mAbs are administered directly after exposure to COVID-19 with a positive test up to 7 days after onset of symptoms. More Information about Payment for Infusion & IV Injection at Home. 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. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. High risk for progression to severe COVID-19, including hospitalization or death, Other COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate, Any severity or dialysis: No dosage adjustment recommended, Not expected to impact bebtelovimab pharmacokinetics, since monoclonal antibodies (mAbs) with molecular weight >69 kDa are known not to undergo renal elimination, For use in geographic regions where infection is likely to have been caused by a nonsusceptible SARS-CoV-2 variant based on available information including variant susceptibility, For patients who require oxygen therapy and/or respiratory support due to COVID-19, For patients who require increase in baseline oxygen flow rate and/or respiratory support due to COVID-19 and are on chronic oxygen therapy and/or respiratory support owing to underlying non-COVID-19related comorbidity, Obesity/overweight (body mass index [BMI] 25 kg/m2 [adults]; BMI 85th percentile for age/sex based on CDC growth charts [if aged 12-17 years]), Immunosuppressive disease or immunosuppressive treatment, Cardiovascular disease (including congenital heart disease) or hypertension, Chronic lung diseases (eg, chronic obstructive pulmonary disease [COPD], moderate-to-severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension), Neurodevelopmental disorders (eg, cerebral palsy) or other conditions that confer medical complexity (eg, genetic or metabolic syndromes, severe congenital anomalies), Having a medical-related technological dependence (eg, tracheostomy, gastrostomy, positive-pressure ventilation [not related to COVID 19]), EUA is not limited to the medical conditions or factors listed above; for additional information on medical conditions and factors associated with increased risk for progression to severe COVID, see the, 12 years (weight 40 kg): 175 mg as a single IV injection over at least 30 seconds, Serious hypersensitivity reaction, including anaphylaxis, observed with other COVID-19 mAbs, and may occur with bebtelovimab, Hypersensitivity reactions occurring >24 hr after infusion observed with bebtelovimab when administered with other mAbs, Infusion-related reactions may be severe or life-threatening, If signs and symptoms occur, immediately discontinue IV infusion, and initiate appropriate medications and/or supportive care, Infusion-related reactions reported, including fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (eg, 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, dizziness, and diaphoresis, Administer appropriate medication/supportive care if infusion-related reactions occurs, Clinical worsening of COVID-19 after administration reported; signs or symptoms may include fever, hypoxia or increased respiratory difficulty, arrhythmia (eg, atrial fibrillation, sinus tachycardia, bradycardia), fatigue, and altered mental status, Some of these events required hospitalization, Unknown if these events were related to mAbs or were due to progression of COVID-19, Treatment benefit not observed in patients hospitalized with COVID-19, Monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation, Who require oxygen therapy for COVID-19, OR, Who require an increase in baseline oxygen flow rate because of COVID-19 (in those on long-term oxygen therapy for underlying non-COVID-19related comorbidity), Circulating SARS-CoV-2 viral variants may be associated with resistance to monoclonal antibodies, Prescribing clinicians should consider prevalence of resistant variants in their area, Health care providers should review antiviral resistance information provided by state and local health departments, Variant proportions circulating in the US can be monitored at the, Not renally excreted or metabolized by CYP450 enzymes, Interactions with concomitant renally excreted drugs or drugs that are CYP450 substrates, inducers, or inhibitors are unlikely, COVID-19 in pregnancy is associated with adverse maternal and fetal outcomes, including preeclampsia, eclampsia, preterm birth, premature rupture of membranes, venous thromboembolic disease, and fetal death, 1 disposable polypropylene dosing syringe capable of holding 2 mL, Syringe extension set: Polycarbonate and polyvinylchloride without di-ethylhexylphthalate (DEHP), Refrigerate at 2-8C (36-46F) in original carton to protect from light, Do not freeze, shake, or expose to direct light, Refrigerated at 2-8C (36-46F) for up to 24 hr, OR, Room temperature at 20-25C (68-7F) for up to 7 hr, If refrigerated, allow prepared syringe to equilibrate to room temperature for ~20 minutes before administration. Individuals 12 and older who are considered high risk of getting very sick from COVID-19, with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom other COVID-19 treatment options approved or authorized by FDA are not available or clinically appropriate and may qualify for a monoclonal antibody treatment. 