Tezepelumab

Tezepelumab-ekko is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody IgG2λ that binds to human TSLP with a dissociation constant of 15.8 pM and blocks its interaction with the heterodimeric TSLP receptor. TSLP is a cytokine mainly derived from epithelial cells and occupies an upstream position in inflammatory cascades.

• TEZSPIRE is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody (IgG2λ), indicated: • for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. ( 1.1 ) Limitations of Use: Not for relief of acute bronchospasm or status asthmaticus.ICD-10: J45.909

• TEZSPIRE is contraindicated in patients who have known hypersensitivity to tezepelumab-ekko or any of its excipients [see Warnings and Precautions (5.1) ] . Known hypersensitivity to tezepelumab-ekko or excipients.contraindicated

Recommended dosage is 210 mg administered once every 4 weeks. ( 2.1 ) • Administer by subcutaneous injection. ( 2.1 ) • See full prescribing information for preparation and administration instructions. ( 2.2 ) 2.1 Recommended Dosage The recommended dosage of TEZSPIRE is 210 mg administered subcutaneously once every 4 weeks. Missed Dose Information If a dose is missed, administer the dose as soon as possible. Thereafter, the patient can continue (resume) dosing on the usual day of administration. If the next dose is already due, then administer as planned. 2.2 Preparation and Administration Instructions TEZSPIRE vial and pre‑filled syringe are intended for administration by a healthcare provider. TEZSPIRE pre-filled pen can be administered by patients/caregivers or healthcare providers. Patients/caregivers may administer TEZSPIRE pre-filled pen after proper training in subcutaneous injection technique and after the healthcare provider determines it is appropriate. Each vial, pre-filled syringe and pre‑filled pen contain a single dose of TEZSPIRE. • Prior to administration, remove TEZSPIRE from the refrigerator and allow it to reach room temperature. This generally takes 60 minutes. Do not expose to heat and do not shake. Do not use if the security seal on the carton has been broken. Do not put back in the refrigerator once TEZSPIRE has reached room temperature. • Visually inspect TEZSPIRE for particulate matter and discoloration prior to administration. TEZSPIRE is a clear to opalescent, colorless to light yellow solution.

• Hypersensitivity Reactions: Hypersensitivity reactions have been observed in the clinical trials (e.g., rash, allergic conjunctivitis) following the administration of TEZSPIRE. Postmarketing cases of anaphylaxis have been reported. Initiate appropriate treatment as clinically indicated in the event of a hypersensitivity reaction. ( 5.1 ) • Risk Associated with Abrupt Reduction in Corticosteroid Dosage: Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with TEZSPIRE. Decrease corticosteroids gradually, if appropriate. ( 5.3 ) • Parasitic (Helminth) Infection: Treat patients with pre-existing helminth infections before therapy with TEZSPIRE. If patients become infected while receiving TEZSPIRE and do not respond to anti-helminth treatment, discontinue TEZSPIRE until the parasitic infection resolves. ( 5.4 ) • Vaccination: Avoid use of live attenuated vaccines. ( 5.5 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions were observed in the clinical trials (e.g., rash and allergic conjunctivitis) following the administration of TEZSPIRE. Postmarketing cases of anaphylaxis have also been reported [see Contraindications (4) and Adverse Reactions (6.2) ] . These reactions can occur within hours of administration, but in some instances have a delayed onset (i.e., 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.

The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Most common adverse reactions (incidence ≥ 3%) are: • Asthma: pharyngitis, arthralgia, and back pain. ( 6.1 ) • Chronic rhinosinusitis with nasal polyps: nasopharyngitis, upper respiratory tract infection, epistaxis, pharyngitis, back pain, influenza, injection site reaction and arthralgia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Adult and Pediatric Patients 12 Years of Age and Older with Asthma The safety of TEZSPIRE in asthma was based on the pooled safety population from PATHWAY and NAVIGATOR, which consists of 665 adult and pediatric patients 12 years of age and older with severe asthma who received at least one dose of TEZSPIRE 210 mg subcutaneously once every 4 weeks. The two placebo-controlled clinical trials were of 52 weeks duration. In addition, a similar safety profile was seen in a trial that enrolled 150 adult patients with severe asthma who required treatment with daily oral corticosteroids [see Clinical Studies (14.1) ] .

