FDA-filed SPL labeling · retrieved through openFDA

Tezepelumab Injection

Tezepelumab (TEZSPIRE) is a biologic injection that helps control severe asthma and nasal polyps by blocking a key inflammation trigger in the body.

Brand name Tezspire
Drug class Thymic Stromal Lymphopoietin Blocker
Rx Route Subcutaneous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveOct 17, 2025
Clinical labels in scope 2
AvailabilityRx
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 22, 2026
💊
HelloPharmacist Editorial Team Bottom Line
Tezepelumab (TEZSPIRE) is a once-monthly biologic injection that helps prevent severe asthma flares and control nasal polyp symptoms by blocking a root-cause inflammation signal in the body. It works best as an add-on to your existing treatment — it is not a rescue medicine. Keep your rescue inhaler handy, never stop your steroids suddenly without guidance, and contact your doctor promptly if you notice any allergic symptoms after an injection.

📖 Tezepelumab Injection: Patient Information Guide

A plain-language walkthrough of Tezepelumab Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Tezepelumab is approved for two conditions in adults and teens 12 and older:

  • Severe asthma — as an add-on maintenance treatment when asthma is not well controlled on existing therapy
  • Chronic rhinosinusitis with nasal polyps (CRSwNP) — for inadequately controlled nasal polyps that cause ongoing sinus and breathing problems

It is not used for sudden asthma attacks or emergency breathing crises.

⚙️How it works

The airways and sinuses release a protein called TSLP (thymic stromal lymphopoietin) when they become inflamed. TSLP sits at the very top of the inflammation chain — once activated, it recruits immune cells like eosinophils (allergy-related white blood cells), mast cells, and others, triggering the release of chemicals that cause swelling, mucus, and airway narrowing. Tezepelumab is a lab-made antibody that binds tightly to TSLP and stops it from activating this chain reaction.

By blocking TSLP early in the process, the drug helps lower multiple inflammation markers — including blood eosinophils, IgE (an allergy antibody), and certain inflammatory messengers (IL-5 and IL-13) — reducing both airway and nasal inflammation over time.

💊How it's taken

Tezepelumab is given as a subcutaneous injection (under the skin) once every 4 weeks. It comes as a vial, pre-filled syringe, or pre-filled pen. The vial and pre-filled syringe are given by a healthcare provider; the pre-filled pen can be used at home after proper training.

  • Inject into the thigh, abdomen (avoiding 2 inches around the navel), or upper arm (healthcare provider/caregiver only — not for self-injection in the arm)
  • Rotate injection sites each time; avoid skin that is bruised, red, tender, or hardened
  • Let the medicine warm to room temperature for about 60 minutes before injecting — do not shake or heat it
  • If you miss a dose, take it as soon as possible and then return to your normal schedule
🤒Side effects — in detail

The most common side effects (reported in at least 3% of patients) include:

  • For asthma patients: throat/pharyngitis infections, joint pain (arthralgia), and back pain
  • For nasal polyp patients: cold-like symptoms (nasopharyngitis), upper respiratory infections, nosebleeds (epistaxis), throat irritation, back pain, flu, injection site reactions, and joint pain

More serious reactions include allergic responses — ranging from rash and eye irritation to rare but severe anaphylaxis (a life-threatening whole-body allergic reaction). Seek emergency care immediately if you experience hives, swelling of the throat, difficulty breathing, or sudden dizziness after an injection.

