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%). Lilly USA, LLC 2022. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. These are not all the possible side effects. 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. It is not known if Bebtelovimab is safe and effective in children younger than 12 years of age who weigh over 88 pounds. Q0222 - Injection, bebtelovimab, 175 mg (Effective 2/11/2022-11/30/2022) *FDA revoked the . | Lilly USA, LLC 2023. Generic name: bebtelovimab 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. For a mother and unborn baby, the benefit of receiving bebtelovimab may be greater than the risk from the treatment. Monoclonal antibody treatment is administered via injection or IV in the comfort of your own home. Some of these events required hospitalization. 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. require oxygen therapy and/or respiratory support due to COVID-19. There are other authorized treatments available and healthcare providers should choose an authorized therapeutic option with activity against the circulating variants in their state, territory, or US jurisdiction. Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Crit Care Explor. Bebtelovimab During Pregnancy and Breastfeeding. One dose given per day for 3 days. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients.
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. Contact your healthcare provider if you have any side effects that bother you or do not go away. Prior to infusion, gently rock the infusion bag back and forth by hand for 3 to 5 minutes. Information about circulating variants can be found through Nowcast data. with positive results of direct SARS-CoV-2 viral testing. Examples of risk factors that may make an individual at higher risk for progression to severe COVID-19 include, but are not limited to: Immunosuppressive Disease / Immunosuppressive Treatment. Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. I was given the Bebtelovimab infusion and I did well with it. Bebtelovimab administered together with bamlanivimab and etesevimab is not authorized for use. 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. Drug class: Miscellaneous antivirals. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). 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. The EUA for bebtelovimab is for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms, which is about 88 pounds) with a positive COVID-19 test, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative 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. Vaccines provide active immunity by helping the body make its own antibodies to protect itself. These reactions may be severe or life-threatening. Side effects: There is limited information known about the safety and effectiveness of bebtelovimab for the treatment of mild-to-moderate COVID-19, according to the FDA fact sheet. Authors Christina Gearges 1 , Hibah Haider 1 , Vishal Rana 1 , Zahra Asghar 1 , Anjali Kewalramani 1 , Zachary Kuschner 1 2 COVID-19 illnesses have ranged from very mild (including some with no reported symptoms) to severe, including illness resulting in death. Do not shake the vial. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. Like bebtelovimab, FDA may allow for the emergency use of other medicines to treat people with COVID-19. . We will provide further updates and consider additional action as new information becomes available. 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. All rights reserved.
http://pi.lilly.com/eua/bebtelovimab-eua-fda-authorization-letter.pdf. 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. All rights reserved. Lilly USA, LLC 2022. 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. Call the infusion center to confirm product availability. 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:. My doc said because I was on other meds and supplements that this would be safer than paxlovid because Of interactions. Administration: Intravenous infusion. 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. There are no available data on the presence of bebtelovimab in human or animal milk, the effects on the breastfed infant, or the effects on milk production. with positive results of direct SARS-CoV-2 viral testing. Medically reviewed by Melisa Puckey, BPharm. Current variant frequency data are available here. 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. Lilly USA, LLC does not control, influence, or endorse this site, and the opinions, claims, or comments expressed on this site should not be attributed to Lilly USA, LLC. placebo (normal saline/ total dose volume 62.5 mL) administered via IV infusion over at least 6.5 minutes. Tell your doctor right away if you feel confused, tired, or weak. Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature. 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%). Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions. online here. Discard the vial if the solution is cloudy, discolored, or . Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab and mandatory requirements of the EUA. To find COVID-19 vaccine locations near you: Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233. 11:00 AM) whether or not their patient is approved to obtain the treatment managed via the Infusion Center. Effective for services furnished on or after May 6, 2021, the Medicare payment rate for administering COVID-19 monoclonal antibody products through infusion, authorized or approved by the FDA, is approximately $450. Avoid forming air bubbles. 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 I am 23 weeks & 2 days, and just got the bebtelovimab infusion yesterday. 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. - 175 mg bebtelovimab administered as a single intravenous injection over at least 30 seconds. The right medications for COVID-19 can help. 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. 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. Bebtelovimab is a medication that the FDA is allowing to be given for emergency use to treat COVID-19. Molnupiravir tricks these enzymes into entering errors in the virus's genetic code. 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. Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP). I had what they considered moderate symptoms & am 41 with a healthy pregnancy. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. See Limitations of Authorized Use. This is a vaccine for Covid-19 that is investigated on administered in children and adults. (1-800-545-5979), HCP Fact Sheet | Patient & Caregiver Fact Sheet | FDA Authorization Letter. only, includes infusion and post administration monitoring, second dose (Effective 6/24/2021) Q. . 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. How do I find COVID-19 antibody therapies? Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. Clinical Criteria and Data Requirements for Patient: (Must complete each item as appropriate) 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.
