STELARA- ustekinumab injection, solution
STELARA- ustekinumab solution
Janssen Biotech, Inc.
STELARA® is indicated for the treatment of patients 6 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
STELARA® is indicated for the treatment of adult patients with active psoriatic arthritis. STELARA® can be used alone or in combination with methotrexate (MTX).
STELARA® is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease.
STELARA® is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.
Subcutaneous Adult Dosage Regimen
- For patients weighing 100 kg or less, the recommended dose is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks.
- For patients weighing more than 100 kg, the recommended dose is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.
In subjects weighing more than 100 kg, 45 mg was also shown to be efficacious. However, 90 mg resulted in greater efficacy in these subjects [see Clinical Studies (14)].
Subcutaneous Pediatric Dosage Regimen
Administer STELARA® subcutaneously at Weeks 0 and 4, then every 12 weeks thereafter.
The recommended dose of STELARA® for pediatric patients (6–17 years old) based on body weight is shown below (Table 1).
| Body Weight of Patient at the Time of Dosing||Recommended Dose|
| less than 60 kg||0.75 mg/kg|
| 60 kg to 100 kg||45 mg|
| more than 100 kg||90 mg|
For pediatric patients weighing less than 60 kg, the administration volume for the recommended dose (0.75 mg/kg) is shown in Table 2; withdraw the appropriate volume from the single-dose vial.
| Body Weight (kg) at the time of dosing||Dose (mg)||Volume of injection (mL)|
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