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]). Bebtelovimab is available for purchase by U.S. states/territories, hospitals, and a broad set of other providers through AmerisourceBergen Specialty Distributors (ASD). 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. Copyright 2023 IBM Watson Health. This is a vaccine for Covid-19 that is investigated on administered in children and adults. This content does not have an English version. These reactions may be severe or life-threatening. 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. for whom other COVID-19 treatment options approved or authorized by FDA are not available or clinically appropriate. Monoclonal antibodies, like bebtelovimab, are designed to help provide passive immunity by giving the body antibodies to protect itself. MedWatch adverse event reports can be submitted to the FDA by calling 1-800-FDA-1088 or 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. Withdraw 2 mL of bebtelovimab (1 vial) into disposable syringe. 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. 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. It looks like your browser does not have JavaScript enabled. The Food and Drug Administration (FDA) issued an emergency use authorization for bebtelovimab on Feb. 11. 2United States Food and Drug Administration. 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 Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. . We have been isolating and using N95s when we use the bathroom, opening windows & leaving a good 12 hours between us each showering etc. Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. | Lilly USA, LLC 2023. 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 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 people with mild to moderate COVID-19 and shown a benefit in reducing the risk of hospitalization or death. Monoclonal antibody drugs are designed to start working faster than vaccines, while protection provided by vaccines may last longer. 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. Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab and mandatory requirements of the EUA. The Food and Drug Administration (FDA) said it's to be administered only when other . An FDA form 3500 is required for serious adverse events or medication errors. Observe patient for at least 1 hour after injection. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. If you log out, you will be required to enter your username and password the next time you visit. How do I find COVID-19 antibody therapies? 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. Please see the enclosed Fact Sheet for authorized dosing information. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Prescribers should monitorCDC regional variant frequency dataand refer to the Antiviral Resistance information in the Healthcare Provider Fact Sheet for details regarding specific variants and resistance against SARS-CoV-2 variants in your area, particularly Omicron subvariants BQ.1 and BQ.1.1. All rights reserved. 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. Sibley Infusion Center staff will call the patient to schedule administration of the therapy in the non-urgent setting. 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. 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. Discard the vial if the solution is cloudy, discolored, or . There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Exceptions for weekly dose quantities beyond 270 will be evaluated on a case-by-case basis. (1-800-545-5979), HCP Fact Sheet | Patient & Caregiver Fact Sheet | FDA Authorization Letter. Signs and symptoms of infusion-related reactions may include: COVID-19 is caused by a virus called a coronavirus (SARS-CoV-2). with positive results of direct SARS-CoV-2 viral testing. As of 11/30/2022, the Centers for Disease Control and Prevention (CDC) estimated the proportion of COVID-19 cases to be caused by the Omicron subvariant BQ.1 and BQ.1.1to be above 50% in all U.S. Department of Health and Human Services (HHS) regions. 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. Thresholds, Orders, and Replenishment by Jurisdiction, HHS, Administration for Strategic Preparedness and Response (ASPR) Bebtelovimab is not FDA-approved for any use, including for use as treatment of COVID-19. Are taking any medicines (prescription, and over-the-counter, vitamins, or herbal products). Use the yellow button below to refer patients directly for infusion treatment. Serious and unexpected side effects may happen. There are limited clinical data available for bebtelovimab. On May 6, 2021, CMS updated the Medicare payment rates for the administration of COVID-19 monoclonal antibody products. How do you prepare, administer, and monitor bebtelovimab for treatment of COVID-19? 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. There is a code for the injectable antiviral drug as well . Treatment should be administered within 7 days of symptom onset (see Fact Sheet for Healthcare Providers for additional information on dosage/administration). This content does not have an English version. . 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. Assess that alternative COVID-19 treatment options that are approved or authorized by FDA are not accessible or clinically appropriate. Healthcare providers should consider the benefit-risk for an individual patient. INDIANAPOLIS, June 29, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) . All rights reserved. . All rights reserved. At this time, bebtelovimab remains authorized in all U.S. regions until further notice by FDA. Healthcare providers should consider the benefit-risk for an individual patient. 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 healthcare providers only. You can get COVID19 through contact with another person who has the virus. 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. To limit the potential for overstocking, no returns will be accepted for bebtelovimab. You are being redirected to The following provides essential safety information on the unapproved use of bebtelovimab under the Emergency Use Authorization. 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. Bebtelovimab may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis. There are no available data on the presence of bebtelovimab in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Tell your doctor if you are pregnant or plan to become pregnant before using bebtelovimab; severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. Do not shake the vial. All monoclonal antibody (mAb) therapies are in limited supply, and not everyone will be eligible for treatment. Older age, with or without other conditions, also places people at higher risk of being hospitalized for COVID-19. 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. Generic name: bebtelovimab Conditions and Privacy Policy linked below with administration of COVID-19 monoclonal antibody ( mAb ) therapies are in supply. Time, bebtelovimab remains authorized in all U.S. regions until further notice FDA. Protect itself without other Conditions, also places people at higher risk of bebtelovimab infusion. To limit the potential for overstocking, no returns will be evaluated on a case-by-case basis advice! 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