Tezspire: Uses, Dosage & Side Effects
A first-in-class anti-TSLP monoclonal antibody for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps
Tezspire (tezepelumab) is a first-in-class prescription monoclonal antibody that targets thymic stromal lymphopoietin (TSLP), an upstream epithelial cytokine involved in multiple inflammatory pathways. Approved for the add-on maintenance treatment of severe asthma in adults and adolescents aged 12 years and older, and for chronic rhinosinusitis with nasal polyps (CRSwNP) in adults, Tezspire is administered as a 210 mg subcutaneous injection once every four weeks. Unlike other asthma biologics that target specific downstream mediators, Tezspire acts at the top of the inflammatory cascade, making it effective across all asthma phenotypes regardless of eosinophil levels or inflammatory biomarker status. Clinical trials have demonstrated significant reductions in asthma exacerbations, improvements in lung function, and reduced need for oral corticosteroids.
Quick Facts: Tezspire
Key Takeaways
- Tezspire (tezepelumab) is the first biologic for severe asthma that targets TSLP, an upstream cytokine, making it effective regardless of the patient's inflammatory phenotype or eosinophil count.
- Administered as a simple 210 mg subcutaneous injection every 4 weeks, Tezspire can be self-injected at home using a pre-filled pen after initial training from a healthcare professional.
- In the pivotal NAVIGATOR trial, Tezspire reduced asthma exacerbations by up to 70–77% in patients with high baseline eosinophil counts, and by 56% across the overall severe asthma population.
- Tezspire is also approved for chronic rhinosinusitis with nasal polyps (CRSwNP) in adults, where it reduces polyp size, improves nasal congestion, and restores sense of smell.
- The most common side effects are sore throat, rash, joint pain, and injection site reactions; no clinically significant drug interactions have been identified, and it can be used alongside standard asthma controller medications.
What Is Tezspire and What Is It Used For?
Tezspire contains the active substance tezepelumab, a human monoclonal antibody of the immunoglobulin G2 lambda (IgG2λ) subclass. Monoclonal antibodies are highly specialized proteins engineered to recognize and bind to a single molecular target in the body. For tezepelumab, that target is thymic stromal lymphopoietin (TSLP), an epithelial-derived cytokine that occupies a unique position at the very top of the inflammatory cascade in asthma and other airway diseases.
TSLP is produced by airway epithelial cells in response to a wide variety of environmental triggers, including allergens (such as house dust mites, pollen, and pet dander), respiratory viruses, air pollutants, cigarette smoke, and bacterial products. When these triggers damage or stimulate the airway epithelium, TSLP is released and acts as a master alarm signal that activates and coordinates multiple downstream immune pathways. TSLP stimulates dendritic cells, mast cells, eosinophils, basophils, and innate lymphoid cells (ILC2s), driving both type 2 (Th2/eosinophilic) and non-type 2 inflammatory responses. This upstream position makes TSLP a fundamentally different therapeutic target compared to the downstream mediators targeted by other asthma biologics.
Existing biologic therapies for severe asthma each target a specific downstream mediator: omalizumab binds immunoglobulin E (IgE), mepolizumab and reslizumab target interleukin-5 (IL-5), benralizumab targets the IL-5 receptor alpha subunit, and dupilumab blocks IL-4 and IL-13 signaling. While these biologics are effective for patients with the corresponding inflammatory profile (typically elevated eosinophils or IgE), they leave a significant proportion of severe asthma patients without a targeted biologic option—particularly those with low eosinophil counts or non-type 2 inflammation. By targeting TSLP at the top of the cascade, tezepelumab broadly suppresses all of these downstream pathways simultaneously, regardless of which specific inflammatory pathway is dominant.
