Brand Name

Tezspire

Generic Name
Tezepelumab-Ekko
View Brand Information
FDA approval date: December 17, 2021
Classification: Thymic Stromal Lymphopoietin Blocker
Form: Injection

What is Tezspire (Tezepelumab-Ekko)?

Living with severe asthma can feel like a constant battle for breath. Despite using daily inhalers, many people still experience frequent, frightening asthma attacks, persistent wheezing, and limitations on their daily activities. This struggle often leads to a reliance on oral steroids, which can have significant side effects. For those caught in this cycle of uncontrolled symptoms, newer biologic therapies have opened a new door to relief. One of the most groundbreaking of these is Tezspire (tezepelumab-ekko).

Tezspire is a modern prescription medication used as an add-on maintenance treatment for severe asthma. It is not a rescue inhaler for sudden breathing problems. Instead, it is a biologic, a type of drug made from living cells, that is administered regularly to help prevent asthma attacks before they start. What makes Tezspire unique is that it is the first and only asthma biologic that targets a key protein at the very top of the inflammatory chain. This allows it to work effectively for a wide range of patients with severe asthma, regardless of the specific type of inflammation driving their disease. For many, it represents a new level of control and a chance to breathe easier.

What does Tezspire do?

Tezspire is approved by the U.S. Food and Drug Administration (FDA) for the add-on maintenance treatment of severe asthma in adults and children aged 12 years and older. It is specifically for patients whose asthma is not well-controlled with their current high-dose inhaled corticosteroids and other asthma medications.

The primary goals of treatment with Tezspire are to reduce the frequency and severity of asthma attacks (also known as exacerbations) and to improve overall lung function. Patients taking Tezspire may experience:

  • A significant reduction in the number of asthma attacks they have per year.
  • Fewer hospitalizations or emergency room visits for asthma.
  • Improved breathing and less day-to-day asthma symptoms.
  • A reduced need for oral corticosteroid medications.

Clinical studies have demonstrated Tezspire’s powerful effects. It significantly reduced asthma exacerbations by 56% in the NAVIGATOR trial, benefiting a wide range of patients regardless of inflammatory cell levels. (Menzies-Gow et al., 2021).

How does Tezspire work?

To understand how Tezspire works, it helps to think of the inflammation in your airways as a fire. In asthma, the immune system overreacts to triggers like allergens or viruses, starting an inflammatory fire that causes the airways to swell, tighten, and produce excess mucus. Many different types of immune cells and signals act as the “fuel” for this fire.

Thymic Stromal Lymphopoietin (TSLP), a “master alarm” protein, initiates the inflammatory cascade in asthma. Released when the lung lining is irritated, it triggers various inflammatory pathways leading to asthma symptoms.

Tezspire, a monoclonal antibody, uniquely blocks TSLP, stopping the inflammatory “spark” that ignites various types of severe asthma by neutralizing it “upstream.” This comprehensive action calms a broad range of inflammation, making it effective for many severe asthma types.

Tezspire side effects

Tezspire is generally well-tolerated, but like all medications, it can cause side effects. The most common ones are often mild to moderate.

Common side effects may include:

  • Sore throat (pharyngitis)
  • Joint pain (arthralgia)
  • Back pain
  • Injection site reactions (such as redness, swelling, or pain where the shot was given)

Serious side effects are rare but possible. The most important to be aware of is a hypersensitivity or allergic reaction. While this is not common, it can be severe. You should seek immediate medical attention if you experience signs of a serious allergic reaction after your injection, such as:

  • Hives or a severe rash
  • Swelling of the face, mouth, or tongue
  • Breathing problems
  • Fainting, dizziness, or feeling lightheaded

Before starting treatment, tell your doctor if you have a parasitic (helminth) infection, as Tezspire may affect your body’s ability to fight it. Your doctor will want to treat the infection before you begin taking Tezspire.

Tezspire dosage

Tezspire is a subcutaneous injection given every four weeks. It can be administered by a healthcare professional or at home by trained patients/caregivers using a pre-filled pen or syringe.

Tezspire treatment doesn’t need routine blood tests. Your doctor will clinically monitor your asthma control through symptom assessment, frequency of attacks, and rescue inhaler/oral steroid use during follow-up appointments, ensuring the medication’s safety and effectiveness.

Does Tezspire have a generic version?

