Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden
Wainzua is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (ATTRv) in adult patients with stage 1 or stage 2 polyneuropathy.
Treatment should be prescribed and supervised by a physician experienced in the treatment of patients with hereditary transthyretin-mediated amyloidosis.
The recommended dose of eplontersen is 45 mg administered monthly.
Vitamin A supplementation at approximately, but not exceeding, 2 500 IU to 3 000 IU vitamin A per day is advised for patients treated with Wainzua (see section 4.4).
Treatment should be initiated as early as possible after symptom onset (see section 5.1).
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.
If a dose of Wainzua is missed, then the next dose should be administered as soon as possible. Dosing should be resumed at monthly intervals from the date of the last dose; a double dose should not be administered.
No dose adjustment is required in elderly patients (≥65 years of age) (see section 5.2).
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). Eplontersen has not been studied in patients with eGFR <45 mL/min/1.73 m² or end-stage renal disease (see section 5.2) and should only be used in these patients if the anticipated clinical benefit outweighs the potential risk.
No dose adjustment is necessary in patients with mild hepatic impairment. Eplontersen has not been studied in patients with moderate or severe hepatic impairment and should only be used in these patients if the anticipated clinical benefit outweighs the potential risk (see section 5.2).
The safety and efficacy of Wainzua have not been evaluated in patients undergoing liver transplant.
No data are available.
The safety and efficacy of Wainzua in children and adolescents below 18 years of age have not been established. No data are available (see section 5.1).
Wainzua is for subcutaneous use. Wainzua is a pre-filled pen for single-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 Wainzua.
The pre-filled pen 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, Wainzua should be injected in the abdomen or upper thigh region. If a caregiver administers the injection, the back of the upper arm can also be used.
Wainzua should not be injected into skin that is bruised, tender, red, or hard, into scars or damaged skin, the area around the navel should be avoided.
Comprehensive instructions for administration using the pre-filled pen are provided in the ‘Instructions for Use’.
There is no specific treatment for an overdose with eplontersen. In the event of an overdose, supportive medical care should be provided.
3 years.
Wainzua may be stored in original carton unrefrigerated for up to 6 weeks below 30°C. If not used within 6 weeks, it should be discarded.
Store in a refrigerator (2°C–8°C). Do not freeze.
Store in the original package in order to protect from light.
0.8 ml sterile solution for injection in a single-use, type I glass syringe with a staked 27-gauge ½ inch (12.7 mm) stainless steel needle, rigid needle shield, and siliconised chlorobutyl elastomer stopper in a pre-filled pen.
Pack size of one single-use pre-filled pen.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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