Tezepelumab

What is Tezepelumab?

• Tezepelumab (Tezspire) is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody (IgG2λ), used for the treatment of adult and pediatric patients aged 12 years and older with severe asthma.

Structural_basis_for_inhibition_of_TSLP-signaling_by_Tezepelumab

What are the uses of this medicine?

• Tezepelumab (Tezspire) is a medicine used with other asthma medicines 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.
• Tezspire helps prevent severe asthma attacks (exacerbations) and can improve your breathing.

Limitations of use:

• Tezspire is not used to treat sudden breathing problems.
• Not for relief of acute bronchospasm or status asthmaticus.

How does this medicine work?

• Tezepelumab-ekko is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody IgG2λ that binds to human TSLP and blocks its interaction with the heterodimeric TSLP receptor.
• TSLP is a cytokine mainly derived from epithelial cells and occupies an upstream position in the asthma inflammatory cascade.
• Airway inflammation is an important component in the pathogenesis of asthma.
• Multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes, ILC2 cells) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) are involved in airway inflammation.
• Blocking TSLP with tezepelumab-ekko reduces biomarkers and cytokines associated with inflammation including blood eosinophils, airway submucosal eosinophils, IgE, FeNO, IL-5, and IL-13.
• The mechanism of tezepelumab-ekko action in asthma has not been definitively established.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to tezepelumab or any of the ingredients in Tezspire.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been performed with Tezspire.

Is this medicine FDA approved?

• It was approved for medical use in the United States in December 2021.

How should this medicine be used?

Recommended dosage:

• The recommended dosage of Tezspire is 210 mg administered subcutaneously once every 4 weeks.

Administration:

• Your healthcare provider will give you Tezspire in a healthcare setting.
• Tezspire is injected under your skin (subcutaneously) 1 time every 4 weeks.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Injection:

• 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.

This medicine is available in fallowing brand namesː

• Tezspire

What side effects can this medication cause?

The most common side effects of this medicine include:

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

Tezspire may cause serious side effects, including:

• severe allergic reactions

What special precautions should I follow?

• Hypersensitivity reactions (e.g., rash, allergic conjunctivitis) can occur after administration of Tezspire. Initiate appropriate treatment as clinically indicated in the event of a hypersensitivity reaction.
• 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.
• Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with Tezspire. Decrease corticosteroids gradually, if appropriate.
• Thymic stromal lymphopoietin (TSLP) may be involved in the immunological response to some helminth infections. 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.
• 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.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no available data on Tezspire use in pregnant women to evaluate for any drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
• It is not known if Tezspire may harm your unborn baby.

Can this medicine be used in children?

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

What are the active and inactive ingredients in this medicine?

• Active ingredient: tezepelumab-ekko
• Inactive ingredients: glacial acetic acid, L-proline, polysorbate 80, sodium hydroxide, and water for injection

Who manufactures and distributes this medicine?

Manufactured by:

• AstraZeneca AB, Sodertalje, Sweden SE-15185

Manufactured at:

• Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA

Marketed by: Amgen Inc. and AstraZeneca AB AstraZeneca and Amgen 2021

• Tezspire is a trademark of Amgen Inc.

What should I know about storage and disposal of this medication?

• Store refrigerated between 36°F to 46°F (2°C to 8°C).
• If necessary, Tezspire 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 put back in the refrigerator once Tezspire has reached room temperature.
• 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.
• Do not freeze.
• Do not shake.
• Do not expose to heat.

• Dailymed label info on Tezepelumab
• FDA Tezepelumab

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