Severe Asthma
Tezspire is indicated as an add-on maintenance treatment for severe asthma in adults and adolescents aged 12 years and older whose asthma is inadequately controlled despite high-dose inhaled corticosteroids (ICS) plus at least one additional controller medication (such as a long-acting beta2-agonist, LABA). The pivotal evidence supporting this indication comes from three major phase III clinical trials:
- NAVIGATOR: This randomized, double-blind, placebo-controlled trial enrolled 1,061 adults and adolescents with severe, uncontrolled asthma. Over 52 weeks, tezepelumab 210 mg every 4 weeks reduced the annualized asthma exacerbation rate (AAER) by 56% compared with placebo in the overall population. In patients with baseline blood eosinophil counts of 300 cells/µL or higher, the reduction was 70%, and in those with counts of 150 cells/µL or higher, it was 70%. Remarkably, even in patients with baseline eosinophil counts below 150 cells/µL, tezepelumab still reduced exacerbations by 41%, demonstrating efficacy across the full spectrum of eosinophil levels.
- SOURCE: This trial evaluated the ability of tezepelumab to reduce oral corticosteroid (OCS) dependence in patients with severe OCS-dependent asthma. While the primary endpoint (percentage reduction in final OCS dose) did not reach statistical significance in the overall population, meaningful reductions in OCS use were observed, particularly in patients with higher eosinophil counts.
- DESTINATION: This long-term extension study followed patients from NAVIGATOR and SOURCE for up to 2 years of additional treatment. Results confirmed that the efficacy and safety of tezepelumab were maintained over the long term, with sustained reductions in exacerbations and stable or improved lung function.
In addition to reducing exacerbations, tezepelumab has been shown to improve pre-bronchodilator forced expiratory volume in 1 second (FEV1) by approximately 130–160 mL compared with placebo at 52 weeks. Patients also reported improvements in asthma symptom control (as measured by the Asthma Control Questionnaire, ACQ-6) and health-related quality of life (as measured by the Asthma Quality of Life Questionnaire, AQLQ). Tezepelumab consistently reduced key inflammatory biomarkers, including blood eosinophil counts, fractional exhaled nitric oxide (FeNO), and serum total IgE, confirming its broad anti-inflammatory activity.
Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
Tezspire is also approved for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adults whose disease is inadequately controlled despite intranasal corticosteroids. CRSwNP is a chronic inflammatory condition characterized by the growth of benign polyps in the nasal passages and sinuses, leading to persistent nasal congestion, loss of smell (anosmia), facial pain or pressure, and thick nasal discharge. The condition significantly impairs quality of life and often requires repeated courses of systemic corticosteroids or surgical intervention.
The WAYPOINT phase III trial evaluated tezepelumab in adults with severe CRSwNP. Tezepelumab 210 mg every 4 weeks significantly reduced nasal polyp score (NPS), improved nasal congestion/obstruction severity, and restored sense of smell compared with placebo. The treatment also reduced the need for systemic corticosteroids and nasal polyp surgery. These benefits are consistent with the role of TSLP in driving the type 2 inflammation that underlies most cases of CRSwNP.
Unlike other asthma biologics that target specific downstream mediators (IL-5, IL-4/IL-13, IgE), Tezspire blocks TSLP—an upstream epithelial cytokine that initiates multiple inflammatory pathways. This means Tezspire is the first biologic shown to reduce asthma exacerbations across a broad population regardless of baseline eosinophil count, FeNO level, or allergy status, offering a treatment option for patients who may not qualify for or respond to other biologics.
What Should You Know Before Taking Tezspire?
Contraindications
The primary contraindication to Tezspire use is hypersensitivity (allergy) to tezepelumab or to any of the other ingredients in the formulation. The excipients in Tezspire include acetic acid (E 260), L-proline, polysorbat 80 (E 433), sodium hydroxide, and water for injections. If you have a known allergy to any of these substances, you must not use Tezspire. If you are uncertain whether any ingredient may cause a reaction, consult your doctor or pharmacist before starting treatment.
Post-marketing reports and clinical trial data have identified allergic reactions, including rare cases of anaphylaxis, associated with Tezspire. Symptoms of allergic reactions can include swelling of the face, tongue, or mouth, difficulty breathing, rapid heartbeat, fainting, dizziness, hives, and rash. These reactions can occur within hours or days after injection. If you experience any signs of a severe allergic reaction, seek immediate medical attention and do not administer further doses until you have consulted your healthcare provider.