⚠️Warnings & precautions
  • Serious allergic reactions (including anaphylaxis): Can occur within hours — or sometimes days — after an injection. Know the warning signs: hives, swelling, trouble breathing, feeling faint. Get emergency help right away.
  • Not a rescue medication: Do not use tezepelumab for a sudden asthma attack, acute bronchospasm, or status asthmaticus (a severe, prolonged asthma attack). Always keep a fast-acting rescue inhaler on hand.
  • Steroid tapering risk: If you use steroid medications, do not stop them abruptly when starting tezepelumab. A sudden stop can cause withdrawal symptoms or uncover conditions the steroids were suppressing. Your doctor will guide any gradual reduction.
  • Parasitic (helminth) infections: TSLP plays a role in fighting parasitic worm infections. If you have one, it should be treated before starting tezepelumab. If you develop one during treatment and it doesn't respond to treatment, your doctor may pause this medication.
  • Live vaccines: Avoid live attenuated vaccines (e.g., live flu nasal spray, MMR) while on tezepelumab. Talk to your doctor about which vaccines are safe.
🔀What it interacts with

No formal drug interaction studies have been conducted with tezepelumab. However, there are important considerations to be aware of:

  • Live vaccines — should be avoided during treatment, as the immune effects of tezepelumab may interfere with how live vaccines work
  • Corticosteroids (steroid medications) — do not stop these abruptly when starting tezepelumab; any reduction should be gradual and supervised by your doctor

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Known allergy: Do not use tezepelumab if you have had a hypersensitivity reaction to it or any of its ingredients — this is a contraindication
  • Pregnancy: There is limited data in pregnant women. This antibody can cross the placenta, especially in the third trimester, which may affect the baby. Poorly controlled asthma in pregnancy also carries its own risks — talk to your doctor about the right balance
  • Breastfeeding: The label does not provide clear data on use during breastfeeding — discuss with your doctor
  • Children under 12: Not approved for children under 12 years of age
  • Parasitic infections: Pre-existing helminth (worm) infections should be treated before starting therapy
  • Live vaccine use: Avoid live vaccines during treatment; discuss your vaccination history and needs with your prescriber
  • Body weight: Higher body weight can slightly reduce drug exposure, but this does not require a dose change and does not meaningfully affect how well the drug works
📡Pharmacodynamics — effects in the body

Tezepelumab starts reducing measurable signs of inflammation within 2 weeks of the first dose. It lowers the level of eosinophils (allergy-related immune cells) in the blood and airways, reduces FeNO (fractional exhaled nitric oxide — a marker of airway inflammation), and decreases levels of inflammatory proteins IL-5 and IL-13. It also causes a slow, steady reduction in total IgE (an allergy antibody) over the course of treatment. These reductions are sustained throughout the full treatment period (up to 52 weeks in clinical studies), suggesting the drug consistently damps down the underlying inflammatory process.

🔬Pharmacokinetics — how your body processes it

After an injection under the skin, tezepelumab reaches peak blood levels in roughly 3 to 10 days, and about 77% of the dose is absorbed into the bloodstream. With once-every-4-weeks dosing, steady blood levels (steady state) are reached after about 12 weeks. The drug has an elimination half-life of approximately 26 days — meaning it takes about 26 days for the body to clear half of the drug. Tezepelumab is broken down by the body's natural protein-digesting enzymes and is not processed by the liver in the way most pills are. Age, sex, and race do not meaningfully affect how the body handles this medication.

📦How to store it

Store refrigerated between 36°F to 46°F (2°C to 8°C). refrigerator once TEZSPIRE has reached room temperature. refrigerator, TEZSPIRE must be used within 30 days or discarded.

📄 Written from Tezepelumab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

53

Supplements & herbs that interact with Tezepelumab Injection

53 supplements and herbal products have documented interactions with Tezepelumab Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Moderate · 52
  • Minor · 1
Every supplement checked against Tezepelumab Injection — ranked by severity The full interaction hub: 52 moderate · 1 minor · every one linked to its full report. Check Tezepelumab Injection against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Tezepelumab Injection — the kind of thing our pharmacy team would talk through with you at the counter.

