or weak chills, fatigue, arrhythmia ( e.g controlled studies in pregnant women show no of! Major birth defects, miscarriage, or weak the Agency paxlovid because of interactions is not known these... Positive test up to 7 days of symptom onset ( see Fact Sheet | FDA Authorization paused in November.. Material copyrighted by 3rd parties if you have Any side effects that bother you or do not go away Fact! Sheet for authorized dosing information treatment options approved or authorized by FDA are not accessible or clinically appropriate or by... Arrest bebtelovimab-induced Bradycardia Leading to Cardiac Arrest bebtelovimab-induced Bradycardia Leading to Cardiac Arrest bebtelovimab-induced Bradycardia Leading to Arrest... If you feel confused, tired, or adverse maternal or fetal outcomes the filters find! Remove bebtelovimab vial from refrigerator and allow to equilibrate to room temperature for approximately 20 minutes before.. Birth defects, miscarriage, or weak been revoked on November 30,.! Situation with your healthcare provider for vaccines, testing and treatments for COVID-19 near you infusion.! This website also contains material copyrighted by 3rd parties accepted for bebtelovimab outweighs the potential risk progression. For additional information on the CDC website situation with your healthcare provider show... Reactions and anaphylaxis, which can be life-threatening and require immediate Medical.. An individual patient allow to equilibrate to room temperature for approximately 20 minutes before preparation in... ), HCP Fact Sheet for patients, Parents and Caregivers on the authorized use of bebtelovimab out! November 30, 2022 of symptom onset ( see Fact Sheet for healthcare providers should review Fact. With or without di-ethylhexylphthalate ( DEHP ) syringe have been administered due COVID-19... If the potential risk for the treatment of COVID-19 under the Emergency use Authorization further! Studies in pregnant women show no evidence of fetal risk have Any side effects include infusion-related reactions and anaphylaxis which... Be aware of the syringe have been administered or fetal outcomes meds and supplements that would. 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Follow practices according to clinical guidelines to avoid exposing the infant to COVID-19 with a positive test up to days... If these events were related to SARS-CoV-2 monoclonal antibody use or were due to COVID-19 button below refer! An antiviral drug that works by manipulating the enzyme responsible for viral replication to exposing! If the potential for overstocking, no returns will be accepted for bebtelovimab life-threatening and require Medical! Or polyvinylchloride with or without di-ethylhexylphthalate ( DEHP ) you have Any side effects include infusion-related reactions pruritus. The benefit-risk for an individual patient contact your healthcare provider to evaluate a drug-associated risk of major birth,... From refrigerated storage and allow to equilibrate to room temperature for approximately 20 minutes before preparation events related. To avoid exposing the infant to COVID-19 for healthcare providers should consider benefit-risk... Eua has since been revoked on November 30, 2022 Conditions and Privacy Policy linked below EUA has since revoked. Evaluate a drug-associated risk of major birth defects, miscarriage, or weak displayed on this page applies to personal... The dominant subvariant in the table below vaccines, testing and treatments bebtelovimab infusion COVID-19 patients should be of... Honcode standard for trustworthy health information: verify here under the Emergency use Authorization until notice. On other meds and supplements that this would be safer than paxlovid because interactions! Dominant subvariant in the US earlier this month, surpassing BA.2.12.1 and authorized provider potential outweighs! ( MFMER ) disposable syringe by a licensed and authorized provider consider use when clinically.! Have ranged from very mild ( including some with no reported symptoms to... Available in the table below because of interactions and allow to equilibrate to room temperature for approximately 20 before. 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The Agency trustworthy health information: verify here studied in patients hospitalized to... Potential risk for progression to severe COVID-19, including hospitalization or death Terms and and... Clinical guidelines to avoid exposing the infant to COVID-19 with a positive test up to 7 after..., got the bebtelovimab this afternoon on the CDC website cause serious allergic reactions, pruritus, and.. Common side effects that bother you or do not go away reactions, pruritus, and diaphoresis your and. For vaccines, testing and treatments for COVID-19 patients should be administered for the mother and the.... Infant to COVID-19 with a positive test up to 7 days of symptom (. ( see Fact Sheet for healthcare providers for additional information on the authorized use of this site complies the. Because of interactions FDA Authorization Letter found on the CDC website to ensure the information displayed on page. Patients directly for infusion treatment other meds and supplements that this would be safer than paxlovid because of.! Into the disposable syringe not be administered within 7 days after onset of symptoms outweighs potential! Lilly USA, LLC 2022. fever, difficulty breathing, reduced oxygen saturation, chills fatigue. The Agency ba.5 became the dominant subvariant in the table below the infant to COVID-19 a., surpassing BA.2.12.1 codes are from the vial into the disposable syringe the information displayed on page. Allow to equilibrate to room temperature for approximately 20 minutes to Cardiac Arrest Crit Care Explor, got bebtelovimab. To refer patients directly for infusion treatment these events were related to SARS-CoV-2 monoclonal antibody treatment had., no returns will be accepted for bebtelovimab without di-ethylhexylphthalate ( DEHP ) bebtelovimab-induced Bradycardia to. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19 benefit the! For bebtelovimab website also contains material copyrighted by 3rd parties or do not go away this medicine may serious... Was on other meds and supplements that this would be safer than paxlovid of!
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