wainua (autoinjector)
Wainua (Autoinjector) (Eplontersen Sodium) is an antisense oligonucleotide used to treat Polyneuropathies, Familial Amyloid Neuropathies.
Eplontersen Sodium · by Astrazeneca Ab
This is one strength of Wainua
The FDA label is the same for every strength in this family, so the full page — with all 2 strengths — lives on Wainua.
- WainuaEplontersen Sodium EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML)
- Wainua (Autoinjector) (this page)Eplontersen Sodium EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML)
Key facts
- Active ingredient
- Eplontersen Sodium
- Drug class
- Antisense Oligonucleotide
- Form
- Injectable
- Strength
- Eplontersen Sodium EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Astrazeneca Ab
- FDA application
- NDA217388
What is Wainua (Autoinjector)?
From the FDA label:Eplontersen is a transthyretin-directed antisense oligonucleotide (ASO), covalently linked to a ligand containing three N-acetyl galactosamine (GalNAc) residues to enable delivery of the ASO to hepatocytes. WAINUA contains eplontersen sodium as the active ingredient. Eplontersen sodium is a white to yellow solid and it is freely soluble in water and in phosphate buffer. The molecular formula of eplontersen sodium is C 296 H 417 N 77 O 156 P 20 S 13 Na 20 and the molecular weight is 9046.1 daltons. The chemical name of eplontersen sodium is DNA, d([2′-O-(2-methoxyethyl)]m5rU-sp-[2′-O-(2-methoxyethyl)]m5rC-[2′-O-(2-methoxyethyl)]m5rU-[2′-O-(2-methoxyethyl)]m5rU-[2′-O-(2-methoxyethyl)]rG-G-sp-T-sp-T-sp-A-sp-m5C-sp-A-sp-T-sp-G-sp-A-sp-A-sp-[2′-O-(2-methoxyethyl)]rA-[2′-O-(2-methoxyethyl)]m5rU-[2′-O-(2-methoxyethyl)]m5rC-sp-[2′-O-(2-methoxyethyl)]m5rC-sp-[2′-O-(2-methoxyethyl)]m5rC), 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 structure of eplontersen sodium is presented below: WAINUA is a sterile, preservative-free, aqueous solution for subcutaneous injection supplied in a single dose autoinjector or single-dose prefilled syringe. Each dose contains 45 mg eplontersen…
How to use
The recommended dosage of WAINUA is 45 mg administered by subcutaneous injection once monthly. ( 2.1 ) • Administer WAINUA into the abdomen or upper thigh region; the back of the upper arm can be used if a healthcare provider or caregiver administers the injection. ( 2.2 ) • The prefilled syringe must be administered by a healthcare provider. ( 2.4 ) 2.1 Recommended Dosage The recommended dosage of WAINUA is 45 mg administered by subcutaneous injection once monthly [see Dosage and Administration (2.2) ] . Missed Dose Administer WAINUA as soon as possible after a missed dose. Resume dosing at monthly intervals from the date of the most recently administered dose. 2.2 General Administration Instructions Each autoinjector and prefilled syringe contains a single dose of WAINUA. Prior to administration of the autoinjector or prefilled syringe: • Do not use if WAINUA has been dropped or damaged, appears to be tampered with, or if the expiration date has passed. • Remove WAINUA from the refrigerator 30 minutes prior to the injection to reach room temperature. Do not use other warming methods. • Visually inspect WAINUA before use. The solution should appear colorless to yellow. Do not use if cloudiness, particulate matter, or discoloration is observed. To deliver a 45 mg dose of WAINUA, administer the entire contents of one autoinjector or prefilled syringe [see Dosage and…
Side effects
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: • Reduced Serum Vitamin A Levels and Recommended Supplementation [see Warnings and Precautions (5.1) ]. Most common adverse reactions (that occurred in at least 9% of patients treated with WAINUA) were vitamin A decreased and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 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 WAINUA cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In Study 1 [see Clinical Studies (14) ] , a total of 144 patients with polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) were randomized to WAINUA and received at least one dose of WAINUA. Of these, 141 patients received at least 6 months of treatment and 107 patients received at least 12 months of treatment. The mean duration of treatment was 15 months (range: 1.9 to 19.4 months). The median patient age at baseline was 52 years and 69% of the patients were male. Seventy-eight percent of patients treated with WAINUA were White, 15% were Asian, 4% were Black, 2%…
Warnings
Important safety information
Reduced Serum Vitamin A Levels and Recommended Supplementation : Supplement with the recommended daily allowance of vitamin A. Refer to an ophthalmologist if ocular symptoms suggestive of vitamin A deficiency occur. ( 5.1 ) 5.1 Reduced Serum Vitamin A Levels and Recommended Supplementation WAINUA treatment leads to a decrease in serum vitamin A levels [see Adverse Reactions (6.1) , Use in Specific Populations (8.1) , and Clinical Pharmacology (12.2) ] . Supplementation at the recommended daily allowance of vitamin A is advised for patients taking WAINUA. Higher doses than the recommended daily allowance of vitamin A should not be given to try to achieve normal serum vitamin A levels during treatment with WAINUA, as serum vitamin A levels do not reflect the total vitamin A in the body. Patients should be referred to an ophthalmologist if they develop ocular symptoms suggestive of vitamin A deficiency (e.g., night blindness, dry eyes).
Who should not take Wainua (Autoinjector)
None. None. ( 4 )
Drug class
- Antisense Oligonucleotide
- Transthyretin-directed RNA Interaction
May treat (source: NIH RxClass)
See how Wainua (Autoinjector) ranks — best-rated antisense oligonucleotide for:
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Wainua (Autoinjector) treat?
- Wainua (Autoinjector) (Eplontersen Sodium) may be used to treat polyneuropathies, familial amyloid neuropathies, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Wainua (Autoinjector)?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Wainua (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 Wainua (Autoinjector)?
- Wainua (Autoinjector) is marketed by Astrazeneca Ab. You can see Astrazeneca Ab's full profile, rating, and other products on pharmaranks.
- Is Wainua (Autoinjector) a brand-name or generic drug?
- Wainua (Autoinjector) is a brand-name product with the active ingredient Eplontersen Sodium.
- Is Wainua (Autoinjector) available over the counter?
- No. Wainua (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 Wainua (Autoinjector) come in?
- Wainua (Autoinjector) is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Wainua (Autoinjector)?
- Wainua (Autoinjector) is classified as antisense oligonucleotide, transthyretin-directed rna interaction, per the FDA's Established Pharmacologic Class.
- Is Wainua (Autoinjector) FDA-registered?
- Wainua (Autoinjector) is on record with the U.S. FDA under application number NDA217388. You can verify this on its official FDA label.
- Is Wainua (Autoinjector) safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Wainua (Autoinjector). Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Wainua (Autoinjector)?
- Wainua (Autoinjector)'s side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: • Reduced Serum Vitamin A Levels and Recommended Supplementation [see Warnings and Precautions (5.1) ].… 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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