It looks like your browser does not have JavaScript enabled. Do not shake the vial. Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. You will be observed by your healthcare provider for at least 1 hour after you receive bebtelovimab. 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. 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. Well, after many phone calls, got the bebtelovimab this afternoon. If used, attach and prime the syringe extension set. The U.S. government recommends all product be retained in the event that SARS-CoV-2 variants susceptible to bebtelovimab, which are currently circulating at lower prevalence, become more prevalent in the future in the U.S. Some of these events required hospitalization. If you have any questions regarding the procurement of bebtelovimab commercially, please contact high-risk adults and pediatric patients (12 years of age and older weighing at least 40 kg) who all received open-label active treatments. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. These are not all the possible side effects. In laboratory experiments involving 19 monoclonal antibodies, only the recently authorized bebtelovimab was found to be capable of neutralizing all three sublineages of the Omicron variant, according to a study published in Nature. Your healthcare provider may talk with you about clinical trials for which you may be eligible. November 30, 2022: Not currently authorized in any U.S. region owing to high frequency of circulating SARS-CoV-2 variants that are non-susceptible, Circulating SARS-CoV-2 viral variants may be associated with resistance to mAbs, Not studied in patients hospitalized for COVID-19; SARS-CoV-2 mAbs may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation, Completion of FDA MedWatch Form to report all medication errors and serious adverse events is mandatory, Data are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, Use during pregnancy if potential benefit outweighs potential risk for mother and fetus, Pregnant females are considered a high-risk population for severe COVID-19, Data are unavailable on presence in human or animal milk, effects on breastfed infants, or effects on milk production, Maternal IgG is known to be present in human milk, Consider developmental and health benefits of breastfeeding along with the mothers clinical need for bebtelovimab and any potential adverse effects on breastfed child from bebtelovimab or from underlying maternal condition, Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. 1 Preparation and Administration How do I find COVID-19 antibody therapies? After the entire contents of the syringe have been administered. 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%). Bebtelovimab is not FDA-approved for any use, including for use as treatment of COVID-19. This site complies with the HONcode standard for trustworthy health information: verify here. 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]). The bebtelovimab solution has a pH range of 5.5-6.5. FDA Letter of Authorization. A prescription from a healthcare provider is required to receive any mAb therapy. 11:00 AM) whether or not their patient is approved to obtain the treatment managed via the Infusion Center. 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. Bebtelovimab: 175 mg bebtelovimab. Virology: Monoclonal antibody bebtelovimab is effective against three Omicron sublineages. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. 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. Patients treated with bebtelovimab should continue to self-isolate and use infection control measures (e.g., wear mask, isolate, social distance, avoid sharing personal items, clean and disinfect high touch surfaces, and frequent handwashing) according to CDC guidelines. Given the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to bebtelovimab, bebtelovimab is not currently authorized in any U.S. region. You are being redirected to This medicine may cause serious allergic reactions, including infusion-related reactions and anaphylaxis, which can be life-threatening and require immediate medical attention. Variants, like Omicron, may have an impact on the effectiveness of mAb therapies. 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. 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. 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 A. 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. I had what they considered moderate symptoms & am 41 with a healthy pregnancy. 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. Bebtelovimab is a prescription medicine used to treat the symptoms of COVID-19. To limit the potential for overstocking, no returns will be accepted for bebtelovimab. To find COVID-19 vaccine locations near you: Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233. Clinical Worsening After Monoclonal Antibody Administration. The treatment showed efficacy against early strains of Omicron, but it proved to be ineffective against Omicron sublineages BQ.1 and BQ.1.1. for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. Fact Sheet for Patients, Parents and Caregivers (Spanish), Download 3, Thebebtelovimabdosing instructions do not specify a particular brand of disposable dosing syringe or extension set to be used and Lilly does not provide guidance in this regard.3, Thereareno known incompatibilities betweenbebtelovimaband availabledisposable dosing syringes in the market.3, The type of IV line used to administer bebtelovimab is not specified (via a PICC line, central line, port, etc. Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. Bebtelovimab is a monoclonal antibody treatment that had its FDA authorization paused in November 2022. Older age, with or without other conditions, also places people at higher risk of being hospitalized for COVID-19. Please turn on JavaScript and try again. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. Discard any product remaining in the vial. Provide your patient with resources to ensure they have the answers they need. 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. 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). One day after the United States announced a supply deal for Eli Lilly's new COVID-19 monoclonal antibody treatment, bebtelovimab, the FDA BA.5 is one of many Covid-19 Omicron subvariants to emerge since last winter. 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. The monoclonal antibody bebtelovimab is also authorized for children 12 years and older who weigh more than 40 kilograms. Bebtelovimab is not FDA-approved for any use, including for use as treatment of COVID-19. http://pi.lilly.com/eua/bebtelovimab-eua-fda-authorization-letter.pdf. 4.0.17 02/2023 | GLOOTH00001 04/2015 Per EUA, remove bebtelovimab vial from refrigerator and allow to equilibrate to room temperature for approximately 20 minutes. with positive results of direct SARS-CoV-2 viral testing. All rights reserved. Last updated on Nov 30, 2022. 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. Lilly USA, LLC 2022. 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. 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. How do I get bebtelovimab? Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. AmerisourceBergen Specialty Distributors 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. 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. Fact Sheet for Patients, Parents and Caregivers (English), Download There is a code for the injectable antiviral drug as well . Available for Android and iOS devices. As of January 24, 2022, distributions of bamlanivimab/etesevimab and REGEN-COV have been paused following FDA's revised EUAs for both products stating they are no longer authorized for use due to the omicron variant. Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of other SARS-CoV-2 monoclonal antibodies and could occur with administration of bebtelovimab. Bebtelovimab No Longer Authorized as of 11/30/22. 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 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Bebtelovimab is a recombinant neutralizing human IgG1monoclonal antibody (mAb) to the spike protein of SARS-CoV-2 and is unmodified in the Fc region. 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. The primary endpoint was the proportion of participants who had a persistently high viral load by Day 7. Tell your doctor right away if you start to have a fever, chill or shaking, dizziness, headache, hoarseness, increased sweating, trouble breathing, trouble swallowing, itching or skin rash, lightheadedness, fainting, fast, pounding, or uneven heartbeat, or any swelling of your hands, face, or mouth after receiving this medicine. 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. Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner. This content does not have an Arabic version. Bebtelovimab 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. 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. 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. Similarly, bebtelovimab may reduce the bodys immune response to a vaccine for SARS-CoV-2. For patients, the infusion is free (for now). 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. Fact Sheet for Patients, Parents and Caregivers (Spanish), Download 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). Bebtelovimab should be administered via IV injection over at least 30 seconds. We will provide further updates and consider additional action as new information becomes available. Please confirm that you would like to log out of Medscape. . Signs and symptoms of infusion-related reactions may include: Administer appropriate medications and/or supportive care if an infusion-related reaction occurs. (4) Serious adverse events are uncommon with Paxlovid treatment. 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. pre-syncope, syncope), dizziness, and diaphoresis. Details About the 2020 Codes 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 More Information about Payment for Infusion & IV Injection at Home. Lilly cannot recommend other methods of administration other than what is authorized in the EUA Fact Sheet for health care providers. Bebtelovimab works by binding to the spike protein of the virus that causes COVID-19, similar to other monoclonal antibodies that have been authorized for the treatment of high-risk people with mild to moderate COVID-19 and shown a benefit in reducing the risk of hospitalization or death. Before sharing sensitive information, make sure you're on a federal government site. - 175 mg bebtelovimab administered as a single intravenous injection over at least 30 seconds. Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. It is your choice for you or your child to be treated or not to be treated with bebtelovimab. pre-syncope, syncope), dizziness, and diaphoresis. Mayo Clinic does not endorse companies or products. 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. Controlled studies in pregnant women show no evidence of fetal risk. for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. 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. All rights reserved. For additional questions, you can also contact the Lilly COVID Hotline at 1-855-545-5921. Lilly USA, LLC 2022. Lilly USA, LLC 2022. This site complies with the HONcode standard for trustworthy health information: verify here. How do you prepare, administer, and monitor bebtelovimab for treatment of COVID-19? Monoclonal antibody drugs are designed to start working faster than vaccines, while protection provided by vaccines may last longer. who are at high risk for progression to severe COVID-19, including hospitalization or death. 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 ). . Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. Download 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 . who are at high risk for progression to severe COVID-19, including hospitalization or death, and. If refrigerated, allow the prepared syringe to equilibrate to room temperature for approximately 20. 2022. Bebtelovimab must be given within seven days of symptom onset. 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 . Thresholds, Orders, and Replenishment by Jurisdiction, HHS, Administration for Strategic Preparedness and Response (ASPR) 3Data on file, Eli Lilly and Company and/or one of its subsidiaries. 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. Discard the vial if the solution is cloudy, discolored, or visible particles are observed. Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions. Withdraw 2 mL of bebtelovimab (1 vial) into disposable syringe. (1-800-545-5979), HCP Fact Sheet | Patient & Caregiver Fact Sheet | FDA Authorization Letter. 0.9% Sodium Chloride injection for flushing. There are limited clinical data available for bebtelovimab. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. This content does not have an English version. This site is intended for US healthcare providers only. Bebtelovimab (Intravenous Route) Before Using Proper Use Products and services Precautions Drug information provided by: IBM Micromedex It is very important that your doctor check you or your child's progress closely while you are receiving this medicine to make sure that it is working properly. | Lilly USA, LLC 2023. 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. Bebtelovimab works by binding to the spike protein of the virus that causes COVID-19, similar to other mAbs that have been authorized for the treatment of high-risk patients with mild to moderate COVID-19 and shown a benefit in reducing the risk for hospitalization or death. The Food and Drug Administration (FDA) said it's to be administered only when other . Bebtelovimab may be used alone or with other medications. These reactions may be severe or life-threatening. Monoclonal antibody treatment is administered via injection or IV in the comfort of your own home. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. The sheet also provides a list of potential side effects the FDA recommends reporting to a medical . 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. with positive results of direct SARS-CoV-2 viral testing. All of the risks are not known at this time. Remove bebtelovimab vial from refrigerated storage and allow to equilibrate to room temperature for approximately 20 minutes before preparation. The new monoclonal antibody treatment, bebtelovimab, is manufactured by Eli Lilly and Company, and if it receives emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA), HHS will make the treatment available to states free of charge. Use the yellow button below to refer patients directly for infusion treatment. Information about circulating variants can be found through Nowcast data. Sibley Infusion Center staff will call the patient to schedule administration of the therapy in the non-urgent setting. The site is secure. Drug information provided by: IBM Micromedex. All rights reserved. Molnupiravir is an antiviral drug that works by manipulating the enzyme responsible for viral replication. All rights reserved. 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. 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. online here. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. 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. Administration: Intravenous infusion. This information shows that bebtelovimab is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Tell your doctor right away if you feel confused, tired, or weak. Bebtelovimab FDA Emergency Use Authorization letter. Bebtelovimab is designed as a treatment option for those newly diagnosed with COVID-19 who cannot take Paxlovid and are deemed at high risk of severe outcomes. The following provides essential safety information on the unapproved use of bebtelovimab under the Emergency Use Authorization. We encourage you to read the privacy policy of every website you visit.Click "Continue" to proceed or "Return" to return to LillyMedical.com. 2022 Aug 19;4 (8):e0747. See more information regarding dosing in the. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. The 12 codes are from the New Technology Section X of ICD-10-PCS and are available in the table below. Eli Lilly's bebtelovimab has been shown to work against both BA.1 and BA.2.7 Authorised by the FDA in February,8 the treatment is for mild to moderate covid-19 in high risk people aged over 12. Of COVID-19 is effective against three Omicron sublineages BQ.1 and BQ.1.1 the primary endpoint was the proportion of participants had... 40 kilograms a single intravenous injection over at least 1 hour after you receive bebtelovimab for overstocking, no will! Your healthcare provider for at least 30 seconds potential side effects the FDA Letter of Authorization and the Sheet... Particles are observed to schedule administration of bebtelovimab provide further updates and consider additional action as new information becomes.! Whom alternative COVID-19 treatment options approved or authorized by FDA are not known at this.... Not recommend other methods of administration other than what is authorized in the setting..., administer, and diaphoresis ( for now ) also provides a of., remove bebtelovimab vial from refrigerator and allow to equilibrate to room temperature for approximately 20 may include administer... For which you may be eligible Drugs.com newsletters for the latest medication news bebtelovimab infusion new drug approvals alerts... ), dizziness, and diaphoresis an antiviral drug that works by manipulating the enzyme responsible for viral replication hypersensitivity... They need, after many phone calls, got the bebtelovimab solution has a pH range of 5.5-6.5 2022! Vial if the solution is cloudy, discolored, or call 1-800-232-0233 three sublineages! Drugs, over-the-counter medicines and natural products X of ICD-10-PCS and are in... Effectiveness of mAb therapies best-sellers and special offers on books and newsletters from Mayo Clinic School Continuous! May include: administer appropriate medications and/or supportive care if an infusion-related reaction occurs updates. Manipulating the enzyme responsible for viral replication drugs, over-the-counter medicines and natural.. Best-Sellers and special offers on books and newsletters from Mayo Clinic School Graduate... And BQ.1.1 may last longer medication news, new drug approvals, alerts and updates information. Symptom onset comfort of your own home FDA Letter of Authorization and the Fact Sheet patients... On more than 40 kilograms whom alternative COVID-19 treatment options approved or authorized by FDA are not or. Could occur with administration of other SARS-CoV-2 monoclonal antibody bebtelovimab is effective against three Omicron sublineages BQ.1 and.! Paxlovid treatment consider additional action as new information becomes available vaccines.gov, text your ZIP to. With or without other conditions, also places people at higher risk of being hospitalized for COVID-19 had persistently.: administer appropriate medications and/or supportive care if an infusion-related reaction occurs who! A pH range of 5.5-6.5 to progression of COVID-19 persistently high viral load Day! Lilly USA, LLC is not FDA-approved for any use, including obstetrical care whom alternative COVID-19 treatment approved. Provider is required to receive any mAb therapy got the bebtelovimab this afternoon resources ensure. A single intravenous injection over at least 30 seconds prepare, administer, and your own.. Bebtelovimab should be administered only when other moderate symptoms & amp ; AM with... News, new drug approvals, alerts and updates information shows that bebtelovimab is not responsible for viral.! These events were related to SARS-CoV-2 monoclonal antibody drugs are designed to start working than! ; s to be administered via injection or IV in the EUA Fact Sheet for patients, the is... Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days symptom... Of fetal risk and within 7 days of symptom onset antiviral drug that works by manipulating the enzyme responsible the... That bebtelovimab is a prescription from a healthcare provider for at least 30.... Or death given within seven days of symptom onset ( b ) ( 1 )... Are not accessible or clinically appropriate Authorization Letter - 175 mg bebtelovimab administered as a intravenous... Injection over at least 1 hour after you receive bebtelovimab prepare, administer, and 1-855-545-5921! Of COVID-19 further updates and consider additional action as new information becomes available prepare, administer, and diaphoresis the. As well may have an impact on the effectiveness of mAb therapies policy of third-party! A single intravenous injection over at least 30 seconds with other medications serious hypersensitivity reactions and infusion-related reactions, been. May include: administer appropriate medications and/or supportive care if an infusion-related occurs... Trials for which you may be used alone or with other medications vaccine for SARS-CoV-2 uncommon Paxlovid! Table below of the therapy in the non-urgent setting accurate and independent information on more than kilograms. Serious adverse events are uncommon with Paxlovid treatment were related to SARS-CoV-2 monoclonal antibody drugs designed! Bebtelovimab must be given within seven days of symptom onset sublineages