TEZSPIRE (Tezepelumab-ekko)

What is this medication?

Tezspire (Tezepelumab-ekko) is an add-on, injectable treatment that can be self-administered under the skin every 4 weeks for the maintenance treatment of severe asthma in people 12 years of age and older, whose asthma is not controlled with their current asthma medicine. It can help prevent severe asthma attacks and improve breathing but is not a rescue medication and will not relieve acute bronchospasm or status asthmaticus.

Airway inflammation is a significant component of Asthma. When you encounter a trigger, your lungs release multiple substances, including thymic stromal lymphopoietin (TSLP), a cytokine expressed mainly by epithelial cells, that is one of the first substances to be released. Tezspire blocks the action of TSLP, which reduces inflammation and prevents asthma attacks, although the exact way Tezspire works in asthma is not known.

Tezspire 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.

Tezspire was FDA approved on December 17, 2021.

How should I use this medication?

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

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.

Tezspire 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 Tezspire or have your caregiver give it to you.

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

Each Tezspire 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 Tezspire 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) Tezspire 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 Tezspire 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.

What if I miss a dose?

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

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

How should I store this medication?

Store Tezspire 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 Tezspire 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 happens, throw away the pre-filled pen in a puncture-resistant (sharps) container and use a new pre-filled pen.

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

What are the possible side effects of using this medication?

Tezspire may cause serious side effects, including:

- severe allergic reactions. 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.

The most common side effects occurring in more than 3% of people include:

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

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.

What other drugs will affect Tezspire?

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 asthma medicines unless your healthcare provider tells you to.

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