Warnings and Precautions
Tezspire is not a rescue inhaler and must not be used to treat acute asthma attacks, acute bronchospasm, or status asthmaticus. Always keep your rescue inhaler (such as salbutamol/albuterol) readily available. If you experience a sudden worsening of asthma symptoms, use your rescue inhaler as prescribed and seek medical attention if symptoms do not improve.
Before starting Tezspire, discuss the following with your healthcare provider:
- Infections: Be alert for signs of serious infection while taking Tezspire, including fever, flu-like symptoms, night sweats, persistent cough, warm/red/painful skin, or a painful rash with blisters. If you develop signs of a serious infection, contact your doctor immediately. If you currently have a serious infection, talk to your doctor before starting Tezspire, as the medication may need to be delayed until the infection resolves.
- Cardiac symptoms: Be aware of symptoms that may indicate a heart problem, such as chest pain, shortness of breath, general malaise, or feeling dizzy or faint. While cardiovascular events have not been identified as a common side effect, any new cardiac symptoms should be reported to your healthcare provider promptly.
- Parasitic infections: TSLP plays a role in the immune defense against parasitic (helminth) infections. If you have an existing parasitic infection, or if you live in or travel to an area where parasitic infections are common, inform your doctor. Tezspire may weaken the body's ability to fight certain types of parasites. Your doctor may recommend treatment for any pre-existing parasitic infection before initiating Tezspire.
- Corticosteroid management: Do not suddenly stop taking your other asthma medications, particularly inhaled or oral corticosteroids, when you begin Tezspire. These medications must be reduced gradually under medical supervision, based on your response to treatment. Abrupt corticosteroid withdrawal can cause adrenal crisis or uncontrolled asthma symptoms.
Children and Adolescents
For the treatment of severe asthma, Tezspire is approved in adults and adolescents aged 12 years and older. The safety and efficacy in children under 12 years of age have not been established for this indication, and Tezspire should not be used in younger children for asthma. For the treatment of chronic rhinosinusitis with nasal polyps, Tezspire is approved only for adults (18 years and older), as the safety and efficacy have not been established in pediatric patients for this indication.
Pregnancy and Breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before using Tezspire. The effects of tezepelumab on human pregnancy have not been adequately studied. As a monoclonal antibody (IgG2), tezepelumab is expected to cross the placenta, particularly during the second and third trimesters, when active transport of IgG molecules from mother to fetus occurs via the neonatal Fc receptor (FcRn). Animal reproductive toxicity studies in cynomolgus monkeys did not reveal evidence of fetal harm at doses up to 300 mg/kg administered during organogenesis. However, animal data are not always predictive of human outcomes. As a precautionary measure, Tezspire should be avoided during pregnancy unless the potential benefit to the mother clearly justifies the potential risk to the fetus.
It is not known whether tezepelumab is excreted in human breast milk. Human IgG antibodies are known to be present in breast milk, and tezepelumab may therefore also pass into breast milk. A risk to the breastfed infant cannot be excluded. The decision to breastfeed during Tezspire treatment should be made in consultation with your doctor, weighing the benefits of breastfeeding for the infant against the benefits of treatment for the mother.
Driving and Operating Machinery
Tezspire is not expected to affect your ability to drive or operate machinery. No specific studies on driving performance have been conducted, but based on the pharmacological properties and known side effect profile, tezepelumab is unlikely to impair your ability to perform tasks requiring concentration, coordination, or motor skills.
Important Information About Ingredients
Tezspire contains less than 1 mmol (23 mg) of sodium per 210 mg dose, meaning it is essentially sodium-free. This is relevant for patients on sodium-restricted diets. The formulation also contains L-proline (48 mg per 210 mg dose, equivalent to 25 mg/mL). L-proline may be harmful for patients with hyperprolinemia, a rare hereditary condition that causes accumulation of L-proline in the body. If you or your child has hyperprolinemia, inform your doctor and do not use Tezspire unless your doctor has specifically recommended it. Additionally, the formulation contains polysorbate 80 (0.19 mg per 210 mg dose), which may cause allergic reactions in some individuals. Inform your doctor if you have any known allergies to polysorbates.
How Does Tezspire Interact with Other Drugs?
