Wainua.ca | Safety and Tolerability Profile

WAINUA^®

WAINUA was generally well tolerated in NEURO-TTRansform, with a discontinuation rate of 5.6% vs. 3.3% in the external placebo group over 65 weeks

Adverse reactions reported in ≥5% of patients treated with WAINUA
up to Week 85

Vision blurred	6
	WAINUA N=144 (%)
Eye Disorders
Cataract	6
Gastrointestinal Disorders
Vomiting	9
General Disorders and Administration Site Conditions
Injection site reactions*	6
Metabolism and Nutrition Disorders
Vitamin A deficiency	12
Renal and Urinary Disorders
Proteinuria	8

Adapted from the WAINUA Product Monograph.

* Includes injection site erythema and injection site pruritus.

Demonstrated safety and tolerability profile based on WAINUA exposure in 144 patients with hATTR-PN who were randomized to WAINUA and received ≥1 dose of WAINUA for up to 85 weeks.

141 patients received ≥6 months of treatment and 137 patients received ≥12 months of treatment.
The mean duration of treatment was 541 days (range: 57 to 582 days).

SAEs occurred in 18.8% of patients treated with WAINUA for up to 85 weeks. The most common SAEs (≥1%) were vomiting (3.5%), nausea (1.4%), urinary tract infection (1.4%), and syncope (1.4%).
The most frequent causally related adverse reaction with WAINUA during treatment was reduced serum vitamin A levels.

See NEURO-TTRansform trial design

hATTR-PN: hereditary transthyretin-mediated amyloidosis with polyneuropathy; SAEs: serious adverse events.

Reference: WAINUA® Product Monograph. AstraZeneca Canada Inc. August 26, 2025.

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WAINUA®

Safety & Tolerability Profile

WAINUA was generally well tolerated in NEURO-TTRansform, with a discontinuation rate of 5.6% vs. 3.3% in the external placebo group over 65 weeks

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