Tezepelumab

Tezepelumab (Tezspire) is used in adults and adolescents 12 years and older for the maintenance treatment of severe asthma in those whose asthma is not controlled with their current asthma medicine or for inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP), as add-on maintenance treatment. Tezspire injection is self-administered under the skin every 4 weeks and is used in addition to other treatments.

Tezepelumab is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody IgG2λ. It is the only biologic approved for severe asthma with no phenotype (ie, eosinophilic or allergic) or biomarker limitation within its approved label. It can help prevent severe asthma attacks and improve breathing, but is not a rescue medication and will not relieve acute bronchospasm or status asthmatics.

Tezepelumab is a monoclonal antibody that blocks thymic stromal lymphopoietin (TSLP), a cytokine released early in inflammatory cascades by airway epithelial cells. Elevated TSLP levels are found in asthmatic airways and nasal polyp tissue. By binding TSLP and preventing its receptor interaction, tezepelumab reduces inflammatory biomarkers, including blood eosinophils, IgE, FeNO, IL-5, and IL-13, thereby decreasing airway and mucosal inflammation in asthma and chronic rhinosinusitis with nasal polyps, although the exact mechanism remains not definitively established.

Tezepelumab gained FDA approval on December 17, 2021, under the brand name Tezspire. There is no Tezspire generic or biosimilar. The full biological name of tezepelumab is tezepelumab-ekko.

You should not receive tezepelumab if you are allergic to tezepelumab or any of the other ingredients. See the end of this page for a complete list of ingredients.

There is no available data on the use of tezepelumab injection during pregnancy, but it is known placental transfer of monoclonal antibodies, such as tezepelumab, is greater during the third trimester of pregnancy. Consider risks versus benefits, including disease-associated maternal and/or embryo/fetal risk in women with poorly or moderately controlled asthma (such as increased risk of preeclampsia, prematurity, low birth weight, and small for gestational age in the neonate) or with CRSwNP.

There is no information regarding the presence of tezepelumab in human milk, its effects on the breastfed infant, or its effects on milk production.

Before you receive tezepelumab, tell your healthcare provider about all of your medical conditions, including if you:

• have ever had a severe allergic reaction (hypersensitivity) to tezepelumab, Tezspire, or any of the inactive ingredients in the Tezspire injection
• have a parasitic (helminth) infection
• have recently received or are scheduled to receive any live attenuated vaccinations. People who receive tezepelumab should not receive live attenuated vaccines
• are pregnant, think you may be pregnant, or plan to become pregnant. It is not known if tezepelumab may harm your unborn baby
• are breastfeeding or plan to breastfeed. It is not known if tezepelumab passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive tezepelumab.

The most common side effects of tezepelumab are:

• sore throat (pharyngitis)
• joint pain (arthralgia)
• back pain.

Weight gain has not been reported as a side effect of tezepelumab.

Serious side effects and warnings

Tezepelumab injection may cause allergic reactions, such as a rash and allergic conjunctivitis. Severe reactions, including anaphylaxis, have also been reported. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of an allergic reaction:

• rash
• hives
• breathing problems
• red, itchy, swollen, or inflamed eyes.

Abrupt reductions in corticosteroid dosage may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy. Your healthcare provider will taper off your corticosteroid dose gradually, if appropriate.

The cytokine TSLP, involved with tezepelumab's mechanism of action, may be involved in the immunological response to some helminth (worm and parasitic) infections. If you have a worm or parasite infection, it should be treated before starting treatment with tezepelumab. If you develop a worm or parasite infection during treatment that does not respond, your healthcare provider may temporarily discontinue your tezepelumab injection until the infection resolves.

You should avoid receiving a live attenuated vaccine (such as a measles, chickenpox, or rotavirus vaccine) while you are receiving tezepelumab injections.

Tell your healthcare provider if your asthma or CRSwNP does not get better or if it gets worse after you start treatment with tezepelumab.

It is not known if this medicine is safe and effective in children under 12 years of age.

See What are 5 key Tezspire side effects to watch out for? for more detailed information.

These are not all of the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tezepelumab injection is available as a vial, a pre-filled syringe, and a prefilled pen. Each contains a single dose of tezepelumab.

