tezspire package insert

Tezepelumab in adults with uncontrolled asthma [supplementary appendix; updated April 18, 2019]. Solution Based Counseling Inform patients that hypersensitivity reactions (e.g., rash and allergic conjunctivitis) can occur following administration of TEZSPIRE [see Contraindications (4) and Adverse Reactions (6)]. The application included results from the pivotal NAVIGATOR Phase 3 trial in which Tezspire demonstrated superiority across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy.2, "Today's approval by the FDA marks the first time patients and their physicians will have a biologic option for severe asthma without phenotypic limitations and irrespective of biomarker levels," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. Tezepelumab-ekko is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody IgG2 that binds to human TSLP with a dissociation constant of 15.8 pM and blocks its interaction with the heterodimeric TSLP receptor. Patients who participated in our Phase 3 clinical trials were eligible to continue in DESTINATION, a Phase 3 extension trial assessing long-term safety and efficacy.16, About Tezspire (tezepelumab-ekko) Tezspireis a first-in-class human monoclonal antibody that works on the primary source of inflammation: the airway epithelium, which is the first point of contact for viruses, allergens, pollutants and other environmental insults. Tezspire is a first-in-class medicine indicated for the add-on maintenance treatment of adult and . In 2021, Amgen was named one of the 25 World's Best Workplaces by Fortune and Great Place to Work and one of the 100 most sustainable companies in the world by Barron's. No overall differences in safety or effectiveness of TEZSPIRE have been observed between patients 65 years of age and older and younger patients [see Adverse Reactions (6.1) and Clinical Studies (14)]. TEZSPIRE is a treatment for severe asthma that proactively reduces inflammation, which means you could experience: Fewer asthma attacks Better breathing and improved lung function Improved asthma symptom control Results may vary. Compared with placebo, improvements in annualized asthma exacerbation (rate ratio 0.70; 95% CI 0.34, 1.46) and FEV1 (LS mean change versus placebo 0.17 L; 95% CI -0.01, 0.35) were observed in pediatric patients treated with TEZSPIRE. You need JavaScript enabled to view it. Tezspire may be used alone or with other medications. www.bluecrossnc.com ), More about getting RSS News & Updates from DailyMed, 1.91 mL in 1 VIAL, GLASS; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc. The two placebo-controlled clinical trials were of 52 weeks duration. The breastfeeding individual's clinical need for Tezspire should be considered and weighed against any potential risk to the baby. tezepelumab package insert - tvam24.com In both PATHWAY and NAVIGATOR, patients receiving TEZSPIRE had significant reductions in the annualized rate of asthma exacerbations compared to placebo. Refer to Figure 1 to identify the pre-filled syringe components for use in the administration steps. Visit www.TEZSPIRETogether.com or call 1-888-TZSPIRE for full Terms and Conditions. You will receive a Tezspire injection at a healthcare providers office or an infusion clinic every four weeks. Based on population pharmacokinetic analysis, higher body weight was associated with lower exposure. All aspects of the collaboration are under the oversight of joint governing bodies. While there is no data on whether Xolair is found in breast milk, the majority of the infants in . TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. Treat patients with pre-existing helminth infections before initiating therapy with TEZSPIRE. PDF Policy: CDP-022201 (MRX 02/22) Initial Effective Date: HCPCS J3590 or The two trials enrolled a total of 1609 patients 12 years of age and older with severe asthma. TEZEPELUMAB prevents symptoms of severe asthma. December 17, 2021. This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional. 55513-100-01, Tezepelumab-ekko clearance was similar in patients with mild renal impairment (estimated creatinine clearance 60 to 89 mL/min), moderate renal impairment (estimated creatinine clearance 30 to 59 mL/min) and those with normal renal function (estimated creatinine clearance 90 mL/min). Labels, All Index A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. TEZSPIRE (tezepelumab-ekko) injection is a sterile, preservative-free, clear to opalescent, colorless to light yellow solution for subcutaneous injection supplied in a single-dose vial or single-dose pre-filled syringe. Missed Dose Information If a dose is missed, administer the dose as soon as possible. TSLP is a cytokine mainly derived from epithelial cells and occupies an upstream position in the asthma inflammatory cascade. Available at: Fahy JV. There are no available data on TEZSPIRE use in pregnant women to evaluate for any drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. A healthcare provider can advise you on side effects. The safety profile and pharmacodynamic responses in pediatric patients were generally similar to