8.1 Pregnancy Risk Summary 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. In an enhanced pre- and post-natal development (ePPND) study conducted in cynomolgus monkeys, placental transport of tezepelumab-ekko was observed but there was no evidence of fetal harm following intravenous administration of tezepelumab-ekko throughout pregnancy at doses that produced maternal exposures up to 168 times the exposure at the maximum recommended human dose (MRHD) of 210 mg administered subcutaneously (see Data) . The estimated background risk of major birth defects and miscarriages for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Metabolism

The pharmacokinetics of tezepelumab-ekko is similar in patients with asthma and CRSwNP. The pharmacokinetics of tezepelumab-ekko were dose-proportional following administration of a single subcutaneous dose over a dose range from 0.01 to 2 times the recommended dose.

• Dec 17, 2021BLABLA761224Astrazeneca Ab

1. 1Asthma86515%
2. 2Dyspnoea5169.1%
3. 3Arthralgia4768.4%
4. 4Drug Ineffective4728.3%
5. 5Cough2644.6%
6. 6Pneumonia2494.4%
7. 7Product Dose Omission Issue2434.3%
8. 8Headache2243.9%
9. 9Fatigue2143.8%
10. 10Back Pain2133.7%
11. 11Rash2053.6%
12. 12Pain2003.5%
13. 13Dizziness1763.1%
14. 14Injection Site Pain1713.0%
15. 15Death1622.8%

The 10 most recently updated of 66 ClinicalTrials.gov registrations naming Tezepelumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
  Active not recruiting · Phase 3 · Interventional · 181 enrolled · AstraZeneca
  NCT06706817updated 2026-06-10
• Efficacy of Tezepelumab in Peanut Oral Immunotherapy
  Not yet recruiting · Phase 2 · Interventional · 62 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT07015996updated 2026-06-09
• Prospective, Non-interventional Single-arm Study With Tezepelumab to Investigate the Change in Clinical and Patient-reported Outcomes in Patients With CRSwNP in Real-world (PETRICHOR)
  Not yet recruiting · Observational · 200 enrolled · AstraZeneca
  NCT07633158updated 2026-06-08
• Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea
  Not yet recruiting · Observational · 210 enrolled · AstraZeneca
  NCT06998095updated 2026-06-04
• Tezspire Cardiac Events PASS
  Recruiting · Observational · 16,640 enrolled · AstraZeneca
  NCT06951867updated 2026-06-04
• ReAl-woRld Evaluation of tEzepelumab for Chronic rhinoSinusitis With Nasal Polyps in Russia
  Recruiting · Observational · 110 enrolled · AstraZeneca
  NCT07399665updated 2026-06-03
• A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma
  Recruiting · Phase 3 · Interventional · 231 enrolled · AstraZeneca
  NCT06023589updated 2026-06-01
• Phase 3b Study in Patients With Severe Asthma Treated With Tezepelumab
  Recruiting · Phase 3 · Interventional · 400 enrolled · AstraZeneca
  NCT07363642updated 2026-05-26
• A Study to Investigate NPS and Symptoms in Chinese Adult Participants With CRSwNP Initiating Treatment With Tezepelumab
  Recruiting · Phase 3 · Interventional · 230 enrolled · AstraZeneca
  NCT07520162updated 2026-05-26
• Taiwan Severe Asthma Biologic Registry
  Recruiting · Observational · 500 enrolled · Taichung Veterans General Hospital
  NCT06456450updated 2026-05-19

Frequently asked questions

How does Tezepelumab work?

Tezepelumab-ekko is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody IgG2λ that binds to human TSLP with a dissociation constant of 15.8 pM and blocks its interaction with the heterodimeric TSLP receptor. TSLP is a cytokine mainly derived from epithelial cells and occupies an upstream position in inflammatory cascades.

What is Tezepelumab used for?

According to FDA labeling, Tezepelumab carries indications including: TEZSPIRE is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody (IgG2λ), indicated: • for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. ( 1.1 ) Limitations of Use: Not for relief of acute bronchospasm or status asthmaticus.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Tezepelumab?

Tezepelumab is classified as Other systemic drugs for obstructive airway diseases, Thymic Stromal Lymphopoietin Blocker, Antibody-Receptor Interactions, Thymic Stromal Lymphopoietin Blockers, Respiratory/Pulmonary Activity Alteration.

What are the brand names for Tezepelumab?

Tezepelumab is marketed under brand names including Tezspire.

What are the contraindications for Tezepelumab?

Tezepelumab labeling lists contraindications including: TEZSPIRE is contraindicated in patients who have known hypersensitivity to tezepelumab-ekko or any of its excipients [see Warnings and Precautions (5.1) ] . Known hypersensitivity to tezepelumab-ekko or excipients.. Always consult the full prescribing information and a clinician.