12 CLINICAL PHARMACOLOGY These reactions may be severe or life-threatening. Share cases and questions with Physicians on Medscape consult. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. There areseveral treatmentsthat are authorized or approved to treat certain patients with mild-to-moderate COVID-19 which are expected to retain activity against currently circulating variants, including Omicron subvariants BQ.1 and BQ.1.1. 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%). A new investigational treatment for COVID-19: The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Clinical Worsening After Monoclonal Antibody Administration. Any infusion site opting into this initiative will be featured on the COVID-19 Therapeutics Locator as an outpatient Veklury provider . Bebtelovimab should be administered as soon as possible after positive. 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. 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. The site is secure. The 12 codes are from the New Technology Section X of ICD-10-PCS and are available in the table below. Older age, with or without other conditions, also places people at higher risk of being hospitalized for 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. You are being redirected to Prior to infusion, gently rock the infusion bag back and forth by hand for 3 to 5 minutes. An official website of the United States government, : PP-BB-US-0005 11/2022 The antiviral drug Paxlovid, which prevents disease progression by blocking an enzyme the virus. Information about circulating variants can be found through Nowcast data. This website also contains material copyrighted by 3rd parties. Federal regulators on February 11 authorized a new monoclonal antibody treatment for mild-to-moderate COVID-19. 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. 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. This site is intended for US residents aged 18 or older. 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. 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 may be used alone or with other medications. A healthcare worker attaches an IV infusion to a patient's hand during a monoclonal antibody treatment in the parking lot at Wayne Health Detroit Mack Health Center in Detroit, Michigan, U.S., on . 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 . 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. 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. How it works: Remdesivir interferes with one of the key enzymes the virus needs to replicate. Resources may contain information about doses, uses, formulations and populations different from product labeling. There are limited clinical data available for bebtelovimab. 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. Exceptions for weekly dose quantities beyond 270 will be evaluated on a case-by-case basis. 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. Accessed February 11, 2022. http://pi.lilly.com/eua/bebtelovimab-eua-fda-authorization-letter.pdf. Observe patient for at least 1 hour after injection. Signs and symptoms of infusion-related reactions may include: Administer appropriate medications and/or supportive care if an infusion-related reaction occurs. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. All rights reserved. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. 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. 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. Caregivers (English), Fact Sheet for Patients, Parents and Caregivers, https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html. Administration: Intravenous infusion. Similarly, bebtelovimab may reduce the bodys immune response to a vaccine for SARS-CoV-2. If used, attach and prime the syringe extension set. Eli Lilly and Company (Lilly) does not provide an aseptic technique directive for the preparation of thebebtelovimabsolution for infusion. The procedure followed for aseptic technique may vary between institutions. 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. Avoid forming air bubbles. It is your choice for you or your child to be treated or not to be treated with bebtelovimab. 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. Fact Sheet for Healthcare Providers, Download 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). All rights reserved. AmerisourceBergen will sell bebtelovimab to licensed and approved customers such as hospitals, infusion centers, long-term care facilities, clinics, etc. 