FDA

Dawnzera (Autoinjector)

Approved 21 Aug 2025SubcutaneousSolution

Indications

DAWNZERA™ is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older. DAWNZERA is a prekallikrein directed antisense oligonucleotide indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older. ( 1 )

Contraindications

DAWNZERA is contraindicated in patients with a history of serious hypersensitivity reactions, including anaphylaxis, to donidalorsen or any of the excipients in DAWNZERA [see Warnings and Precautions (5.1) and Adverse Reactions (6) ] . History of serious hypersensitivity reactions, including anaphylaxis, to donidalorsen or any of the excipients in DAWNZERA.

Warnings and precautions

Hypersensitivity reactions including anaphylaxis have been reported following use of DAWNZERA. Advise patients to discontinue DAWNZERA and seek immediate medical attention if serious hypersensitivity reactions occur. ( 5.1 )

5.1Risk of Hypersensitivity Reactions, Including Anaphylaxis

Hypersensitivity reactions, including anaphylaxis, have been reported in patients treated with DAWNZERA [see Adverse Reactions (6.1) ] . If signs and symptoms of serious hypersensitivity reactions occur, discontinue DAWNZERA and institute appropriate therapy.

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

There are no available data on DAWNZERA use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, subcutaneous administration of donidalorsen or a pharmacologically active mouse‑specific surrogate in a combined fertility and embryo‑fetal development study in mice and a pre‑ and postnatal development study in mice with F0 parental doses up to 5 times the maximum recommended human dose (MRHD, 80 mg) on a body surface area (BSA, mg/m 2 ) basis did not result in any adverse effects on embryofetal development, or behavioral, fertility, and reproductive development in the F1 offspring.

At a glance

Brand name: Dawnzera (Autoinjector)
Active substance: donidalorsen sodium
Route: Subcutaneous
Dosage form: Solution
Applicant: Ionis Pharms Inc
Status: Prescription
FDA approval: 21 Aug 2025
Application: NDA219407-001

Indications

Contraindications

Warnings and precautions

5.1Risk of Hypersensitivity Reactions, Including Anaphylaxis

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

The following clinically significant adverse reactions are discussed elsewhere in the labeling: Risk of Hypersensitivity Reactions, Including Anaphylaxis [see Warnings and Precautions (5.1) ] Most common adverse reactions (incidence ≥ 5%) are injection site reactions, upper respiratory tract infection, urinary tract infection, and abdominal discomfort. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ionis Pharmaceuticals at 1-833-644-6647 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of DAWNZERA reflects the exposure in a total of 171 adult and pediatric patients 12 years and older with hereditary angioedema (HAE) from a placebo-controlled trial (OASIS-HAE) [see Clinical Studies (14) ] , and 2 other clinical studies.

The average duration of DAWNZERA treatment exposure across the 3 clinical studies was 14 months. The safety data below is based on the 24-week multicenter, randomized, double-blind, placebo-controlled trial (OASIS-HAE), in which patients received at least one subcutaneous dose of DAWNZERA 80 mg once every 4 weeks (n=45), DAWNZERA 80 mg once every 8 weeks (n=23), or matching placebo (n=22). Demographics of the patients in OASIS-HAE are summarized in Clinical Studies [see Clinical Studies (14) ] .

Table 1 provides the most common adverse reactions with DAWNZERA with incidence ≥5% and more common than placebo. Table 1: Adverse Reactions with DAWNZERA with Incidence ≥5% and More Common than Placebo in Patients with HAE (OASIS-HAE) N = number of patients; n = number of patients experiencing the event; q4wks = every 4 weeks; q8wks = every 8 weeks. * Injection site reactions include: erythema, discoloration, pain, pruritus, induration, bruising, haematoma, hypersensitivity, swelling, reaction, and urticaria. † All injection site reactions were mild, nonserious, and the majority of them resolved without receiving any treatment.

Adverse Reaction DAWNZERA Placebo (N=22) 80 mg q4wks (N=45) 80 mg q8wks (N=23) n (%) n (%) 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 Specific Adverse Reactions Hypersensitivity Reactions, Including Anaphylaxis In clinical trials, hypersensitivity reactions, including anaphylaxis, have occurred.

Symptoms included generalized rash, dyspnea, chest pain, and peri-oral swelling. Laboratory Tests Decrease in Platelet Count : DAWNZERA can cause reductions in platelet count. In OASIS-HAE, the mean platelet count at baseline was 266,000/mm 3 for the DAWNZERA 80 mg every 4 weeks group, 265,000/mm 3 for the DAWNZERA 80 mg every 8 weeks group, and 245,000/mm 3 for the placebo group. The mean percent change in platelet count at Week 25 was -9.6% for the DAWNZERA 80 mg every 4 weeks group, -7.9% for the DAWNZERA 80 mg every 8 weeks group, and -1.4% for the placebo group.

In OASIS-HAE and 2 other clinical studies no DAWNZERA-treated patient had a platelet count of <50,000/mm 3 , and there were no major bleeding events associated with a low platelet count. Increase in Liver Function Tests : Increases from baseline in liver enzymes (alanine aminotransferase, aspartate aminotransferase, and gamma-glutamyl transferase) were observed with DAWNZERA use. The increased levels were generally below 3 times the upper limit of normal and stabilized.

Discontinuations due to liver function test increases were infrequent.

Dawnzera (Autoinjector)

Indications

Contraindications

Warnings and precautions

5.1Risk of Hypersensitivity Reactions, Including Anaphylaxis

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

At a glance

Two medicines in one question?

Dawnzera (Autoinjector)

Indications

Contraindications

Warnings and precautions

5.1Risk of Hypersensitivity Reactions, Including Anaphylaxis

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

At a glance

Two medicines in one question?

Adverse reactions

6.1Clinical Trials Experience

Composition

Official product information