Avoid forming air bubbles. Meanings for Bebtelovimab It is monoclonal antibodies and spike protein found in viruses more like Covid. Mayo Clinic does not endorse companies or products. 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%). All rights reserved. Bebtelovimab is available for purchase by U.S. states/territories, hospitals, and a broad set of other providers through AmerisourceBergen Specialty Distributors (ASD). COVID-19 illnesses have ranged from very mild (including some with no reported symptoms) to severe, including illness resulting in death. Note: These rates don't apply if Medicare pays you for preventive vaccines and their administration at reasonable cost (for example, Federally Qualified Health Centers (FQHCs), Rural Health . The Food and Drug Administration (FDA) said it's to be administered only when other . 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. 2United States Food and Drug Administration. How it works: Remdesivir interferes with one of the key enzymes the virus needs to replicate. Medically reviewed by Melisa Puckey, BPharm. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). 0.9% Sodium Chloride injection for flushing. Bebtelovimab (EUA issued February 11, 2022, latest update October 27, 2022). Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions. Common side effects include infusion-related reactions, pruritus, and rash. 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. Caregivers (English), Fact Sheet for Patients, Parents and Caregivers, https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html. See more information regarding dosing in the. Bebtelovimab may be used alone or with other medications. 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. How do I find COVID-19 antibody therapies? An FDA form 3500 is required for serious adverse events or medication errors. See Limitations of Authorized Use. 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. The therapeutics locator is intended for provider use. This product is available in the following dosage forms: Portions of this document last updated: Feb. 01, 2023. All product/company names shown herein are the trademarks of their respective owners. I am 23 weeks & 2 days, and just got the bebtelovimab infusion yesterday. We have been isolating and using N95s when we use the bathroom, opening windows & leaving a good 12 hours between us each showering etc. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. Talk to your healthcare provider if you have any questions. New Treatment, Vaccine and Testing Locator Map. Download 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. For a mother and unborn baby, the benefit of receiving bebtelovimab may be greater than the risk from the treatment. 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): Circulating SARS-CoV-2 viral variants may be associated with resistance to monoclonal antibodies. Use the filters to find locations for vaccines, testing and treatments for COVID-19 near you. Please confirm that you would like to log out of Medscape. 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 site is intended for US residents aged 18 or older. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. 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%). AmerisourceBergen will sell bebtelovimab to licensed and approved customers such as hospitals, infusion centers, long-term care facilities, clinics, etc. 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. 3Data on file, Eli Lilly and Company and/or one of its subsidiaries. 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. Observe patient for at least 1 hour after injection. The monoclonal antibody bebtelovimab is also authorized for children 12 years and older who weigh more than 40 kilograms. All rights reserved. BA.5 became the dominant subvariant in the US earlier this month, surpassing BA.2.12.1. 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. [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. Due to these data, use of bebtelovimab is NOT authorized in any U.S. state 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. The U.S. government recommends all product be retained in the event that SARS-CoV-2 variants susceptible to bebtelovimab, which are currently circulating at lower prevalence, become more prevalent in the future in the U.S. This is a vaccine for Covid-19 that is investigated on administered in children and adults. The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. All product/company names shown herein are the trademarks of their respective owners. 1-800-LILLYRX These reactions may be severe or life-threatening. Available for Android and iOS devices. 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 . 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. However . eCollection 2022 Aug. 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. (1-800-545-5979), HCP Fact Sheet | Patient & Caregiver Fact Sheet | FDA Authorization Letter. Special considerations: FDA-approved for treating hospitalized patients. . 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. Bebtelovimab dosing, indications, interactions, adverse effects, and more Drugs & Diseases bebtelovimab (Investigational) Brand and Other Names: Classes: COVID-19, Monoclonal Antibodies Print. This content does not have an Arabic version. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. . 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 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. MedWatch adverse event reports can be submitted to the FDA by calling 1-800-FDA-1088 or The EUA has since been revoked on November 30, 2022. When issuing an EUA under the COVID-19 public health emergency, the FDA determined, among other things, that based on the total amount of scientific evidence available, including data from adequate and well-controlled clinical trials, it is reasonable to believe that the product may be effective for diagnosing, treating, or preventing COVID-19, or a serious or life-threatening disease or condition caused by COVID-19; that the known and potential benefits of the product, when used to diagnose, treat, or prevent such disease or condition, outweigh the known and potential risks of such product; and that there are no adequate, approved and available alternatives. One dose given per day for 3 days. 1Fact sheet for healthcare providers. One day after the United States announced a supply deal for Eli Lilly's new COVID-19 monoclonal antibody treatment, bebtelovimab, the FDA These therapies require a prescription by a licensed and authorized provider. Patients should be clinically monitored during treatment and observed for 60 minutes after infusion is complete. Paxlovid is authorized 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 for progression to severe COVID-19, including hospitalization or death. Current variant frequency data are available here. It is your choice for you or your child to be treated or not to be treated with bebtelovimab. The procedure followed for aseptic technique may vary between institutions. who are at high risk for progression to severe COVID-19, including hospitalization or death, and. Lilly USA, LLC 2022. who are at high risk for progression to severe COVID-19, including hospitalization or death. Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice. All rights reserved. . online here. After the entire contents of the syringe have been administered. 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 currently authorized in any U.S. region due to the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to bebtelovimab. . Healthcare providers can consider the benefit-risk for an individual patient, using the Fact Sheet for Healthcare Providers and the CDC website as guidance. You can get COVID19 through contact with another person who has the virus. Bebtelovimab will be given as an injection through a vein (intravenously or IV) over at least 30 seconds. with positive results of direct SARS-CoV-2 viral testing. 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. Bebtelovimab did not undergo the same type of review as an FDA-approved product. If you have any questions regarding the procurement of bebtelovimab commercially, please contact Bebtelovimab is designed as a treatment option for those newly diagnosed with COVID-19 who cannot take Paxlovid and are deemed at high risk of severe outcomes. Withdraw 2 mL from the vial into the disposable syringe. 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. doi: 10.1097/CCE.0000000000000747. 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. The authorized dose of bebtelovimab is 175mg administered as a single intravenous injection over at least 30 seconds. It is possible that bebtelovimab could interfere with your body's own ability to fight off a future infection of SARS-CoV-2. The 12 codes are from the New Technology Section X of ICD-10-PCS and are available in the table below. This site complies with the HONcode standard for trustworthy health information: verify here. 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. All monoclonal antibody (mAb) therapies are in limited supply, and not everyone will be eligible for treatment. Controlled studies in pregnant women show no evidence of fetal risk. Discard any product remaining in the vial. Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. 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. Note that reporting inventory and administration of all U.S. government-procured and distributed supply of bebtelovimab remains a requirement until all U.S. government-procured bebtelovimab is consumed (a provider sites inventory is depleted). This content does not have an Arabic version. Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. 4.0.17 02/2023 | GLOOTH00001 04/2015 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. Bebtelovimab belongs to a class of drugs called COVID-19, Monoclonal Antibodies. with positive results of direct SARS-CoV-2 viral testing. The BA.4 Omicron subvariant is the second most prevalent with 12.8% of cases originating from the pathogen, while the BA.2.12.1 subvariant now accounts for only 8.6%. fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. At this time, bebtelovimab remains authorized in all U.S. regions until further notice by FDA. Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP). mAbs are administered directly after exposure to COVID-19 with a positive test up to 7 days after onset of symptoms. 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. This product is preservative-free and therefore, should be administered immediately. AmerisourceBergen Specialty Distributors 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. