Ustekinumab
اوستکینومب
🎗️ Antineoplastic And Immunomodulating AgentsIL-12/23 inhibitor
Market / country: 🇺🇸 USA
Stelara (US)
🧮 Dose calculator
Crohn’s disease · Regimen source: FDA Stelara · 2.3, Table 4FDA Stelara · 2.5
- • One infusion (≥1 h); then 90 mg SC 8 weeks later and every 8 weeks. FDA Stelara · 2.3
Enter age and weight.
🛡️ Safety & information
Contraindications
- ⛔ Clinically significant hypersensitivity to ustekinumab or excipients. FDA Stelara · 4
Warnings
- • Serious infections and TB (test first); malignancy; posterior reversible encephalopathy; no live vaccines. FDA Stelara · 5
Formulations
- 130 mg/26 mL (5 mg/mL) IV vial — injection 🇺🇸 USA FDA Stelara · 3
- 45 mg/0.5 mL prefilled syringe (also 90 mg/mL) — injection 🇺🇸 USA FDA Stelara · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Stelara · 8.1
“Risk Summary Available data from the Organization of Teratology Information Specialists (OTIS)/MotherToBaby STELARA Pregnancy Registry, published literature and pharmacovigilance in pregnant women have not identified a STELARA-associated risk of major birth defects, miscarriage or other adverse maternal or fetal …”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Stelara · 8.2
“Risk Summary Limited data from published literature suggests that ustekinumab is present in human breast milk.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Stelara · 8.4
“Plaque Psoriasis The safety and effectiveness of STELARA have been established for the treatment of moderate to severe plaque psoriasis in pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Stelara · 8.5
“Of the 6709 subjects exposed to STELARA, a total of 340 were 65 years of age or older (183 subjects with plaque psoriasis, 65 subjects with psoriatic arthritis, 58 subjects with Crohn's disease, and 34 subjects with ulcerative colitis), and 40 subjects were 75 years of age or older.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)BLA125261
- DailyMed (FDA label)FDA Stelara
- MedlinePlus (NIH)Ustekinumab Injection
- WHO ATC/DDDL04AC05
- Darooyab (Iran)Ustekinumab
🇮🇷 Registered in Iran Darooyab · G-5322/Ustekinumab
Dosage forms with Iranian generic codes, per Darooyab.
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Stelara · 3FDA Stelara · 2.3, Table 4FDA Stelara · 2.5FDA Stelara · 2.3FDA Stelara · 2.1FDA Stelara · 2.2FDA Stelara · 4FDA Stelara · 5FDA Stelara · SPL approval / marketing categoryFDA Stelara · 8.1FDA Stelara · 8.2FDA Stelara · 8.4FDA Stelara · 8.5
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-5322/Ustekinumab
- Clinical review⚠ Unverified