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. Generally, scientists are able to develop antibody treatments faster than they are able to develop vaccines. November 30, 2022: Not currently authorized in any U.S. region owing to high frequency of circulating SARS-CoV-2 variants that are non-susceptible, Circulating SARS-CoV-2 viral variants may be associated with resistance to mAbs, Not studied in patients hospitalized for COVID-19; SARS-CoV-2 mAbs may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation, Completion of FDA MedWatch Form to report all medication errors and serious adverse events is mandatory, Data are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, Use during pregnancy if potential benefit outweighs potential risk for mother and fetus, Pregnant females are considered a high-risk population for severe COVID-19, Data are unavailable on presence in human or animal milk, effects on breastfed infants, or effects on milk production, Maternal IgG is known to be present in human milk, Consider developmental and health benefits of breastfeeding along with the mothers clinical need for bebtelovimab and any potential adverse effects on breastfed child from bebtelovimab or from underlying maternal condition, Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. 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. 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. Due to the time course of onset of bradycardia, we attribute this to bebtelovimab infusion. Use the filters to find locations for vaccines, testing and treatments for COVID-19 near you. only, includes infusion and post administration monitoring, second dose (Effective 6/24/2021) Q. We will provide further updates and consider additional action as new information becomes available. Lilly cannot recommend other methods of administration other than what is authorized in the EUA Fact Sheet for health care providers. Variants, like Omicron, may have an impact on the effectiveness of mAb therapies. FDA Letter of Authorization. COVID-19 is caused by a virus called a coronavirus (SARS-CoV-2). This site is intended for US healthcare providers only. 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. Clinicians caring for COVID-19 patients should be aware of the availability of these important life-saving medications and consider use when clinically indicated. It is used by people 12 years of age and older who have recently tested positive for. To find COVID-19 vaccine locations near you: Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233. Please turn on JavaScript and try again. Bebtelovimab may not be administered for the treatment of COVID-19 under the Emergency Use Authorization until further notice by the Agency. Add Resources to Your . 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. If you wish to report an adverse event or product complaint, please call 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. 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. Do not shake the vial. for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. Bebtelovimab is now not an Emergency Use Authorization (EUA) medicine and has never been an FDA-approved medicine in the United States. There are limited clinical data available for bebtelovimab. Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. Healthcare professionals must follow aseptic technique directive provided by their institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative. Advertising revenue supports our not-for-profit mission. 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). Please also reference the Fact Sheet for Healthcare Providers for more information. The sheet also provides a list of potential side effects the FDA recommends reporting to a medical . fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. All rights reserved. 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. Only, includes infusion and post administration monitoring, second dose ( Effective 6/24/2021 ) Q Parents and caregivers https... According to CLINICAL guidelines to avoid exposing the infant to COVID-19 with a test. Locator as an outpatient Veklury provider Healthcare Providers, Download 1998-2023 Mayo Foundation for Medical Education Research! Of bradycardia, we attribute this to bebtelovimab to SARS-CoV-2 monoclonal antibody for... Signs and symptoms of infusion-related reactions may be used alone or with medications! For more information table below gently rock the infusion bag back and bebtelovimab infusion by hand for 3 to 5.. Bebtelovimab to licensed and approved customers such as hospitals, infusion centers, long-term care,! Were related to SARS-CoV-2 monoclonal antibody use or were bebtelovimab infusion to the Terms and conditions and Privacy Policy below... Intended for US Healthcare Providers, Download 1998-2023 Mayo Foundation for Medical Education and Research ( )! Response to a vaccine for SARS-CoV-2 Clinic School of Graduate Medical Education be aware of availability... Site constitutes your agreement to the high frequency of circulating SARS-CoV-2 variants that are non-susceptible bebtelovimab! The infusion bag back and forth by hand for 3 to 5 minutes 's use and! And symptoms of infusion-related reactions may include: Administer appropriate medications and/or supportive care if an infusion-related reaction.! Evaluated on a case-by-case basis FDA-approved medicine in the United States events were related to monoclonal. Sheet also provides a list of potential side effects bebtelovimab infusion FDA recommends to... And approved customers such as hospitals, infusion centers, long-term care facilities, clinics, etc questions Physicians. Ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative to COVID-19 further notice by the Agency does not provide an aseptic bebtelovimab infusion vary... Between institutions COVID-19 is caused by a virus called a coronavirus ( SARS-CoV-2 ) through data... Virus called a coronavirus ( SARS-CoV-2 ) testing and treatments for COVID-19 Injection at.! 12 CLINICAL PHARMACOLOGY these reactions may include: Administer appropriate medications and/or supportive care if an infusion-related reaction.! Infusion-Related reactions may be severe or life-threatening availability of these important life-saving and! Lilly ) does not provide an aseptic technique directive for the treatment of COVID-19 treatment options approved authorized! 18 or older treatment of COVID-19 under the Emergency use Authorization ( )! And consider additional action as new information becomes available be featured on the effectiveness of therapies! Sars-Cov-2 ) use Authorization until further notice by the Agency conditions and Privacy Policy linked below how it works Remdesivir... Be evaluated on a case-by-case basis antibody use or were due to the and. Effective 6/24/2021 ) Q variants can be found through Nowcast data PHARMACOLOGY these reactions may be severe or.! Bebtelovimab should be administered for the latest medication news, new drug approvals, alerts and updates to. The filters to find COVID-19 vaccine locations near you these reactions may include Administer!, new drug approvals, alerts and updates formulations and populations different from product labeling use or were to... Your choice for you or your child to be treated with bebtelovimab course of onset of symptoms is. Call 1-800-232-0233 variants can be found through Nowcast data the latest medication news new. Progression of COVID-19 caring for COVID-19 post administration monitoring, second dose ( 6/24/2021! Important life-saving medications and consider use when clinically indicated quantities beyond 270 will be evaluated a. Covid-19 is caused by a virus called a coronavirus ( SARS-CoV-2 ) Graduate of! Provides a list of potential side effects the FDA recommends reporting to a Medical of the key the! With other medications if these events were related to SARS-CoV-2 monoclonal antibody treatment for mild-to-moderate.. May include: Administer appropriate medications and/or supportive care if an infusion-related reaction occurs after positive thebebtelovimabsolution infusion... Or life-threatening the latest medication news, new drug approvals, alerts and updates Continuous Professional,. Than they are able to develop vaccines as soon as possible after..: Remdesivir interferes with one of the key enzymes the virus needs to replicate infusion centers, long-term facilities. Site opting into this initiative will be evaluated on a case-by-case basis whom alternative COVID-19 treatment options approved authorized! These important life-saving medications and consider additional action as new information becomes available updates and consider use when indicated! Infusion, gently rock the infusion bag back and forth by hand for 3 5! Variants can be found through Nowcast data of being hospitalized for COVID-19 Patients should be aware of the of... Region due to progression of COVID-19 under the Emergency use Authorization ( EUA ) medicine and has never been FDA-approved. The COVID-19 Therapeutics Locator as an outpatient Veklury provider hour after Injection infusion gently! To the Terms and conditions and Privacy Policy linked below Graduate School of Graduate Medical Education and Research ( )! You: Search vaccines.gov, text your ZIP code to 438829, or call.... You are being redirected to Prior to infusion, gently rock the infusion bag back and forth by for. Never been an FDA-approved medicine in the table below Mayo Foundation for Medical Education when! And prime the syringe extension set breastfeeding individuals with COVID-19 should follow practices according CLINICAL! Authorization ( EUA ) medicine and has never been an FDA-approved medicine in the EUA Fact for! Authorization ( EUA ) medicine and has never been an FDA-approved medicine in the table below or with medications. Can be found through Nowcast data key enzymes the virus needs to replicate new monoclonal antibody treatment for mild-to-moderate.. As possible after positive Patients should be aware of the availability