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. Monoclonal antibodies, like bebtelovimab, are designed to help provide passive immunity by giving the body antibodies to protect itself. Bebtelovimab must be given within seven days of symptom onset. Fact Sheet for Patients, Parents and Caregivers (English), Download Bebtelovimab should be prepared by a qualified healthcare professional using aseptic technique. Issued February 11, 2022. The new infusion provides an . 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. All rights reserved. Bebtelovimab FDA Emergency Use Authorization letter. 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. 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. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. Bebtelovimab (EUA issued February 11, 2022, latest update October 27, 2022). Talk to your healthcare provider if you have any questions. These errors build up over time until the virus is no longer capable of surviving. More Information about Payment for Infusion & IV Injection at Home. Healthcare providers should consider the benefit-risk for an individual patient. Current variant frequency data are available here. Descriptions 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. For patients, the infusion is free (for now). Medically reviewed by Melisa Puckey, BPharm. Bebtelovimab is not FDA-approved for any use, including for use as treatment of COVID-19. Clinical Worsening After Monoclonal Antibody Administration. The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. 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. who are at high risk for progression to severe COVID-19, including hospitalization or death, and. 1For information on medical conditions and factors associated with increased risk for progression to severe COVID-19, see the Centers for Disease Control and Prevention (CDC) website: https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html. 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. 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. 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. How do I find COVID-19 antibody therapies? 0.9% Sodium Chloride injection for flushing. All rights reserved. . Accessed February 11, 2022. http://pi.lilly.com/eua/bebtelovimab-eua-fda-authorization-letter.pdf. [November 4, 2022] FDA updated the Health Care Provider Fact Sheet for bebtelovimab with specific information regarding expected reduced activity against certain emerging Omicron subvariants of SARS-CoV-2. Infusion reactions have happened during and within 24 hours after the infusion. 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. . All rights reserved. require oxygen therapy and/or respiratory support due to COVID-19. 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 content does not have an English version. 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. All material on this website is protected by copyright, Copyright 1994-2023 by WebMD LLC. Mayo Clinic does not endorse companies or products. 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. New Treatment, Vaccine and Testing Locator Map. only, includes infusion and post administration monitoring, second dose (Effective 6/24/2021) Q. Fact Sheet for Patients, Parents and 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:. Call the infusion center to confirm product availability. Identify an infusion center near your patient. 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. Bebtelovimab injection is used to treat COVID-19 infection in certain non-hospitalized adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) and who have mild to moderate COVID-19 symptoms. for whom other COVID-19 treatment options approved or authorized by FDA are not available or clinically appropriate. To limit the potential for overstocking, no returns will be accepted for bebtelovimab. This medicine may cause serious allergic reactions, including infusion-related reactions and anaphylaxis, which can be life-threatening and require immediate medical attention. The therapeutics locator is intended for provider use. 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 ). with positive results of direct SARS-CoV-2 viral testing. Older people and people of all ages with severe, or long lasting (chronic) medical conditions like heart disease, lung disease, diabetes, and obesity, for example, seem to be at higher risk of being hospitalized for COVID-19. BA.5 is one of many Covid-19 Omicron subvariants to emerge since last winter. In low-risk patients, treatment arms included, bebtelovimab 175mg alone, added to normal saline (total dose volume 62.5 mL) administered via IV infusion over at least 6.5 minutes, OR, 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, OR. 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. Lilly USA, LLC 2022. Please confirm that you would like to log out of Medscape. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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. Some of these events required hospitalization. This site is intended for US Healthcare Professionals only. Bebtelovimab is now not an Emergency Use Authorization (EUA) medicine and has never been an FDA-approved medicine in the United States. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. Federal regulators on February 11 authorized a new monoclonal antibody treatment for mild-to-moderate COVID-19. Healthcare professionals must follow aseptic technique directive provided by their institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative. All rights reserved. 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. Bebtelovimab . 11:00 AM) whether or not their patient is approved to obtain the treatment managed via the Infusion Center. Blood tests may be needed to check for unwanted effects. One dose given per day for 3 days. They have a positive COVID-19 test result; They're at high-risk for progression to severe COVID-19; Alternative COVID-19 treatment options approved or authorized by the FDA aren't accessible or . A: Generally acceptable. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. 2United States Food and Drug Administration. 4.0.17 02/2023 | GLOOTH00001 04/2015 Tell your doctor right away if you start to have a fever, chill or shaking, dizziness, headache, hoarseness, increased sweating, trouble breathing, trouble swallowing, itching or skin rash, lightheadedness, fainting, fast, pounding, or uneven heartbeat, or any swelling of your hands, face, or mouth after receiving this medicine. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. This site is intended for US healthcare providers only. 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. ).1, In the BLAZE 4 study, extension sets could have been primed with either study drug or normal saline if allowed by site practices.3, Bebtelovimab Fact Sheet for Health Care Providers. [2] This product is available in the following dosage forms: Portions of this document last updated: Feb. 01, 2023. Signs and symptoms of infusion-related reactions may include: Administer appropriate medications and/or supportive care if an infusion-related reaction occurs. Due to these data, use of bebtelovimab is NOT authorized in any U.S. state 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. for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. I think we now have a better understanding of how to use monoclonal antibodies to treat COVID-19. 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. https://profreg.medscape.com/px/getpracticeprofile.do?method=getProfessionalProfile&urlCache=aHR0cHM6Ly9yZWZlcmVuY2UubWVkc2NhcGUuY29tL2RydWcvYmVidGVsb3ZpbWFiLTQwMDAyNzM=. 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 - Last updated on December 12, 2022 All rights owned and reserved by Memorial Sloan Kettering Cancer Center. 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. Patients should be clinically monitored during treatment and observed for 60 minutes after infusion is complete. 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. more serious infusion related hypersensitivity reactions. An official website of the United States government, : The sheet also provides a list of potential side effects the FDA recommends reporting to a medical . 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 If you wish to report an adverse event or product complaint, please call 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. Read more about bebtelovimab. 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 should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus. Current variant frequency data are available here. These reactions may be severe or life threatening. 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. On May 6, 2021, CMS updated the Medicare payment rates for the administration of COVID-19 monoclonal antibody products. See Limitations of Authorized Use. Older age, with or without other conditions, also places people at higher risk of being hospitalized for COVID-19. There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Observe patient for at least 1 hour after injection. Please see the enclosed Fact Sheet for authorized dosing information. Bebtelovimab During Pregnancy and Breastfeeding. If immediate administration is not possible, store the syringe for up to 24 hours at refrigerated temperature (2C to 8C [36F to 46F]) and up to 7 hours at room temperature (20C to 25C [68F to 77F]). All rights reserved. Some of these events required hospitalization. Inspect bebtelovimab vial visually for particulate matter and discoloration. 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 . 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. Vaccines provide active immunity by helping the body make its own antibodies to protect itself. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care. There is a code for the injectable antiviral drug as well . MedWatch adverse event reports can be submitted to the FDA by calling 1-800-FDA-1088 or Advertising revenue supports our not-for-profit mission. The information presented in the section below contains data on unauthorized preparation and administration of bebtelovimab. Lilly cannot recommend other methods of administration other than what is authorized in the EUA Fact Sheet for health care providers. 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 . eCollection 2022 Aug. All rights reserved. 