Recommended Dosing for Pediatric Crohn's Disease
Stelara (ustekinumab) is approved for children 6 years and older weighing at least 40 kg with moderately to severely active Crohn's disease. Dosing follows a weight-based intravenous (IV) induction followed by subcutaneous (SC) maintenance [1].
- Induction dose (IV, single dose): Administered over at least 60 minutes.
| Weight | Dose |
|--------|------|
| ≥40 kg to <55 kg | 260 mg |
| ≥55 kg to <85 kg | 390 mg |
| ≥85 kg | 520 mg |
- Maintenance dose (SC): Starts 8 weeks after induction, then every 8 or 12 weeks.
| Weight | Q8W Dose | Q12W Dose |
|--------|----------|-----------|
| ≥40 kg to <55 kg | 90 mg | 90 mg |
| ≥55 kg to <85 kg | 90 mg | 90 mg |
| ≥85 kg | 90 mg | 90 mg |
Doses use prefilled syringes (90 mg/mL). For children <40 kg, Stelara is not approved; clinical trials are ongoing [1][2].
How Providers Adjust Dosing
Adjust based on response and tolerability. If no response after induction, discontinue. For loss of response on Q12W maintenance, switch to Q8W. No formal dose adjustments for mild renal/hepatic impairment, but monitor closely [1].
Differences from Adult Dosing
Pediatric induction is strictly weight-tiered (260/390/520 mg IV), while adults often get 520 mg IV regardless of weight (unless <85 kg). Maintenance aligns at 90 mg SC Q8W/Q12W for ≥40 kg kids matching heavier adults [1][3].
What If Weight Changes?
Recheck weight before each dose. Switch tiers if child moves categories (e.g., from 390 mg to 520 mg IV if gaining weight). Providers may interpolate for edge cases, but follow labeled tiers [1].
Common Administration Questions
IV induction requires infusion center; SC maintenance is self- or caregiver-administered after training. Store refrigerated; allow to reach room temperature before injecting. Full course needs TB screening pre-treatment [1][2].
Safety and Monitoring in Kids
Monitor for infections, hypersensitivity. No black-box warnings specific to pediatrics, but same as adults: risk of serious infections, malignancy. Long-term data limited; growth monitored in trials [1].
[1]: Stelara Prescribing Information (FDA, 2023)
[2]: Crohn's & Colitis Foundation - Stelara for Kids
[3]: DrugPatentWatch.com - Stelara Pediatric Approvals