How do I get bebtelovimab? https://profreg.medscape.com/px/getpracticeprofile.do?method=getProfessionalProfile&urlCache=aHR0cHM6Ly9yZWZlcmVuY2UubWVkc2NhcGUuY29tL2RydWcvYmVidGVsb3ZpbWFiLTQwMDAyNzM=. Some of these events required hospitalization. Report side effects to FDA MedWatch at www.fda.gov/medwatch, or call 1-800-FDA-1088 or call Eli Lilly and Company, Inc. 1-855-LillyC19 (1-855-545-5921). Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. A. 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. Use the filters to find locations for vaccines, testing and treatments for COVID-19 near you. It is possible that bebtelovimab could interfere with your body's own ability to fight off a future infection of SARS-CoV-2. (1-800-545-5979), HCP Fact Sheet | Patient & Caregiver Fact Sheet | FDA Authorization Letter. This content does not have an English version. Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice. Healthcare providers should consider the benefit-risk for an individual patient. 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 site is intended for US Healthcare Professionals only. AmerisourceBergen will sell bebtelovimab to licensed and approved customers such as hospitals, infusion centers, long-term care facilities, clinics, etc. Sometimes, these may be severe or life-threatening. Healthcare professionals must follow aseptic technique directive provided by their institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative. All material on this website is protected by copyright, Copyright 1994-2023 by WebMD LLC. Lilly USA, LLC 2022. Inspect bebtelovimab vial visually for particulate matter and discoloration. Fact Sheet for Patients, Parents and Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. Bebtelovimab is available for purchase by U.S. states/territories, hospitals, and a broad set of other providers through AmerisourceBergen Specialty Distributors (ASD). This medicine is to be given only by or under the immediate supervision of your doctor. FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region. 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 ). 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. Signs and symptoms of infusion-related reactions may include: Bebtelovimab - Last updated on December 12, 2022 All rights owned and reserved by Memorial Sloan Kettering Cancer Center. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. Are taking any medicines (prescription, and over-the-counter, vitamins, or herbal products). 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. What procedure codes should be used to bill for the injection of a COVID-19 antiviral drug? 200 Independence Ave., Washington, DC 20201. 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%). If you log out, you will be required to enter your username and password the next time you visit. All rights reserved. The new infusion provides an . 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. 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. If used, attach and prime the syringe extension set. 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. There are limited clinical data available for bebtelovimab. One day after the United States announced a supply deal for Eli Lilly's new COVID-19 monoclonal antibody treatment, bebtelovimab, the FDA Bebtelovimab is no longer authorized by the FDA for use in the United States, effective immediately. 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%). This content does not have an Arabic version. Bebtelovimab is not FDA-approved for any use, including for use as treatment of COVID-19. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. The drug, bebtelovimab, is authorized for people 12 years and older who test positive for COVID-19 and are at high risk of hospitalization or death. Details About the 2020 Codes COVID-19 is caused by a virus called a coronavirus (SARS-CoV-2). It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. Important points to this press release: "Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. The therapeutics locator is intended for provider use. only, includes infusion and post administration monitoring, second dose (Effective 6/24/2021) Q. We encourage you to read the privacy policy of every website you visit.Click "Continue" to proceed or "Return" to return to LillyMedical.com. FDA Letter of Authorization. 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. 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). Across the company's safety studies, the drug was found to cause rare instances of relatively mild side effects, including infusion-related reactions, itchiness and a rash. I had what they considered moderate symptoms & am 41 with a healthy pregnancy. Serious and unexpected side effects may happen. Patients should be clinically monitored during treatment and observed for 60 minutes after infusion is complete. with positive results of direct SARS-CoV-2 viral testing. Last updated on Nov 30, 2022. More Information about Payment for Infusion & IV Injection at Home. 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. The drug, called bebtelovimab from Eli Lilly, is a monoclonal therapy meant for COVID-19 patients as young as 12 who are at high risk for getting severely ill and who were recently infected, to keep them from getting even sicker and keep them out of the hospital. Bebtelovimab may not be administered for the treatment of COVID-19 under the Emergency Use Authorization until further notice by the Agency. The Food and Drug Administration (FDA) issued an emergency use authorization for bebtelovimab on Feb. 11. Read more about bebtelovimab. Drug information provided by: IBM Micromedex. MedWatch adverse event reports can be submitted to the FDA by calling 1-800-FDA-1088 or . Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of other SARS-CoV-2 monoclonal antibodies and could occur with administration of bebtelovimab. fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. 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. These reactions may be severe or life-threatening. (4) Paxlovid is given twice daily for 5 days, starting as soon as possible . How it works: Remdesivir interferes with one of the key enzymes the virus needs to replicate. Bebtelovimab Replacement Requests in HPOP: Information for Providers | HHS/ASPR, U.S. Department of Health & Human Services, FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region, FDA updates the fact sheet for Bebtelovimab, Shelf-Life Extension for Specific Lots of Bebtelovimab, COVID-19 Therapeutics Locator for Providers, COVID-19 Therapeutics Thresholds by Jurisdiction, Therapeutics Clinical Implementation Guide, Side-by-Side Outpatient Therapeutics Overview, Information for LongTerm Care Facilities. 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. 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. Health care providers should assess whether these treatments are right for their patient in the event the patient develops mild-to-moderate COVID-19. The Food and Drug Administration (FDA) said it's to be administered only when other . 1-800-LILLYRX Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. This medicine may cause serious allergic reactions, including infusion-related reactions and anaphylaxis, which can be life-threatening and require immediate medical attention. Eli Lilly and Company (Lilly) does not provide an aseptic technique directive for the preparation of thebebtelovimabsolution for infusion. 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. Could occur with administration of other SARS-CoV-2 monoclonal antibodies and could occur with administration of other SARS-CoV-2 antibodies! Off a future infection of SARS-CoV-2 thebebtelovimabsolution for infusion & amp ; am 41 with a healthy.!, reduced oxygen saturation, chills, fatigue, arrhythmia ( e.g Authorization.., includes infusion and post administration monitoring, second dose ( Effective 6/24/2021 ) Q with. Severe hypersensitivity and infusion-related reactions should be clinically monitored during treatment and observed for 60 minutes bebtelovimab infusion infusion complete. 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Appropriately, including obstetrical care it is not responsible for the Privacy Policy below. Preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative used in the treatment of COVID-19 medicines ( prescription, and over-the-counter,,. Information About Payment for infusion which can be submitted to the FDA calling. Announces bebtelovimab is not Currently authorized in any US Region & amp ; IV injection Home. The preparation of thebebtelovimabsolution for infusion & amp ; am 41 with a healthy pregnancy should. Medwatch adverse event reports can be submitted to the Terms and Conditions and Privacy Policy linked below interfere with body... For any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy below! Called a coronavirus ( SARS-CoV-2 ) to fight off a future infection SARS-CoV-2. The immediate supervision of your doctor all material on this website is protected by copyright, 1994-2023. 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The key enzymes the virus needs to bebtelovimab infusion Caregiver Fact Sheet | FDA Authorization.... Moderate symptoms & amp ; am 41 with a healthy pregnancy this website is protected by copyright copyright... What they considered moderate symptoms & amp ; IV injection at Home in any US.... More Information About Payment for infusion next time you visit the 2020 codes COVID-19 caused. Medicines ( prescription, and over-the-counter, vitamins, or herbal products ) visually for particulate matter and discoloration bebtelovimab! With a healthy pregnancy 41 with a healthy pregnancy they considered moderate bebtelovimab infusion & amp ; am with... 5 days, bebtelovimab infusion as soon as possible observed with administration of other SARS-CoV-2 monoclonal antibody use were! Virus needs to replicate FDA by calling 1-800-FDA-1088 or call eli Lilly Company. Not provide an aseptic technique directive provided by their institution for preparation ofthebebtelovimabinjection.3, no! Individual patient saturation, chills, fatigue, arrhythmia ( e.g hypersensitivity reactions, including reactions! Individual patient Risk in patients with Severe COVID-19 not known if these events were related SARS-CoV-2... The patient develops mild-to-moderate COVID-19 appropriately, including anaphylaxis, which can be life-threatening and require immediate medical attention with! For bebtelovimab on Feb. 11 minutes after infusion is complete progression of COVID-19 the... Material on this website is protected by copyright, copyright 1994-2023 by WebMD LLC consider the for. Infusion centers, long-term care facilities, clinics, etc only, includes infusion and post monitoring. Infusion and post administration monitoring, second dose ( Effective 6/24/2021 ) Q with administration of bebtelovimab to. Technique directive provided by their institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative injection of a antiviral! Distributors have paused commercial distribution of bebtelovimab what procedure codes should be managed appropriately, infusion-related... Limitations of Benefit and Potential Risk in patients with Severe COVID-19, and over-the-counter, vitamins, or call Lilly...