Established long-term safety over 1 year in clinical trials1

The safety of DAWNZERA reflects an average duration of exposure of 14 months in 171 adult and pediatric patients aged ≥12 across 3 clinical trials.2

Adverse reactions (≥5% with DAWNZERA and more common than placebo) in OASIS-HAE at Week 242

Adverse reaction,  n (%)

DAWNZERA 

 Q4W (n=45)

DAWNZERA 

 Q8W (n=23)

Placebo 

 (n=22)

Injection-site reactions*11 (24)1 (4)1 (5)
Upper respiratory tract infection4 (9)2 (9)1 (5)
Urinary tract infection4 (9)2 (9)0
Abdominal discomfort3 (7)00

*Injection-site reactions: erythema, discoloration, pain, pruritus, induration, bruising, hematoma, hypersensitivity, swelling, reaction, and urticaria.2

Pivotal trial

  • All injection-site reactions were mild and nonserious, and the majority resolved without receiving any treatment2
    • Erythema was the most common injection-site reaction3

Open-label extension at Week 521

  • No new safety signals were observed
  • The most common TEAEs (>10%) across both treatment arms were influenza, nasopharyngitis, back pain, headache, upper respiratory tract infection, and COVID-19
  • Two patients discontinued the trial due to TEAE†

†One patient experienced chest tightness, dyspnea, and back pain; the other patient experienced a 30-day persistence of alanine aminotransferase levels at >5 times the upper limit of normal with normal blood bilirubin concentration that resolved after treatment discontinuation.1

The majority of adverse reactions with DAWNZERA were mild to moderate1,3 

TEAE=treatment-emergent adverse event; Q4W=every 4 weeks; Q8W=every 8 weeks.

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IMPORTANT SAFETY INFORMATION & INDICATION

CONTRAINDICATIONS

DAWNZERA is contraindicated in patients with a history of serious hypersensitivity reactions, including anaphylaxis, to donidalorsen or any of the excipients in DAWNZERA.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis, have been reported in patients treated with DAWNZERA. If signs and symptoms of serious hypersensitivity reactions occur, discontinue DAWNZERA and institute appropriate therapy.

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥ 5%) are injection site reactions, upper respiratory tract infection, urinary tract infection, and abdominal discomfort.

INDICATION

DAWNZERA (donidalorsen) is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older.

Please see full Prescribing Information for DAWNZERA.

References: 1. Lumry WR, Tachdjian R, Craig T, et al. Donidalorsen for long-term prophylaxis of hereditary angioedema attacks: results from the OASISplus open-label extension cohort at year 1. J Asthma Allergy. 2026;19:592079. doi:10.2147/JAA.S592079 2. DAWNZERA. Prescribing information. Ionis Pharmaceuticals. 3. Riedl MA, Tachdjian R, Lumry WR, et al. Efficacy and safety of donidalorsen for hereditary angioedema. N Engl J Med. 2024;391(1):21-31. doi:10.1056/NEJMoa2402478