One of the practical advantages of Tezspire is its favorable drug interaction profile. Unlike many small-molecule drugs used in respiratory medicine (such as theophylline or certain oral corticosteroids), which are metabolized by hepatic cytochrome P450 (CYP) enzymes and can interact with a wide range of other medications, tezepelumab is a monoclonal antibody that is cleared through general protein catabolic pathways—specifically, degradation into small peptides and amino acids via intracellular lysosomal proteolysis, similar to endogenous immunoglobulin G.
No formal drug-drug interaction studies have been conducted with tezepelumab. However, based on its mechanism of clearance, no clinically significant pharmacokinetic interactions are expected. Population pharmacokinetic analyses from the clinical trial program (including NAVIGATOR, SOURCE, and PATHWAY studies) did not identify any meaningful effects of concomitant medications on tezepelumab pharmacokinetics. Similarly, tezepelumab is not expected to affect the absorption, distribution, metabolism, or elimination of other drugs.
In clinical trials, Tezspire was used concomitantly with a wide range of medications commonly used by patients with severe asthma and chronic rhinosinusitis with nasal polyps:
| Drug Category | Examples | Interaction Status |
|---|---|---|
| Inhaled Corticosteroids (ICS) | Fluticasone, budesonide, beclomethasone, mometasone | No interaction identified |
| Long-Acting Beta2-Agonists (LABA) | Formoterol, salmeterol, vilanterol | No interaction identified |
| ICS/LABA Combinations | Fluticasone/salmeterol, budesonide/formoterol | No interaction identified |
| Oral Corticosteroids | Prednisolone, prednisone, methylprednisolone | No interaction identified |
| Leukotriene Receptor Antagonists | Montelukast, zafirlukast | No interaction identified |
| Long-Acting Muscarinic Antagonists (LAMA) | Tiotropium, glycopyrronium | No interaction identified |
| Short-Acting Bronchodilators | Salbutamol (albuterol), ipratropium | No interaction identified |
| Intranasal Corticosteroids | Mometasone nasal, fluticasone nasal | No interaction identified |
Although no clinically significant drug-drug interactions have been identified, patients should always inform their doctor or pharmacist about all medications, supplements, and over-the-counter products they are currently taking. This standard recommendation ensures comprehensive monitoring and optimal treatment outcomes.
Regarding vaccinations, if you have recently been or are soon to be vaccinated, inform your doctor. While there are no specific contraindications to vaccines during Tezspire treatment, the theoretical immunomodulatory effects of blocking TSLP on vaccine responses have not been fully characterized. Live attenuated vaccines should be discussed with your doctor on a case-by-case basis. Inactivated vaccines are generally considered safe to administer during biologic therapy.
Tezspire has not been studied in combination with other biologic therapies for asthma (such as omalizumab, mepolizumab, benralizumab, or dupilumab). The concurrent use of multiple biologics is not recommended due to the lack of safety and efficacy data for such combinations. If you are switching from one biologic to Tezspire, your doctor will advise on the appropriate washout period and transition protocol.
What Is the Correct Dosage of Tezspire?
Adults
Severe Asthma – Adults (18 years and older)
Dose: 210 mg subcutaneously every 4 weeks
Route: Subcutaneous injection (thigh, abdomen, or upper arm)
Duration: Continuous; response should be assessed after 12–16 weeks
Chronic Rhinosinusitis with Nasal Polyps – Adults (18 years and older)
Dose: 210 mg subcutaneously every 4 weeks
Route: Subcutaneous injection (thigh, abdomen, or upper arm)
Duration: Continuous; clinical benefit typically observed within first months
Tezspire is administered as a subcutaneous injection using a pre-filled single-use pen. Each pen contains one complete dose of 210 mg. The injection can be given by a healthcare professional, or it can be self-administered by the patient or administered by a caregiver after appropriate training on proper injection technique. Before self-injecting, you or your caregiver must receive instruction from a healthcare professional on the correct preparation and injection of Tezspire.
