HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use STELARA ® safely and effectively. See full prescribing information for STELARA ®.
STELARA ® (ustekinumab) injection, for subcutaneous or intravenous use
Initial U.S. Approval: 2009
RECENT MAJOR CHANGES
Indications and Usage, Crohn's Disease (1.3) 09/2016
Dosage and Administration (2.3) 09/2016
Dosage and Administration (2.6) 09/2016
INDICATIONS AND USAGE
STELARA® is a human interleukin-12 and -23 antagonist indicated for the treatment of adult patients with:
moderate to severe plaque psoriasis (Ps) who are candidates for phototherapy or systemic therapy. (1.1)
active psoriatic arthritis (PsA), alone or in combination with methotrexate. (1.2)
moderately to severely active Crohn's disease (CD) who have
failed or were intolerant to treatment with immunomodulators or corticosteroids, but never failed a tumor necrosis factor (TNF) blocker or
failed or were intolerant to treatment with one or more TNF blockers. (1.3)
DOSAGE AND ADMINISTRATION
Psoriasis Recommended Adult Subcutaneous Dosage (2.1):
Weight Range (kilogram) Dosage Regimen
less than or equal to 100 kg 45 mg administered subcutaneously initially and 4 weeks later, followed by 45 mg administered subcutaneously every 12 weeks
greater than 100 kg 90 mg administered subcutaneously initially and 4 weeks later, followed by 90 mg administered subcutaneously every 12 weeks
Psoriatic Arthritis Recommended Adult Subcutaneous Dosage (2.2):
The recommended dosage is 45 mg administered subcutaneously initially and 4 weeks later, followed by 45 mg administered subcutaneously every 12 weeks.
For patients with co-existent moderate-to-severe plaque psoriasis weighing greater than 100 kg, the recommended dosage is 90 mg administered subcutaneously initially and 4 weeks later, followed by 90 mg administered subcutaneously every 12 weeks.
Crohn's Disease Recommended Initial Adult Intravenous Dosage (2.3):
A single intravenous infusion using weight-based dosing:
Weight Range (kilogram) Recommended Dosage
Up to 55 kg 260 mg (2 vials)
Greater than 55 kg to 85 kg 390 mg (3 vials)
Greater than 85 kg 520 mg (4 vials)
Crohn's Disease Recommended Maintenance Adult Subcutaneous Dosage (2.3):
A subcutaneous 90 mg dose 8 weeks after the initial intravenous dose, then every 8 weeks thereafter.
DOSAGE FORMS AND STRENGTHS
Subcutneous Injection
Injection: 45 mg/0.5 mL or 90 mg/mL in a single-dose prefilled syringe (3)
Injection: 45 mg/0.5 mL in a single-dose vial (3)
Intravenous Infusion
Injection: 130 mg/26 mL (5 mg/mL) solution in a single-dose vial (3)
CONTRAINDICATIONS
Clinically significant hypersensitivity to ustekinumab or to any of the excipients. (4)
WARNINGS AND PRECAUTIONS
Infections: Serious infections have occurred. Do not start STELARA® during any clinically important active infection. If a serious infection or clinically significant infection develops, consider discontinuing STELARA® until the infection resolves. (5.1)
Theoretical Risk for Particular Infections: Serious infections from mycobacteria, salmonella and Bacillus Calmette-Guerin (BCG) vaccinations have been reported in patients genetically deficient in IL-12/IL-23. Diagnostic