tezspire
Tezspire (Tezepelumab-Ekko) is a medication used to treat Asthma.
Tezepelumab-Ekko · by Astrazeneca Ab
Key facts
- Active ingredient
- Tezepelumab-Ekko
- Form
- Injectable
- Strength
- TEZEPELUMAB-EKKO 210MG/1.91ML(110MG/ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- asthma
- Manufacturer
- Astrazeneca Ab
- FDA application
- BLA761224
What is Tezspire?
From the FDA label: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.
How to use
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…
Side effects
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…
Warnings
Important safety information
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. 5.2 Acute Asthma Symptoms or Deteriorating Disease TEZSPIRE should not be used to treat acute asthma symptoms or acute exacerbations. Do not use TEZSPIRE to treat acute bronchospasm or status asthmaticus. Patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with TEZSPIRE. 5.3 Risk Associated with 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. 5.4 Parasitic (Helminth) Infection Thymic stromal lymphopoietin (TSLP) may be involved in the immunological response to some helminth infections. Patients with known helminth infections were excluded from participation in clinical trials. 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 treatment with TEZSPIRE and do not respond to anti-helminth treatment, discontinue treatment with TEZSPIRE until infection resolves. 5.5 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.
Who should not take Tezspire
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. ( 4 )
Interactions
No formal drug interaction studies have been performed with TEZSPIRE.
Storing Tezspire, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “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.”
- “and Disposal Advise patients to refrigerate TEZSPIRE at 36°F to 46°F (2°C to 8°C).”
May treat (source: NIH RxClass)
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
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Request a 90-day supply
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Use copay cards
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Frequently asked questions
- What does Tezspire treat?
- Tezspire (Tezepelumab-Ekko) may be used to treat asthma, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Tezspire?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Tezspire. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Tezspire?
- Tezspire is marketed by Astrazeneca Ab. You can see Astrazeneca Ab's full profile, rating, and other products on pharmaranks.
- Is Tezspire a brand-name or generic drug?
- Tezspire is a brand-name product with the active ingredient Tezepelumab-Ekko.
- Is Tezspire available over the counter?
- No. Tezspire is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Tezspire come in?
- Tezspire is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Tezspire FDA-registered?
- Tezspire is on record with the U.S. FDA under application number BLA761224. You can verify this on its official FDA label.
- Is Tezspire safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Tezspire. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Tezspire?
- Tezspire's side effects are taken directly from its FDA label. From the label: 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.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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