Recommended injection sites include the front of the thigh or the lower abdomen (at least 5 cm from the navel). If a caregiver is administering the injection, the upper arm may also be used. For each injection, choose a different site that is at least 3 cm from the previous injection location. Do not inject into skin that is tender, bruised, scaly, hard, scarred, or damaged, and do not inject through clothing.
Adolescents (12–17 years)
For the treatment of severe asthma in adolescents aged 12 to 17 years, the recommended dose is the same as for adults: 210 mg subcutaneously every 4 weeks. No dose adjustment is necessary based on age or weight within this population. Tezspire is not approved for adolescents for the CRSwNP indication.
Elderly Patients
No dose adjustment is required for elderly patients. Clinical trials included patients up to 80 years of age, and no clinically meaningful differences in safety or efficacy were observed between older and younger adults. Population pharmacokinetic analyses did not identify age as a significant covariate affecting tezepelumab clearance or distribution.
Missed Dose
If you forget to inject a dose, administer it as soon as possible. Then take the next injection on your regularly scheduled injection day. If you do not realize that you missed a dose until it is time for your next scheduled dose, simply inject the next dose as planned. Do not inject a double dose to make up for a missed dose. If you are unsure about when to inject, contact your doctor, pharmacist, or nurse for guidance.
Overdose
There is limited experience with overdose of tezepelumab. In clinical trials, doses up to 280 mg subcutaneously and 700 mg intravenously have been administered without dose-limiting toxicities. In the event of an overdose, the patient should be monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment should be given. There is no specific antidote for tezepelumab.
Stopping Treatment
Do not stop using Tezspire without first consulting your doctor. Discontinuing treatment may cause your asthma symptoms or nasal polyp symptoms to return or worsen. The decision to stop Tezspire should be made in collaboration with your healthcare provider, who will assess whether the treatment should continue based on your clinical response and disease control.
| Patient Group | Indication | Dose | Frequency |
|---|---|---|---|
| Adults (18+) | Severe asthma | 210 mg SC | Every 4 weeks |
| Adolescents (12–17) | Severe asthma | 210 mg SC | Every 4 weeks |
| Adults (18+) | CRSwNP | 210 mg SC | Every 4 weeks |
| Elderly | Severe asthma / CRSwNP | 210 mg SC | Every 4 weeks (no adjustment) |
| Children (<12) | Not approved | — | — |
What Are the Side Effects of Tezspire?
Like all medicines, Tezspire can cause side effects, although not everyone will experience them. The safety profile of tezepelumab has been extensively evaluated in clinical trials involving over 2,000 patients with severe asthma and chronic rhinosinusitis with nasal polyps, with treatment durations of up to 2 years. The overall incidence of adverse events was similar between tezepelumab and placebo groups, indicating a favorable tolerability profile.
The side effects of Tezspire are categorized below by frequency. Understanding these categories helps put the risk of each side effect into perspective:
Common
- Sore throat (pharyngitis)
- Rash (skin rash)
- Joint pain (arthralgia)
- Injection site reactions (redness, swelling, pain at the injection site)
Not Known
- Allergic reactions (hypersensitivity), including anaphylaxis
- Swelling of the face, tongue, or mouth
- Breathing difficulties
- Rapid heartbeat
- Fainting, dizziness
- Hives (urticaria) and other rashes
Contact your doctor or seek emergency care immediately if you experience signs of a severe allergic reaction after receiving Tezspire. These signs may include difficulty breathing, swelling of the face, lips, tongue or throat, rapid heartbeat, fainting, widespread hives, or severe dizziness. Allergic reactions can occur within hours or days after the injection.
Injection Site Reactions
Injection site reactions are among the most commonly reported side effects of Tezspire. These typically include mild to moderate redness (erythema), swelling, and pain at the site of injection. In clinical trials, injection site reactions occurred in approximately 3.6% of patients receiving tezepelumab compared with 3.0% of those receiving placebo. These reactions are generally self-limiting and resolve within a few days without specific treatment. Rotating injection sites with each dose can help minimize the frequency and severity of injection site reactions.