No, there is no generic or biosimilar version of Tezspire (tezepelumab-ekko) currently available. However, international versions may exist in other markets. Tezspire is a complex biologic medication that is protected by patents. The equivalent of a generic drug for a biologic is called a biosimilar. The process to develop and approve a biosimilar is lengthy and highly regulated, and none exist for Tezspire at this time. Therefore, it is only available under its brand name.

Conclusion

Tezspire represents a major advancement in the management of severe asthma, offering a powerful option for a broad range of patients who have struggled to find relief. Its unique mechanism of blocking the “master alarm” protein TSLP allows it to control multiple inflammatory pathways at once, leading to fewer asthma attacks, better breathing, and an improved quality of life.

With its convenient four-week dosing schedule and no requirement for routine lab monitoring, it provides an effective and manageable long-term treatment strategy. A thorough discussion with your doctor will help determine if Tezspire is the right choice to help you take control of your severe asthma and breathe more freely.

References

  1. Amgen & AstraZeneca. (2021). TEZSPIRE® (tezepelumab-ekko) injection Prescribing Information. U.S. Food and Drug Administration. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761224s000lbl.pdf
  2. Mayo Clinic. (2024). Tezepelumab-ekko (Subcutaneous Route). Retrieved from https://www.mayoclinic.org/drugs-supplements/tezepelumab-ekko-subcutaneous-route/symptoms/drg-20521612
  3. Menzies-Gow, A., Corren, J., Bourdin, A., Chupp, G., Israel, E., Wechsler, M. E., … & Colice, G. (2021). Tezepelumab in adults and adolescents with severe, uncontrolled asthma. New England Journal of Medicine, 384(19), 1800-1809. https://www.nejm.org/

