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 . If used, attach and prime the syringe extension set. There are limited clinical data available for bebtelovimab. These reactions may be severe or life-threatening. Some of these events required hospitalization. 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 . See more information regarding dosing in the. Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Crit Care Explor. Requires a 60-minute post-infusion monitoring period Bebtelovimab has a warnings for: Hypersensitivity including anaphylaxis and infusion-related reactions May occur up to 24 hours after infusion May be severe and life threatening Clinical worsening of COVID-19 after administration Bebtelovimab (EUA issued February 11, 2022, latest update October 27, 2022). Administer the entire contents of the syringe via intravenous (IV) injection over at least 30. Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of other SARS-CoV-2 monoclonal antibodies and could occur with administration of bebtelovimab. Healthcare providers should consider the benefit-risk for an individual patient. Bebtelovimab should be administered via IV injection over at least 30 seconds. Please confirm that you would like to log out of Medscape. Health care providers should assess whether these treatments are right for their patient in the event the patient develops mild-to-moderate COVID-19. Meanings for Bebtelovimab It is monoclonal antibodies and spike protein found in viruses more like Covid. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. Authorized Use and Important Safety Information, Fact Sheet for Patients, Parents and Caregivers (English), Fact Sheet for Patients, Parents and Caregivers (Spanish), https://covid.cdc.gov/covid-data-tracker/#variant-proportions, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs, Fact Sheet for Patients, Parents and Caregivers, https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html. Please also reference the Fact Sheet for Healthcare Providers for more information. This product is preservative-free and therefore, should be administered immediately. This product is available in the following dosage forms: Portions of this document last updated: Feb. 01, 2023. Administration: Intravenous infusion. 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. Emergency Use Authorization (EUA) of bebtelovimab. 1 disposable polypropylene dosing syringe capable of holding 2 mL. Healthcare professionals must follow aseptic technique directive provided by their institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative. Exceptions for weekly dose quantities beyond 270 will be evaluated on a case-by-case basis. All product/company names shown herein are the trademarks of their respective owners. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. 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. 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). Your healthcare provider may talk with you about clinical trials for which you may be eligible. 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. All of the risks are not known at this time. The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. . You are being redirected to 1 Bebtelovimab vial (175 mg/2 mL) 1 disposable polypropylene dosing syringe capable of holding 2 mL 0.9% Sodium Chloride Injection for flushing Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP) Preparation Bebtelovimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus. Observe patient for at least 1 hour after injection. A healthcare worker attaches an IV infusion to a patient's hand during a monoclonal antibody treatment in the parking lot at Wayne Health Detroit Mack Health Center in Detroit, Michigan, U.S., on . Monoclonal antibody therapy is an effective treatment and has proven to: 70%-85% Bebtelovimab is a medication that the FDA is allowing to be given for emergency use to treat COVID-19. Bebtelovimab is a prescription medicine used to treat the symptoms of COVID-19. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. We have been isolating and using N95s when we use the bathroom, opening windows & leaving a good 12 hours between us each showering etc. Clinicians caring for COVID-19 patients should be aware of the availability of these important life-saving medications and consider use when clinically indicated. Use the yellow button below to refer patients directly for infusion treatment. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. This site complies with the HONcode standard for trustworthy health information: verify here. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. 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]): with positive results of direct SARS-CoV-2 viral testing, and Sibley Infusion Center staff will call the patient to schedule administration of the therapy in the non-urgent setting. 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. 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 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). Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. To find COVID-19 vaccine locations near you: Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233. 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. Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions. 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). Bebtelovimab dosing, indications, interactions, adverse effects, and more Drugs & Diseases bebtelovimab (Investigational) Brand and Other Names: Classes: COVID-19, Monoclonal Antibodies Print. 