Vaccination Prior to Treatment

Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with ADBRY [see Warnings and Precautions (5.4)].

Recommended Dosage

The recommended dosage of ADBRY is:

• An initial dose of 600 mg (four 150 mg injections), followed by 300 mg (two 150 mg injections) administered every other week.
• After 16 weeks of treatment, for patients with body weight below 100 kg who achieve clear or almost clear skin, a dosage of 300 mg every 4 weeks may be considered.

ADBRY is administered by subcutaneous injection [see Dosage and Administration (2.5, 2.6)].

Concomitant Topical Therapies

ADBRY can be used with or without topical corticosteroids. Topical calcineurin inhibitors may be used, but should be reserved for problem areas only, such as the face, neck, intertriginous and genital areas.

Missed Doses

If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.

Preparation for Use

• Before injection, remove ADBRY prefilled syringes from the refrigerator and allow to reach room temperature (30 minutes for the 150 mg/mL prefilled syringes) without removing the needle cap.
• After removal from the refrigerator, prefilled syringes may be kept at room temperature up to 30°C (86°F) and must be used within 14 days or discarded.
• Inspect ADBRY visually for particulate matter and discoloration prior to administration. ADBRY injection is a clear to opalescent, colorless to pale yellow solution. Do not use if the liquid contains visible particulate matter, is discolored or cloudy (other than clear to opalescent, colorless to pale yellow).
• ADBRY does not contain preservatives; therefore, discard any unused product.

Important Administration Instructions

• ADBRY is intended for use under the guidance of a healthcare provider. A patient may self-inject ADBRY after training in subcutaneous injection technique. Provide proper training to patients and/or caregivers on the preparation and administration according to the "Instructions for Use" [see Instructions for Use].
• For the initial 600 mg dose, administer each of the four ADBRY 150 mg injections at different injection sites within the same body area.
• For the subsequent 300 mg doses, administer the two ADBRY 150 mg injections at different injection sites within the same body area.
• Administer subcutaneous injection into the thigh or abdomen, except for the 2 inches (5 cm) around the navel. The upper arm can also be used if a caregiver administers the injection.
• Rotate the body area with each subsequent set of injections. DO NOT inject ADBRY into skin that is tender, damaged, bruised, or scarred.