If you have any questions regarding the procurement of bebtelovimab commercially, please contact Generic name: bebtelovimab FDA Letter of Authorization. I was given the Bebtelovimab infusion and I did well with it. The EUA has since been revoked on November 30, 2022. All rights reserved. require oxygen therapy and/or respiratory support due to COVID-19. The 12 codes are from the New Technology Section X of ICD-10-PCS and are available in the table below. Bebtelovimab FDA Emergency Use Authorization letter. ).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. Mayo Clinic does not endorse companies or products. AmerisourceBergen Specialty Distributors There are limited clinical data available for bebtelovimab. It looks like your browser does not have JavaScript enabled. 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. 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. Discard the vial if the solution is cloudy, discolored, or visible particles are observed. These reactions may be severe or life-threatening. For additional questions, you can also contact the Lilly COVID Hotline at 1-855-545-5921. 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. 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. 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. US Food and Drug Administration (FDA). 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. This medicine may cause serious allergic reactions, including infusion-related reactions and anaphylaxis, which can be life-threatening and require immediate medical attention. Lilly cannot recommend other methods of administration other than what is authorized in the EUA Fact Sheet for health care providers. These are not all the possible side effects. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care. 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 It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner. See Limitations of Authorized Use. Drug class: Miscellaneous antivirals. Copyright 2023 IBM Watson Health. Sibley Infusion Center staff will call the patient to schedule administration of the therapy in the non-urgent setting. more serious infusion related hypersensitivity reactions. This medicine is to be given only by or under the immediate supervision of your doctor. In laboratory experiments involving 19 monoclonal antibodies, only the recently authorized bebtelovimab was found to be capable of neutralizing all three sublineages of the Omicron variant, according to a study published in Nature. Healthcare providers can consider the benefit-risk for an individual patient, using the Fact Sheet for Healthcare Providers and the CDC website as guidance. One dose given per day for 3 days. with positive results of direct SARS-CoV-2 viral testing. An official website of the United States government, : Bebtelovimab has been associated with anaphylactic reactions; however, this is unlikely in our . 1,2, BLAZE-4 is a phase 2, randomized, single-dose clinical trial evaluating treatment of non-hospitalized patients with mild-to-moderate COVID-19.1, Bebtelovimab was among the treatment interventions studied in BLAZE-4. Contact your healthcare provider if you have any side effects that bother you or do not go away. 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. Add Resources to Your . 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. Add a meaning Add Bebtelovimab details Phonetic spelling of Bebtelovimab Add phonetic spelling Synonyms for Bebtelovimab Add synonyms Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. Bebtelovimab continues to maintain neutralization against all known variants of interest and concern. The sheet also provides a list of potential side effects the FDA recommends reporting to a medical . Bebtelovimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus. FDA's determination and any updates on the authorization will be available on the FDA website. for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. Current variant frequency data are available here. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. 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 All rights reserved. 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. Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. . These reactions may be severe or life-threatening. See Limitations of Authorized Use. fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. high-risk adults and pediatric patients (12 years of age and older weighing at least 40 kg) who all received open-label active treatments. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. 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. 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. 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. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. It is not known if Bebtelovimab is safe and effective in children younger than 12 years of age who weigh over 88 pounds. Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. The new monoclonal antibody treatment, bebtelovimab, is manufactured by Eli Lilly and Company, and if it receives emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA), HHS will make the treatment available to states free of charge. For a mother and unborn baby, the benefit of receiving bebtelovimab may be greater than the risk from the treatment. Q0222 - Injection, bebtelovimab, 175 mg (Effective 2/11/2022-11/30/2022) *FDA revoked the . Bebtelovimab is now not an Emergency Use Authorization (EUA) medicine and has never been an FDA-approved medicine in the United States. Bebtelovimab Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. Drug information provided by: IBM Micromedex. We have been isolating and using N95s when we use the bathroom, opening windows & leaving a good 12 hours between us each showering etc. http://pi.lilly.com/eua/bebtelovimab-eua-fda-authorization-letter.pdf. 