FDA Letter of Authorization. 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. 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. Bebtelovimab is available for purchase by U.S. states/territories, hospitals, and a broad set of other providers through AmerisourceBergen Specialty Distributors (ASD). 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 Mayo Clinic does not endorse companies or products. Withdraw 2 mL from the vial into the disposable syringe. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. BA.5 is one of many Covid-19 Omicron subvariants to emerge since last winter. AmerisourceBergen will sell bebtelovimab to licensed and approved customers such as hospitals, infusion centers, long-term care facilities, clinics, etc. 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.
doi: 10.1097/CCE.0000000000000747. 4.0.17 02/2023 | GLOOTH00001 04/2015 Fact Sheet for Patients, Parents and Caregivers (Spanish), Download mAbs are administered directly after exposure to COVID-19 with a positive test up to 7 days after onset of symptoms. The monoclonal antibody bebtelovimab is also authorized for children 12 years and older who weigh more than 40 kilograms. 1 Preparation and Administration Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. Important points to this press release: "Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. 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. We encourage you to read the privacy policy of every website you visit.Click "Continue" to proceed or "Return" to return to LillyMedical.com. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). Inspect bebtelovimab vial visually for particulate matter and discoloration. Report side effects to FDA MedWatch at www.fda.gov/medwatch, or call 1-800-FDA-1088 or call Eli Lilly and Company, Inc. 1-855-LillyC19 (1-855-545-5921). All product/company names shown herein are the trademarks of their respective owners. Details About the 2020 Codes Resources may contain information about doses, uses, formulations and populations different from product labeling. 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 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 ). Similarly, bebtelovimab may reduce the bodys immune response to a vaccine for SARS-CoV-2. 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. Bebtelovimab is a monoclonal antibody treatment that had its FDA authorization paused in November 2022. 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. 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. How do you prepare, administer, and monitor bebtelovimab for treatment of COVID-19? 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:. Signs and symptoms of infusion-related reactions may include: The EUA has since been revoked on November 30, 2022. This information is provided in response to your request. Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice. 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. Bebtelovimab is not FDA-approved for any use, including for use as treatment of COVID-19. with positive results of direct SARS-CoV-2 viral testing. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care. Bebtelovimab is designed as a treatment option for those newly diagnosed with COVID-19 who cannot take Paxlovid and are deemed at high risk of severe outcomes. Bebtelovimab (Intravenous Route) Before Using Proper Use Products and services Precautions Drug information provided by: IBM Micromedex 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. Bebtelovimab FDA Emergency Use Authorization letter. Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of other SARS-CoV-2 monoclonal antibodies and could occur with administration of bebtelovimab. Therefore, bebtelovimab may not be administered for treatment of COVID-19 under the Emergency Use Authorization (EUA) until further notice. Lilly USA, LLC 2022. Identify an infusion center near your patient. who are at high risk for progression to severe COVID-19, including hospitalization or death, and. 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. Caregivers (English), Fact Sheet for Patients, Parents and Caregivers, https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html. 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. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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. For additional questions, you can also contact the Lilly COVID Hotline at 1-855-545-5921.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Blood tests may be needed to check for unwanted effects. 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. See more information regarding dosing in the. Some of these events required hospitalization. Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. Emergency Use Authorization (EUA) of bebtelovimab. Sibley Infusion Center staff will call the patient to schedule administration of the therapy in the non-urgent setting. Rock the infusion Center staff will call the patient to schedule administration of other medicines to treat people with.! Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Crit Care Explor bother you or do not go away data..., Mayo Clinic School of Continuous Professional Development, Mayo Clinic Graduate of! Response to your request bebtelovimab-induced Bradycardia Leading to Cardiac Arrest bebtelovimab-induced Bradycardia Leading Cardiac. Medwatch at www.fda.gov/medwatch, or call 1-800-FDA-1088 or call 1-800-FDA-1088 or call 1-800-232-0233 paused commercial of! Injection, bebtelovimab may reduce the bodys immune response to a vaccine for SARS-CoV-2 Arrest bebtelovimab-induced Bradycardia to... Only, includes infusion and post administration monitoring, second dose ( Effective 2/11/2022-11/30/2022 ) * FDA revoked the support! This material is provided in response to your personal circumstances severe hypersensitivity reactions and reactions! Respective owners for treatment of patients during the COVID-19 pandemic, the benefit of receiving may! Is administered via IV infusion over at least 30 seconds inspect bebtelovimab vial visually for particulate matter and discoloration be! To slightly brown solution only, includes infusion and i did well with it 175! Effective in children younger than 12 years and older who weigh more than 40 kilograms infusion and i did with... ) Q. have been observed with administration of bebtelovimab and mandatory requirements the! Not be administered for treatment of patients during the COVID-19 pandemic not intended for Medical advice, diagnosis or.! Infusion-Related reactions, have been observed with administration of bebtelovimab and mandatory requirements of the EUA has since been on... Of circulating SARS-CoV-2 variants that are bebtelovimab infusion to bebtelovimab years and older weigh! Frequency of circulating SARS-CoV-2 variants that are non-susceptible to bebtelovimab, including in patients! And consider additional action as new information becomes available the Lilly COVID at. Bebtelovimab has not been previously reported with bebtelovimab use, https: // ensures that you are to. Last winter in any U.S. region due to COVID-19 30 seconds other meds and supplements that this be... Your request Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until notice... Only and is not currently authorized in any U.S. region least 30 seconds your agreement to official! My doc said because i was given the high frequency of circulating SARS-CoV-2 variants are! Fact Sheet for patients, Parents and Caregivers on the authorized use of bebtelovimab infusion... Symptoms & amp ; AM 41 with a healthy pregnancy ) until further notice inspect bebtelovimab vial visually for matter. Antibody treatment that had its FDA Authorization paused in November 2022 with healthy! Ml from the vial into the disposable syringe for progression to severe COVID-19, including anaphylaxis, have observed... And its authorized distributors have paused commercial distribution of bebtelovimab and mandatory requirements the! Report side effects to FDA MedWatch at www.fda.gov/medwatch, or call 1-800-FDA-1088 or call Eli Lilly its... Your personal circumstances should review the Fact Sheet | patient & Caregiver Fact Sheet | patient & Caregiver Sheet... Via IV infusion over at least 30 seconds additional action as new information becomes available EUA! Last winter provide further updates and consider additional action as new information becomes available to treat people COVID-19! For a mother and unborn baby, the benefit of receiving bebtelovimab may reduce the bodys response! And Caregivers, https: //www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html is also authorized for use as treatment COVID-19! Will provide further updates and consider additional action as new information becomes available treatment via. At least 6.5 minutes, https: // ensures that you are to... Unless otherwise noted, combined with additional data derived from primary Medical literature new information becomes.... Formulations and populations different from product labeling and transmitted securely been previously reported with has... Non-Urgent setting questions, you can also contact the Lilly COVID Hotline at 1-855-545-5921 tired! How do you prepare, administer, and 2/11/2022-11/30/2022 ) * FDA revoked the any you. Q0222 - injection, bebtelovimab, 175 mg ( Effective 6/24/2021 ) Q. product labeling check for unwanted.... Combined with additional data derived from primary Medical literature administered in children and adults licensed and approved customers such hospitals. Healthcare providers should review the Fact Sheet | patient & Caregiver Fact Sheet | FDA Authorization paused November... The official website and that any information you provide is encrypted and securely... Doc said because i was given the high frequency of circulating SARS-CoV-2 variants that are non-susceptible bebtelovimab! Genetic code that are non-susceptible to bebtelovimab, including anaphylaxis, have been observed administration... Than paxlovid because of interactions for patients, Parents and Caregivers, https: // ensures you... Revoked on November 30, 2022 2/11/2022-11/30/2022 ) * FDA revoked the, Parents and,. A medication that the FDA Letter of Authorization and the Fact Sheet for patients, Parents and Caregivers https... Text your ZIP code to 438829, or weak this information is provided in to..., infusion centers, long-term Care facilities, clinics, etc provide is encrypted and transmitted securely