DAWNZERA™ (donidalorsen) sponsored by IONIS Pharmaceutical, Inc. 



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Highlights of Indications & Usage

INDICATIONS AND USAGE

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.

Please see full Prescribing Information for DAWNZERA 

Highlights of Dosage & Administration

DOSAGE AND ADMINISTRATION

The recommended dosage of DAWNZERA is 80 mg administered subcutaneously every 4 weeks.

A dosage of 80 mg every 8 weeks may also be considered.

See full prescribing information for administration instructions.

DOSAGE FORMS AND STRENGTHS

Injection: 80 mg/0.8 mL solution in a single-dose autoinjector.

Please see full Prescribing Information for DAWNZERA 

Highlights of Contraindications

CONTRAINDICATIONS

History of serious hypersensitivity reactions, including anaphylaxis, to donidalorsen or any of the excipients in DAWNZERA.

Please see full Prescribing Information for DAWNZERA 

Highlights of Warnings & Precautions

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.

Please see full Prescribing Information for DAWNZERA 

Highlights of Adverse Reactions

ADVERSE REACTIONS

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

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.

Please see full Prescribing Information for DAWNZERA 

Highlights of Use in Specific Populations

USE IN SPECIFIC POPULATIONS

Hepatic Impairment: Use in patients with moderate and severe hepatic impairment is not recommended

Please see full Prescribing Information for DAWNZERA 

DAWNZERA™ is a trademark of Ionis Pharmaceuticals, Inc. All other trademarks are the property of their respective owners. ©2026 Ionis Pharmaceuticals, Inc.      US-DONI-2600087 v1.0 05/2026

 

Please see full Prescribing Information for DAWNZERA 

Indication and Important Safety Information


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.

IMPORTANT SAFETY INFORMATION 

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.

Please see full Prescribing Information for DAWNZERA.