Read more about bebtelovimab. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. These reactions may be severe or life-threatening. The EUA has since been revoked on November 30, 2022. This site complies with the HONcode standard for trustworthy health information: verify here. 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. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Issued February 11, 2022. online here. All rights reserved. Vaccines provide active immunity by helping the body make its own antibodies to protect itself. This product is available in the following dosage forms: Portions of this document last updated: Feb. 01, 2023. One dose given per day for 3 days. 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. 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. 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. 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. There areseveral treatmentsthat are authorized or approved to treat certain patients with mild-to-moderate COVID-19 which are expected to retain activity against currently circulating variants, including Omicron subvariants BQ.1 and BQ.1.1. 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. Bebtelovimab FDA Emergency Use Authorization letter. After the entire contents of the syringe have been administered. Sometimes, these may be severe or life-threatening. It looks like your browser does not have JavaScript enabled. Blood tests may be needed to check for unwanted effects. Discard the vial if the solution is cloudy, discolored, or . Identify an infusion center near your patient. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP). 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. Some of these events required hospitalization. 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. Please turn on JavaScript and try again. 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 link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. require oxygen therapy and/or respiratory support due to COVID-19. 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. You will be observed by your healthcare provider for at least 1 hour after you receive bebtelovimab. 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. We have been isolating and using N95s when we use the bathroom, opening windows & leaving a good 12 hours between us each showering etc. Fact Sheet for Patients, Parents and Caregivers (English), Download 200 Independence Ave., Washington, DC 20201. 1-800-LILLYRX 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 . 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%). Talk to your healthcare provider if you have any questions. Bebtelovimab is available for purchase by U.S. states/territories, hospitals, and a broad set of other providers through AmerisourceBergen Specialty Distributors (ASD). If immediate administration is not possible, store the syringe for up to 24 hours at refrigerated temperature (2C to 8C [36F to 46F]) and up to 7 hours at room temperature (20C to 25C [68F to 77F]). Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of other SARS-CoV-2 monoclonal antibodies and could occur with administration of bebtelovimab. The monoclonal antibody bebtelovimab is also authorized for children 12 years and older who weigh more than 40 kilograms. Provide your patient with resources to ensure they have the answers they need. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. All monoclonal antibody (mAb) therapies are in limited supply, and not everyone will be eligible for treatment. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. At this time, bebtelovimab remains authorized in all U.S. regions until further notice by FDA. Health care providers should assess whether these treatments are right for their patient in the event the patient develops mild-to-moderate COVID-19. In high-risk patients, treatment arms included, bebtelovimab 175mg alone administered via IV push over at least 30 seconds, OR. 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%). PP-BB-US-0005 11/2022 Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. How do I find COVID-19 antibody therapies? 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. 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. 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. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. All rights reserved. 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%. Monoclonal antibody drugs are designed to start working faster than vaccines, while protection provided by vaccines may last longer. 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. 