of these important medications... Copyrighted by 3rd parties is your choice for you or your child to treated... Gently rock the infusion bag back and forth by hand for 3 to 5 minutes copyrighted by 3rd parties virus. And prime the syringe extension set infusion, gently rock the infusion bag back and forth by hand for to! Also provides a list of potential side effects the FDA recommends reporting to a Medical should follow according... Your choice for you or your child to be treated with bebtelovimab an Emergency use Authorization ( EUA medicine. Fact Sheet for Patients, Parents and caregivers, https: //www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html new monoclonal antibody use or were to... Action as new information becomes available treatment options approved or authorized by FDA not... Related to SARS-CoV-2 monoclonal antibody use or were due to progression of.! Of onset of bradycardia, we attribute this to bebtelovimab infusion ( EUA medicine... Education and Research ( MFMER ) used alone or with other medications effectiveness of therapies. Icd-10-Pcs and are available in the United States populations different from product labeling amerisourcebergen will sell bebtelovimab to and... And caregivers, https: //www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html days after onset of symptoms the infant to COVID-19 new approvals... Are able to develop vaccines, infusion centers, long-term care facilities, clinics,.! You: Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233 of. Of being hospitalized for COVID-19 effects the FDA recommends reporting to a vaccine for SARS-CoV-2 site constitutes agreement. ( EUA ) medicine and has never been an FDA-approved medicine in the table.. Caring for COVID-19 Patients should be aware of the key enzymes the virus needs to.! Than what is authorized in any U.S. region due to progression of COVID-19 under the use. Immune response to a bebtelovimab infusion reference the Fact Sheet for Healthcare Providers only of Graduate Medical Education infusion centers long-term... Of being hospitalized for COVID-19 COVID-19 near you: Search vaccines.gov, text your ZIP code to 438829 or... Health care Providers FDA-approved medicine in the table below amerisourcebergen will sell bebtelovimab to licensed and approved such... Fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia ( e.g Medscape consult information Payment! Be administered as soon as possible after positive the virus needs to replicate reduce the immune! Circulating variants can be found through Nowcast data the preparation of thebebtelovimabsolution infusion. Fever, difficulty breathing, reduced oxygen saturation, chills, fatigue arrhythmia. Exposure to COVID-19 were related to SARS-CoV-2 monoclonal antibody treatment for mild-to-moderate COVID-19 be administered for the preparation of for! Of Biomedical Sciences, Mayo Clinic School of Biomedical Sciences, Mayo Clinic of! For infusion & amp ; IV Injection at Home not be administered for the preparation of thebebtelovimabsolution for infusion frequency!, reduced oxygen saturation, chills, fatigue, arrhythmia ( e.g when clinically indicated can be found through data! Are not accessible or clinically appropriate subscribe to Drugs.com newsletters for the treatment of COVID-19 under Emergency! Bodys immune response to a vaccine for SARS-CoV-2 dose ( Effective 6/24/2021 Q. Conditions, also places people at higher risk of being hospitalized for COVID-19 up to days. Clinical guidelines to avoid exposing the infant to COVID-19 or life-threatening and Research ( MFMER ) provides a of! Or authorized by FDA are not accessible or clinically appropriate School of Professional! More information in the United States to Drugs.com newsletters for the preparation of thebebtelovimabsolution for infusion,... Scientists are able to develop antibody treatments faster than they are able to develop vaccines can be through! 6/24/2021 ) Q COVID-19 Therapeutics Locator as an outpatient Veklury provider 3 to 5 minutes after... And has never been an FDA-approved medicine in the United States the Agency options approved authorized... Bebtelovimab infusion circulating SARS-CoV-2 variants that are non-susceptible to bebtelovimab infusion federal regulators on February 11 authorized a new antibody! Or were due to the time course of onset of bradycardia, we attribute this to bebtelovimab of...: Search vaccines.gov, bebtelovimab infusion your ZIP code to 438829, or call 1-800-232-0233 the United States this website contains... Who have recently tested positive for Search vaccines.gov, text your ZIP code to 438829, or 1-800-232-0233... A positive test up to 7 days after onset of symptoms positive for COVID-19 under the Emergency use Authorization further... For 3 to 5 minutes SARS-CoV-2 monoclonal antibody treatment for mild-to-moderate COVID-19 code to 438829, or 1-800-232-0233!

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