eplontersen
Wainzua · ATC code N07XX21
- Key facts
- Active substance
- eplontersen
- ATC code
- N07XX21
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Wainzua 45 mg solution for injection in pre-filled pen
- Marketing authorisation holder
- AstraZeneca AB
- Information as of
- 2026-10-29
Key facts
Eplontersen is an antisense oligonucleotide that lowers transthyretin production. It is used in adults with hereditary transthyretin-mediated amyloidosis (ATTRv) with stage 1 or 2 polyneuropathy.
What it is used for
- Treatment of hereditary transthyretin-mediated amyloidosis (ATTRv) in adults with stage 1 or stage 2 polyneuropathy (Wainzua).
Dosing
- Wainzua 45 mg pre-filled pen: 45 mg subcutaneously once monthly; start as early as possible after symptom onset.
- Vitamin A supplementation of approximately, but not exceeding, 2,500 IU to 3,000 IU per day is advised.
- Missed dose: give as soon as possible, then resume monthly from that date; no double dose.
- No dose adjustment in the elderly, mild to moderate renal impairment (eGFR ≥ 45 to < 90 mL/min/1.73 m2) or mild hepatic impairment; not studied with eGFR < 45, end-stage renal disease or moderate/severe hepatic impairment - use only if benefit outweighs risk.
- The first self-injection is done under the guidance of a healthcare professional. Continuing treatment after progression to stage 3 is a physician's decision.
Contraindications
- Hypersensitivity to the active substance or any of the excipients.
Important warnings
- Lowers serum vitamin A below normal: correct deficiency before starting and supplement vitamin A; refer for eye assessment if ocular symptoms (e.g. night blindness, dry eyes) develop.
- In the first 60 days of pregnancy, both too high and too low vitamin A levels may increase the risk of malformation; exclude pregnancy before starting and use effective contraception.
- If pregnancy is planned, stop Wainzua and vitamin A; vitamin A levels should have returned to normal before conception.
Side effects
- Very common: vitamin A decreased (97% of patients).
- Common: vomiting (9%), injection site erythema, pain and pruritus.
Interactions
- No interaction studies; in vitro it is not a substrate or inhibitor of transporters and not an inhibitor or inducer of CYP enzymes.
Pregnancy and breastfeeding
- Vitamin A reduction poses a risk to foetal development; exclude pregnancy before starting and use effective contraception. Vitamin A levels may remain reduced for more than 15 weeks after the last dose.
- See the full text for further pregnancy and breast-feeding information.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- WainzuaAstraZeneca AB · EMEA/H/C/006295
Source: European Medicines Agency (EMA), product information
Turkey
- VeynuaASTRAZENECA İLAÇ SAN. VE TİC. LTD. ŞTİ. · 1 register entry
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 3 more European countries
- Iceland
- Wainzua
- Liechtenstein
- Wainzua
- Norway
- Wainzua
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Wainzua – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/wainzua-epar-product-information_en.pdf
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.