Pharyngitis (Sore Throat)
Sore throat was the most frequently reported side effect in clinical trials. This is consistent with the immunomodulatory mechanism of tezepelumab: by blocking TSLP, which plays a role in airway epithelial immune surveillance, there may be a marginally increased susceptibility to upper respiratory tract irritation. However, the incidence of pharyngitis was only modestly higher in the tezepelumab group compared with placebo, and episodes were generally mild and self-limiting.
Long-Term Safety
Long-term safety data from the DESTINATION extension study, which followed patients for up to 2 additional years of tezepelumab treatment, showed no new safety signals and confirmed a stable, favorable safety profile over time. The overall rates of serious adverse events, malignancies, and serious infections were comparable between tezepelumab and placebo groups. No evidence of increased cardiovascular risk, immunosuppression-related opportunistic infections, or injection-related systemic reactions was identified over the extended treatment period.
It is important to report suspected side effects after a medicine has been authorized. This allows continued monitoring of the benefit-risk balance of the medicine. Healthcare professionals and patients are encouraged to report any suspected adverse reactions to their national pharmacovigilance authority (e.g., FDA MedWatch in the US, Yellow Card Scheme in the UK, or EMA EudraVigilance in the EU).
How Should You Store Tezspire?
Proper storage of Tezspire is essential to maintain the medication's effectiveness and safety. The pre-filled pen should be stored in a refrigerator at 2°C to 8°C (36°F to 46°F). Keep the pen in its original outer carton to protect it from light. Do not freeze Tezspire, and do not shake the pen. If the pen has been accidentally frozen, do not use it—dispose of it safely and use a new one.
If needed, Tezspire can be stored at room temperature between 20°C and 25°C (68°F to 77°F) in its original carton for a maximum of 30 days. This is useful for travel or situations where refrigeration is temporarily unavailable. Once the pen has been brought to room temperature, do not place it back in the refrigerator. If Tezspire has been stored at room temperature for more than 30 days, it must be discarded safely.
Before each injection, remove the pen from the refrigerator and allow it to reach room temperature for approximately 60 minutes. Do not warm the pen by any other means—do not use a microwave, hot water, or direct sunlight. Before use, visually inspect the solution through the inspection window. The liquid should appear clear to opalescent and colorless to light yellow. Do not use the pen if the liquid is cloudy, discolored, or contains large particles. Small air bubbles are normal and do not affect the medication.
- Do not use the pen if it has been dropped or damaged
- Do not use the pen if the safety seal on the carton has been broken
- Do not use the pen after the expiration date (EXP) printed on the label and carton
- Do not expose the pen to heat or direct sunlight
- Keep out of the sight and reach of children
Used pens and caps should be placed in a sharps disposal container immediately after use. Do not throw the pen in household waste or recycling. Follow your local regulations for disposal of sharps containers, or ask your pharmacist for guidance on proper disposal.
What Does Tezspire Contain?
Understanding the composition of Tezspire can help you identify potential allergens and discuss any concerns with your healthcare provider. Each pre-filled pen contains one complete dose of tezepelumab.
| Component | Role | Amount per Dose |
|---|---|---|
| Tezepelumab | Active ingredient (anti-TSLP monoclonal antibody) | 210 mg |
| Acetic acid (E 260) | Buffer (pH adjustment) | As needed |
| L-proline | Stabilizer | 48 mg |
| Polysorbate 80 (E 433) | Surfactant | 0.19 mg |
| Sodium hydroxide | pH adjustment | As needed |
| Water for injections | Solvent | To volume |
Appearance: Tezspire is a clear to opalescent, colorless to light yellow solution for injection. It is available in pre-filled single-use pens. Pack sizes include cartons containing 1 pre-filled pen or multipacks containing 3 pens (3 cartons of 1 pen each). Not all pack sizes may be available in all markets.
Marketing Authorization Holder: AstraZeneca AB, SE-151 85 Södertälje, Sweden. Tezspire was co-developed by AstraZeneca and Amgen as part of a collaboration agreement for respiratory biologics.
Frequently Asked Questions About Tezspire
Tezspire (tezepelumab) is used as an add-on maintenance treatment for two conditions: (1) severe asthma in adults and adolescents aged 12 years and older whose disease is inadequately controlled with high-dose inhaled corticosteroids plus another controller medication, and (2) chronic rhinosinusitis with nasal polyps (CRSwNP) in adults. Tezspire targets TSLP, an upstream cytokine, making it effective across all inflammatory phenotypes of severe asthma.