Can I use tezepelumab when I'm having an asthma attack?
No — tezepelumab is not a rescue medication. It works in the background to prevent flares over time, not to open your airways in a crisis. If you're having an acute asthma attack, use your rescue inhaler and seek emergency care if it doesn't improve. Always keep your fast-acting inhaler with you.
How long does it take to start working?
Measurable reductions in inflammation markers start appearing within about 2 weeks of your first injection. That said, the full benefit — like fewer asthma attacks or improved nasal polyp symptoms — tends to build gradually over months of regular treatment. Stick with it even if you don't notice dramatic changes right away.
Can I stop taking my other asthma medications once I start tezepelumab?
Not on your own — especially if you're on any steroid medications. Stopping steroids suddenly can cause serious withdrawal effects or allow other health issues to surface. If your doctor feels your other medications can be reduced, they'll guide a slow, careful taper. Tezepelumab is designed to work alongside your existing treatment, not replace it overnight.
What should I watch out for after my injection?
Most people tolerate it well, but allergic reactions can happen — sometimes within hours, sometimes a day or two later. Watch for signs like hives, swelling of the face or throat, trouble breathing, or dizziness. If any of those occur, get emergency help right away. Milder reactions like a rash or eye irritation should still be reported to your doctor.
Is it safe to get vaccinated while on tezepelumab?
Most vaccines are fine, but live vaccines — like the nasal spray flu vaccine or the MMR shot — should be avoided while you're on tezepelumab. If you're due for any vaccines, check with your doctor first so they can recommend the right type and timing.
What if I miss an injection?
Give yourself the missed dose as soon as you remember. Then just go back to your regular every-4-weeks schedule from there. If your next scheduled dose is already coming right up, take it as planned and don't double up. Missing one dose occasionally shouldn't be a major setback, but try to stay as consistent as possible for the best results.
Is Tezepelumab Injection available over the counter?
Tezepelumab Injection is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.

💬 Answers drafted from Tezepelumab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

📈 How widely Tezepelumab Injection is used

A general measure of how commonly Tezepelumab Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Tezepelumab Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

42,607
Medicaid prescriptions filled (Q1–Q4 2025)
$179.9M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Tezepelumab Injection prescribed? Of the 1,596 medications we measure, Tezepelumab Injection ranks #664 by Medicaid prescriptions — more than 58% of them.

Where Tezepelumab Injection ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Tezepelumab Injection product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 1.91 mL / 110 mg/mL auto-injector is the most-dispensed Tezepelumab Injection product — about 61% of these Medicaid prescriptions.

1.91 ML tezepelumab-ekko 110 MG/ML Auto-Injector Most dispensed

25,908 Medicaid prescriptions (Q1–Q4 2025) 61% of Tezepelumab Injection prescriptions shown $120.4M gross reimbursement (before rebates) ≈ $4,647 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2628920

1.91 ML tezepelumab-ekko 110 MG/ML Prefilled Syringe

16,699 Medicaid prescriptions (Q1–Q4 2025) 39% of Tezepelumab Injection prescriptions shown $59.5M gross reimbursement (before rebates) ≈ $3,565 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2587803

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Tezepelumab Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 5 listed Tezepelumab Injection NDCs with Medicaid activity.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Tezepelumab Injection RxCUI 2587789 2 dose forms · 2 strengths

Look up RxCUI 2587789 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Tezspire

RxNorm drug class

Tezepelumab Injection belongs to the Thymic Stromal Lymphopoietin Blocker class.

Pharmacologic class Thymic Stromal Lymphopoietin Blocker
Drug family (ATC) Other systemic drugs for obstructive airway diseases
How it works Thymic Stromal Lymphopoietin Blockers

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Oct 17, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Tezepelumab Injection.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Tezepelumab Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
2
Linked representative label
Amgen, Inc
Linked label effective
Oct 17, 2025
Composite sections available
21
Linked SPL Set ID
60f0aa03-ad25-4d48-80ce-7fcfa76f325f
Linked SPL Document ID
7aa761f9-01a0-48d3-a553-fa93fee5f243
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Amgen, Inc is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.