DAWNZERA 80 mg/.8mL
donidalorsen · INJECTION, SOLUTION · Ionis Pharmaceuticals Inc.
DAWNZERA is a injection, solution containing donidalorsen at 80 mg/.8mL, taken subcutaneous. Manufactured by Ionis Pharmaceuticals Inc..
Key Facts
- Brand Name
- DAWNZERA
- Generic Name
- donidalorsen
- NDC Code (Product)
71860-103- Manufacturer
- Ionis Pharmaceuticals Inc.
- Strength
- 80 mg/.8mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- NDA219407
- Marketing Start
- 08/21/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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 )
Dosage & Administration
2 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. ( 2.1 ) See full prescribing information for administration instructions. ( 2.2 ) 2.1 Recommended Dosage The recommended dosage of DAWNZERA is 80 mg administered subcutaneously every 4 weeks. A dosage of 80 mg administered subcutaneously every 8 weeks may be considered. Missed Dose(s) If a dose of DAWNZERA is missed, administer DAWNZERA as soon as possible. Resume treatment at the recommended dosing frequency from the date of the most recently administered dose. 2.2 Administration Instructions For subcutaneous use. DAWNZERA is intended for self-administration or administration by a caregiver. Prior to treatment initiation, train patients and/or caregivers on proper preparation and subcutaneous administration technique of DAWNZERA autoinjector [see Instructions for Use ] . Remove the single‑dose autoinjector from the refrigerator 30 minutes prior to the injection and allow to warm to room temperature. Do not use other warming methods. Inspect DAWNZERA visually for particulate matter and discoloration prior to admin…
Contraindications
4 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.
Adverse Reactions
6 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 . 6.1 Clinical 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 …
Frequently Asked Questions
What is DAWNZERA used for?
DAWNZERA contains donidalorsen. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is DAWNZERA a controlled substance?
DAWNZERA is not classified as a controlled substance by the DEA.
What is the generic name for DAWNZERA?
The generic name for DAWNZERA is donidalorsen. There are no other listed brand versions of donidalorsen.
What is the NDC code for DAWNZERA 80 mg/.8mL?
The NDC (National Drug Code) for DAWNZERA 80 mg/.8mL is 71860-103, listed by Ionis Pharmaceuticals Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)