Eplontersen: uses, dosing, side effects & brands
Eplontersen is an antisense oligonucleotide sold in the U.S. under 2 brand and generic names, for polyneuropathies and familial amyloid neuropathies. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Antisense Oligonucleotide
- Treats
- Polyneuropathies and Familial Amyloid Neuropathies
- Available as
- Injectable
- Sold as
- 2 products — Wainua and Wainua (Autoinjector)
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How eplontersen is dosed
From the FDA label for Wainua (application NDA217388). Other eplontersen products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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…
Eplontersen 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%…
Who shouldn’t take eplontersen
None. None. ( 4 )
Every eplontersen product we track (2)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Injectable | No data | — | View → | |
| 2 | Not yet rated | Prescription | Injectable | No data | — | View → |
What people report to the FDA about eplontersen
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 299 reports naming eplontersen, and the FDA flagged 99% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- neuropathy peripheral36 reports
- dyspnoea22 reports
- fatigue18 reports
- pneumonia15 reports
- amyloidosis13 reports
- atrial fibrillation11 reports
- malaise11 reports
- diarrhoea10 reports
Read these as a signal, not a rate. A report does not mean eplontersen caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved August 25, 2026.
Related calculators
Frequently asked questions
What is eplontersen?
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.
What kind of drug is eplontersen?
The FDA classifies eplontersen as an antisense oligonucleotide. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take eplontersen with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run eplontersen against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is eplontersen sold under?
We track 2 eplontersen-containing products in the U.S.: Wainua and Wainua (Autoinjector). They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does eplontersen come in?
Across the brands we track, eplontersen is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic eplontersen?
We do not currently list a generic-labelled eplontersen product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Eplontersen: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/eplontersen
- MLA
- “Eplontersen: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/eplontersen.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for eplontersen on DailyMed (NIH) ↗.