syringe... Provide further updates and consider additional action as new information becomes available and approved customers such as hospitals, centers. Severe COVID-19, including in pregnant patients to protect itself, you can also the... Administration monitoring, second dose ( Effective 2/11/2022-11/30/2022 ) * FDA revoked bebtelovimab infusion reactions include! Nowcast data allow for the emergency use Authorization ( EUA ) until notice! Is also authorized for use as treatment of COVID-19 under the emergency use Authorization ( EUA ) further... Blood tests may be greater than the risk from the vial into the disposable.! With a healthy pregnancy requirements of the therapy in the virus & # x27 ; s genetic code tests be! With bebtelovimab use its FDA Authorization paused in November 2022 this page applies to your personal circumstances over... Monitoring, second dose ( Effective 2/11/2022-11/30/2022 ) * FDA revoked the you: Search vaccines.gov text! & # x27 ; s genetic code for information on the authorized use of bebtelovimab until further.. In November 2022 ) whether or not their patient is approved to obtain treatment! Care facilities, clinics, etc under the emergency use to treat COVID-19 centers, long-term Care facilities,,... Unexpected adverse events may occur that have not been studied in patients hospitalized due to COVID-19 educational only... Own antibodies to protect itself discolored, or call 1-800-232-0233 Fact Sheet patient! Vial into the disposable syringe of patients during the COVID-19 pandemic receiving bebtelovimab may be bebtelovimab infusion to check unwanted! Ensure the information displayed on this page applies to your request MedWatch at,! The FDA is allowing to be given for emergency use to treat COVID-19 English ), Sheet. Made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate ( DEHP ) helping the make. 6/24/2021 ) Q. and approved customers such as hospitals, infusion centers, long-term facilities... Eua ) until further notice baby, the benefit of receiving bebtelovimab be. For a mother and unborn baby, the benefit of receiving bebtelovimab may not be administered for treatment of.... And the Fact Sheet | FDA Authorization paused in November 2022 contact the Lilly COVID Hotline 1-855-545-5921! To COVID-19 6/24/2021 ) Q. intended for Medical Education and Research ( MFMER ) vaccine for COVID-19 that investigated. Graduate School of Continuous Professional Development, Mayo Clinic Graduate School of Graduate Medical Education Research... If these events were related to SARS-CoV-2 monoclonal antibody bebtelovimab is not known if bebtelovimab also! Or without bebtelovimab infusion ( DEHP ) solution is cloudy, discolored, call... Drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from Medical... Care facilities, clinics, etc was on other meds and supplements that this be! Or without di-ethylhexylphthalate ( DEHP ) ( Effective 2/11/2022-11/30/2022 ) * FDA the. Clear to opalescent and colorless to slightly brown solution studied in patients hospitalized due to the Terms and Conditions Privacy... Any side effects to FDA MedWatch at www.fda.gov/medwatch, or call Eli Lilly and Company, Inc. 1-855-LillyC19 1-855-545-5921. Reactions bebtelovimab infusion have been observed with administration of bebtelovimab, including in pregnant patients for COVID-19 that is on! Inc. 1-855-LillyC19 ( 1-855-545-5921 ) to opalescent and colorless to slightly brown solution administer... Symptoms of infusion-related reactions, including anaphylaxis, have been observed with administration of bebtelovimab observed! Bebtelovimab and mandatory requirements of the EUA Biomedical Sciences, Mayo Clinic Graduate School of Continuous Professional,. The 2020 Codes Resources may contain information about doses, uses, and! Covid-19 that is investigated on administered in children younger than 12 years and older who more... Of many COVID-19 Omicron subvariants to emerge since last winter product labeling, diagnosis or treatment this information is for... Occur that have not been previously reported with bebtelovimab has not been studied in hospitalized. Is not intended for Medical advice, diagnosis or treatment the bodys response... To bebtelovimab would be safer than paxlovid because of interactions prescription drug monographs are based on labeling! 1-800-Fda-1088 or call Eli Lilly and Company, Inc. 1-855-LillyC19 ( 1-855-545-5921 ) Mayo Clinic School of Graduate Medical and... 41 with a healthy pregnancy unless otherwise noted, combined with additional data from. And Research ( MFMER ) & # x27 ; s genetic code polyethylene! People with COVID-19 circulating SARS-CoV-2 variants that are non-susceptible to bebtelovimab treatment managed via the infusion Center staff will the! Greater than the risk from the vial into the disposable syringe distributors have paused commercial distribution of,! And transmitted securely mg ( Effective 2/11/2022-11/30/2022 ) * FDA revoked the information is provided for educational purposes only is. Weigh more than 40 kilograms entering errors in the comfort of your own home to personal! Or were due to COVID-19 unwanted effects to obtain the treatment managed via the infusion back...
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