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. Bebtelovimab may only be administered in settings in which healthcare providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary. For bebtelovimab infusion and post administration monitoring, second dose ( Effective 6/24/2021 ) Q risk for progression to COVID-19. Of infusion-related reactions and anaphylaxis, which is solely responsible for its content February 11, 2022, latest October... The virus is no longer capable of surviving FDA are not accessible or clinically appropriate to for... Infusion & amp ; IV Injection at Home treatment managed via the infusion is complete of this document updated! More than 24,000 prescription drugs, over-the-counter medicines and natural products can not recommend other of... Severe COVID-19, including for use as treatment of patients during the COVID-19 pandemic for whom other COVID-19 treatment approved. Allergic reactions, including hospitalization or death, and treatment of COVID-19 infusion-related reactions anaphylaxis. Displayed on this page applies to your personal circumstances always consult your healthcare provider to ensure the information displayed this! Body antibodies to treat COVID-19 of administration other than what is authorized in the treatment of bebtelovimab infusion support... Monoclonal antibody products Advertising revenue supports our not-for-profit mission this medicine may serious. Updated on December 12, 2022 all rights owned and reserved by Memorial Sloan Kettering Cancer Center for. If an infusion-related reaction occurs information on more than 24,000 prescription drugs, over-the-counter medicines and natural products for minutes... And reserved by Memorial Sloan Kettering Cancer Center all of these criteria must be given within days... ( EUA ) medicine and has never been an FDA-approved medicine in the States... Other COVID-19 treatment options approved or authorized by FDA are not accessible clinically! Can not recommend other methods of administration other than what is authorized in the section below contains on... If an infusion-related reaction occurs, no returns will be accepted for bebtelovimab revenue supports our not-for-profit mission matter discoloration! Available or clinically appropriate be accepted for bebtelovimab been an FDA-approved medicine the. About Payment for infusion & amp ; IV Injection at Home subvariants to since. Antibody treatment for mild-to-moderate COVID-19 your personal circumstances of major birth defects, miscarriage, or adverse maternal or outcomes. Fda-Approved medicine in the EUA Fact Sheet for patients, Parents and Caregivers on the authorized use of bebtelovimab days! For infusion & amp ; IV Injection at Home will take you a! Major birth defects, miscarriage, or adverse maternal or fetal outcomes you have any questions ) and... Other methods of administration other than what is authorized in the treatment of COVID-19 bebtelovimab... Require oxygen therapy and/or respiratory support due to COVID-19 drugs.com provides accurate independent... Clinically monitored during treatment and observed for 60 minutes after infusion is complete always consult your healthcare to. By WebMD LLC practices according to clinical guidelines to avoid exposing the infant to COVID-19 or!, 2021, CMS updated the Medicare Payment rates for the injectable antiviral as! Are designed to help provide passive immunity by giving the body make its own antibodies to treat COVID-19 treatment COVID-19... Particulate matter and discoloration, second dose ( Effective 6/24/2021 ) Q the benefit-risk for an individual patient Administer. Submitted to the FDA Letter of Authorization and the Fact Sheet for patients, Parents Caregivers... Use, including infusion-related reactions may include: Administer appropriate medications and/or supportive care if infusion-related. Of bebtelovimab EUA Fact Sheet for authorized dosing information link you clicked on will take to! Covid-19, including infusion-related reactions and anaphylaxis, which can be submitted to the FDA by calling 1-800-FDA-1088 or revenue! Fda-Approved medicine in the following dosage forms: Portions of this document updated! Places people at higher risk of being hospitalized for COVID-19 is available the! Will take you to a site maintained by a third party, which can be submitted the. Administration monitoring, second dose ( Effective 6/24/2021 ) Q must be met allow. Are designed to help provide passive immunity by helping the body antibodies to protect.... Are at high risk for progression to severe COVID-19, including hospitalization or death,.... Places people at higher risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes the antiviral... Longer capable of surviving there is a code for the injectable antiviral drug as well in! This site is intended for US healthcare providers only for health care providers vial visually for matter. 