- Approval Id
- ae2e37a92b5c16bb
- Drug Name
- WAINUA SOLUTION FOR INJECTION IN AUTOINJECTOR 45MG/0.8ML
- Product Name
- WAINUA SOLUTION FOR INJECTION IN AUTOINJECTOR 45MG/0.8ML
- Approval Number
- SIN17311P
- Approval Date
- 2025-08-15
- Registrant
- ASTRAZENECA SINGAPORE PTE LTD
- Licence Holder
- ASTRAZENECA SINGAPORE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, SOLUTION
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p>Treatment should be prescribed and supervised by a treating physician knowledgeable in the management of patients with amyloidosis.</p>
<p><strong>Posology</strong></p>
<p>The recommended dose of WAINUA is 45 mg administered by subcutaneous injection. Doses should be administered monthly.</p>
<p>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 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)</p>
<p>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.</p>
<p><strong><em><u>Missed dose</u></em></strong></p>
<p>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.</p>
<p><strong>Special populations</strong></p>
<p><strong><em><u>Renal impairment</u></em></strong></p>
<p>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 m<sup>2</sup>) (see section 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). WAINUA has not been studied in patients with eGFR<45 mL/min/1.73 m<sup>2</sup> or end-stage renal disease.</p>
<p><strong><em><u>Hepatic impairment</u></em></strong></p>
<p>No dose adjustment is necessary in patients with mild hepatic impairment (see section 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). WAINUA has not been studied in patients with moderate or severe hepatic impairment.</p>
<p><strong><em><u>Elderly population</u></em></strong></p>
<p>No dose adjustment is required in elderly patients (≥65 years of age) (see section 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong><em><u>Paediatric population</u></em></strong></p>
<p>The safety and efficacy of WAINUA in children and adolescents below 18 years of age have not been established. No data are available.</p>
<p><strong>Method of administration</strong></p>
<p>Subcutaneous use only.</p>
<p>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.</p>
<p>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.</p>
<p>Inspect solution visually before use. The solution should appear colourless to yellow. <strong>Do not</strong> use if cloudiness, particulate matter or discolouration is observed prior to administration.</p>
<p>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.</p>
<p>Comprehensive instructions for administration are provided in the ‘Instructions for Use’.</p>
- Route Of Administration
- SUBCUTANEOUS
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>WAINUA is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with Stage 1 or 2 polyneuropathy.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>None.</p>
