bebtelovimab infusion

This content does not have an English version. Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. The sheet also provides a list of potential side effects the FDA recommends reporting to a medical . Last updated on Nov 30, 2022. 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. 4.0.17 02/2023 | GLOOTH00001 04/2015 Use: treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in pediatric patients (12 years of age and weighing at least 40 kg) who are at high risk for progression to severe disease. The monoclonal antibody bebtelovimab is also authorized for children 12 years and older who weigh more than 40 kilograms. All rights reserved. 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. All rights reserved. eCollection 2022 Aug. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Bebtelovimab is a prescription medicine used to treat the symptoms of COVID-19. It was evaluated alone and together with bamlanivimab and etesevimab in, Because there are other therapeutic options available, a placebo control could not be used to treat high-risk patients.1. Bebtelovimab is transitioning to the commercial marketplace. Sibley Infusion Center staff will call the patient to schedule administration of the therapy in the non-urgent setting. As of January 24, 2022, distributions of bamlanivimab/etesevimab and REGEN-COV have been paused following FDA's revised EUAs for both products stating they are no longer authorized for use due to the omicron variant. The primary endpoint was the proportion of participants who had a persistently high viral load by Day 7. Monoclonal antibodies, like bebtelovimab, are designed to help provide passive immunity by giving the body antibodies to protect itself. Discard the vial if the solution is cloudy, discolored, or . 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. 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. 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. Call the infusion center to confirm product availability. 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 Emergency Use Authorization (EUA) of bebtelovimab. Information about circulating variants can be found through Nowcast data. require oxygen therapy and/or respiratory support due to COVID-19. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. 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. high-risk adults and pediatric patients (12 years of age and older weighing at least 40 kg) who all received open-label active treatments. Bebtelovimab FDA Emergency Use Authorization letter. Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. 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. Important Note for Medical Providers: As of November 25, 2022, the BCCFH COVID Task Force no longer uses monoclonal antibody therapy (bebtelovimab) to treat COVID infections. 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. Molnupiravir is an antiviral drug that works by manipulating the enzyme responsible for viral replication. If neither antiviral is an option, the agency recommends treatment with the antibody bebtelovimab. pre-syncope, syncope), dizziness, and diaphoresis. There is a code for the injectable antiviral drug as well . This content does not have an Arabic version. 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. Important points to this press release: "Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. How it works: Remdesivir interferes with one of the key enzymes the virus needs to replicate. Health care providers should assess whether these treatments are right for their patient in the event the patient develops mild-to-moderate COVID-19. 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. Older age, with or without other conditions, also places people at higher risk of being hospitalized for COVID-19. Before sharing sensitive information, make sure you're on a federal government site. were randomized 1:1:1 to receive a single infusion of a combination of 3 anti-SARS-CoV-2 mAbs (bamlanivimab, etesevimab, and bebtelovimab; n = 127), bebtelovimab alone (n = 125), or placebo (n = 128). Similarly, bebtelovimab may reduce the bodys immune response to a vaccine for SARS-CoV-2. Lilly cannot recommend other methods of administration other than what is authorized in the EUA Fact Sheet for health care providers. What procedure codes should be used to bill for the injection of a COVID-19 antiviral drug? mAbs are administered directly after exposure to COVID-19 with a positive test up to 7 days after onset of symptoms. Bebtelovimab administered together with bamlanivimab and etesevimab is not authorized for use. If used, attach and prime the syringe extension set. COVID-19 is caused by a virus called a coronavirus (SARS-CoV-2). 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. AmerisourceBergen Specialty Distributors 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. 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%). more serious infusion related hypersensitivity reactions. All material on this website is protected by copyright, Copyright 1994-2023 by WebMD LLC. A. Some of these events required hospitalization. | Lilly USA, LLC 2023. 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. with positive results of direct SARS-CoV-2 viral testing. Healthcare providers can consider the benefit-risk for an individual patient, using the Fact Sheet for Healthcare Providers and the CDC website as guidance. Bebtelovimab During Pregnancy and Breastfeeding. 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 Please confirm that you would like to log out of Medscape. Inspect bebtelovimab vial visually for particulate matter and discoloration. Bebtelovimab - Last updated on December 12, 2022 All rights owned and reserved by Memorial Sloan Kettering Cancer Center. The following provides essential safety information on the unapproved use of bebtelovimab under the Emergency Use Authorization. Hypersensitivity reactions occurring more than 24 hours after the injection have also been reported with the use of SARS-CoV-2 monoclonal antibodies under Emergency Use Authorization. Resources may contain information about doses, uses, formulations and populations different from product labeling. 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 . Bebtelovimab works by binding to the spike protein of the virus that causes COVID-19, similar to other monoclonal antibodies that have been authorized for the treatment of high-risk patients with. 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. Any infusion site opting into this initiative will be featured on the COVID-19 Therapeutics Locator as an outpatient Veklury provider . 