Dawnzera
- Prescription status not stated
- Blood, clotting and anaemia
- Active substance
- Donidalorsen
- Used in
- Blood, clotting and anaemia
- Made by
- Otsuka Pharmaceutical Netherlands B.V.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- Dawnzera is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older.
From the official label · 2026-09-30 · European Medicines Agency
How it works
From the US prescribing label for the same active substance (DAWNZERA). It describes the substance, not this exact product.
Donidalorsen is an ASO‑GalNAc conjugate that causes ribonuclease H1 (RNase H1)‑mediated degradation of PKK mRNA through binding to PKK mRNA, which results in reduced production of PKK protein.
PKK is a pro‑enzyme for plasma kallikrein, which results in the release of bradykinin, a potent vasodilator causing swelling and pain in HAE.
The oligonucleotide moiety of donidalorsen is expected to be metabolized by endo‑ and exonucleases to short oligonucleotide fragments of varying sizes within the liver.
The mean fraction of unchanged ASO eliminated in urine was less than 1% of the administered dose in healthy subjects within 24 hours post-dose.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-09-24
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
SpainNo exact match for this strength and form
Details
| Made by | Otsuka Pharmaceutical Netherlands B.V. |
|---|---|
| Active substance | Donidalorsen |
| Used in | Blood, clotting and anaemia |
| Classification | B06AC · Blood, clotting and anaemia |
| Additional monitoring ▼ | Yes — under additional monitoring (black triangle). Report suspected side effects. |
| Authorised on | 2026-01-19 |
| Last updated by the regulator | 2026-02-20 |
| EMA product number | EMEA/H/C/006554 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).