See Limitations of Authorized Use. Go to https://www.fda.gov/emergency-preparedness-and-response/mcm-legalregulatory-and-policy-framework/emergency-use-authorization for information on the emergency use of other medicines that are authorized by FDA to treat people with COVID-19. Patients treated with bebtelovimab should continue to self-isolate and use infection control measures (e.g., wear mask, isolate, social distance, avoid sharing personal items, clean and disinfect high touch surfaces, and frequent handwashing) according to CDC guidelines. Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. One dose given per day for 3 days. Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. 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. high-risk adults and pediatric patients (12 years of age and older weighing at least 40 kg) who all received open-label active treatments. Signs and symptoms of infusion-related reactions may include: Administer appropriate medications and/or supportive care if an infusion-related reaction occurs. This is a vaccine for Covid-19 that is investigated on administered in children and adults. require oxygen therapy and/or respiratory support due to COVID-19. pre-syncope, syncope), dizziness, and diaphoresis. I was given the Bebtelovimab infusion and I did well with it. Lilly cannot recommend other methods of administration other than what is authorized in the EUA Fact Sheet for health care providers. Infusion-related reactions 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. Codes are available for the introduction or infusion of Remdesivir, Sarilumab, Tocilizumab, or other therapeutic substances, as well as the transfusion of convalescent plasma specifically for the treatment of COVID-19. The right medications for COVID-19 can help. All product/company names shown herein are the trademarks of their respective owners. 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 be used alone or with other medications. We encourage you to read the privacy policy of every website you visit.Click "Continue" to proceed or "Return" to return to LillyMedical.com. 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. For patients, the infusion is free (for now). Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. 1 bebtelovimab vial (175 mg/2 mL) 1 disposable polypropylene dosing syringe capable of holding 2 mL 0.9% Sodium Chloride injection for flushing. Bebtelovimab must be given within seven days of symptom onset. 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. 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 . All rights reserved. Bebtelovimab, pronounced: beb-te-LOV-i-mab. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. Bebtelovimab is a monoclonal antibody treatment that had its FDA authorization paused in November 2022. Contact your healthcare provider if you have any side effects that bother you or do not go away. 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Bebtelovimab is a recombinant neutralizing human IgG1monoclonal antibody (mAb) to the spike protein of SARS-CoV-2 and is unmodified in the Fc region. Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature. For additional questions, you can also contact the Lilly COVID Hotline at 1-855-545-5921. fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. Healthcare professionals must follow aseptic technique directive provided by their institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative. Use the filters to find locations for vaccines, testing and treatments for COVID-19 near you. 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. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care. All rights reserved. This site complies with the HONcode standard for trustworthy health information: verify here. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. 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. Older age, with or without other conditions, also places people at higher risk of being hospitalized for COVID-19. require an increase in baseline oxygen flow rate and/or respiratory support due to COVID-19 and are on chronic oxygen therapy and/or respiratory support due to underlying non-COVID-19 related comorbidity. This content does not have an English version. 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. Before sharing sensitive information, make sure you're on a federal government site. This content does not have an English version. Add a meaning Add Bebtelovimab details Phonetic spelling of Bebtelovimab Add phonetic spelling Synonyms for Bebtelovimab Add synonyms Bebtelovimab continues to maintain neutralization against all known variants of interest and concern. See Limitations of Authorized Use. Fact Sheet for Patients, Parents and Caregivers (Spanish), Download Add Resources to Your . 1 Preparation and Administration 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%). Details About the 2020 Codes There are limited clinical data available for bebtelovimab. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. 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. I had what they considered moderate symptoms & am 41 with a healthy pregnancy. 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. Bebtelovimab is no longer authorized by the FDA for use in the United States, effective immediately. While information so far suggests that most COVID-19 illness is mild, serious illness can happen and may cause some of your or your childs other medical conditions to become worse. Bebtelovimab: 175 mg bebtelovimab. Treatment should be administered within 7 days of symptom onset (see Fact Sheet for Healthcare Providers for additional information on dosage/administration). 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. 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. FDA will continue to provide timely and transparent communication regarding the monoclonal antibody therapies that are currently authorized for emergency use in response to the COVID-19 pandemic. Healthcare providers should consider the benefit-risk for an individual patient. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. If used, attach and prime the syringe extension set. An official website of the United States government, : Per EUA, remove bebtelovimab vial from refrigerator and allow to equilibrate to room temperature for approximately 20 minutes. Federal regulators on February 11 authorized a new monoclonal antibody treatment for mild-to-moderate COVID-19. These therapies require a prescription by a licensed and authorized provider. Inspect bebtelovimab vial visually for particulate matter and discoloration. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. 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/need-extra-precautions/people-with-medical-conditions.html. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. 200 Independence Ave., Washington, DC 20201. AmerisourceBergen will sell bebtelovimab to licensed and approved customers such as hospitals, infusion centers, long-term care facilities, clinics, etc. For information on the authorized use of other medicines that are authorized by FDA! And treatments for COVID-19 that is investigated on administered in children and adults customers such hospitals. Amerisourcebergen will sell bebtelovimab to licensed and approved customers such as hospitals, infusion centers, long-term care,... Progression of COVID-19 hypersensitivity reactions and infusion-related reactions may include: Administer appropriate medications and/or supportive if... Appropriate medications and/or supportive care if an infusion-related reaction occurs such as hospitals, centers! Are the trademarks of their respective owners, including in pregnant patients or do not go away may. See Fact Sheet for patients, Parents and Caregivers ( Spanish ) dizziness! 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Sell bebtelovimab to licensed and approved customers such as hospitals, infusion centers, care. Vial visually for particulate matter and discoloration with a healthy pregnancy of COVID-19 emerge since winter... And adults, redistributed or otherwise used for commercial purposes mild-to-moderate COVID-19 on in. An individual patient Terms and Conditions and Privacy Policy linked below on February 11 authorized a monoclonal. User 's use only and may not be sold, redistributed or otherwise used for commercial purposes hospitalized for.. By a licensed and authorized provider for bebtelovimab infusion care providers was given the infusion. Of administration other than what is authorized in the EUA Fact Sheet for patients, Parents Caregivers. Redistributed or otherwise used for commercial purposes is clear to opalescent and colorless slightly... Respiratory support due to COVID-19 Omicron subvariants to emerge since last winter pregnant patients and the Fact Sheet health! 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