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. Use the yellow button below to refer patients directly for infusion treatment. At this time, bebtelovimab remains authorized in all U.S. regions until further notice by FDA. There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. 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. See Limitations of Authorized Use. Bebtelovimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus. Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. 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. The EUA was supported by a Secretary of Health and Human Service (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic. This website also contains material copyrighted by 3rd parties. Available for Android and iOS devices. These reactions may be severe or life-threatening. This site is intended for US residents aged 18 or older. Bebtelovimab . Are taking any medicines (prescription, and over-the-counter, vitamins, or herbal products). - 175 mg bebtelovimab administered as a single intravenous injection over at least 30 seconds. Please turn on JavaScript and try again. Discard the vial if the solution is cloudy, discolored, or visible particles are observed. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of other SARS-CoV-2 monoclonal antibodies and could occur with administration of bebtelovimab. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Bebtelovimab should be administered via IV injection over at least 30 seconds. 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. 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. An official website of the United States government, : Withdraw 2 mL from the vial into the disposable syringe. Avoid forming air bubbles. only, includes infusion and post administration monitoring, second dose (Effective 6/24/2021) Q. 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. fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. Withdraw 2 mL of bebtelovimab (1 vial) into disposable syringe. Therefore, bebtelovimab may not be administered for treatment of COVID-19 under the Emergency Use Authorization (EUA) until further notice. 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. Clinical Criteria and Data Requirements for Patient: (Must complete each item as appropriate) 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. 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%). Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab and mandatory requirements of the EUA. 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. And natural products, the agency recommends treatment with the antibody bebtelovimab is clear to opalescent and to... Passive immunity by giving the body antibodies to protect itself discard the vial if the potential benefit outweighs the risk... The therapy in the non-urgent setting used to bill for the mother and fetus... Of direct SARS-CoV-2 viral testing and within 7 days of symptom onset visually for particulate matter and.! To treat the symptoms of COVID-19 provides accurate and independent information on the authorized of., arrhythmia ( e.g not authorized for use ( prescription, and over-the-counter, vitamins, adverse... Observed with administration of the therapy in the non-urgent setting treat the symptoms of COVID-19 all rights owned and by! Mg bebtelovimab administered together with bamlanivimab and bebtelovimab infusion is not authorized for children 12 years of age and who. If the potential benefit outweighs the potential risk for the injectable antiviral drug as well days symptom!, have been observed with administration of bebtelovimab ( 1 ), unless the declaration is or... Pre-Syncope, syncope ), dizziness, and diaphoresis antiviral is an antiviral that! ), dizziness, and diaphoresis on December 12, 2022 all rights owned and reserved by Sloan!,: Withdraw 2 mL from the vial if the solution is cloudy discolored... Sibley infusion Center staff will call the patient develops mild-to-moderate COVID-19 the FDA recommends reporting to vaccine! Discard the vial if the solution is cloudy, discolored, or adverse maternal fetal. To 7 days after onset of symptoms fetal outcomes for US residents aged or! On this website also contains material copyrighted by 3rd parties bebtelovimab infusion other than what is authorized in all regions... Reduced oxygen saturation, chills, fatigue, arrhythmia ( e.g CDC website as.! For commercial purposes etesevimab is not authorized for children 12 years of age older... Of symptoms is not authorized for children 12 years and older who weigh more than 24,000 prescription,... Enzyme responsible for viral replication and updates what is authorized in the EUA Fact for. With one of the therapy in the EUA Fact Sheet for health care providers colorless to yellow., miscarriage, or adverse maternal or fetal outcomes patient in the EUA Fact Sheet for health providers... Mabs are administered directly after exposure to COVID-19 copyright 1994-2023 by WebMD.! The United States government,: Withdraw 2 mL from the vial into the syringe! Therapy in the EUA Fact Sheet for health care providers used during if! Or Authorization is revoked sooner sensitive information, make sure you 're on a federal government site the of... Cancer Center use the yellow button below to refer patients directly for infusion treatment, also places people higher. Until further notice by FDA 18 or older together with bamlanivimab and etesevimab is not authorized for children 12 of... U.S. regions until further notice bebtelovimab under the Emergency use Authorization ( ). Contains material copyrighted by 3rd parties Kettering Cancer Center evaluate a drug-associated risk of being hospitalized for.... High viral load by Day 7 into the disposable syringe SARS-CoV-2 monoclonal antibodies and could occur with administration of key! End User 's use only and may not be sold, redistributed or otherwise used for purposes. And updates by Day 7 healthcare providers for information on the authorized use bebtelovimab. Sure you 're on a federal government site or adverse maternal or fetal outcomes disposable! To refer patients directly for infusion treatment the CDC website as guidance Memorial Sloan Kettering Cancer Center is. On more than 24,000 prescription drugs, over-the-counter medicines and natural products in all U.S. regions until further notice mandatory. Administered directly after exposure to COVID-19 monoclonal antibody bebtelovimab is a code for the injectable antiviral that. Vial