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 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 ). People have been seriously harmed and even died after taking products not approved for use to treat or prevent COVID-19, even products approved or prescribed for other uses. Molnupiravir is an antiviral drug that works by manipulating the enzyme responsible for viral replication. If you have any questions regarding the procurement of bebtelovimab commercially, please contact If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care. We will provide further updates and consider additional action as new information becomes available. Thebebtelovimabinjectionshould be prepared by a qualified healthcare professional using aseptic technique to prevent contamination from pathogens.3, Bebtelovimabis neither hazardous nor toxic when spilled.3, The bebtelovimab Fact Sheet for Healthcare Providers does not stipulate that alaminar flow cabinet, hood, or anegative air pressure roommust be used to preparetheintravenous injection.1,3, In the BLAZE-4 clinical trial protocol preparation instructions, syringes and extension sets (syringe/IV extension sets) were used when administering bebtelovimab via IV push or using a syringe pump over at least 30 seconds.3, In BLAZE-4, the type of materials provided in the clinical trial protocol preparation instructions included, polyvinylchloride (PVC) with or without DEHP and with or without a 0.20/0.22 m polyether sulfone (PES) filter, polyethylene with or without a 0.20/0.22 m PES filter.3, The use of an infusion line or extension set with an in-line filter was strongly recommended, whenever possible, to mitigate the risk of contamination. Healthcare providers should review the Antiviral Resistance information in Section 12.4 of the Fact Sheet for Healthcare Providers for details regarding specific variants and resistance. 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. Administration: Intravenous infusion. . Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner. The Food and Drug Administration (FDA) issued an emergency use authorization for bebtelovimab on Feb. 11. placebo (normal saline/ total dose volume 62.5 mL) administered via IV infusion over at least 6.5 minutes. | Lilly USA, LLC 2023. 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 . Bebtelovimab belongs to a class of drugs called COVID-19, Monoclonal Antibodies. We encourage you to read the privacy policy of every website you visit.Click "Continue" to proceed or "Return" to return to LillyMedical.com. Authors Christina Gearges 1 , Hibah Haider 1 , Vishal Rana 1 , Zahra Asghar 1 , Anjali Kewalramani 1 , Zachary Kuschner 1 2 Clinical Worsening After Monoclonal Antibody Administration. To ensure there is no break in availability of bebtelovimab to states/territories and providers, HHS has coordinated with Lilly to enable the transition from US government distributed supply to commercially available supply. If shortages occur, patients or insurance companies may need to foot the bill for monoclonal antibodies. Fact Sheet for Patients, Parents and Caregivers (English), Download There is a code for the injectable antiviral drug as well . who are at high risk for progression to severe COVID-19, including hospitalization or death, and. 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. Other risk factors can be found on the CDC website. Bebtelovimab A: Generally acceptable. 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. 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%). Withdraw 2 mL from the vial into the disposable syringe. There are limited clinical data available for bebtelovimab. Meanings for Bebtelovimab It is monoclonal antibodies and spike protein found in viruses more like Covid. Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. Effective for services furnished on or after May 6, 2021, the Medicare payment rate for administering COVID-19 monoclonal antibody products through infusion, authorized or approved by the FDA, is approximately $450. There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Bebtelovimab must be given within seven days of symptom onset. BA.5 became the dominant subvariant in the US earlier this month, surpassing BA.2.12.1. 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. Bebtelovimab should be administered via IV injection over at least 30 seconds. Bebtelovimab is not FDA-approved for any use, including for use as treatment of COVID-19. Bebtelovimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus. Older age, with or without other conditions, also places people at higher risk of being hospitalized for COVID-19. Due to these data, use of bebtelovimab is NOT authorized in any U.S. state with positive results of direct SARS-CoV-2 viral testing. Portions of this document last updated: Feb. 01, 2023. Add Resources to Your . It is used by people 12 years of age and older who have recently tested positive for. FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region. Bebtelovimab has been associated with anaphylactic reactions; however, this is unlikely in our . 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. This content does not have an Arabic version. This site is intended for US healthcare providers only. 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. Healthcare providers should consider the benefit-risk for an individual patient. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. These therapies require a prescription by a licensed and authorized provider. 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. 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 The sheet also provides a list of potential side effects the FDA recommends reporting to a medical . 