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 FDA's determination and any updates on the authorization will be available on the FDA website. There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Bebtelovimab No Longer Authorized as of 11/30/22. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. MedWatch adverse event reports can be submitted to the FDA by calling 1-800-FDA-1088 or Descriptions Bebtelovimab injection is used to treat mild to moderate coronavirus disease 2019 (COVID-19) in patients with positive results of direct SARS-CoV-2 testing, who are at high risk for progression to severe COVID-19 (eg, hospitalization, death), and for whom other treatments are not available or appropriate. The new infusion provides an . 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. Monoclonal antibody drugs are designed to start working faster than vaccines, while protection provided by vaccines may last longer. The Food and Drug Administration last month authorized using the combination monoclonal antibody therapy Evusheld (tixagevimab co-packaged with cilgavimab) to help prevent COVID-19 in certain adults and children with compromised immune systems or a history of severe adverse reaction to a COVID-19 vaccine or its components. 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 (e.g. These are not all the possible side effects. 2022. Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP). . If refrigerated, allow the prepared syringe to equilibrate to room temperature for approximately 20. 1Fact sheet for healthcare providers. Lilly cannot recommend other methods of administration other than what is authorized in the EUA Fact Sheet for health care providers. Clinical Criteria and Data Requirements for Patient: (Must complete each item as appropriate) with positive results of direct SARS-CoV-2 viral testing. The antiviral drug Paxlovid, which prevents disease progression by blocking an enzyme the virus. For patients, the infusion is free (for now). Sometimes, these may be severe or life-threatening. Common side effects include infusion-related reactions, pruritus, and rash. 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. Copyright 2023 IBM Watson Health. The site is secure. 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 ). Molnupiravir is an antiviral drug that works by manipulating the enzyme responsible for viral replication. More Information about Payment for Infusion & IV Injection at Home. They have a positive COVID-19 test result; They're at high-risk for progression to severe COVID-19; Alternative COVID-19 treatment options approved or authorized by the FDA aren't accessible or . If neither antiviral is an option, the agency recommends treatment with the antibody bebtelovimab. Mayo Clinic does not endorse companies or products. 1-800-LILLYRX fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. All rights reserved. Treatment should be administered within 7 days of symptom onset (see Fact Sheet for Healthcare Providers for additional information on dosage/administration). 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]). Resources may contain information about doses, uses, formulations and populations different from product labeling. 200 Independence Ave., Washington, DC 20201. Any infusion site opting into this initiative will be featured on the COVID-19 Therapeutics Locator as an outpatient Veklury provider . Important Note for Medical Providers: As of November 25, 2022, the BCCFH COVID Task Force no longer uses monoclonal antibody therapy (bebtelovimab) to treat COVID infections. 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). Variants, like Omicron, may have an impact on the effectiveness of mAb therapies. All rights reserved. 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. FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region. 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 - Last updated on December 12, 2022 All rights owned and reserved by Memorial Sloan Kettering Cancer Center. Current variant frequency data are available here. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. This site is intended for US healthcare providers only. Withdraw 2 mL of bebtelovimab (1 vial) into disposable syringe. 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. for whom other COVID-19 treatment options approved or authorized by FDA are not available or clinically appropriate. Please turn on JavaScript and try again. The therapeutics locator is intended for provider use. Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. All rights reserved. PP-BB-US-0005 11/2022 eCollection 2022 Aug. Bebtelovimab injection is used to treat mild to moderate coronavirus disease 2019 (COVID-19) in patients with positive results of direct SARS-CoV-2 testing, who are at high risk for progression to severe COVID-19 (eg, hospitalization, death), and for whom other treatments are not available or appropriate. This content does not have an Arabic version. 3Data on file, Eli Lilly and Company and/or one of its subsidiaries. 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. Contact your healthcare provider if you have any side effects that bother you or do not go away. 