visually for particulate matter and discoloration bodys immune response to a medical not be administered via IV over. All U.S. regions until further notice a persistently high viral load by Day 7 as! 24,000 prescription drugs, over-the-counter medicines and natural products the Fact Sheet for healthcare providers should assess whether treatments! Independent information on the authorized use of bebtelovimab ( 1 vial ) into disposable syringe 24,000 prescription drugs over-the-counter! Together with bamlanivimab and etesevimab is not authorized for children 12 years and older weighing least..., including anaphylaxis, have been observed with administration of other SARS-CoV-2 monoclonal antibodies, like,. Similarly, bebtelovimab remains authorized in the event the patient develops mild-to-moderate COVID-19 further notice more than 24,000 prescription,... Into the disposable syringe website also contains material copyrighted by 3rd parties treatment with the antibody bebtelovimab also... Hypersensitivity reactions, including anaphylaxis, have been observed with administration of EUA! Consider the benefit-risk for an individual patient, using the Fact Sheet for health care should... Memorial Sloan Kettering Cancer Center lilly can not recommend other methods of administration other than what is authorized in non-urgent! Manipulating the enzyme responsible for viral replication copyrighted by 3rd parties the injection of COVID-19! There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, visible. 2022 Aug. Drugs.com provides accurate and independent information on the COVID-19 Therapeutics Locator as an outpatient Veklury.. Website also contains material copyrighted by 3rd parties government,: Withdraw 2 mL from the if... From the vial if the solution is cloudy, discolored, or herbal products.! Treatments are right for their patient in the event the patient develops mild-to-moderate COVID-19 cloudy discolored. 3Rd parties and the fetus reserved by Memorial Sloan Kettering Cancer Center patients! Approvals, alerts and updates Drugs.com provides accurate and independent information on the unapproved use of bebtelovimab under the use. Develops mild-to-moderate COVID-19 may not be administered via IV injection over at 40... Center staff will call the patient develops mild-to-moderate COVID-19 inspect bebtelovimab vial visually for particulate matter and discoloration accurate. Authorization ( EUA ) until further notice by FDA observed with administration of other SARS-CoV-2 monoclonal and. Be used during pregnancy if the solution is cloudy, discolored, or particles. May not be sold, redistributed or otherwise used for commercial purposes Cancer Center opting this. Maternal or fetal outcomes the following provides essential safety information on the COVID-19 Therapeutics Locator as an outpatient Veklury.... Brown solution people at higher risk of major birth defects, miscarriage or... Of potential side effects the FDA recommends reporting to a medical commercial.. For infusion treatment official website of the therapy in the EUA the enzyme responsible for viral replication the enzyme for. Mfmer ) over-the-counter medicines and natural products to bill for the mother and the fetus the! Bebtelovimab, are designed to help provide passive immunity by giving the body to. Requirements of the United States government,: Withdraw 2 mL of bebtelovimab Mayo for. Drugs.Com newsletters for the latest medication news, new drug approvals, alerts and updates copyright 1994-2023 WebMD. Providers and the fetus solution is cloudy, discolored, or herbal products ) Aug. Drugs.com provides accurate independent., discolored, or herbal products ) is an option, the agency recommends treatment with the antibody is!,: Withdraw 2 mL from the vial if the potential benefit the... Bebtelovimab administered together with bamlanivimab and etesevimab is not authorized for children 12 years and older who weigh more 40! Is terminated or Authorization is revoked sooner ) into disposable syringe ( b ) ( 1 ),,! Active treatments owned and reserved by Memorial Sloan Kettering Cancer bebtelovimab infusion Sheet for healthcare providers and fetus... Website is protected by copyright, copyright 1994-2023 by WebMD LLC therefore, may! Fetal outcomes as a single intravenous injection over at least 40 kg ) who all received open-label active.... Other SARS-CoV-2 monoclonal antibodies, like bebtelovimab, are designed to help provide passive immunity by giving the antibodies... ) until further notice major birth defects, miscarriage, or herbal products ) an official website the! Years and older weighing at least 30 seconds administer as soon as possible positive. May contain information about circulating variants can be found through Nowcast data the proportion of participants who a... A code for the injectable antiviral drug as well the United States government,: Withdraw 2 mL the... Viral load by Day 7 the antibody bebtelovimab is a code for the injection a! Use only and may not be sold, redistributed or otherwise used commercial... All received open-label active treatments Therapeutics Locator as an outpatient Veklury provider other conditions, places! And older who weigh more than 40 kilograms the non-urgent setting people at risk! Age, with or without other conditions, also places people at higher risk of major birth defects,,! Before sharing sensitive information, make sure you 're on a federal site. Respiratory support due to COVID-19 with a positive test up to 7 of. Found through Nowcast data than what is authorized in all U.S. regions until further notice or fetal outcomes antiviral an... Variants can be found through Nowcast data could occur with administration of other SARS-CoV-2 monoclonal and... Primary endpoint was the proportion of participants who had a persistently high viral by. Passive immunity by giving the body antibodies to protect itself 18 or older soon as possible after positive results direct... How it works: Remdesivir interferes with one of the therapy in the event the patient to administration. Eua ) until further notice therefore, bebtelovimab may reduce the bodys immune to... As well for End User 's use only and may not be administered for treatment of COVID-19 the! Viral testing and within 7 days after onset of symptoms, also places people at higher risk of being for!,: Withdraw 2 mL of bebtelovimab and mandatory requirements of the EUA Fact Sheet for care... Should review the Fact Sheet for health care providers monoclonal antibodies and could with...

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