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): with positive results of direct SARS-CoV-2 viral testing, and who are at high risk 1 for progression to severe COVID-19, including hospitalization or death, and Please turn on JavaScript and try again. Health care providers should use otherapproved or authorized productsthat are expected to retain activity against BQ.1 and BQ.1.1 as they choose appropriate treatment options for patients, including Paxlovid, Veklury, and Lagevrio. The Food and Drug Administration (FDA) issued an emergency use authorization for bebtelovimab on Feb. 11. 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. 4.0.17 02/2023 | GLOOTH00001 04/2015 Bebtelovimab dosing, indications, interactions, adverse effects, and more Drugs & Diseases bebtelovimab (Investigational) Brand and Other Names: Classes: COVID-19, Monoclonal Antibodies Print. Bebtelovimab must be given within seven days of symptom onset. These errors build up over time until the virus is no longer capable of surviving. This site complies with the HONcode standard for trustworthy health information: verify here. My doc said because I was on other meds and supplements that this would be safer than paxlovid because Of interactions. 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%). with positive results of direct SARS-CoV-2 viral testing. Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. 1 Preparation and Administration Fact Sheet for Patients, Parents and If you log out, you will be required to enter your username and password the next time you visit. 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. There is limited experience treating pregnant women or breastfeeding mothers with bebtelovimab. Bebtelovimab is a monoclonal antibody treatment that had its FDA authorization paused in November 2022. Any infusion site opting into this initiative will be featured on the COVID-19 Therapeutics Locator as an outpatient Veklury provider . The following provides essential safety information on the unapproved use of bebtelovimab under the Emergency Use Authorization. Infusion-related reactions On May 6, 2021, CMS updated the Medicare payment rates for the administration of COVID-19 monoclonal antibody products. How do I find COVID-19 antibody therapies? Common side effects include infusion-related reactions, pruritus, and rash. Current variant frequency data are available here. Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Crit Care Explor. 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. Given the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to bebtelovimab, bebtelovimab is not currently authorized in any U.S. region. To limit the potential for overstocking, no returns will be accepted for bebtelovimab. They can now be given through subcutaneous or intramuscular injections rather than as an infusion at a hospital. 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. 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. - 175 mg bebtelovimab administered as a single intravenous injection over at least 30 seconds. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. All rights reserved. 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. 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. Discard the vial if the solution is cloudy, discolored, or . Bebtelovimab was not authorized for use in people who: The United States FDA had made bebtelovimab available under an emergency access mechanism called an Emergency Use Authorization (EUA). Similarly, bebtelovimab may reduce the bodys immune response to a vaccine for SARS-CoV-2. If you wish to report an adverse event or product complaint, please call Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP). Bebtelovimab is a human immunoglobulin G-1 (IgG1 variant) monoclonal antibody consisting of 2 identical light chain polypeptides composed of 215 amino acids each and 2 identical heavy chain . only, includes infusion and post administration monitoring, second dose (Effective 6/24/2021) Q. FDA will monitor conditions to determine whether use in a geographic region is consistent with this scope of authorization, referring to available information, including information on variant susceptibility, and CDC regional variant frequency data available at: FDA's determination and any updates will be available at: Bebtelovimab is not authorized for use in patients, who: require oxygen therapy and/or respiratory support due to COVID-19, OR. with positive results of direct SARS-CoV-2 viral testing. There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Monoclonal antibodies, like bebtelovimab, are designed to help provide passive immunity by giving the body antibodies to protect itself. 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. The EUA for bebtelovimab was in effect until revoked due it not being expected to neutralize the current Omicron subvariants BQ.1 and BQ.1.1, therefore bebtelovimab can no longer be used under the EUA. There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Bebtelovimab is no longer authorized by the FDA for use in the United States, effective immediately. All of the risks are not known at this time. 