[Last accessed: July 2021]. TEZSPIRE is being developed in collaboration with AstraZeneca. 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage - The recommended dosage of TEZSPIRE is 210 mg administered subcutaneously once every 4 weeks. Find prescribing information for TEZSPIRE (anifrolumab-fnia) Injection from AstraZeneca. Tezspire is not used to treat sudden breathing problems. eosinophilic or allergic) or biomarker limitation within its approved label.1, Professor Andrew Menzies-Gow, Director of the Lung Division, Royal Brompton Hospital, London, UK, and principal investigator of the NAVIGATOR trial, said: "Due to the complex and heterogeneous nature of severe asthma and despite recent advances, many patients continue to experience frequent exacerbations, an increased risk of hospitalization and a significantly reduced quality of life. Wechsler ME, et al. 2018; 6 (1): 51-64. Failure to administer the treatment correctly could reduce its therapeutic effectiveness. AstraZeneca's Tezspire (tezepelumab) has been approved in Japan for the treatment of bronchial asthma in patients with severe or refractory disease in whom asthma symptoms cannot be controlled with mid- or high-dose inhaled corticosteroids and other long-term maintenance therapies. Applies to tezepelumab: subcutaneous solution General The most reported adverse reactions have included pharyngitis, arthralgia, and back pain. TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus. Indication information has been sourced directly from the manufacturer's product labeling and is updated periodically. Here are 10 ways to save money on prescription drugs, *See Additional Information section below, FDA Approved Diagnosis - See Program Website for Details. Oral corticosteroid-sparing effect of tezepelumab in adults with severe asthma. Manufacturer # 55513011201: Brand: TEZSPIRE . [Last accessed: December 2021]. For Media contacts, click here. Tezspire (tezepelumab) hasn't been studied during pregnancy or breastfeeding, so it's not known whether this medication is safe in pregnant females, their unborn babies, or their breastfed babies. TEZSPIRE (tezepelumab-ekko) Important Safety Information. N Engl J Med. If you are having difficulty accessing this website, please call or email us at (855) 268-2822 or ada@goodrx.com so that we can provide you with the services you require through alternative means. Talk to your healthcare provider about the best way to feed your baby if you receive Tezspire. Priority Review. Tezspire (tezepelumab) is being developed by AstraZeneca in collaboration with Amgen as a first-in-class human monoclonal antibody that inhibits the action of TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and is critical in the initiation and persistence of allergic, eosinophilic and other types of airway inflammation associated with severe asthma, including airway hyperresponsiveness.3,4 TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles.3,4 Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity.3,5 Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of asthma exacerbations and improved asthma control.2,3,5 Tezspire acts at the top of the inflammation cascade and has the potential to help address a broad population of severe asthma patients irrespective of biomarker levels.2,3. Lancet Respir Med.2021. Patients, caregivers and physicians who need support or resources can contact the TEZSPIRE Together program starting on Monday, Dec. 20 at 8:00 a.m. Please see full Prescribing Information, including Patient Information. Outside of the US, AstraZeneca will record product sales, with Amgen recording profit share as Other/Collaboration revenue. Price D, et al. Eligibility requirements vary for each program. With common pathways and underlying disease drivers across respiratory and immunology, AstraZeneca is following the science from chronic lung diseases to immunology-driven disease areas. 10. Tezspire (tezepelumab-ekko) Injection; Subcutaneous More information please phone: 866-316-7263 Visit Website Provider: Tezspire Together Program Elligibility requirements: Determined case by case Based on FPL FDA-approved diagnosis Must be treated by US licensed healthcare provider You have selected a link that will take you to a site maintained by a third party who is solely responsible for its contents. These reactions can occur within hours of administration, but in some instances have a delayed onset (i.e., days). NPJ Prim Care Respir Med. Injection; Subcutaneous, Must be treated by US licensed healthcare provider. 1,3 On December 17, 2021, tezepelumab (Tezspire, AstraZeneca/Amgen) received regulatory approval from the US Food and Drug Administration for treatment of . Page 3: Amgen, Inc: TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. Chung KF, et al. 2014; 24: 14009. Patients, caregivers and physicians who need support or. The Global Asthma Network. You may report side effects related to AstraZeneca . News - UCB, Tezspire Flurry of Japanese drug approvals. April 22, 2022. Do not use this medication to treat a sudden asthma attack. Available at: https://www.worldallergy.org/educational_programs/world_allergy_forum/anaheim2005/blaiss.php [Last accessed: December 2021]. Note: All new enrollment is now done electronically or over the phone. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. AstraZeneca provides this link as a service to website visitors. Ann Allergy Asthma Immunol. I have read this warning and will not be using any of the contained product information for clinical purposes. World Allergy Organization (WAO). You can ask your pharmacist or healthcare provider for information about Tezspire that is written for health professionals. Tezspire helps prevent severe asthma attacks (exacerbations) and can improve your breathing. TEZSPIRE helps prevent severe asthma attacks (exacerbations) and can improve your breathing. N Engl J Med. All patients received their prescribed controller medications without change throughout the trial.2, The primary efficacy endpoint was the annualized asthma exacerbation rate (AAER) during the 52-week treatment period. N Engl J Med. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. If Yes or Unknown, skip to #8 Yes No Unknown 7. TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus. Has asthma control improved on Tezspire treatment as demonstrated by a reduction in the frequency and/or severity The Companys growing presence in immunology is focused on five mid- to late-stage franchises with multi-disease potential, in areas including rheumatology (including systemic lupus erythematosus), dermatology, gastroenterology, and systemic eosinophilic-driven diseases. Side effects that you should report to your care team as soon as possible: Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome): Tezspire (tezepelumab) can cause some serious health issues. You may report side effects related to AstraZeneca products by clicking here. Tran TN, et al. Don't stop taking or change the dose of any of your other asthma medications suddenly, especially if you're taking a. 2018; 9: 1595. Can I take Tezspire (tezepelumab) at home? It is not known if Tezspire is safe and effective in children younger than 12 years of age. Tezspire may cause serious side effects, including: The most common side effects of Tezspire include: These are not all of the possible side effects of Tezspire. You should use your clinical judgment to determine which product may be appropriate in each instance. Ann Allergy Asthma Immunol. 2005; 172: 149-160. For more information, please visit www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS. The Company aims to transform the treatment of asthma and COPD by focusing on earlier biology-led treatment, eliminating preventable asthma attacks, and removing COPD as a top-three leading cause of death. AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. 866-316-7263 No, Tezspire (tezepelumab) is only used as an add-on medication when your severe asthma isn't getting better with standard maintenance treatment. Corren J, et al. tezspire is a first-in-class biologic for severe asthma that acts at the top of the inflammatory cascade by targeting thymic stromal lymphopoietin (tslp), an epithelial cytokine. All aspects of the collaboration are under the oversight of joint governing bodies. Heatwaves are on the rise worldwide putting you at risk of dehydration, heat exhaustion and heat stroke. 2 Data show that TEZSPIRE reduced the AAER . Prices are for cash paying customers only and are not valid with insurance plans. SoC was treatment with medium- or high-dose inhaled corticosteroids plus at least one additional controller medication with or without daily OCS treatment. It is not known if Tezspire may harm your unborn baby. Under the amended agreement, Amgen and AstraZeneca will jointly commercialise Tezspire in North America. 2022 total revenues guidance revised to $26.0 - $26.3 billion; EPS . Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe, Uncontrolled Asthma (DESTINATION) [Online]. 2014; 24: 14009. The Companys early respiratory research is focused on emerging science involving immune mechanisms, lung damage and abnormal cell-repair processes in disease and neuronal dysfunction. The trial comprised a five-to-six-week screening period, a 52-week treatment period and a 12-week post-treatment follow-up period. Form more information phone: 888-897-7473 or You may report side effects to FDA at 1800-FDA-1088. Amgen and AstraZeneca are committed to providing appropriate patients who are prescribed Tezspire with affordable access to the medicine. Fernandes AG, et al. 7. An estimated 25 million Americans have asthma, with fewer than 5-10% having severe asthma. Tezspire NDC #: 55513-0112-01 . 2005; 172: 149-160. However, you shouldn't receive live vaccines because it's not known if they work well while you're taking Tezspire (tezepelumab). Call your healthcare provider or get emergency medical care if you get any of the following symptoms of allergic reaction. 2 Despite missing the primary end point of significantly reducing oral corticosteroid dose, patients with asthma on Tezspire in the SOURCE trial received other benefits from the drug. Note: Site of Care Utilization Management Policy applies. TEZSPIRE Tezepelumab-ekko 210 mg Injection Prefilled Syringe 1.91 mL Amgen Inc 55513011201. 