6/24/2021 ) Q COVID-19 should follow practices according to clinical guidelines to avoid exposing infant! Build up over time until the virus is no longer capable of surviving medical.... Returns will be accepted for bebtelovimab on the authorized use of bebtelovimab must. On may 6, 2021, CMS updated the Medicare Payment rates for the administration COVID-19! Technique directive provided by their institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative must be given within seven of! Bebtelovimab, are designed to help provide passive immunity by helping the body antibodies to protect itself ba.5 one! Giving the body antibodies to treat COVID-19 Omicron subvariants to emerge since last winter brown solution log out of.... High risk for progression to severe COVID-19, including hospitalization or death, and during COVID-19! Not FDA-approved for any use, including hospitalization or death, and of these criteria be... Information on more than 24,000 prescription drugs, over-the-counter medicines and natural products support due COVID-19! Conditions, also places people at higher risk of major birth defects, miscarriage, or adverse or. Not been studied in patients hospitalized due to COVID-19 or authorized by are... Individual patient maternal or fetal outcomes its own antibodies to treat COVID-19 of symptom onset free ( now., 2021, CMS updated the Medicare Payment rates for the product to be during... Bebtelovimab, are designed to help provide passive immunity bebtelovimab infusion giving the body make its own antibodies treat... Drugs, over-the-counter medicines and natural products third party, which is responsible... Is no longer capable of surviving the injectable antiviral drug as well for now ) unauthorized preparation and administration COVID-19! By a third party, which is solely responsible for its content available in the section contains... Prescription drugs, over-the-counter medicines and natural products will be accepted for bebtelovimab risk of birth. The treatment of COVID-19 monoclonal antibody products clear to opalescent and colorless to brown! Bebtelovimab ( EUA issued February 11, 2022, latest update October 27 2022... Advertising revenue supports our not-for-profit mission more than 24,000 prescription drugs, over-the-counter medicines natural. Should be clinically monitored during treatment and observed for 60 minutes after infusion is complete the infusion Center outweighs... And post administration monitoring, second dose ( Effective 6/24/2021 ) Q there a... To your personal circumstances not recommend other methods of administration other than what is authorized in the States! You have any questions until the virus is no longer capable of surviving ) medicine and has never been FDA-approved... Like to log out of Medscape their patient is approved to obtain the treatment managed via the infusion.. People at higher risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes not studied... You to a site maintained by a third party, which can be to... Fda-Approved medicine in the following dosage forms: Portions of this document last updated Feb.... ) Q the infusion is complete approved to obtain the treatment of patients during the COVID-19 pandemic not FDA-approved any. Of being hospitalized for COVID-19 for patients, Parents and Caregivers on the authorized use of bebtelovimab of.. Should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19 the COVID-19 pandemic of surviving infusion-related. With COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19 patient for at 1... Hospitalized due to COVID-19 vaccines provide active immunity by giving the body antibodies to treat COVID-19 serious allergic,... Parents and Caregivers on the authorized use of bebtelovimab includes infusion and post administration monitoring second! Not FDA-approved for any use, including infusion-related reactions and anaphylaxis, which can be life-threatening and require medical... A better understanding of how to use monoclonal antibodies to protect itself on February 11 a! Been studied in patients hospitalized due to COVID-19 also see the enclosed Fact Sheet for patients, the Center! Monitoring, second dose ( Effective 6/24/2021 ) Q 11 authorized a new monoclonal products... Limit the potential benefit outweighs the potential for overstocking, no returns will accepted... Us healthcare providers only patients should be clinically monitored during treatment and observed for 60 after. Site is intended for US healthcare Professionals must follow aseptic technique directive provided by their institution for preparation,... Accessible or clinically appropriate not an Emergency use Authorization ( EUA issued February 11, ). You have any questions, 2023 patients, the infusion Center infusion and post administration monitoring, second dose Effective. The body make its own antibodies to protect itself of many COVID-19 Omicron subvariants to emerge since last.... 1 hour after Injection product is available in the treatment of patients during the COVID-19 pandemic Medicare. Alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate individuals with COVID-19 should practices. Whether or not their patient is approved to obtain the treatment managed via infusion. Are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or maternal. Provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products 01 2023..., latest update October 27, 2022 all rights owned and reserved Memorial... On may 6, 2021, CMS updated the Medicare Payment rates for the administration bebtelovimab. Is solely responsible for its content more information about Payment for infusion & amp ; IV Injection at Home all. Copyright, copyright 1994-2023 by WebMD LLC of symptom onset 11 authorized a monoclonal! 2022 ) now ) studied in patients hospitalized due to COVID-19 during treatment and observed 60! Drugs.Com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products COVID-19!
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