of subjects who were rerandomizedto placebo.
For PASI 75 responders at Week 28 who were re-randomized to treatment withdrawal (i.e.,placebo), the median time to loss of PASI 75 was approximately 20 weeks.In addition, for subjects who were re-randomized to placebo and also had a PGA score of 0 or 1 atWeek 28, the median time to loss of PGA score of 0 or 1 was approximately 16 weeks.
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
ILUMYA (tildrakizumab-asmn) Injection is a sterile, preservative-free, clear to slightly opalescent,colorless to slightly yellow solution. ILUMYA is supplied as one single-dose prefilled syringe per cartonthat delivers 1 mL of a 100 mg/mL solution.
NDC 0006-4241-00
Each prefilled syringe is equipped with a passive needle guard and a needle cover.
16.2 Storage and Handling
Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until thetime of use. Do not freeze. Do not shake. ILUMYA can be kept at room temperature at 25°C (77°F) for upto 30 days in the original carton to protect from light. Once stored at room temperature, do not place backin the refrigerator. If not used within 30 days, discard ILUMYA. Do not store ILUMYA above 25°C (77°F).
17 PATIENT COUNSELING INFORMATION
Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide).
Instruct patients and/or caregivers to read the Medication Guide before starting ILUMYA therapyand to reread the Medication Guide each time the prescription is renewed. Advise patients of the potentialbenefits and risks of ILUMYA.
Hypersensitivity
Advise patients to seek immediate medical attention if they experience any symptoms of serioushypersensitivity reactions [see Warnings and Precautions (5.1)].
Infections
Instruct patients of the importance of communicating any history of infections to the doctor andcontacting their doctor if they develop any symptoms of infection [see Warnings and Precautions (5.2)].
https://mma.prnewswire.com/media/656994/Sun_Pharma_ILUMYA_US_Prescribing_Information.pdf |
