WAINUA 45 mg/.8mL
EPLONTERSEN · INJECTION, SOLUTION · AstraZeneca Pharmaceuticals LP
WAINUA is a injection, solution containing eplontersen at 45 mg/.8mL, taken subcutaneous. Manufactured by AstraZeneca Pharmaceuticals LP.
Key Facts
- Brand Name
- WAINUA
- Generic Name
- EPLONTERSEN
- NDC Code (Product)
0310-9420- Manufacturer
- AstraZeneca Pharmaceuticals LP
- Strength
- 45 mg/.8mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- NDA217388
- Drug Class
- Transthyretin-directed RNA Interaction [EPC]; Antisense Oligonucleotide [EPC]
- Marketing Start
- 04/30/2026
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 WAINUA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. WAINUA is a transthyretin-directed antisense oligonucleotide indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • 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 co…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS 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 mo…
Frequently Asked Questions
What is WAINUA used for?
WAINUA contains EPLONTERSEN. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is WAINUA a controlled substance?
WAINUA is not classified as a controlled substance by the DEA.
What is the generic name for WAINUA?
The generic name for WAINUA is EPLONTERSEN. There are no other listed brand versions of EPLONTERSEN.
What is the NDC code for WAINUA 45 mg/.8mL?
The NDC (National Drug Code) for WAINUA 45 mg/.8mL is 0310-9420, listed by AstraZeneca Pharmaceuticals LP.
Other WAINUA Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)