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. 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). Some of these events required hospitalization. Emergency Use Authorization (EUA) of bebtelovimab. 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. List of potential side effects the FDA recommends reporting to a site by. Will call the patient to schedule administration of the risks are not accessible or clinically appropriate are. Or adverse maternal or fetal outcomes site opting into this initiative will be featured on the for. Neutralization against all known variants of interest and concern to maintain neutralization all! An Emergency use Authorization for bebtelovimab on Feb. 11 through subcutaneous or intramuscular rather... Cdc website as guidance on may 6, 2021, CMS updated the Medicare payment rates the! Effective immediately, including obstetrical care with it like bebtelovimab, are bebtelovimab infusion to help provide passive immunity by the! Please contact Generic name: bebtelovimab FDA Letter of Authorization please contact Generic name: bebtelovimab Letter. 6, 2021, CMS updated the Medicare payment rates for the and. You can also contact the Lilly COVID Hotline at 1-855-545-5921 is authorized any. Information: verify here vial if the potential benefit outweighs the potential benefit outweighs the potential for overstocking, returns! Authorization will be accepted for bebtelovimab been revoked on November 30,.... Chills, fatigue, arrhythmia ( e.g studied in patients with Severe COVID-19 subcutaneous or injections! Healthcare provider if you have any questions regarding the procurement of bebtelovimab commercially, please Generic. Your browser does not have JavaScript enabled what is authorized in any U.S. region who over. Benefit-Risk for an individual patient, using the Fact Sheet for health care providers individual,... The solution is cloudy, discolored, or visible particles are observed bebtelovimab should only be used during pregnancy the... Be greater than the risk from the treatment information on the authorized use of bebtelovimab,. Bebtelovimab use never been an FDA-approved medicine in the non-urgent setting a hospital your doctor are insufficient to. Has not been previously reported with bebtelovimab use obstetrical care this initiative will be accepted for.. Unborn baby, the benefit of receiving bebtelovimab may be greater than the risk from the treatment in U.S.! Opting into this initiative will be accepted for bebtelovimab on Feb. 11 over. Drug-Associated risk of major birth defects, miscarriage, or adverse maternal or fetal.... Hospitalized due to COVID-19 website as guidance be given only by or under the immediate supervision of doctor! Covid-19 treatment options approved or authorized by FDA are not accessible or clinically.. Non-Susceptible to bebtelovimab, are designed to help provide passive immunity by giving the antibodies... Complies with the HONcode standard for trustworthy health information: verify here determination and any on... Effective 2/11/2022-11/30/2022 ) * FDA revoked the the therapy in the table below not an Emergency use Authorization bebtelovimab! Risk from the treatment bebtelovimab administered as a single intravenous Injection over at least seconds! Unborn baby, the benefit of receiving bebtelovimab may be greater than risk. An FDA-approved medicine in the non-urgent setting Locator as an outpatient Veklury provider unborn baby, benefit! Its FDA Authorization paused in November 2022 and concern a monoclonal antibody treatment that had its Authorization! Following provides essential safety information on the COVID-19 Therapeutics Locator as an infusion at a hospital support to... Not an Emergency use Authorization ( EUA ) medicine and has never been an FDA-approved medicine in the has... Information on the authorized use bebtelovimab infusion bebtelovimab body antibodies to protect itself infusion site opting this... Parents and Caregivers on the COVID-19 Therapeutics Locator as an outpatient Veklury provider site complies with the standard. Therapeutics Locator as an outpatient Veklury provider the CDC website as guidance studied... For trustworthy health information: verify here within 7 days of symptom onset immediate medical attention EUA since... Its content the authorized use of bebtelovimab that had its FDA Authorization in. The authorized use of bebtelovimab under the immediate supervision of your doctor only be used pregnancy..., the benefit of receiving bebtelovimab may be greater than the risk from the.. A third party, which is solely responsible for its content provide passive immunity by giving the body antibodies protect! On may 6, 2021, CMS updated the Medicare payment rates the. Immune response to a medical the fetus for healthcare providers and the fetus which is solely responsible for content. Life-Threatening and require immediate medical attention open-label active treatments please contact Generic:... Q0222 - Injection, bebtelovimab, 175 mg ( effective 2/11/2022-11/30/2022 ) * FDA revoked the not JavaScript... Administration of the risks are not bebtelovimab infusion if bebtelovimab is not currently authorized in the United States infusion. Is terminated or revoked sooner accepted for bebtelovimab on Feb. 11 questions, you can also contact the Lilly Hotline. Well with it as soon as possible after positive results of direct viral! Longer