TEZSPIRE® approved for self-administration in the US with a new pre-filled pen
First and only respiratory biologic without phenotype or biomarker limitations that offers the choice of administration at home or in a doctor’s office
The approval by the
TEZSPIRE self-administration and the TEZSPIRE pre-filled pen are also approved in the
TEZSPIRE® (tezepelumab-ekko) Important Safety Information
Known hypersensitivity to tezepelumab-ekko or excipients.
WARNINGS AND PRECAUTIONS
Hypersensitivity reactions were observed in the clinical trials (eg, rash and allergic conjunctivitis) following the administration of TEZSPIRE. Postmarketing cases of anaphylaxis have been reported. These reactions can occur within hours of administration, but in some instances have a delayed onset (ie, days). In the event of a hypersensitivity reaction, consider the benefits and risks for the individual patient to determine whether to continue or discontinue treatment with TEZSPIRE.
Acute Asthma Symptoms or Deteriorating Disease
TEZSPIRE should not be used to treat acute asthma symptoms, acute exacerbations, acute bronchospasm, or status asthmaticus.
Abrupt Reduction of Corticosteroid Dosage
Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with TEZSPIRE. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
Parasitic (Helminth) Infection
It is unknown if TEZSPIRE will influence a patient’s response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with TEZSPIRE. If patients become infected while receiving TEZSPIRE and do not respond to anti-helminth treatment, discontinue TEZSPIRE until infection resolves.
Live Attenuated Vaccines
The concomitant use of TEZSPIRE and live attenuated vaccines has not been evaluated. The use of live attenuated vaccines should be avoided in patients receiving TEZSPIRE.
The most common adverse reactions (incidence ≥3%) are pharyngitis, arthralgia, and back pain.
USE IN SPECIFIC POPULATIONS
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. Placental transfer of monoclonal antibodies such as tezepelumab-ekko is greater during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy.
TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.
TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus.
Full Prescribing Information including Patient Information and Instructions for Use .
You may report side effects related to
TEZSPIREwill be available as a fixed-dose 210mg subcutaneous injection via a pre-filled, single-use auto-injector (the TEZSPIRE pre-filled pen) or via a pre-filled, single-use syringe (the TEZSPIREpre-filled syringe). Both are administered every four weeks.
The TEZSPIREpre-filledpenenables patients and caregivers to self-administer the medicine at home or in clinic via a simple process. The device is fitted with a safety guard and viewing window and has audible clicks at the start and end of the injection to guide patients.
PATH-HOME was a Phase III multi-center, open-label, parallel-group trial designed to assess patient, caregiver and healthcare provider-reported functionality and performance of a single-use, pre-filled syringe (PFS) or auto-injector (AI) with a fixed 210mg dose of TEZSPIREadministered subcutaneously every four weeksin a clinic and in an at-home setting in 216 patients aged 12 years and older with severe asthma.3
The majority (92%) of healthcare providers, patients and caregivers were able to successfully administer the TEZSPIREpre-filled penboth in the clinic and at home throughout the trial.3 At-home administration of the TEZSPIREpre-filled pen at weeks 12 and 16 was successful in 97% of the patients or caregivers (102/105).3 The trial also demonstrated for the first time that adolescents can successfully administer TEZSPIRE using the two devices.3 The very low proportion of device malfunctions (0.9% of PFS and 0.8% of AIs) provides support that the instructions for use provided to healthcare providers, patients and caregivers is adequate for successful subcutaneous administration of TEZSPIRE both in the clinic and at home.3
PATH-BRIDGE was a single-center, randomized, open-label, parallel-group Phase I trial in healthy people to compare the pharmacokinetic (PK) exposure following a single 210mg dose of TEZSPIRE by using a vial-and-syringe (V-S), PFS or pre-filled AI device.2 TEZSPIRE PK exposure was comparable following subcutaneous administration via V-S, PFS or AI.2 In addition, injection site-pain was low in severity and injection-site reactions were uncommon in all device groups.2
In addition to PATH-BRIDGE and PATH-HOME, the PATHFINDER clinical trial program included the pivotal NAVIGATOR Phase III 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.7
NAVIGATOR was the first Phase III trial to show benefit in severe asthma irrespective of eosinophils by targeting thymic stromal lymphopoietin (TSLP).7 These results support the FDA Breakthrough Therapy Designation granted to TEZSPIRE in
TEZSPIRE (tezepelumab-ekko) is being developed by
TEZSPIRE is approved in the US, EU,
In 2020, Amgen and
Respiratory & Immunology, part of BioPharmaceuticals, is one of AstraZeneca’s main disease areas and is a key growth driver for the Company.
With common pathways and underlying disease drivers across respiratory and immunology,
Tezspire US prescribing information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761224s000lbl.pdf. [Last accessed:
Zheng Y, et al. Tezepelumab Pharmacokinetics, Safety, and
Tolerability After Administrationvia Vial-and-syringe, Accessorized Prefilled Syringe, or Autoinjector: A Randomized Trial in Healthy Volunteers. Clin Thera. 2020;43(1):142-155.
Alpizar S, et al. Functionality and Performance of an Accessorized Pre-Filled Syringe and an Autoinjector for
At-Home Administration of Tezepelumabin Patients with Severe, Uncontrolled Asthma. J. Asthma Allergy. 2021;14:381-392.
AstraZeneca plc. Tezspire (tezepelumab) approved in the US for severe asthma. Available at: https://www.astrazeneca.com/media-centre/press-releases/2021/tezspire-tezepelumab-approved-in-the-us-for-severe-asthma.html. [Last accessed: January 2023].
AstraZeneca plc. Tezspire approved in the EU for the treatment of severe asthma. 2022. Available at: https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2022/tezspire-approved-in-the-eu-for-the-treatment-of-severe-asthma.html. [Last accessed: January 2023].
AstraZeneca plc. Tezspire approved in Japanfor the treatment of severe asthma. Available at: https://www.astrazeneca.com/media-centre/press-releases/2022/tezspire-approved-in-japan-for-severe-asthma.html. [Last accessed: January 2023].
- Menzies-Gow A, et al. Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma. N Engl J Med. 2021;384: 1800-1809. DOI: 10.1056/NEJMoa2034975.
Corren J, et al. Tezepelumab in adults with uncontrolled asthma [supplementary appendix; updated
April 18, 2019]. N Engl J Med. 2017;377:936-946.
- Varricchi G, et al. Thymic Stromal Lymphopoietin Isoforms, Inflammatory Disorders, and Cancer. Front Immunol. 2018;9:1595.
- Li Y, et al. Elevated Expression of IL-33 and TSLP in the Airways of Human Asthmatics In Vivo: A Potential Biomarker of Severe Refractory Disease. J Immunol. 2018;200:2253-2262.
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