DAWNZERA Solution for injection Ref.[116065] Active ingredients: Donidalorsen

2.1 Recommended Dosage

The recommended dosage of DAWNZERA is 80 mg administered subcutaneously every 4 weeks.

• A dosage of 80 mg administered subcutaneously every 8 weeks may be considered.

Missed Dose(s)

If a dose of DAWNZERA is missed, administer DAWNZERA as soon as possible. Resume treatment at the recommended dosing frequency from the date of the most recently administered dose.

2.2 Administration Instructions

• For subcutaneous use.
• DAWNZERA is intended for self-administration or administration by a caregiver. Prior to treatment initiation, train patients and/or caregivers on proper preparation and subcutaneous administration technique of DAWNZERA autoinjector [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 DAWNZERA visually for particulate matter and discoloration prior to administration. The solution should appear clear and colorless to yellow. Do not use if cloudiness, particulate matter, or discoloration is observed prior to administration.
• Administer DAWNZERA subcutaneously into the abdomen or upper thigh region. The back of the upper arm can also be used as an injection site if a caregiver or healthcare provider administers the injection.

Store the DAWNZERA autoinjector in the refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton.

The DAWNZERA autoinjector can be stored at room temperature up to 86°F (30°C) in the original carton for up to 6 weeks; if not used within the 6 weeks stored at room temperature, discard DAWNZERA.

Do not freeze. Do not expose to heat. Protect from direct light.