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

Injection: 80 mg/0.8 mL of donidalorsen as a sterile, clear, colorless to yellow solution in a single-dose autoinjector.

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

The following clinically significant adverse reactions are discussed elsewhere in the labeling:

Donidalorsen is a prekallikrein-directed antisense oligonucleotide (ASO) covalently linked to a ligand containing three

DAWNZERA contains donidalorsen sodium as the active ingredient. Donidalorsen sodium is a white to yellow solid and it is freely soluble in water and in sodium phosphate buffer. The molecular formula of donidalorsen sodium is C

The chemical structure of donidalorsen sodium is presented below:

DAWNZERA (donidalorsen) injection is a sterile, preservative‑free solution for subcutaneous injection supplied as a single-dose autoinjector. Each single‑dose autoinjector contains 80 mg of donidalorsen (equivalent to 84 mg donidalorsen sodium) in 0.8 mL of solution. The solution also contains disodium hydrogen phosphate; sodium chloride; sodium dihydrogen phosphate; water for injection; and may include hydrochloric acid and/or sodium hydroxide for pH adjustment between 6.9 to 7.9. Each dose of DAWNZERA injection contains 6 mg of phosphorous and 5 mg of sodium.

The efficacy of DAWNZERA for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older was evaluated in a 24‑week multicenter, randomized, double‑blind, placebo‑controlled trial (OASIS-HAE [

The trial (OASIS-HAE) included 90 adult and pediatric patients 12 years of age and older with Type I and Type II HAE, who had at least 2 investigator‑confirmed attacks during the 8‑week run‑in period. Patients were randomized to receive DAWNZERA 80 mg once every 4 weeks (n=45), DAWNZERA 80 mg once every 8 weeks (n=23), or matching placebo (n=22). Patients were required to discontinue other prophylactic HAE medications, except androgens and tranexamic acid, prior to entering the trial; all patients were allowed to use rescue medications for treatment of breakthrough HAE attacks.

The demographics and baseline characteristics of OASIS-HAE trial are provided in Table 3.

The primary endpoint for OASIS-HAE was the HAE attack rate (number of investigator-confirmed HAE attacks per 4 weeks) from Week 0 to Week 24. As shown in Table 4, DAWNZERA 80 mg administered subcutaneously every 4 or 8 weeks demonstrated statistically significant reductions in the HAE attack rate compared to placebo.

The mean decreases from baseline in the HAE attack rate observed throughout the treatment period in the DAWNZERA treatment groups are shown in Figure 1.

HAE = hereditary angioedema; q4wks = every 4 weeks; q8wks = every 8 weeks; SC = subcutaneous; SEM = standard error of the mean.

Pre-defined secondary endpoints were assessed from Week 4 to Week 24. The moderate or severe HAE attack rate was 0.12 for the DAWNZERA 80 mg every 4 weeks group, 0.68 for the DAWNZERA 80 mg every 8 weeks group, and 1.15 for the placebo group, representing a reduction of 89% (95% CI: 66, 97) and 41% (95% CI: -26, 72) in moderate or severe HAE attack rate relative to placebo, respectively. The HAE attacks requiring acute therapy was 0.15 for the DAWNZERA 80 mg every 4 weeks group, 0.59 for the DAWNZERA 80 mg every 8 weeks group, and 1.80 for the placebo group, representing a reduction of 92% (95% CI: 77, 97) and 67% (95% CI: 29, 85) in HAE attacks requiring acute therapy relative to placebo, respectively.

The proportion of patients who were attack-free from Week 4 to Week 24 were 53% in the DAWNZERA 80 mg every 4 weeks group, 35% in the DAWNZERA 80 mg every 8 weeks group, and 9% in the placebo group, representing an odds ratio of being attack-free of 11.79 (95% CI: 2.34, 59.36) and 3.23 (95% CI: 0.46, 22.85), respectively.

The proportion of patients with a ≥50%, ≥70%, and ≥90% reduction from baseline to Week 4 through Week 24 was 93%, 82%, and 62% in the DAWNZERA 80 mg every 4 weeks group, 83%, 65%, and 48% in the DAWNZERA 80 mg every 8 weeks group, and 27%, 18%, and 9% in the placebo group, respectively.

DAWNZERA (donidalorsen) 80 mg/0.8 mL injection is a sterile, preservative‑free, clear, colorless to yellow solution supplied in a single‑dose autoinjector. Each autoinjector of DAWNZERA is filled to deliver 0.8 mL of solution containing 80 mg of donidalorsen. Table 5 provides the presentation and strength for DAWNZERA.

Advise the patient to read the FDA‑approved patient labeling (Patient Information and Instructions for Use).

Instruct patients to use DAWNZERA as prescribed. If a dose is missed, instruct patients to administer DAWNZERA as soon as they remember. Instruct patients to resume treatment at the recommended dosing frequency (every 4 weeks or every 8 weeks) from the date of the most recently administered dose

Advise patients hypersensitivity reactions, including anaphylaxis, have been reported following administration of DAWNZERA. Instruct patients to immediately discontinue DAWNZERA and seek medical attention if they experience signs and symptoms of serious hypersensitivity reaction

DAWNZERA is a trademark of Ionis Pharmaceuticals Inc. All other trademarks are the property of their respective owners.

©2025 Ionis Pharmaceuticals Inc.

This Instructions for Use has been approved by the U.S. Food and Drug Administration                                                          Approved: 08/2025

This Patient Information has been approved by the U.S. Food and Drug Administration                                                              Issued: 08/2025

(donidalorsen) 80mg/0.8mL

                                                                                            1 single-dose autoinjector

Each Dawnzera autoinjector contains 80 mg donidalorsen (equivalent to 84 mg donidalorsen