WAINUA SOLUTION FOR INJECTION IN AUTOINJECTOR 45MG/0.8ML [SIN17311P]
Active ingredients: WAINUA SOLUTION FOR INJECTION IN AUTOINJECTOR 45MG/0.8ML
Last updated 24 April 2026
Product Info
WAINUA SOLUTION FOR INJECTION IN AUTOINJECTOR 45MG/0.8ML
[SIN17311P]
Product information
Active Ingredient and Strength | EPLONTERSEN SODIUM EQV EPLONTERSEN - 45 MG/0.8 ML |
Dosage Form | INJECTION, SOLUTION |
Manufacturer and Country | VETTER PHARMA-FERTIGUNG GMBH & CO KG - GERMANY |
Registration Number | SIN17311P |
Licence Holder | ASTRAZENECA SINGAPORE PTE LTD |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | N07XX21 |
Prescription-only Medicines with Exemptions for Supply without Prescription | NA |
Indication
4.1 Therapeutic indications
WAINUA is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with Stage 1 or 2 polyneuropathy.
Dosing
4.2 Posology and method of administration
Treatment should be prescribed and supervised by a treating physician knowledgeable in the management of patients with amyloidosis.
Posology
The recommended dose of WAINUA is 45 mg administered by subcutaneous injection. Doses should be administered monthly.
Vitamin A supplementation at approximately, but not exceeding, 2 500 international units to 3 000 international units vitamin A per day is advised for patients treated with WAINUA (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)
The decision to continue treatment in those patients whose disease progresses to stage 3 polyneuropathy should be taken at the discretion of the physician based on the overall benefit and risk assessment.
Missed dose
If a dose of eplontersen is missed, then the next dose should be administered as soon as possible. Resume dosing at monthly intervals from the date of the last dose.
Special populations
Renal impairment
No dose adjustment is necessary in patients with mild to moderate renal impairment (estimated glomerular filtration rate [eGFR] ≥45 to <90 mL/min/1.73 m2) (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). WAINUA has not been studied in patients with eGFR<45 mL/min/1.73 m2 or end-stage renal disease.
Hepatic impairment
No dose adjustment is necessary in patients with mild hepatic impairment (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). WAINUA has not been studied in patients with moderate or severe hepatic impairment.
Elderly population
No dose adjustment is required in elderly patients (≥65 years of age) (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Paediatric population
The safety and efficacy of WAINUA in children and adolescents below 18 years of age have not been established. No data are available.
Method of administration
Subcutaneous use only.
The first injection administered by the patient or caregiver should be performed under the guidance of an appropriately qualified health care professional. Patients and/or caregivers should be trained in the subcutaneous administration of WAINUA.
The autoinjector should be removed from refrigerated storage at least 30 minutes before use and allowed to reach room temperature prior to injection. Other warming methods should not be used.
Inspect solution visually before use. The solution should appear colourless to yellow. Do not use if cloudiness, particulate matter or discolouration is observed prior to administration.
If self-administered, inject WAINUA in the abdomen or upper thigh region. If a caregiver administers the injection, the back of the upper arm can also be used.
Comprehensive instructions for administration are provided in the ‘Instructions for Use’.
Contraindications
4.3 Contraindications
None.