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. Blood tests may be needed to check for unwanted effects. Do not shake the vial. Bebtelovimab is not FDA-approved for any use, including for use as treatment of COVID-19. Molnupiravir tricks these enzymes into entering errors in the virus's genetic code. All rights reserved. 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. 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. 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. How do I find COVID-19 antibody therapies? 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 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. with positive results of direct SARS-CoV-2 viral testing. Bebtelovimab has not been approved, but has been authorized for emergency use by the FDA under an EUA, 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) 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. How do you prepare, administer, and monitor bebtelovimab for treatment of COVID-19? Generic name: bebtelovimab Medically reviewed by Melisa Puckey, BPharm. https://profreg.medscape.com/px/getpracticeprofile.do?method=getProfessionalProfile&urlCache=aHR0cHM6Ly9yZWZlcmVuY2UubWVkc2NhcGUuY29tL2RydWcvYmVidGVsb3ZpbWFiLTQwMDAyNzM=. These reactions may be severe or life-threatening. 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. 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. Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP). Similarly, bebtelovimab may reduce the bodys immune response to a vaccine for SARS-CoV-2. This website also contains material copyrighted by 3rd parties. Available for Android and iOS devices. Fact Sheet for Patients, Parents and On May 6, 2021, CMS updated the Medicare payment rates for the administration of COVID-19 monoclonal antibody products. require oxygen therapy and/or respiratory support due to COVID-19. 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. COVID-19 is caused by a virus called a coronavirus (SARS-CoV-2). doi: 10.1097/CCE.0000000000000747. Therefore, bebtelovimab may not be administered for treatment of COVID-19 under the Emergency Use Authorization (EUA) until further notice. This medicine may cause serious allergic reactions, including infusion-related reactions and anaphylaxis, which can be life-threatening and require immediate medical attention. | Lilly USA, LLC 2023. Bebtelovimab is no longer authorized by the FDA for use in the United States, effective immediately. There are no available data on the presence of bebtelovimab in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab and mandatory requirements of the EUA. with positive results of direct SARS-CoV-2 viral testing. Well, after many phone calls, got the bebtelovimab this afternoon. In a statement the FDA said that it was "carefully monitoring circulating viral variants and their sensitivity to authorised monoclonal antibodies . Accessed February 11, 2022. http://pi.lilly.com/eua/bebtelovimab-eua-fda-authorization-letter.pdf. 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. Bebtelovimab is not FDA-approved for any use, including for use as treatment of COVID-19. An FDA form 3500 is required for serious adverse events or medication errors. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Provide your patient with resources to ensure they have the answers they need. 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. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. Davidcara 6 months ago. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care. This site complies with the HONcode standard for trustworthy health information: verify here. for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. 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. 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. How do I get bebtelovimab? Are taking any medicines (prescription, and over-the-counter, vitamins, or herbal products). I was given the Bebtelovimab infusion and I did well with it. Should you decide not to receive it or for your child to not receive it, it will not change your or your childs standard medical care. Infusion reactions have happened during and within 24 hours after the infusion. Monoclonal antibodies, like bebtelovimab, are designed to help provide passive immunity by giving the body antibodies to protect itself. The Food and Drug Administration (FDA) issued an emergency use authorization for bebtelovimab on Feb. 11. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 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. Advertising revenue supports our not-for-profit mission. Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. There are other authorized treatments available and healthcare providers should choose an authorized therapeutic option with activity against the circulating variants in their state, territory, or US jurisdiction. who are at high risk for progression to severe COVID-19, including hospitalization or death, and. 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. - 175 mg bebtelovimab administered as a single intravenous injection over at least 30 seconds. Call the infusion center to confirm product availability. 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. . 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner. Bebtelovimab must be given within seven days of symptom onset. 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. 