%placebo); PASI 100 (47% SKYRIZI and 1% placebo); and PASI 75 (89% SKYRIZI and 8%
placebo).
Maintenance and Durability of Response
In ULTIMMA-1 and ULTIMMA-2, among the subjects who received SKYRIZI and had PASI100 at Week 16, 80% (206/258) of the subjects who continued on SKYRIZI had PASI 100 at
Week 52. For PASI 90 responders at Week 16, 88% (398/450) of the subjects had PASI 90 atWeek 52.
In IMMHANCE, subjects who were originally on SKYRIZI and had sPGA 0 or 1 at Week 28were re-randomized to continue SKYRIZI every 12 weeks or withdrawal of therapy. At Week52, 87% (97/111) of the subjects re-randomized to continue treatment with SKYRIZI had sPGA0 or 1 compared to 61% (138/225) who were re-randomized to withdrawal of SKYRIZI.
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
SKYRIZI (risankizumab-rzaa) injection is a sterile, preservative-free, colorless to slightly yellowand clear to slightly opalescent solution. The product is supplied in a 1 mL glass syringe with afixed 29 gauge ½ inch needle with needle guard.
• NDC 0074-2042-02: one carton containing two prefilled syringes and two alcohol pads
16.2 Storage and Handling
• Store in a refrigerator at 2°C to 8°C (36°F to 46° F).
• Do not freeze.
• Do not shake.
• Keep the prefilled syringes in the outer carton to protect from light.
• Not made with natural rubber latex.
17 PATIENT COUNSELING INFORMATION
Advise the patient and/or caregiver to read the FDA-approved patient labeling (MedicationGuide and Instructions for Use) before starting SKYRIZI therapy and to reread the MedicationGuide each time the prescription is renewed. Advise patients of the potential benefits and risks ofSKYRIZI.
Infections
Inform patients that SKYRIZI may lower the ability of their immune system to fight infections.
Instruct patients of the importance of communicating any history of infections to the healthcareprovider and contacting their healthcare provider if they develop any symptoms of an infection[see Warnings and Precautions (5.1)].
Administration Instruction
Instruct patients or caregivers to perform the first self-injected dose under the supervision andguidance of a qualified healthcare professional for training in preparation and administration ofSKYRIZI, including choosing anatomical sites for administration, and proper subcutaneousinjection technique [see Instructions for Use].
Instruct patients or caregivers to administer two 75 mg single-dose syringes to achieve the 150mg dose of SKYRIZI [see Instructions for Use].
Instruct patients or caregivers in the technique of needle and syringe disposal [see Instructions
for Use].
Manufactured by:
AbbVie Inc.
North Chicago, IL
60064, USA
US License Number 1889
© 2019 AbbVie Inc.
20059380 04/2019
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