• The vial and pre-filled syringe are intended for administration by a healthcare provider. This will take place in their clinic or other suitable location.
• Tezepelumab pre-filled pens can be administered by patients, their caregivers, or by a healthcare provider. Proper training in the subcutaneous (under the skin) administration technique will be given to you by your healthcare provider if you wish to self-administer tezepelumab or have your caregiver give it to you.

The usual dosage of tezepelumab is 210mg (one vial/syringe/pen) administered under your skin (subcutaneously) once every 4 weeks.

Each tezepelumab pre-filled pen contains 1 dose that can only be used 1 time. It can only be given as an injection under the skin (subcutaneous).

To use the tezepelumab pen:

• Take it out of the refrigerator, and leave it in the carton and allow it to come to room temperature between 68°F to 77˚F (20°C to 25°C) for about 60 minutes before giving the injection. Do not remove the cap just yet.
• Do not warm the pre-filled pen in any other way. For example, do not warm it in a microwave or hot water, in direct sunlight, or near other heat sources.
• Do not put the injection back in the refrigerator after it has reached room temperature. Throw away (dispose of) tezepelumab that has been stored at room temperature for more than 30 days.
• Check the pen for damage and check the expiry date. Do not use it if there is damage, the expiry date has passed, or if the solution looks cloudy, discolored, or contains large particles. The liquid should be clear and colorless to light yellow. Small air bubbles in the liquid are normal.
• Choose an injection site. If you are giving yourself the injection, the recommended site is the front of your thigh or the lower part of your stomach (abdomen). Do not inject yourself in the arm.
• A caregiver may inject you in the upper arm, thigh, or abdomen.
• For each injection, choose a different site that is at least 1 inch (3 cm) away from where you last injected.
• Do not inject: into the 2-inch (5 cm) area around your belly button where the skin is tender, bruised, scaly or hard into scars or damaged skin through clothing.
• Wash your hands well with soap and water and clean the injection site with an alcohol wipe. Let it air dry.
• Pull off the cap. You should see an orange needle guard. This is there to prevent you from touching the needle. Do not touch the needle or push on the orange needle guard with your finger.
• Follow your healthcare provider’s instructions on how to inject. You can either gently pinch the skin at the injection site or give the injection without pinching the skin.
• Inject tezepelumab by holding it straight up and down (at a 90-degree angle) to your skin. Press down firmly so you cannot see the needle guard. You will hear the first click that tells you the injection has started. Press and hold the pre-filled pen for 15 seconds until you hear the second click.
• Do not change the position of the pre-filled pen after the injection has started.
• Once you have completed the injection, lift the pen straight up. The orange plunger should fill the viewing window. If it does not, contact your healthcare provider because you may not have received a full dose.
• Cover the injection site with a small bandage if needed. Do not rub the injection site. Dispose of the used pen in an FDA-approved sharps container.

See How do I use the Tezspire Pen? for more detailed information.

If you miss an appointment, ask your healthcare provider when to schedule your next treatment.

If you are self-administering tezepelumab and you miss a dose, inject the dose as soon as you can. Ring your healthcare provider for more information.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not change or stop your corticosteroid medicines or other medicines unless your healthcare provider tells you to.

No formal drug interaction studies have been performed with tezepelumab. Refer to the product information for any updates.

Store tezepelumab in a refrigerator between 36°F to 46°F (2°C to 8°C) in its original carton to protect it from light until you are ready to use it.

It 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 return to the refrigerator, instead, discard it if it has not been used within this time.

Do not use your tezepelumab pre-filled pen if:

• It has been frozen
• It has been dropped or damaged
• The security seal on the carton has been broken
• The expiration date (EXP) has passed.

Do not:

• Freeze your pre-filled pen or expose it to heat
• Shake your pre-filled pen
• Share, or use your pre-filled pen more than 1 time

If any of the above happen, throw away the pre-filled pen in a puncture-resistant (sharps) container and use a new pre-filled pen.

Keep the tezepelumab pre-filled pen and all medicines out of the sight and reach of children

Amgen Inc. and AstraZeneca make tezepelumab under the brand name Tezspire.

Tezepelumab is only available as the brand Tezspire.

Active ingredient: tezepelumab-ekko. 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.

Inactive ingredients: glacial acetic acid, L-proline, polysorbate 80, sodium hydroxide, and water for injection