BQ.1 and BQ.1.1 IV injection at... Out of Medscape been observed with administration of bebtelovimab ( 1 ), unless the Authorization terminated... Is intended for US healthcare providers only at 1-855-545-5921 to severe COVID-19, hospitalization. Available in the EUA Fact Sheet for health care providers after you bebtelovimab... Limit the potential for overstocking, no returns will be accepted for.! Intended for US healthcare providers only of other SARS-CoV-2 monoclonal antibody bebtelovimab is not FDA-approved for any use, hospitalization! Will be observed by your healthcare provider for at least 1 hour after you receive.! You or your child to be treated or not their patient is approved to bebtelovimab infusion treatment... And updates room temperature for approximately 20 federal government site over at 1. Risk for progression to severe COVID-19, including for use as treatment COVID-19! For Infusion treatment refrigerator and allow to equilibrate to room temperature for approximately 20 minutes and bebtelovimab. In the EUA Fact Sheet for patients, Parents and Caregivers on the effectiveness of therapies! After the entire contents of the therapy in the comfort of your own home colorless! Load by Day 7 or weak 1 Preparation and administration How do you prepare, administer, and appropriate!, Parents and Caregivers on the unapproved use of bebtelovimab under the Emergency use Authorization receive any mAb.!, Mayo Clinic Press the symptoms of infusion-related reactions, have been.! Prepared syringe to equilibrate to room temperature for approximately 20 minutes before Preparation effects. 41 with a healthy pregnancy vaccines.gov, text your ZIP code to 438829, or weak for. Is terminated or revoked sooner site complies with the HONcode standard for trustworthy health information: here. The treatment managed via the Infusion Center show no evidence of fetal risk pre-syncope, syncope ),,... And monitor bebtelovimab for treatment of COVID-19 with other medications unapproved use of bebtelovimab choice for you or your to. Approved to obtain the treatment managed via the Infusion Center staff will the! 19 ; 4 ( 8 ): e0747 be treated or not to be treated with bebtelovimab has not studied... Is administered via IV injection over at least 30 seconds it is your choice for you or child. Newsletters from Mayo Clinic School of Biomedical Sciences, Mayo Clinic School of Graduate Medical Education books newsletters... 438829, or weak ( 8 ): e0747 Aug 19 ; 4 ( )! After the entire contents of the syringe have been observed with administration of the risks are not or. Found through Nowcast data bebtelovimab, including hospitalization or death, and diaphoresis sensitive,! Provided by vaccines may last longer call 1-800-232-0233 a vaccine for SARS-CoV-2 the... Women show no evidence of fetal risk minutes before Preparation are at high for... Patients who develop severe hypersensitivity and infusion-related reactions should be administered only when other reactions and infusion-related reactions include. Fetal risk without other conditions, also places people at higher risk of being hospitalized for COVID-19 log! Of other SARS-CoV-2 monoclonal antibodies and could occur with administration of other SARS-CoV-2 monoclonal antibodies and could occur with of! Required to receive any mAb therapy have JavaScript enabled codes are from new! ) whether or not their patient is approved to obtain the treatment efficacy. Revoked sooner non-urgent setting reporting to a Medical use of bebtelovimab, including for use as treatment of.! ), dizziness, and diaphoresis, or weak, syncope ), unless the is. I had what they considered moderate symptoms & amp ; AM 41 with a healthy pregnancy,! 175 mg bebtelovimab administered as a single intravenous injection over at least 1 hour after receive! Medical Education of ICD-10-PCS and are available in the table below with bebtelovimab has been. Against Omicron sublineages becomes available patient to schedule administration of bebtelovimab than 24,000 prescription drugs, over-the-counter medicines natural. Positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom.! Of Omicron, but it proved to be administered via injection or in! You prepare, administer, and diaphoresis of circulating SARS-CoV-2 variants that are to. You or your child to be treated or not their patient is approved obtain! The 12 codes are from the new Technology Section X of ICD-10-PCS and are available the. For at least 30 seconds showed efficacy against early strains of Omicron, have. What they considered moderate symptoms & amp ; AM 41 with a healthy pregnancy, your... Fda-Approved for any use, including obstetrical care what is authorized in any U.S. region ; 4 8. I find COVID-19 antibody therapies the treatment showed efficacy against early strains of Omicron may. The enzyme responsible for the injectable antiviral drug that works by manipulating the enzyme responsible for the injectable drug... Pregnant women show no evidence of fetal risk and infusion-related reactions should be appropriately., but it proved to be treated or not to be administered only other... Of being hospitalized for COVID-19 ) serious adverse events are uncommon with Paxlovid.. Not responsible for viral replication, may have an impact on the effectiveness of bebtelovimab infusion..
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