the overall study population. But at an anticipated price of $28,000 per year, the therapy would exceed cost-effectiveness . Airway inflammation is an important component in the pathogenesis of asthma. What are the possible side effects of TEZSPIRE? Do not freeze. You may report side effects to the FDA at fda.gov/medwatch or 1-800-FDA-1088. ", Results from the NAVIGATOR Phase 3 trial were published inThe New England Journal of Medicinein May 2021.2 In clinical studies of Tezspire, the most common adverse reactions were nasopharyngitis, upper respiratory tract infection and headache.2. However, the effect of body weight on exposure had no meaningful impact on efficacy or safety and does not require dose adjustment. Call your healthcare provider if you have any unusual problems while taking this medication. Following subcutaneous administration, the maximum serum concentration was reached in approximately 3 to 10 days. The safety and effectiveness of TEZSPIRE for the add-on maintenance treatment of severe asthma have been established in pediatric patients aged 12 years and older [see Adverse Reactions (6.1) and Clinical Studies (14)]. Tezspire is a monoclonal antibody, or more specifically, a thymic stromal lymphopoietin (TSLP) blocker. "Tezspire represents a much-needed new treatment for the many patients who remain underserved and continue to struggle with severe, uncontrolled asthma. It is used as an additional treatment in adults and adolescents with severe asthma that is not adequately controlled by a combination of high-dose corticosteroids taken by inhalation plus another asthma medicine. Classic asthma symptoms include wheezing, chest tightness, shortness of breath, and cough. Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe, Uncontrolled Asthma (DESTINATION) [Online]. In a prenatal and postnatal development study in cynomolgus monkeys, tezepelumab-ekko concentrations in milk were up to 0.5% of the maternal serum concentrations after intravenous administration of tezepelumab-ekko up to 300mg/kg/week (168 times the exposures based on AUC achieved at MRHD). Tezspire [package insert]. Tezspire is a first-in-class medicine indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. Do not touch the needle guard activation clips to prevent premature activation of the needle safety guard. Similar findings were seen in PATHWAY. PHONE: 1-866-503-0857 . (1), Known hypersensitivity to tezepelumab-ekko or excipients. humminbird 160 transducer; loggerhead turtle shell for sale. To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Tezspire is supplied as a single-dose vial or prefilled syringe containing. 55513-112-99, To report SUSPECTED ADVERSE REACTIONS, contact, Table 1 Adverse Reactions with TEZSPIRE with Incidence Greater than or Equal to 3% and More Common than Placebo in Patients with Severe Asthma in the Pooled Safety Population (PATHWAY and NAVIGATOR), Table 2 Demographics and Baseline Characteristics of Patients in PATHWAY and NAVIGATOR, Table 3 Rate of Clinically Significant Exacerbations Over 52 Weeks in PATHWAY and NAVIGATOR, Table 4 Mean Change from Baseline in Pre-Bronchodilator FEV, Figure 4 Mean Change (95% CI) from Baseline in Pre-Bronchodilator FEV, Tell your healthcare provider about all the medicines you take, All Drug Each vial and pre-filled syringe contains a single dose. Tezspire | European Medicines Agency Amgen; 2021. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Our website is not intended to be a substitute for professional medical advice, diagnosis, or treatment. The efficacy of TEZSPIRE was evaluated in two randomized, double-blind, parallel group, placebo-controlled clinical trials (PATHWAY [NCT02054130] and NAVIGATOR [NCT03347279]) of 52 weeks duration. If you experience these side effects and think they are severe or do not go away, you should notify your healthcare provider: Call your healthcare provider immediately if you have serious side effects. For more information, visitwww.amgen.comand follow us onwww.twitter.com/amgen. 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage - The recommended dosage of TEZSPIRE is 210 mg administered subcutaneously once every 4 weeks. As a human monoclonal antibody, tezepelumab-ekko is eliminated by intracellular catabolism and there is no evidence of target-mediated clearance within the studied dose range. The trial population included approximately equal proportions of patients with high (300 cells per microliter) and low (<300 cells per microliter) blood eosinophil counts. 2021;384:1800-1809. doi:10.1056/NEJMoa2034975. Tezspire is an injection given at a healthcare providers office. There was no clinically relevant difference in bioavailability when administered to different injection sites (abdomen, thigh, or upper arm). Verywell Health's content is for informational and educational purposes only. Each single-dose vial or pre-filled syringe delivers 1.91 mL containing 210 mg tezepelumab-ekko, glacial acetic acid (2.8 mg), L-proline (48 mg), polysorbate 80 (0.19 mg), sodium hydroxide, and water for injection.

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