STELARA- ustekinumab injection, solution

Jom Pharmaceutical Services Inc.

STELARA® is a human interleukin-12 and -23 antagonist indicated for the treatment of:

Adult patients with:

• moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. ( 1.1)
• active psoriatic arthritis (PsA). ( 1.2)
• moderately to severely active Crohn’s disease (CD). ( 1.3)
• moderately to severely active ulcerative colitis. ( 1.4)

Pediatric patients 6 years and older with:

• moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy. ( 1.1)
• active psoriatic arthritis (PsA). ( 1.2)

Store STELARA® vials and prefilled syringes refrigerated between 2°C to 8°C (36°F to 46°F). Store STELARA® vials upright. Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake.

If needed, individual prefilled syringes may be stored at room temperature up to 30°C (86°F) for a maximum single period of up to 30 days in the original carton to protect from light. Record the date when the prefilled syringe is first removed from the refrigerator on the carton in the space provided. Once a syringe has been stored at room temperature, do not return to the refrigerator. Discard the syringe if not used within 30 days at room temperature storage. Do not use STELARA® after the expiration date on the carton or on the prefilled syringe.