Unlike other asthma biologics that target specific downstream mediators (IL-5, IL-4/IL-13, or IgE), Tezspire blocks thymic stromal lymphopoietin (TSLP), an upstream epithelial cytokine. This means it acts at the very top of the inflammatory cascade, making it effective regardless of the patient's eosinophil count, FeNO level, or allergy status. It is the first biologic for severe asthma that has demonstrated significant exacerbation reductions even in patients with low eosinophil levels.
Yes, after receiving proper training from a healthcare professional, you or a caregiver can self-administer Tezspire at home using the pre-filled pen. Injection sites include the front of the thigh or the lower abdomen. A caregiver can also inject into the upper arm. The pen is designed for single use only and should not be shared. Always follow the instructions for use provided with the pen.
In clinical trials, Tezspire began to show reductions in asthma exacerbations and improvements in lung function within the first few weeks of treatment. However, the full benefit of treatment may take several months to become apparent. Healthcare providers typically assess the response to Tezspire after 12 to 16 weeks of treatment. For nasal polyps, improvements in polyp size and nasal symptoms are generally observed within the first few months of treatment.
No. Tezspire is an add-on therapy and is not meant to replace your current asthma medications, including inhaled corticosteroids, LABAs, or rescue inhalers. Do not stop or reduce your other asthma medications without your doctor's guidance. Over time, if your asthma is well controlled on Tezspire, your doctor may gradually reduce the dose of your other controller medications, particularly oral corticosteroids, under careful supervision.
If you experience symptoms of a serious allergic reaction—such as difficulty breathing, swelling of the face, lips, tongue, or throat, rapid heartbeat, dizziness, or widespread hives—seek emergency medical attention immediately. Do not administer further doses until you have spoken with your healthcare provider. Report the reaction so your treatment plan can be reassessed.
References
- European Medicines Agency (EMA). Tezspire (tezepelumab) – Summary of Product Characteristics. Available at: ema.europa.eu/en/medicines/human/EPAR/tezspire. Accessed December 2025.
- U.S. Food and Drug Administration (FDA). Tezspire (tezepelumab-ekko) Prescribing Information. Reference ID: 5231972. Approved February 2022, updated 2024.
- Menzies-Gow A, Corren J, Bourdin A, et al. Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma (NAVIGATOR). N Engl J Med. 2021;384(19):1800-1809. doi:10.1056/NEJMoa2034975
- Corren J, Parnes JR, Wang L, et al. Tezepelumab in Adults with Uncontrolled Asthma (PATHWAY). N Engl J Med. 2017;377(10):936-946. doi:10.1056/NEJMoa1704064
- Wechsler ME, Menzies-Gow A, Brightling CE, et al. Evaluation of the oral corticosteroid-sparing effect of tezepelumab in adults with oral corticosteroid-dependent asthma (SOURCE). Lancet Respir Med. 2022;10(7):650-660.
- Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention, 2024 Update. Available at: ginasthma.org
- Fokkens WJ, Lund VJ, Hopkins C, et al. European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS 2020). Rhinology. 2020;58(Suppl S29):1-464.
- World Health Organization (WHO). Asthma Fact Sheet. 2024. Available at: who.int/news-room/fact-sheets/detail/asthma
- Gauvreau GM, Sehmi R, Ambrose CS, Griffiths JM. Thymic stromal lymphopoietin: its role and potential as a therapeutic target in asthma. Expert Opin Ther Targets. 2020;24(8):777-792.
Medical Editorial Team
This article was written by the iMedic Medical Editorial Team, comprising licensed specialist physicians in respiratory medicine, clinical pharmacology, and immunology. All content has been reviewed according to international medical guidelines including the EMA Summary of Product Characteristics, FDA Prescribing Information, and GINA 2024 guidelines. Our editorial process follows the GRADE evidence framework, and all medical claims are supported by Level 1A evidence from systematic reviews and randomized controlled trials.