Golimumab
گولیموماب
🎗️ Antineoplastic And Immunomodulating AgentsTNF blocker
Market / country: 🇺🇸 USA
Simponi (US)
🧮 Dose calculator
Rheumatoid arthritis · Regimen source: FDA Simponi · 2.2
- • Before starting: screen for active and latent TB (treat latent TB first) and complete age-appropriate vaccines. FDA Simponi · 2.1
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Warnings
- • Boxed warning: serious infections (TB, invasive fungal, opportunistic) and malignancy (lymphoma, especially in children) — test for latent TB and HBV first. FDA Simponi · Boxed Warning
- • Heart failure; demyelination; HBV reactivation; cytopenias; not with abatacept or anakinra. FDA Simponi · 5
Formulations
- 50 mg/0.5 mL syringe or SmartJect — injection 🇺🇸 USA FDA Simponi · 3
- 100 mg/mL syringe or SmartJect — injection 🇺🇸 USA FDA Simponi · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Simponi · 8.1
“Risk Summary Available data from postmarketing case reports with golimumab use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Simponi · 8.2
“Risk Summary There is no information regarding the presence of SIMPONI in human milk, the effects on breastfed infants, or the effects on milk production.”
- 👶 ChildrenUse with caution
Label: established for ulcerative colitis in children ≥15 kg; boxed warning of lymphoma and malignancy in children and adolescents. FDA Simponi · 8.4
“The safety and effectiveness of SIMPONI for the treatment of moderately to severely active ulcerative colitis have been established in pediatric patients weighing at least 15 kg.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Simponi · 8.5
“Because there is a higher incidence of infections in the geriatric population in general, caution should be used in treating geriatric patients with SIMPONI [see Warnings and Precautions (5.1 , 5.5) ] .”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)BLA125289
- DailyMed (FDA label)FDA Simponi
- MedlinePlus (NIH)Golimumab Injection
- WHO ATC/DDDL04AB06
- Darooyab (Iran)Golimumab
🇮🇷 Registered in Iran Darooyab · G-4758/Golimumab
Dosage forms with Iranian generic codes, per Darooyab.
- 17284 · GOLIMUMAB 50MG/0.5ML VIAL · ویال گولیمومب ۵۰ میلیگرم / ۰٫۵ میلیلیتر
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Simponi · 3FDA Simponi · 2.2FDA Simponi · 2.1FDA Simponi · 2.3, Table 1FDA Simponi · Boxed WarningFDA Simponi · 5FDA Simponi · SPL approval / marketing categoryFDA Simponi · 8.1FDA Simponi · 8.2FDA Simponi · 8.4FDA Simponi · 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-4758/Golimumab
- Clinical review⚠ Unverified