Source: FDA, National Drug Code (US) Revision Year: 2023
WAINUA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
The recommended dosage of WAINUA is 45 mg administered by subcutaneous injection once monthly [see Dosage and Administration (2.2)].
Administer WAINUA as soon as possible after a missed dose. Resume dosing at monthly intervals from the date of the most recently administered dose.
Prior to initiation, train patients and/or caregivers on proper preparation and administration of WAINUA [see Instructions for Use].
Remove the single-dose autoinjector from the refrigerator 30 minutes prior to the injection and allow to warm to room temperature. Do not use other warming methods.
Inspect WAINUA visually for particulate matter and discoloration prior to administration. The solution should appear colorless to yellow. Do not use if cloudiness, particulate matter, or discoloration is observed prior to administration.
Administer WAINUA as a subcutaneous injection into the abdomen or upper thigh region. The back of the upper arm can also be used as an injection site if a healthcare provider or caregiver administers the injection.
Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton protected from light.
If needed, WAINUA can be kept at room temperature (up to 30°C [86°F]) in the original carton for up to 6 weeks. If not used within the 6 weeks stored at room temperature, discard WAINUA.
Do not freeze. Do not expose to heat.
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