Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Otsuka Pharmaceutical Netherlands B.V., Herikerbergweg 292, 1101 CT Amsterdam, Netherlands
Dawnzera 80 mg solution for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Clear, colourless to yellow solution with a pH of approximately 7.4 and osmolality of approximately 290 mOsm/kg. |
Each pre-filled pen contains 80 mg donidalorsen (as donidalorsen sodium) in 0.8 mL of solution.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Donidalorsen is a 2'-O-methoxyethyl–modified antisense oligonucleotide (ASO) conjugated to a triantennary N-acetylgalactosamine (GalNAc3) moiety that causes ribonuclease H1 (RNase H1) mediated degradation of prekallikrein (PKK) mRNA through selective 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 inflammation and swelling in hereditary angioedema (HAE). |
| List of Excipients |
|---|
|
Sodium dihydrogen phosphate (E339) |
0.8 mL sterile solution in a single-use Type I glass syringe with a stainless steel staked needle, rigid needle shield, and siliconised chlorobutyl elastomer plunger stopper. The filled primary container and a pen are assembled to a pre-filled pen, which is labelled and packaged in an opaque carton with a partition to secure the pre-filled pen and protect from light.
Pack size of one pre-filled pen.
Pack size of three pre-filled pens.
Not all pack sizes may be marketed.
Otsuka Pharmaceutical Netherlands B.V., Herikerbergweg 292, 1101 CT Amsterdam, Netherlands
EU/1/25/2001/001
EU/1/25/2001/002
| Drug | Countries | |
|---|---|---|
| DAWNZERA | Austria, Estonia, Lithuania, United States |
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