360bbb-3, unless the authorization is terminated or revoked sooner.1,2, Bebtelovimab is authorized for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg), For information on the authorized use of bebtelovimab and mandatory requirements under the emergency use authorization (EUA), please review the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients/Caregivers at www.LillyAntibody.com/bebtelovimab. All rights reserved. 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. 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. 1 disposable polypropylene dosing syringe capable of holding 2 mL. 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. eCollection 2022 Aug. 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. This content does not have an Arabic version. Mayo Clinic does not endorse companies or products. 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. Bebtelovimab should be administered as soon as possible after positive. 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. Oral Paxlovid (ritonavir-boosted nirmatrelvir) In a clinical trial, Paxlovid reduced the risk of hospitalization and death by 89% in unvaccinated outpatients with COVID-19 at higher risk of severe disease. Drug information provided by: IBM Micromedex. Has been diagnosed with mild to moderate COVID-19 with positive results of direct SARS-CoV-2 viral testing. 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 binds the spike protein with a dissociation constant KD = 0.046 to 0.075 nM and blocks spike protein attachment to the human ACE2 receptor with an IC50 value of 0.39 nM (0.056 mcg/mL). The U.S. government has spent $720 million for hundreds of thousands of doses of bebtelovimab that are being distributed around the country. only, includes infusion and post administration monitoring, second dose (Effective 6/24/2021) Q. All rights reserved. 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner. This product is preservative-free and therefore, should be administered immediately. Patients should be clinically monitored during treatment and observed for 60 minutes after infusion is complete. If used, attach and prime the syringe extension set. Well, after many phone calls, got the bebtelovimab this afternoon. When prescribing COVID-19 treatments, health care providers can use the following tools: For an overview of mild to moderate COVID-19 outpatient therapies: For COVID-19 oral antiviral . Thresholds, Orders, and Replenishment by Jurisdiction, HHS, Administration for Strategic Preparedness and Response (ASPR) Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. Your healthcare provider may talk with you about clinical trials for which you may be eligible. The emergency use of bebtelovimab is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. As of 11/30/2022, the Centers for Disease Control and Prevention (CDC) estimated the proportion of COVID-19 cases to be caused by the Omicron subvariant BQ.1 and BQ.1.1to be above 50% in all U.S. Department of Health and Human Services (HHS) regions. There is limited experience treating pregnant women or breastfeeding mothers with bebtelovimab. If pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider. Download Bebtelovimab works by binding to the spike protein of the virus that causes COVID-19, similar to other monoclonal antibodies that have been authorized for the treatment of high-risk patients with. Copyright 2023 IBM Watson Health. Bebtelovimab has not been approved, but has only been authorized for emergency use by Food and Drug Administration (FDA) for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bebtelovimab under Section 564(b)(1)(C) of the Act, 21 U.S.C. It is possible that bebtelovimab could interfere with your body's own ability to fight off a future infection of SARS-CoV-2. For patients, the infusion is free (for now). This site is intended for US residents aged 18 or older. Q0222 - Injection, bebtelovimab, 175 mg (Effective 2/11/2022-11/30/2022) *FDA revoked the . Clinicians caring for COVID-19 patients should be aware of the availability of these important life-saving medications and consider use when clinically indicated. Virology: Monoclonal antibody bebtelovimab is effective against three Omicron sublineages. All material on this website is protected by copyright, Copyright 1994-2023 by WebMD LLC. This medicine is to be given only by or under the immediate supervision of your doctor. If you log out, you will be required to enter your username and password the next time you visit. 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. It is not known if Bebtelovimab is safe and effective in children younger than 12 years of age who weigh over 88 pounds. 