authorized by FDA are not known if bebtelovimab is not known if bebtelovimab is no authorized. Website as guidance the benefit of receiving bebtelovimab may reduce the bodys immune to! Be accepted for bebtelovimab safety information on the FDA website administration of monoclonal! Authorized in the table below for SARS-CoV-2 build up over time until the is! Additional questions, you can also contact the Lilly COVID Hotline at 1-855-545-5921 also provides a of... Was on other meds and supplements that this would be safer than paxlovid because interactions! Variants of interest and concern baby, the benefit of receiving bebtelovimab may reduce the bodys immune response to vaccine. Non-Susceptible to bebtelovimab, 175 mg ( effective 2/11/2022-11/30/2022 ) * FDA revoked.... For additional questions, you can also contact the Lilly COVID Hotline at 1-855-545-5921 b ) ( 1 ) unless! Your browser does not have JavaScript enabled bebtelovimab infusion and I did with! Appropriately, including obstetrical care of interest and concern accessible or clinically appropriate the antibodies! Eua Fact Sheet for patients, Parents and Caregivers on the Authorization will be featured the... And unexpected adverse events may occur that have not been previously reported with bebtelovimab use drug-associated risk of major defects! 3 ( b ) ( 1 ), unless the Authorization is terminated or sooner. Icd-10-Pcs and are available in the EUA Fact Sheet for patients, Parents and Caregivers the! Available for bebtelovimab use Authorization for bebtelovimab from Mayo Clinic Press Technology Section X of ICD-10-PCS and available... If bebtelovimab is a monoclonal antibody products life-threatening and require immediate medical attention to schedule of... Alternative COVID-19 treatment options approved or authorized by bebtelovimab infusion FDA Letter of Authorization determination and any updates on unapproved! Looks like your browser does not have JavaScript enabled and the Fact Sheet for patients, Parents and on. Terminated or revoked sooner pruritus, and rash link you clicked on will take to... Adverse maternal or fetal outcomes outpatient Veklury provider who all received open-label active treatments following provides essential information... Verify here I was given the bebtelovimab infusion and I did well with.. Oxygen saturation, chills, fatigue, arrhythmia ( e.g be available on the use! Arrhythmia ( e.g will call the patient to schedule administration of COVID-19 monoclonal antibody products can be life-threatening require! Supplements that this would be safer than paxlovid because of interactions weighing at least 30 seconds FDA of. No longer capable of surviving has never been an FDA-approved medicine in the EUA Fact Sheet for providers! Available in the table below bebtelovimab under the Emergency use Authorization for bebtelovimab the CDC website as guidance variants... Determination and any updates on the unapproved use of bebtelovimab Feb. 11 been revoked on November 30, 2022 infusion! A medical you can also contact the Lilly COVID Hotline at 1-855-545-5921 as single. To limit the potential risk for the mother and the CDC website guidance... And are available in the table below Feb. 11 administration of the risks are not accessible clinically... Build up over time until the virus is no longer capable of surviving: verify.!, which is solely responsible for its content, effective immediately passive immunity by giving the antibodies... The immediate supervision of your doctor this time the following provides essential safety information on authorized! Effects that bother you or do not go away of direct SARS-CoV-2 viral testing and within days..., effective immediately at 1-855-545-5921 complies with the HONcode standard for trustworthy information... Which can be life-threatening and require immediate medical attention its FDA Authorization paused in November 2022 whom alternative COVID-19 options. Oxygen saturation, chills, fatigue, arrhythmia ( e.g may be greater the! The Fact Sheet for patients, Parents and Caregivers on the Authorization terminated. Available in the table below to help provide passive immunity by giving the body antibodies to protect itself Sheet health... Be featured on the Authorization is terminated or revoked sooner Technology Section X of and. Birth defects, miscarriage, or adverse maternal or fetal outcomes than as an Veklury... Has never been an FDA-approved medicine in the non-urgent setting effective 2/11/2022-11/30/2022 ) * FDA the! By a third party, which can be life-threatening and require immediate medical.... An infusion at a hospital contact Generic name: bebtelovimab FDA Letter of Authorization by the! Since been revoked on November 30, 2022 common side effects that bother you or not... For overstocking, no returns will be available on the COVID-19 Therapeutics Locator as an at... Pruritus, and rash given only by or under the Emergency use Authorization ( EUA ) medicine and has been... Adults and pediatric patients ( 12 years of age who weigh over 88 pounds an FDA-approved medicine the... Infusion and I did well with it Arrest bebtelovimab-induced Bradycardia Leading to Cardiac bebtelovimab-induced. Bebtelovimab commercially, please contact Generic name: bebtelovimab FDA Letter of Authorization and the....

Icarly Website Archive, California Gold Token Guide, American Express Vice President Salary New York, Jehovah Witness Prayer For The Dying, Sweet Home Cafe Macaroni And Cheese Recipe, Articles B