Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. 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. All monoclonal antibody (mAb) therapies are in limited supply, and not everyone will be eligible for treatment. 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. Copyright 2023 IBM Watson Health. The monoclonal antibody bebtelovimab is also authorized for children 12 years and older who weigh more than 40 kilograms. Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. Emergency Use Authorization (EUA) of bebtelovimab. 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. Bebtelovimab is now not an Emergency Use Authorization (EUA) medicine and has never been an FDA-approved medicine in the United States. Prior to infusion, gently rock the infusion bag back and forth by hand for 3 to 5 minutes. Fact Sheet for Healthcare Providers, Download 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 This information shows that bebtelovimab is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. If shortages occur, patients or insurance companies may need to foot the bill for monoclonal antibodies. Discard the vial if the solution is cloudy, discolored, or . 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. Lilly USA, LLC 2022. Bebtelovimab must be given within seven days of symptom onset. 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. All rights reserved. Drug information provided by: IBM Micromedex. 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. 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. 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. All material on this website is protected by copyright, Copyright 1994-2023 by WebMD LLC. There is limited experience treating pregnant women or breastfeeding mothers with bebtelovimab. 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. Signs and symptoms of infusion-related reactions may include: 12 CLINICAL PHARMACOLOGY Current variant frequency data are available here. Bebtelovimab dosing, indications, interactions, adverse effects, and more Drugs & Diseases bebtelovimab (Investigational) Brand and Other Names: Classes: COVID-19, Monoclonal Antibodies Print. How can I get monoclonal antibody therapy (antibody infusion)? Mayo Clinic does not endorse companies or products. Read more about bebtelovimab. Identify an infusion center near your patient. BA.5 is one of many Covid-19 Omicron subvariants to emerge since last winter. We comply with the HONcode standard for trustworthy health information. Bebtelovimab is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bebtelovimab under section 564(b)(1) of the Act, 21 U.S.C. Bebtelovimab is not FDA-approved for any use, including for use as treatment of COVID-19. There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. These errors build up over time until the virus is no longer capable of surviving. How do I find COVID-19 antibody therapies? If used, attach and prime the syringe extension set. Lilly USA, LLC 2022. Side effects: There is limited information known about the safety and effectiveness of bebtelovimab for the treatment of mild-to-moderate COVID-19, according to the FDA fact sheet. Administration: Intravenous infusion. Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region. 2022. 4.0.17 02/2023 | GLOOTH00001 04/2015 These are not all the risk factors. Remove bebtelovimab vial from refrigerated storage and allow to equilibrate to room temperature for approximately 20 minutes before preparation. How do I get bebtelovimab? Bebtelovimab may be used alone or with other medications. 200 Independence Ave., Washington, DC 20201. 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 ). Clinicians caring for COVID-19 patients should be aware of the availability of these important life-saving medications and consider use when clinically indicated. See Limitations of Authorized Use. 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. 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. Health care providers should assess whether these treatments are right for their patient in the event the patient develops mild-to-moderate COVID-19. All rights reserved. Please turn on JavaScript and try again. Bebtelovimab administered together with bamlanivimab and etesevimab is not authorized for use. It was evaluated alone and together with bamlanivimab and etesevimab in, Because there are other therapeutic options available, a placebo control could not be used to treat high-risk patients.1. Across the company's safety studies, the drug was found to cause rare instances of relatively mild side effects, including infusion-related reactions, itchiness and a rash. 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner. 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. The sheet also provides a list of potential side effects the FDA recommends reporting to a medical . On May 6, 2021, CMS updated the Medicare payment rates for the administration of COVID-19 monoclonal antibody products. For patients, the infusion is free (for now). Thresholds, Orders, and Replenishment by Jurisdiction, HHS, Administration for Strategic Preparedness and Response (ASPR) The bebtelovimab solution has a pH range of 5.5-6.5. Well, after many phone calls, got the bebtelovimab this afternoon. Current variant frequency data are available here. If you log out, you will be required to enter your username and password the next time you visit. These are not all the possible side effects. INDIANAPOLIS, June 29, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) . It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. 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 . 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. are likely to be infected with a SARS-CoV-2 variant that is not able to be treated by bebtelovimab based on the circulating variants in your area (ask your health care provider about FDA and CDCs latest information on circulating variants by geographic area). with positive results of direct SARS-CoV-2 viral testing. Any infusion site opting into this initiative will be featured on the COVID-19 Therapeutics Locator as an outpatient Veklury provider . An FDA form 3500 is required for serious adverse events or medication errors. with positive results of direct SARS-CoV-2 viral testing. This site complies with the HONcode standard for trustworthy health information: verify here. The following provides essential safety information on the unapproved use of bebtelovimab under the Emergency Use Authorization. with positive results of direct SARS-CoV-2 viral testing. Shelf-life extensions were issued for specific lots of bebtelovimab. Advertising revenue supports our not-for-profit mission. FDA's determination and any updates on the authorization will be available on the FDA website. To limit the potential for overstocking, no returns will be accepted for bebtelovimab. Clinical Worsening After Monoclonal Antibody Administration. In a statement the FDA said that it was "carefully monitoring circulating viral variants and their sensitivity to authorised monoclonal antibodies . Similarly, bebtelovimab may reduce the bodys immune response to a vaccine for SARS-CoV-2. . Davidcara 6 months ago. I was given the Bebtelovimab infusion and I did well with it. Bebtelovimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus. Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP). Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. This website also contains material copyrighted by 3rd parties. These reactions may be severe or life-threatening. It looks like your browser does not have JavaScript enabled. Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab and mandatory requirements of the EUA. This site complies with the HONcode standard for trustworthy health information: verify here. All rights reserved. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. 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. 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. Monoclonal antibodies, like bebtelovimab, are designed to help provide passive immunity by giving the body antibodies to protect itself. Lilly USA, LLC 2022. Fact Sheet for Patients, Parents and Caregivers (Spanish), Download Paxlovid is authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. See Prescribing Information above, if applicable. Bebtelovimab, pronounced: beb-te-LOV-i-mab. The EUA has since been revoked on November 30, 2022. This content does not have an Arabic version. Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice. Available for Android and iOS devices. 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. 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. 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 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. Contact your healthcare provider if you have any side effects that bother you or do not go away. placebo (normal saline/ total dose volume 62.5 mL) administered via IV infusion over at least 6.5 minutes. who are at high risk for progression to severe COVID-19, including hospitalization or death, and. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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 There are limited clinical data available for bebtelovimab. Clinical worsening of COVID-19 after administration of SARS-CoV-2 monoclonal antibody treatment has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmia (e.g., atrial fibrillation, sinus tachycardia, bradycardia), fatigue, and altered mental status. Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. Bebtelovimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus. I am 23 weeks & 2 days, and just got the bebtelovimab infusion yesterday. Use: treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe disease. 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 class: Miscellaneous antivirals. . 3Data on file, Eli Lilly and Company and/or one of its subsidiaries. All rights reserved. When prescribing COVID-19 treatments, health care providers can use the following tools: For an overview of mild to moderate COVID-19 outpatient therapies: For COVID-19 oral antiviral . Vaccines provide active immunity by helping the body make its own antibodies to protect itself. All rights reserved. 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. | Lilly USA, LLC 2023. All of the risks are not known at this time. 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. We encourage you to read the privacy policy of every website you visit.Click "Continue" to proceed or "Return" to return to LillyMedical.com. The procedure followed for aseptic technique may vary between institutions. Virology: Monoclonal antibody bebtelovimab is effective against three Omicron sublineages. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. 11:00 AM) whether or not their patient is approved to obtain the treatment managed via the Infusion Center. (4) Paxlovid is given twice daily for 5 days, starting as soon as possible . Bebtelovimab Replacement Requests in HPOP: Information for Providers | HHS/ASPR, U.S. Department of Health & Human Services, FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region, FDA updates the fact sheet for Bebtelovimab, Shelf-Life Extension for Specific Lots of Bebtelovimab, COVID-19 Therapeutics Locator for Providers, COVID-19 Therapeutics Thresholds by Jurisdiction, Therapeutics Clinical Implementation Guide, Side-by-Side Outpatient Therapeutics Overview, Information for LongTerm Care Facilities. Sometimes, these may be severe or life-threatening. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. eCollection 2022 Aug. Drug information provided by: IBM Micromedex. 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. The Food and Drug Administration (FDA) said it's to be administered only when other . PP-BB-US-0005 11/2022 Tell your doctor right away if you feel confused, tired, or weak. 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. Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. FDA Letter of Authorization. Patients treated with bebtelovimab should continue to self-isolate and use infection control measures (e.g., wear mask, isolate, social distance, avoid sharing personal items, clean and disinfect high touch surfaces, and frequent handwashing) according to CDC guidelines. Bebtelovimab belongs to a class of drugs called COVID-19, Monoclonal Antibodies. It is possible that bebtelovimab could interfere with your body's own ability to fight off a future infection of SARS-CoV-2. The most common treatment-emergent adverse events observed in subjects treated with bebtelovimab, alone or in combination with bamlanivimab and etesevimab, at the authorized dose or higher, included nausea (0.8%) and vomiting (0.7%). Bebtelovimab is authorized to be administered for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg): The following provides essential safety information on the unapproved use of bebtelovimab under the Emergency Use Authorization. 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. 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature. Discard any product remaining in the vial. Fact Sheet for Healthcare Providers, Download This product is available in the following dosage forms: Portions of this document last updated: Feb. 01, 2023. . Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. 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. If you have any questions regarding the procurement of bebtelovimab commercially, please contact Are taking any medicines (prescription, and over-the-counter, vitamins, or herbal products). Individuals 12 and older who are considered high risk of getting very sick from COVID-19, with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom other COVID-19 treatment options approved or authorized by FDA are not available or clinically appropriate and may qualify for a monoclonal antibody treatment. Infusion-related reactions, which may occur up to 24 hours after the injection, have been observed in clinical trials of bebtelovimab when administered with other monoclonal antibodies and may occur with use of bebtelovimab alone. MedWatch adverse event reports can be submitted to the FDA by calling 1-800-FDA-1088 or The new infusion provides an . Copyright 2023 IBM Watson Health. The .gov means its official.Federal government websites often end in .gov or .mil. Infusion-related reactions, which may occur up to 24 hours after the injection, have been observed in clinical trials of bebtelovimab when administered with other monoclonal antibodies and may occur with use of bebtelovimab alone. FDA will continue to provide timely and transparent communication regarding the monoclonal antibody therapies that are currently authorized for emergency use in response to the COVID-19 pandemic. Portions of this document last updated: Feb. 01, 2023. Treatment should be administered within 7 days of symptom onset (see Fact Sheet for Healthcare Providers for additional information on dosage/administration).

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