SAFETY
WAINUA was generally well tolerated1
Results from the NEURO-TTRansform trial
Vitamin A warning: Treatment with WAINUA leads to a decrease in serum vitamin A levels. Patients should supplement with the recommended daily allowance of vitamin A while taking WAINUA.*†1
*Refer patients to an ophthalmologist if ocular symptoms suggestive of vitamin A deficiency occur.1
†Higher doses than the recommended daily allowance of vitamin A should not be given to try to achieve normal serum vitamin A levels during treatment with WAINUA, as serum vitamin A levels do not reflect the total vitamin A in the body.1
ADVERSE REACTIONS IN ≥5% OF PATIENTS TREATED WITH WAINUA1
| Adverse reaction | WAINUA (N=144) |
|---|---|
| Vitamin A decreased‡ | 15% |
| Vomiting | 9% |
| Proteinuria | 8% |
| Injection-site reactions§ | 7% |
| Blurred vision | 6% |
| Cataract | 6% |
‡Vitamin A decreased includes vitamin A deficiency and vitamin A decrease.1
§Injection-site reactions include erythema, pain, and pruritus.1
- Three serious adverse reactions of AV heart block (2%) occurred in WAINUA-treated patients, including 1 case of complete AV block1
- Safety and tolerability profile of WAINUA was consistent at Weeks 66 and 852
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FOOTNOTE
AV, atrioventricular.
REFERENCES
- 1. WAINUA® (eplontersen) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2025.
- 2. Coelho T, Marques W Jr, Dasgupta NR, et al. Eplontersen for hereditary transthyretin amyloidosis with polyneuropathy [article and supplementary online content]. JAMA.
2023;330(15):1448-1458.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
- Reduced Serum Vitamin A Levels and Recommended Supplementation WAINUA leads to a decrease in serum vitamin A levels. Supplement with recommended daily allowance of vitamin A. Refer patient to an ophthalmologist if ocular symptoms suggestive of vitamin A deficiency occur.
ADVERSE REACTIONS
Most common adverse reactions (≥9% in WAINUA-treated patients) were vitamin A decreased (15%) and vomiting (9%).
INDICATION
WAINUA injection, for subcutaneous use, 45 mg is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