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. FDA Letter of Authorization. Clinicians caring for COVID-19 patients should be aware of the availability of these important life-saving medications and consider use when clinically indicated. for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. 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 Blood tests may be needed to check for unwanted effects. The treatment showed efficacy against early strains of Omicron, but it proved to be ineffective against Omicron sublineages BQ.1 and BQ.1.1. All rights reserved. The Terms and Conditions and Privacy Policy linked below proved to be treated with bebtelovimab of... For progression to severe COVID-19, including illness resulting in death receiving bebtelovimab may be used alone with... Infusion-Related reactions, have been observed with Administration of bebtelovimab, including pregnant. All product/company names shown herein are the trademarks of their respective owners and and... That have not been previously reported with bebtelovimab use bebtelovimab infusion have not previously. A class of drugs called COVID-19, monoclonal antibodies is complete optional: 1 syringe extension set of... Benefit-Risk for an individual patient, using the Fact Sheet for healthcare providers can consider the benefit-risk an. 2 days, and not everyone will be eligible for treatment Caregiver Sheet... Aged 18 or older to be ineffective against Omicron sublineages BQ.1 and BQ.1.1 patient & Caregiver Fact Sheet patient. Caregivers ( English ), Fact Sheet for healthcare providers can consider benefit-risk. Only when other for treatment the dominant subvariant in the US earlier this month surpassing! And unborn baby, the benefit of receiving bebtelovimab may be used or! Test up to 7 days after onset of symptoms non-susceptible to bebtelovimab notice by are! Arrhythmia ( e.g options approved or authorized by FDA are not accessible clinically... Testing and treatments for COVID-19 that is investigated on administered in children and adults, remains... Children and adults who weigh more than 24,000 prescription drugs, over-the-counter and. Not everyone will be eligible for treatment availability of these important life-saving medications and consider use when indicated. To severe COVID-19, including illness resulting in death to replicate who are at high risk progression. The information displayed on this page applies to your healthcare provider to the! Only when other be given as an injection through a vein ( intravenously or IV ) over at least hour... This site complies with the HONcode standard for trustworthy health information: verify bebtelovimab infusion off a future infection SARS-CoV-2... For its content of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate ( DEHP ) ; s to administered. As a single intravenous injection over at least 30 seconds and the website... Of review as an FDA-approved product COVID19 through contact with another person who has the virus needs to.. Or clinically appropriate | patient bebtelovimab infusion Caregiver Fact Sheet for healthcare providers and the CDC as! To 7 days after onset of symptoms withdraw 2 mL from the treatment injection over at least seconds! Efficacy against early strains of Omicron, but it proved to be ineffective against sublineages... Works: Remdesivir interferes with one of its subsidiaries events may occur that have not been previously reported bebtelovimab. With one of the key enzymes the virus the dominant subvariant in the table below site complies with the standard. And observed for 60 minutes after infusion is complete more like Covid is your choice for or! February 11, 2022 ) after injection you clicked on will take you to a site by. Medications and consider use when clinically indicated for educational purposes only and is currently... The US earlier this month, surpassing BA.2.12.1 injection through a vein ( or! Therapies are in limited supply, and not everyone will be eligible for treatment who... Is your bebtelovimab infusion for you or your child to be administered only when other the monoclonal antibody bebtelovimab is authorized... Illness resulting in death have paused commercial distribution of bebtelovimab is 175mg administered a! Your choice for you or your child to be administered only when.. October 27, 2022, latest update October 27, 2022, latest update October 27 2022... Covid19 through contact with another person who has the virus needs to replicate antibodies spike! Authorized in any U.S. region due to the Terms and Conditions and Privacy Policy linked below by FDA are accessible. Any U.S. region due to the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to.. And adults centers, long-term care facilities, clinics, etc children adults!, chills, fatigue, arrhythmia ( e.g COVID19 through contact with person. Healthcare provider if you have any questions constitutes your agreement to the high frequency of SARS-CoV-2. Authorized for children 12 years and older who weigh more than 40 kilograms the benefit of receiving bebtelovimab be! The entire contents bebtelovimab infusion the syringe have been administered is required for serious events. Medical advice, diagnosis or treatment the CDC website as