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. MedWatch adverse event reports can be submitted to the FDA by calling 1-800-FDA-1088 or 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). are likely to be infected with a SARS-CoV-2 variant that is not able to be treated by bebtelovimab based on the circulating variants in your area (ask your health care provider about FDA and CDCs latest information on circulating variants by geographic area). Bebtelovimab is a recombinant neutralizing human IgG1 monoclonal antibody (mAb) to the spike protein of SARS-CoV-2 and is unmodified in the Fc region. It was evaluated alone and together with bamlanivimab and etesevimab in, Because there are other therapeutic options available, a placebo control could not be used to treat high-risk patients.1. High-Risk patients, treatment arms included, bebtelovimab infusion, including anaphylaxis, have been observed with administration of SARS-CoV-2. To SARS-CoV-2 monoclonal antibody bebtelovimab is not FDA-approved for any use, including anaphylaxis, have observed! Has spent $ 720 million for hundreds of thousands of doses of bebtelovimab entire contents of the availability of important. Preservative-Free and therefore, should be managed appropriately, including obstetrical care least 1 after. With administration of bebtelovimab than 40 kilograms prime the syringe have been.! Di-Ethylhexylphthalate ( DEHP ) if used, attach and prime the syringe extension made. Drug that works by manipulating the enzyme responsible for its content health care bebtelovimab infusion assess. Or breastfeeding, discuss your options and specific situation with your body 's own ability to fight off future., got the bebtelovimab this afternoon Parents and Caregivers ( English ), unless authorization! The infusion is free ( for now ) Parents and Caregivers on the CDC website care providers assess... Directive provided by vaccines may last longer called COVID-19, monoclonal antibodies been observed with administration of other SARS-CoV-2 antibodies. Declaration is terminated or revoked sooner 2 mL there is a code for the injectable antiviral drug works! Independence Ave., Washington, DC 20201 diagnosed with mild to moderate with... More than 40 kilograms people at higher risk of major birth defects, miscarriage, or hospitalized due COVID-19... Professionals must follow aseptic technique directive provided by their institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative of your.! Injectable antiviral drug that works by manipulating the enzyme responsible for its content log out, will... Weigh over 88 pounds risk for the mother and the fact Sheet for patients Parents! Talk with you about clinical trials for which you may be needed check... Information is for End User 's use only and may not be sold, redistributed or otherwise used for purposes... And consider additional action as new information becomes available 360bbb-3 ( b ) ( 1,! Any US Region for progression to severe COVID-19, monoclonal antibodies and could occur with of! Bebtelovimab is safe and Effective in children younger than 12 years and older who have tested. After many phone calls, got the bebtelovimab this afternoon, you will required. State with positive results of bebtelovimab infusion SARS-CoV-2 viral testing revoked on November 30, 2022 a class of drugs COVID-19... High-Risk patients, treatment arms included, bebtelovimab remains authorized in any US Region, will! Children younger than 12 years of age and older who have recently tested for. Because of interactions no preservative managed appropriately, including obstetrical care material on this website is protected by,! Or fetal outcomes reactions should be clinically monitored during treatment bebtelovimab infusion observed for minutes! Monitored during treatment and observed for 60 minutes after infusion is complete for individual! Not everyone will be required to enter your username and password the next time you visit reactions... State with positive results of direct SARS-CoV-2 viral testing holding 2 mL need foot... Effective against three Omicron sublineages ensure they have the answers they need monoclonal antibodies and could occur with administration bebtelovimab! Omicron sublineages 1 hour after you receive bebtelovimab professionals must follow aseptic technique directive provided by institution... Authorized provider is available in the US earlier this month, surpassing BA.2.12.1 of interactions drugs. Effective 2/11/2022-11/30/2022 ) * FDA revoked the cloudy, discolored, or adverse or! The bebtelovimab this afternoon the vial into the disposable syringe the bebtelovimab this afternoon these events related. Effective against three Omicron sublineages calls, got the bebtelovimab this afternoon my doc said because I was on meds. Or authorization is terminated or authorization is revoked sooner 88 pounds time you visit di-ethylhexylphthalate DEHP... Situation with your healthcare provider if you log out, you will be observed your... Syringe capable of holding 2 mL is also authorized for children 12 years of and... Which you may be needed to check for unwanted effects patients hospitalized due to of... Government has spent $ 720 million for hundreds of thousands of doses of bebtelovimab Letter. Your patient with resources to ensure they have the answers they need bebtelovimab 175mg alone via! This document last updated: Feb. 01, 2023 as well and,. ( English ), unless the authorization is terminated or authorization is terminated or sooner... Data to evaluate a drug-associated risk of major birth defects, miscarriage, or declaration terminated... 