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Brand Information

TEZSPIRE (tezepelumab-ekko)
1DOSAGE FORMS AND STRENGTHS
Injection: a clear to opalescent, colorless to light yellow solution available as:
  • 210 mg/1.91 mL (110 mg/mL) solution in a single-dose glass vial.
  • 210 mg/1.91 mL (110 mg/mL) solution in a single-dose pre-filled syringe.
  • 210 mg/1.91 mL (110 mg/mL) solution in a single‑dose pre‑filled pen.
2CONTRAINDICATIONS
TEZSPIRE is contraindicated in patients who have known hypersensitivity to tezepelumab-ekko or any of its excipients
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
  • Hypersensitivity Reactions
3.1Clinical 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
Adverse reactions that occurred at an incidence greater than or equal to 3% and more common than in the placebo group from the pooled safety population (PATHWAY and NAVIGATOR) are shown in Table 1.
Specific Adverse Reactions
Cardiovascular Events
In a randomized, double-blind, long term extension trial, patients 12 years and older with severe asthma from trials NAVIGATOR and the additional trial
Injection Site Reactions
In the pooled safety population (PATHWAY and NAVIGATOR), in which TEZSPIRE or placebo was administered using the vial by a healthcare provider, injection site reactions (e.g., injection site erythema, injection site swelling, injection site pain) occurred at a rate of 3.3% in patients treated with TEZSPIRE compared with 2.7% in patients treated with placebo.
In an open-label trial of 216 patients with asthma in which TEZSPIRE was administered by healthcare providers and patients or caregivers using either the pre-filled pen or pre-filled syringe, injection site reactions (e.g., injection site erythema, injection site swelling, injection site pain) were observed in 5.7% patients using the pre-filled pen and 0% using the pre-filled syringe. However, the trial was not designed to compare injection site reactions between patients who received TEZSPIRE by the pre-filled pen versus pre-filled syringe.
Adverse Reactions in Adult Patients with Chronic Rhinosinusitis with Nasal Polyps
The safety of TEZSPIRE in CRSwNP was based on WAYPOINT, a randomized, double-blind, parallel group, multicenter, placebo-controlled trial of 52 weeks duration, which consisted of 203 adult patients aged 18 years and older on standard of care treatment for CRSwNP who received at least one dose of TEZSPIRE 210 mg subcutaneously once every 4 weeks
Adverse reactions that occurred at an incidence greater than or equal to 3% and more common than in the placebo group from the safety population (WAYPOINT) are shown in Table 2.
3.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of TEZSPIRE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Hypersensitivity reactions: anaphylaxis
4DRUG INTERACTIONS
No formal drug interaction studies have been performed with TEZSPIRE.
5DESCRIPTION
Tezepelumab-ekko, a thymic stromal lymphopoietin (TSLP) blocker, is a human monoclonal antibody immunoglobulin G2λ (IgG2λ) produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Tezepelumab-ekko has a molecular weight of approximately 147 kDa.
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, single-dose pre-filled syringe or single‑dose pre‑filled pen.
Each single-dose vial, pre-filled syringe or pre‑filled pen 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. The pH is 5.2.
6HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
TEZSPIRE (tezepelumab-ekko) injection is a sterile, preservative-free, clear to opalescent, colorless to light yellow solution supplied as a single-dose vial, single-dose pre-filled syringe with a fixed 27-gauge ½ inch needle with a needle cover or single-dose pre-filled pen with a fixed 27-gauge ½ inch needle with a needle cover. The vial, pre-filled syringe and pre-filled pen, including the needle cover and stopper, are not made with natural rubber latex.
TEZSPIRE is available as:
  • Single-Dose Vial: Carton contains one 210 mg/1.91 mL (110 mg/mL) glass vial (NDC 55513‑100‑01)
  • Single-Dose Pre-filled Syringe: Carton contains one 210 mg/1.91 mL (110 mg/mL) pre-filled syringe (NDC 55513‑112‑01)
  • Single-Dose Pre-filled Pen: Carton contains one 210 mg/1.91 mL (110 mg/mL) pre-filled pen (NDC 55513-123‑01)
Storage and Handling
Store refrigerated between 36°F to 46°F (2°C to 8°C). If necessary, TEZSPIRE may be kept at room temperature between 68°F to 77˚F (20°C to 25°C) for a maximum of 30 days. Do not put back in the refrigerator once TEZSPIRE has reached room temperature. After removal from the refrigerator, TEZSPIRE must be used within 30 days or discarded.
Store TEZSPIRE in original carton to protect from light until time of use.
Do not freeze. Do not shake. Do not expose to heat.
7PATIENT COUNSELING INFORMATION
Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Hypersensitivity Reactions
Inform patients that hypersensitivity reactions (e.g., anaphylaxis, rash and allergic conjunctivitis) can occur following administration of TEZSPIRE
Not for Acute Symptoms or Deteriorating Disease
Inform patients that TEZSPIRE does not treat acute asthma symptoms or acute exacerbations. Inform patients to seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with
Risk Associated with Abrupt Reduction of Corticosteroid Dosage
Inform patients to not discontinue systemic or inhaled corticosteroids except under the direct supervision of a healthcare provider. Inform patients that reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy
Administration of Vaccines
Instruct patients to inform the healthcare provider that they are taking TEZSPIRE prior to a potential vaccination
Proper Storage and Disposal
Advise patients to refrigerate TEZSPIRE at 36°F to 46°F (2°C to 8°C). TEZSPIRE may be kept at room temperature between 68°F to 77˚F (20°C to 25°C) for a maximum of 30 days
Manufactured by: AstraZeneca AB, Södertälje, Sweden SE-15185
US License No. 2059
At: Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320-1799
Marketed by: Amgen Inc. and AstraZeneca AB
©AstraZeneca and Amgen 2025
TEZSPIRE is a trademark of Amgen Inc. and AstraZeneca.
8PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 55513-100-01                                 Rx only
TEZSPIRE
(tezepelumab-ekko)
Injection
210 mg/1.91 mL (110 mg/mL)
For Subcutaneous Injection Only
1 singe-dose vial. Discard unused portion.
AMGEN
vial_label_single-dose
9PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 55513-112-01
TEZSPIRE
210 mg/1.91 mL (110 mg/mL)
Rx Only
For Subcutaneous Injection Only
Store the pre-filled syringe refrigerated at 36° F to 46° F
(2° C to 8° C) in original carton to protect from light.
DO NOT SHAKE, FREEEZE, OR EXPOSE TO HEAT.
1 Singe-dose pre-filled syringe. Discard unused portion
AMGEN
carton-apfs-sales
10PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 55513-123-01                                 Rx only
TEZSPIRE
(tezepelumab-ekko)
Injection
210 mg/1.91 mL (110 mg/mL)
For Subcutaneous Injection Only
Store the pre-filled pen refrigerated at 36°F to 46°F
(2°C to 8°C) in original carton to protect from light.
DO NOT SHAKE FREEZE OR EXPOSE TO HEAT.
1 Single-dose pre-filled pen.
Discard unused portion.
ATTENTION: Follow enclosed “Instructions for Use”
to prepare and deliver your dose.
AMGEN
carton_201mg_1.91ml_single-dose_pre-filled_pen