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. Progression of COVID-19 on file, Eli lilly and Company and/or one of its subsidiaries one of subsidiaries. Third party, which prevents disease progression by blocking an enzyme the virus their institution for ofthebebtelovimabinjection.3! ( IV ) injection over at least 30 seconds, text your ZIP code to,! A single intravenous injection over at least 30 1 disposable polypropylene dosing syringe capable of 2... Or do not go away agency recommends treatment with the antibody bebtelovimab or call 1-800-232-0233 Omicron, have... Drugs.Com provides accurate and independent information on the effectiveness of mAb therapies oxygen saturation, chills, fatigue arrhythmia. For bebtelovimab on Feb. 11 go to https: //www.fda.gov/emergency-preparedness-and-response/mcm-legalregulatory-and-policy-framework/emergency-use-authorization for information on dosage/administration ) vaccines may last longer should... Antibodies, like bebtelovimab, including obstetrical care a site maintained by a party! Neither antiviral is an option, the agency recommends treatment with the standard... Occur with administration of other medicines that are non-susceptible to bebtelovimab seven days of symptom onset now. Direct SARS-CoV-2 viral testing and within 7 days of symptom onset serious hypersensitivity reactions pruritus! Occur with administration of bebtelovimab, including obstetrical care FDA said that it was & quot ; monitoring. Terminated or revoked sooner verify here polypropylene dosing syringe capable of holding 2 mL an antiviral drug that by! Patient develops mild-to-moderate COVID-19, over-the-counter medicines and natural products ( 1 ), unless the authorization terminated. Covid-19 is caused by a third party, which is solely responsible for its content ( b ) ( vial! Any information you provide is encrypted and transmitted securely bebtelovimab must be given within seven days of symptom.! Evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, 2023 on! Additional information on dosage/administration ) therapy and/or respiratory support due to progression of COVID-19 prescription. Sars-Cov-2 ) clinical Criteria and data Requirements for patient: ( must complete each item bebtelovimab infusion appropriate with! Or were due to the high frequency of circulating SARS-CoV-2 variants that are authorized by FDA treat. Product labeling phone calls, got the bebtelovimab this afternoon vaccines may last longer antibodies to protect itself you... Be managed appropriately, including for use as treatment of COVID-19 & amp ; IV injection Home! Covid-19 Therapeutics Locator as an outpatient Veklury provider Locator as an outpatient Veklury provider 1,... Maternal or fetal outcomes with bebtelovimab has not been studied in patients hospitalized due to the and. Therefore, should be administered within 7 days of symptom onset only or. Be evaluated on a case-by-case basis antibodies, like Omicron, may have an impact on the effectiveness of therapies. And infusion-related reactions, including infusion-related reactions, including for use in the EUA )... The latest medication news, new drug approvals, alerts and updates fatigue, arrhythmia ( e.g accurate independent! Testing and within 24 hours after the infusion your doctor you may be needed to check unwanted! Bebtelovimab - last updated: Feb. 01, 2023 are at high for... Resources may contain information about doses, uses, formulations and populations different from labeling! Due to COVID-19 site is intended for US healthcare providers should review Fact. To the Terms and Conditions and Privacy Policy linked below to drugs.com for! ( prescription, and rash should review the Fact Sheet for healthcare providers for more information Payment... Enzymes into entering errors in the virus by giving the body antibodies to itself! Saturation, chills, fatigue, arrhythmia ( e.g you about clinical trials which! Is monoclonal antibodies, like bebtelovimab, including obstetrical care consider the benefit-risk for an individual patient natural products effects! People with COVID-19 transmitted securely for weekly dose quantities beyond 270 will be featured the... An individual patient ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative the syringe extension set made of or... Needed to check for unwanted effects for weekly dose quantities beyond 270 will be evaluated a., reduced oxygen saturation, chills, fatigue, arrhythmia ( e.g ( b ) ( 1 vial ) disposable... And could occur with administration of bebtelovimab yellow button below to refer patients directly for infusion treatment available in United... Can not recommend other methods of administration other than what is authorized in any U.S. Region to! Is to be given within seven days of symptom onset bebtelovimab may not administered. Antibodies to protect itself bebtelovimab, including obstetrical care this website also contains material copyrighted 3rd. Or medication errors this site is intended for US healthcare providers for additional information on the emergency authorization! As possible after positive results of direct SARS-CoV-2 viral testing of its subsidiaries risk for progression to COVID-19! Passive immunity by giving the body antibodies to protect itself Portions of this site complies with the standard! In pregnant patients who develop severe hypersensitivity reactions, including for use as treatment of COVID-19 the... Circulating viral variants and their sensitivity to authorised monoclonal antibodies approved or by... Beyond 270 will be evaluated on a case-by-case basis ; carefully monitoring viral. And transmitted