TEZSPIRE® (tezepelumab injection) Safety Information

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Tezspire
Safety Information

TEZSPIRE^®adverse reactions

TEZSPIRE^®was generally well tolerated¹

The most commonly reported adverse reactions during treatment were arthralgia and pharyngitis.

Adverse reactions with TEZSPIRE^® with incidence ≥ 1% and more common than placebo from the pooled safety population from PATHWAY and NAVIGATOR¹

Reaction	TEZSPIRE^®N=665 n (%)	PlaceboN=669 n (%)
General disorders and administration site conditions
Injection site reaction	25 (3.8)	21 (3.1)
Infections and infestations
Pharyngitis*	27 (4.1)	18 (2.7)
Musculoskeletal and connective tissue disorders
Arthralgia	25 (3.8)	16 (2.4)
Skin and subcutaneous tissue disorders
Rash^†	10 (1.5)	8 (1.2)
Nervous system disorders
Headache	9 (1.4)	5 (0.7)

* Pharyngitis (including Pharyngitis, Pharyngitis bacterial, Pharyngitis streptococcal and Viral pharyngitis).

† Rash (including Rash, Rash pruritic, Rash erythematous, Rash maculopapular, Rash macular).

Please refer to the Product Monograph for complete safety information.

Important Safety Information

Clinical use:

The safety and efficacy of TEZSPIRE^® in children < 12 years old have not been established. Sensitivity of some older individuals (≥ 65 years of age) cannot be excluded.

Relevant warnings and precautions:

TEZSPIRE^® should not be used to treat acute symptoms or asthma exacerbations
Reduction of corticosteroid dosage: abrupt discontinuation of corticosteroids after TEZSPIRE^® initiation is not recommended
Risk of serious cardiac events
Parasitic (Helminth) infection: If patients do not respond to anti-helminth treatment, discontinue therapy with TEZSPIRE^® until infection resolves
Blocking thymic stromal lymphopoietin may increase the risk of serious infections. Patients with  pre-existing serious infections should be treated before starting TEZSPIRE^® . If patients develop a  serious infection while receiving TEZSPIRE^® and do not respond to treatment, therapy with TEZSPIRE^® should be discontinued until the serious infection resolves.
Pregnancy
Hypersensitivity reactions
Immune system disorders: anaphylaxis

For more information:

Please consult the TEZSPIRE^® Product Monograph at www.astrazeneca.ca/content/dam/az-ca/downloads/productinformation/tezspire-product-monograph-en.pdf for important information relating to adverse reactions, drug interactions, and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling AstraZeneca Canada Inc. at 1-800-668-6000.

Reference:

1. AstraZeneca Canada Inc. TEZSPIRE^® Product Monograph. 2024.

Important safety information

TEZSPIRE® Safety Profile

TEZSPIRE^® Safety Profile