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. 12 CLINICAL PHARMACOLOGY You will be observed by your healthcare provider for at least 1 hour after you receive bebtelovimab. Lilly USA, LLC 2022. Bebtelovimab has been associated with anaphylactic reactions; however, this is unlikely in our . Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. You are being redirected to FDA's determination and any updates on the authorization will be available on the FDA website. Bebtelovimab: 175 mg bebtelovimab. 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. This site is intended for US Healthcare Professionals only. If neither antiviral is an option, the agency recommends treatment with the antibody bebtelovimab. Avoid forming air bubbles. PP-BB-US-0005 11/2022 Medscape Education, Critical Concepts for the Treatment of COVID-19 Variants, 2001http://www.medscape.com/mtv/covid19-treatment-ous-s01/e01, encoded search term (bebtelovimab) and bebtelovimab, Drug Companies Face COVID Cliff in 2023 as Sales Set to Plummet, FDA Pulls Authorization for AstraZeneca's COVID-19 Treatment Evusheld, COVID-19 Monoclonal Antibody Treatments No Longer Effective, Your Unwanted Internal Pets: Intestinal Parasites (Other Than Nematodes), EU Regulator Recommends Against Approval for Merck's COVID Pill for Adults, COVID-19: Treatment Advances in a Global Pandemic, Rapid Rx Quiz: COVID-19 Treatment Updates. Veklury is approved for the treatment of adults and pediatric patients (28 days of age and older and weighing at least 3 kg) with positive results of direct SARS-CoV-2 viral testing, who are: hospitalized, or not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death. MedWatch adverse event reports can be submitted to the FDA by calling 1-800-FDA-1088 or Bebtelovimab is a medication that the FDA is allowing to be given for emergency use to treat COVID-19. Bebtelovimab 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. Bebtelovimab During Pregnancy and Breastfeeding. Patients should be clinically monitored during treatment and observed for 60 minutes after infusion is complete. only, includes infusion and post administration monitoring, second dose (Effective 6/24/2021) Q. 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. One dose given per day for 3 days. My doc said because I was on other meds and supplements that this would be safer than paxlovid because Of interactions. All rights reserved. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. Fact Sheet for Patients, Parents and Caregivers (Spanish), Download This medicine is to be given only by or under the immediate supervision of your doctor. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). Vaccines provide active immunity by helping the body make its own antibodies to protect itself. 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. 2022. Molnupiravir is an antiviral drug that works by manipulating the enzyme responsible for viral replication. Healthcare professionals must follow aseptic technique directive provided by their institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative. Some of these events required hospitalization. Therefore, bebtelovimab may not be administered for treatment of COVID-19 under the Emergency Use Authorization (EUA) until further notice. Are taking any medicines (prescription, and over-the-counter, vitamins, or herbal products). Bebtelovimab dosing, indications, interactions, adverse effects, and more Drugs & Diseases bebtelovimab (Investigational) Brand and Other Names: Classes: COVID-19, Monoclonal Antibodies Print. Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature. with positive results of direct SARS-CoV-2 viral testing. ).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. Controlled studies in pregnant women show no evidence of fetal risk. All rights reserved. Assess that alternative COVID-19 treatment options that are approved or authorized by FDA are not accessible or clinically appropriate. require an increase in baseline oxygen flow rate and/or respiratory support due to COVID19 and are on chronic oxygen therapy and/or respiratory support due to underlying non-COVID-19 related comorbidity. 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. | Lilly USA, LLC 2023. Discard the vial if the solution is cloudy, discolored, or . A. Bebtelovimab . This information shows that bebtelovimab is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. It is possible that bebtelovimab could interfere with your body's own ability to fight off a future infection of SARS-CoV-2. 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 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. How can I get monoclonal antibody therapy (antibody infusion)? These are not all the possible side effects. Available for Android and iOS devices. The following provides essential safety information on the unapproved use of bebtelovimab under the Emergency Use Authorization. Codes are available for the introduction or infusion of Remdesivir, Sarilumab, Tocilizumab, or other therapeutic substances, as well as the transfusion of convalescent plasma specifically for the treatment of COVID-19. 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. Use the filters to find locations for vaccines, testing and treatments for COVID-19 near you. Bebtelovimab is no longer authorized by the FDA for use in the United States, effective immediately. This content does not have an Arabic version. To limit the potential for overstocking, no returns will be accepted for bebtelovimab. I am 23 weeks & 2 days, and just got the bebtelovimab infusion yesterday. doi: 10.1097/CCE.0000000000000747. Has been diagnosed with mild to moderate COVID-19 with positive results of direct SARS-CoV-2 viral testing. Drug information provided by: IBM Micromedex. Before receiving treatment, tell your healthcare provider about all your or your childs medical conditions including if you or your child: Interactions between bebtelovimab and other drugs are unlikely. 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. See more information regarding dosing in the. Due to these data, use of bebtelovimab is NOT authorized in any U.S. state After the entire contents of the syringe have been administered. An official website of the United States government, : AmerisourceBergen Specialty Distributors 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. 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) with positive results of direct SARS-CoV-2 viral testing, and. Variants, like Omicron, may have an impact on the effectiveness of mAb therapies. pre-syncope, syncope), dizziness, and diaphoresis. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. In high-risk patients, treatment arms included, bebtelovimab 175mg alone administered via IV push over at least 30 seconds, OR. 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. Advertising revenue supports our not-for-profit mission. The 12 codes are from the New Technology Section X of ICD-10-PCS and are available in the table below. - 175 mg bebtelovimab administered as a single intravenous injection over at least 30 seconds. Should be clinically monitored during treatment and observed for 60 minutes after is... For commercial purposes have an impact on the FDA website make its own antibodies to protect itself you are redirected! 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