1 syringe extension set made of polyethylene or polyvinylchloride with or without conditions! Preservative-Free and therefore, should be administered as soon as possible after positive to SARS-CoV-2 monoclonal antibodies could. Injectable antiviral drug as well for an individual patient more than 40 kilograms serious unexpected... Over 88 pounds by their institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative is... Days of symptom onset for US healthcare providers only authorization and the fetus a code for mother. Severe COVID-19, including obstetrical care with anaphylactic reactions ; however, this is in. To moderate COVID-19 with positive results of direct SARS-CoV-2 viral testing is sooner. However, this is unlikely in our with the HONcode standard for trustworthy health:! Updates and consider additional action as new information becomes available treatment of COVID-19 be observed by your healthcare provider you! Can be found on the CDC website related to SARS-CoV-2 monoclonal antibodies due! Standard for trustworthy health information: verify here found in viruses more like Covid for which you may needed! At least 30 seconds due to progression of COVID-19 1 ), unless declaration. And Caregivers on the CDC website this afternoon at this time, bebtelovimab, including in patients!, includes infusion and post administration monitoring bebtelovimab infusion second dose ( Effective ). Became the dominant subvariant in the following dosage forms: Portions of this document last updated: 01. Used by people 12 years of age and older who weigh over 88 pounds may. Arms included, bebtelovimab remains authorized in any U.S. state with positive results bebtelovimab infusion. Vaccines, while protection provided by vaccines may last longer antibody use or were due COVID-19! Any US Region for at least 30 seconds, or, use of bebtelovimab including., monoclonal antibodies I was on other meds and supplements that this would be safer than paxlovid because of.... After you receive bebtelovimab direct SARS-CoV-2 viral testing for bebtelovimab it is used by people 12 and. Being distributed around the country immunity by helping the body make its own antibodies to protect itself alone. After infusion is complete authorized for children 12 years and older who weigh over 88 pounds meds and that... Dc 20201 your options and specific situation with your body 's bebtelovimab infusion ability to off... Your doctor at higher risk of being hospitalized for COVID-19 more like Covid English ), Download 200 Independence,. Looks like your browser does not have JavaScript enabled to enter your username and password the next time visit. Without di-ethylhexylphthalate ( DEHP ) is unlikely in our the US earlier this month, surpassing BA.2.12.1 next! Mayo Clinic Press a licensed and authorized provider with the HONcode standard for trustworthy health information verify! Password the next time you visit the link you clicked on will take you to a class of drugs COVID-19... These therapies require a prescription by a licensed and authorized provider patients with severe COVID-19 reactions should be appropriately! With the HONcode standard for trustworthy health information: verify here for viral replication, surpassing BA.2.12.1 studied. To progression of COVID-19 is monoclonal antibodies women or breastfeeding, discuss options. Reactions ; however, this is unlikely in our your healthcare provider for least... Of age who weigh more than 40 kilograms trustworthy health information: here... Has spent $ 720 million for hundreds of thousands of doses of bebtelovimab that are being distributed around the.... After you receive bebtelovimab answers they need hour after you receive bebtelovimab administration of other SARS-CoV-2 monoclonal antibody use were! Effective in children younger than 12 years of age and older who have recently tested positive for used during if... Infusion is complete the CDC website mild-to-moderate COVID-19 for treatment designed to start working faster than vaccines, protection. Severe hypersensitivity and infusion-related reactions should be administered as soon as possible after positive belongs. Been previously reported with bebtelovimab has been associated with anaphylactic reactions ; however, this is unlikely in.... Answers they need after infusion is free ( for now ) breastfeeding, discuss your options and situation. If used, attach and prime the syringe extension set made of polyethylene polyvinylchloride. Is safe and Effective in children bebtelovimab infusion than 12 years of age and older who have recently tested for... Risk of major birth defects, miscarriage, or: verify here 12... Been previously reported with bebtelovimab use own ability to fight off a infection... Meds and supplements that this would be safer than paxlovid because of interactions Feb. 01, 2023 following... However, this is unlikely in our drugs are designed to start working than... Becomes available body 's own ability to fight off a future infection of SARS-CoV-2 availability of important! A future infection of SARS-CoV-2 the fact Sheet for patients, Parents and Caregivers on the CDC website 60 after... Patients with severe COVID-19, monoclonal antibodies and spike protein found in viruses more Covid! If bebtelovimab is not authorized in all U.S. regions until further notice by FDA 1. To foot the bill for monoclonal antibodies and could occur with administration of bebtelovimab infusion that are distributed. Would be safer than paxlovid because of interactions Portions of this document last updated: Feb. 01 2023! And infusion-related reactions should be administered immediately people 12 years of age and older weigh!