dawnzera (autoinjector)
Dawnzera (Autoinjector) (Donidalorsen Sodium) is a medication supplied as an injection, solution.
Donidalorsen Sodium · by Ionis Pharms Inc
Key facts
- Active ingredient
- Donidalorsen Sodium
- Form
- Injectable
- Strength
- Donidalorsen Sodium EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Ionis Pharms Inc
- FDA application
- NDA219407
What is Dawnzera (Autoinjector)?
From the FDA label:Donidalorsen is a prekallikrein-directed antisense oligonucleotide (ASO) covalently linked to a ligand containing three N ‑acetyl galactosamine (GalNAc) residues to facilitate delivery of the ASO to hepatocytes. 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 296 H 415 N 83 O 151 P 20 S 15 Na 20 and the molecular weight is 9112.27 daltons. The chemical name of donidalorsen is DNA, d([2′- O -(2-methoxyethyl)]m 5 rU-s p -[2′- O -(2-methoxyethyl)]rG-s p -[2′- O -(2-methoxyethyl)]m 5 rC-[2′- O -(2-methoxyethyl)]rA-[2′- O -(2-methoxyethyl)]rA-s p -G-s p -T-s p -m 5 C-s p -T-s p -m 5 C-s p -T-s p -T-s p -G-s p -G-s p -m 5 C-s p -[2′- O -(2-methoxyethyl)]rA-[2′- O -(2-methoxyethyl)]rA-[2′- O -(2methoxyethyl)]rA-s p -[2′- O -(2-methoxyethyl)]m 5 rC-s p -[2′- O -(2-methoxyethyl)]rA), 5′-[26-[[2-(acetylamino)-2-deoxy-β-d-galactopyranosyl]oxy]-14,14-bis[[3-[[6-[[2-(acetylamino)-2-deoxy-β-d-galactopyranosyl]oxy]hexyl]amino]-3-oxopropoxy]methyl]-8,12,19-trioxo-16-oxa-7,13,20-triazahexacos-1-yl hydrogen phosphate], sodium salt (1:20). The chemical structure of donidalorsen sodium is presented below: DAWNZERA (donidalorsen) injection is a sterile, preservative‑free solution for subcutaneous injection supplied as a…
How to use
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 administration. The solution should appear clear and colorless to yellow. Do not use if cloudiness, particulate matter, or discoloration is observed prior to administration. Administer DAWNZERA subcutaneously into the abdomen or…
Side effects
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 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…
Warnings
Important safety information
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 ) 5.1 Risk 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.
Who should not take Dawnzera (Autoinjector)
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.
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
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Request a 90-day supply
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Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
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Frequently asked questions
- Is there a coupon or discount for Dawnzera (Autoinjector)?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Dawnzera (Autoinjector). To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Dawnzera (Autoinjector)?
- Dawnzera (Autoinjector) is marketed by Ionis Pharms Inc. You can see Ionis Pharms Inc's full profile, rating, and other products on pharmaranks.
- Is Dawnzera (Autoinjector) a brand-name or generic drug?
- Dawnzera (Autoinjector) is a brand-name product with the active ingredient Donidalorsen Sodium.
- Is Dawnzera (Autoinjector) available over the counter?
- No. Dawnzera (Autoinjector) is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Dawnzera (Autoinjector) come in?
- Dawnzera (Autoinjector) is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Dawnzera (Autoinjector) FDA-registered?
- Dawnzera (Autoinjector) is on record with the U.S. FDA under application number NDA219407. You can verify this on its official FDA label.
- Is Dawnzera (Autoinjector) safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Dawnzera (Autoinjector). Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Dawnzera (Autoinjector)?
- Dawnzera (Autoinjector)'s side effects are taken directly from its FDA label. From the label: 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,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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