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Safety and tolerability established in clinical trials

FPO
Average 14 months of DAWNZERA exposure1
The safety of DAWNZERA reflects exposure in 171 adult and pediatric patients aged ≥12 across 3 clinical trials1
Adverse reactions (≥5% with DAWNZERA and more common than placebo) in OASIS-HAE at Week 241
Adverse reaction, n (%)
Injection-site reactions*
Upper respiratory tract infection
Urinary tract infection
Abdominal discomfort
DAWNZERA
every 4 weeks (n=45)
11 (24)
4 (9)
4 (9)
3 (7)
DAWNZERA
every 8 weeks (n=23)
1 (4)
2 (9)
2 (9)
0
Placebo
(n=22)
1 (5)
1 (5)
0
0
DAWNZERA
every 4
weeks
(n=45)
DAWNZERA
every 8
weeks
(n=23)
Placebo
(n=22)
Adverse reaction,   n (%)
Injection-site reactions*
11 (24)
1 (4)
1 (5)
Upper respiratory tract infection
4 (9)
2 (9)
1 (5)
Urinary tract infection
4 (9)
2 (9)
0
Abdominal discomfort
3 (7)
0
0
*Injection-site reactions: erythema, discoloration, pain, pruritus, induration, bruising, hematoma, hypersensitivity, swelling, reaction, and urticaria.1
•

All injection-site reactions were mild, nonserious, and the majority resolved without receiving any treatment1

— Erythema was the most common injection-site reaction2
In clinical trials, hypersensitivity reactions, including anaphylaxis, have occurred. Symptoms included generalized rash, dyspnea, chest pain, and
peri-oral swelling.1

The majority of adverse reactions with DAWNZERA were mild, nonserious2

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. DAWNZERA. Prescribing information. Ionis Pharmaceuticals. 2. Riedl MA, Tachdjian R, Lumry WR, et al. Efficacy and safety of donidalorsen for hereditary angioedema. N Engl J Med. 2024 Jul 4;391(1):21-31. doi:10.1056/NEJMoa2402478