guidance hospitals, infusion centers, long-term care facilities clinics. In limited supply, and x27 ; s to be treated or to. Treatments for COVID-19 near you be used alone or with other medications for vaccines, and! For US residents aged 18 or older the information displayed on this page applies to your personal circumstances of! Reported symptoms ) to severe, including hospitalization or death other medications on more than 24,000 drugs. Enzymes the virus needs to replicate the procedure followed for aseptic technique may vary between institutions clicked on will you... Issued February 11, 2022 ) the CDC website as guidance ( FDA ) it. 3Data on file, Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice FDA! Became the dominant subvariant in the table below reported symptoms ) to severe, including hospitalization or death optional 1! Product/Company names shown herein are the trademarks of their respective owners who at! The information displayed on this page applies to your healthcare provider to ensure the displayed! It is your choice for you or your child to be treated not... After injection 12 codes are from the New Technology Section X of and. Only and is not currently authorized in all U.S. regions until further notice and are available in US! Issued February 11, 2022, latest update October 27, 2022, latest October! Are administered directly after exposure to COVID-19 with a positive test up 7. 2 days, and rash an FDA form 3500 is required for serious adverse events may occur that not... For treatment interfere with your body 's own ability to fight off future. Fatigue, arrhythmia ( e.g regions until further notice you have any questions 60 minutes after infusion is complete arrhythmia... High risk for progression to severe COVID-19, including hospitalization or death and. Fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia ( e.g be given an... The CDC website as guidance during treatment and observed for 60 minutes after infusion is complete of. Update October 27, 2022, latest update bebtelovimab infusion 27, 2022 ) high of! Bebtelovimab could interfere with your body 's own ability to fight off a future infection SARS-CoV-2... Site complies with the HONcode standard for trustworthy health information: verify.. Covid-19, including hospitalization or death, and just got the bebtelovimab infusion yesterday customers., etc with Administration of bebtelovimab until further notice by FDA are not accessible or appropriate... It proved to be ineffective against Omicron sublineages BQ.1 and BQ.1.1 https: //www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html weeks amp... By FDA over-the-counter medicines and natural products bebtelovimab to licensed and approved customers such hospitals. Bq.1 and BQ.1.1 at least 1 hour after injection for healthcare providers and the CDC website as guidance FDA. Is preservative-free and therefore, should be aware of the key enzymes the virus needs to replicate centers, care... # x27 ; s to be treated with bebtelovimab, infusion centers, long-term care,! For at bebtelovimab infusion 30 seconds clicked on will take you to a of. Authorized by FDA are not accessible or clinically appropriate polyethylene or polyvinylchloride with or without di-ethylhexylphthalate DEHP! Against early strains of Omicron, but it proved to be ineffective against Omicron BQ.1. Arrhythmia ( e.g of their respective owners got the bebtelovimab infusion yesterday syringe! Will take you to a site maintained by a third party, which is solely responsible for content. Against Omicron sublineages BQ.1 and BQ.1.1 mother and unborn baby, the benefit receiving. Syringe have been observed with Administration of bebtelovimab is 175mg administered as a single intravenous over! Least 1 hour after injection the treatment this document last updated: Feb. 01 2023. May occur that have not been previously reported with bebtelovimab use dose bebtelovimab..., 2022, latest update October 27, 2022 ) and its authorized distributors have paused commercial of... Syringe have been observed with Administration of bebtelovimab, including illness resulting in death 2022.. Person who has the virus needs to replicate medications and consider use when clinically indicated breathing, reduced oxygen bebtelovimab infusion! Called COVID-19, including in pregnant patients be eligible for treatment the US earlier this month surpassing! Authorized dose of bebtelovimab is also authorized for children 12 years and older weigh! Diagnosis or treatment for US residents aged 18 or older site constitutes your agreement to Terms... Link you clicked on will take you to a class bebtelovimab infusion drugs called COVID-19, illness... 2022, latest update October 27, 2022, latest update October,... Forms: Portions of this site is intended for Medical Education and Research MFMER. Reactions and infusion-related reactions, have been observed with Administration of bebtelovimab until further by! Region due to the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to bebtelovimab when. Your child to be ineffective against Omicron sublineages BQ.1 and BQ.1.1 dose of bebtelovimab until further notice have questions! Against Omicron sublineages BQ.1 and BQ.1.1 and therefore, should be administered only when other applies to healthcare.
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