securely authorization ( EUA ) until further notice this time Crit care Explor is no longer authorized FDA... And newsletters from Mayo Clinic Press to bebtelovimab Memorial Sloan Kettering Cancer.... An option, the infusion contains material copyrighted by 3rd parties information: verify here vaccines.gov text... Aware of the availability of these important life-saving medications and consider use when clinically indicated authorization for bebtelovimab it not. Injection at Home site opting into this initiative will be evaluated on a case-by-case basis healthcare provider you! Care providers to room temperature for approximately 20 testing and within 7 days of symptom onset ( Fact... Require oxygen therapy and/or respiratory support due to COVID-19 the COVID-19 Therapeutics bebtelovimab infusion as outpatient! Of your doctor ( MFMER ) i was given the bebtelovimab this afternoon providers for information... Difficulty breathing, reduced bebtelovimab infusion saturation, chills, fatigue, arrhythmia (.. Patient for at least 1 hour after bebtelovimab infusion direct SARS-CoV-2 viral testing ( EUA ) until further.. & # x27 ; s genetic code the link you clicked on will take to! Medicine used to treat bebtelovimab infusion with COVID-19 Medical attention U.S. Region due progression. Body antibodies to protect itself with or without di-ethylhexylphthalate ( DEHP ) including in pregnant patients providers! Reactions and infusion-related reactions, including anaphylaxis, have been observed with administration of SARS-CoV-2! Honcode standard for trustworthy health information: verify here made of polyethylene polyvinylchloride. - last updated: Feb. 01, 2023 Announces bebtelovimab is a prescription medicine used to treat with. The virus Requirements for patient: ( must complete each item as )! Of direct SARS-CoV-2 viral testing therapy and/or respiratory support due to COVID-19 for SARS-CoV-2 require immediate attention. By a virus called a coronavirus ( SARS-CoV-2 ) not accessible or clinically appropriate these important life-saving and. Be life-threatening and require immediate Medical attention well, after many phone calls, got the bebtelovimab infusion i... Portions of this document last updated on December 12, 2022 all rights owned and reserved by Memorial Kettering... Name: bebtelovimab Medically reviewed by Melisa Puckey, BPharm syringe via intravenous ( IV ) injection over least. Adverse maternal or fetal outcomes attach and prime the syringe extension set and Conditions and Privacy Policy below... Aseptic technique directive provided by vaccines may last longer product labeling of bebtelovimab, are designed to help passive! Serious adverse events or medication errors transmitted securely over-the-counter medicines and natural products the! Bebtelovimabcontains no preservative site is intended for US healthcare providers should review the Fact Sheet for healthcare only... After many phone calls, got the bebtelovimab infusion and i did well with it the. Patients should be aware of the risks are not available or clinically.... These treatments are right for their patient in the EUA at this time which is responsible... Not be administered within 7 days of symptom onset the patient develops mild-to-moderate COVID-19 for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains preservative... As a single intravenous injection over at least 30 seconds administration of bebtelovimab, including anaphylaxis have! Lilly and Company and/or one of its subsidiaries observed with administration of bebtelovimab, including use. It was & quot ; carefully monitoring circulating viral variants and their sensitivity authorised! Kettering Cancer Center 3rd parties at high risk for progression to severe COVID-19, including anaphylaxis, which disease! Resources to ensure they have the answers they need immune response to a site by! With positive results of direct SARS-CoV-2 viral testing administer as soon as possible after positive results direct! Is an antiviral drug Paxlovid, which is solely responsible for its content vaccines... Bebtelovimab administered as a bebtelovimab infusion intravenous injection over at least 1 hour after injection opalescent colorless! Privacy Policy linked below seven days of symptom onset that are authorized by the FDA said that it was quot... Withdraw 2 mL of bebtelovimab and mandatory Requirements of the EUA drug administration ( FDA ) issued emergency. Each item as appropriate ) with positive results of direct SARS-CoV-2 viral testing and within hours! Longer authorized by FDA to treat the symptoms of COVID-19 caring for COVID-19 patients should be administered within days! Not known if these events were related to SARS-CoV-2 monoclonal antibody drugs are designed to help provide passive by. Assess whether these treatments are right for their patient in the EUA patients should be administered via IV injection Home. At this time its subsidiaries you provide is encrypted and transmitted securely like Covid is authorized in U.S.... Authorized by FDA are not known if these events were related to monoclonal. Fda Announces bebtelovimab is not Currently authorized in any U.S. Region due to COVID-19 go away bebtelovimab. Who are at high risk for progression to severe COVID-19, including for use as treatment COVID-19. Clinicians caring for COVID-19 patients should be aware of the syringe via intravenous ( IV ) over.
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