3. Lancet. Making simple changes to your diet is the first step to being heart-healthy. Elevated Expression of IL-33 and TSLP in the Airways of Human Asthmatics In Vivo: A Potential Biomarker of Severe Refractory Disease. See the end of this Patient Information leaflet for a complete list of ingredients in Tezspire. Diver S, et al. Tezspire is the first asthma medication that targets thymic stromal lymphopoietin (TSLP), an epithelial cytokine that plays a crucial role in the asthma inflammatory mechanism. Varricchi G, et al. 1 It works by blocking the release of TSLP, a cytokine protein in your body that can cause inflammation. Some simple lifestyle changes can help you reduce your obstructive sleep apnea symptoms. (tezepelumab-ekko) The management of severe asthma: economic analysis of the cost of treatments for severe asthma. How well does Tezspire (tezepelumab) work? Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma. SOURCE: A Phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy and safety of Tezepelumab in reducing oral corticosteroid use in adults with oral corticosteroid dependent asthma. TEZSPIRE helps prevent severe asthma attacks (exacerbations) and can improve your breathing. 2021;384: 1800-1809. Tezspire (tezepelumab) Tezspire is approved in the US for the add-on maintenance treatment of adult and paediatric patients aged 12 years and older with severe asthma.27 Tezspire is also in development for other potential indications including chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria and eosinophilic esophagitis (EoE). 2017;377: 936-946. It works by attaching to certain proteins that are involved in airway inflammation in asthma. Uncontrolled asthma: a review of the prevalence, disease burden and options for treatment. Tezspire (tezepelumab) can be expensive because it's currently only available as a brand-name medication. ). Clinical studies for Tezspire (tezepelumab) didn't include people with parasitic infections, so it's not known if your body will respond differently to a parasite infection while taking Tezspire (tezepelumab). TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. AstraZeneca PLC. Both companies will continue to share costs and profits equally after payment by AstraZeneca of a mid single-digit inventor royalty to Amgen. Asthma control and management in 8,000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. It's injected under the skin once per month by a healthcare provider. Works well to prevent asthma attacks from happening and improve your breathing, Can be used in adults and children 12 years and older, Can't give to yourself at home; needs to be given by a healthcare provider, Only used as add-on therapy to other asthma medications. Contact program for details. Valid at all major chains including Walgreens, CVS Pharmacy, Target, WalMart Pharmacy, Additional medications in the 'Prescription Medications' section by Amgen, Inc. Or get Amgen, . Available at: https://www.worldallergy.org/educational_programs/world_allergy_forum/anaheim2005/blaiss.php [Last accessed: July 2021]. ASD Healthcare makes no representations about which products should be used to treat which conditions. The management of severe asthma: economic analysis of the cost of treatments for severe asthma. eosinophilic or allergic) or biomarker limitation within its approved . Tezspire is approved in the US, the EU and other countries for the treatment of severe asthma. 888-897-7473 22. Omalizumab in severe allergic asthma inadequately controlled with standard therapy: a randomized trial. 2019; 4: 3538. Hanania NA, et al. 2002;89: 46773. Visit www.TEZSPIRETogether.com or call 1-888-TZSPIRE for full Terms and Conditions. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. N Engl J Med. Now, youll enjoy a streamlined experience created specifically for healthcare providers. Show ratings & reviews for. Patients, caregivers and physicians who need support or. Date of birth. It works completely differently than the other five; its 'one thing' is to block thymic stromal lymphopoietin (to which we can thankfully refer as TSLP! Patient assistance programs (PAPs) are usually sponsored by pharmaceutical companies and provide free or TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. For the first time, many people living with severe asthma have the opportunity to receive treatment regardless of the cause of their inflammation. TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus. *Patients must have health insurance and their insurance must cover the qualifying medication for which they seek assistance. Can I receive vaccines while taking Tezspire (tezepelumab)? Can I use Tezspire (tezepelumab) alone for my asthma? TezspireTM (tezepelumab-ekko) Four simple steps to submit your referral. TEZSPIRE is a prescription medicine used with other asthma medicines for the maintenance treatment of severe asthma in people 12 years of age and older whose asthma is not controlled with their current asthma medicine. As part of prespecified analyses, the AAER over 52 weeks was also assessed in patients grouped by baseline blood eosinophil count, FeNO level and serum specific immunoglobin E (IgE) status (perennial aeroallergen sensitivity positive or negative).2 These are inflammatory biomarkers used by clinicians to inform treatment options and involve tests analyzing a patients blood (eosinophils/IgE) and exhaled air (FeNO).
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