Tocilizumab
توسیلیزوماب
🎗️ Antineoplastic And Immunomodulating AgentsAnti-IL-6 receptor antibody
Market / country: 🇺🇸 USA
Actemra (US)
🧮 Dose calculator
Rheumatoid arthritis · Regimen source: FDA Actemra · 2.2
- • Do not start if ANC <2000, platelets <100,000 or ALT/AST >1.5× ULN. FDA Actemra · 2.1
Enter age and weight.
🛡️ Safety & information
Contraindications
- ⛔ Known hypersensitivity to tocilizumab. FDA Actemra · 4
Warnings
- • Boxed warning: serious infections (TB, fungal, opportunistic) — interrupt for serious infection. FDA Actemra · Boxed Warning
- • GI perforation; hepatotoxicity; neutropenia, thrombocytopenia and lipid elevation; demyelinating disorders. FDA Actemra · 5
Formulations
- 20 mg/mL vial (80/200/400 mg) for IV infusion — injection 🇺🇸 USA FDA Actemra · 3
- 162 mg/0.9 mL prefilled syringe or ACTPen — injection 🇺🇸 USA FDA Actemra · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Actemra · 8.1
“Risk Summary The available data with ACTEMRA from a pregnancy exposure registry, retrospective cohort study, pharmacovigilance, and published literature are insufficient to draw conclusions about a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Actemra · 8.2
“Risk Summary No information is available on the presence of tocilizumab in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Actemra · 8.4
“COVID-19 – Intravenous Use The safety and effectiveness of ACTEMRA have been established for the treatment of pediatric patients aged 2 years and older with COVID-19.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Actemra · 8.5
“As there is a higher incidence of infections in the elderly population in general, caution should be used when treating the elderly.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)BLA125276
- DailyMed (FDA label)FDA Actemra
- MedlinePlus (NIH)Tocilizumab Injection
- WHO ATC/DDDL04AC07
- Darooyab (Iran)Tocilizumab
🇮🇷 Registered in Iran Darooyab · G-4308/Tocilizumab
Dosage forms with Iranian generic codes, per Darooyab.
- 15157 · TOCILIZUMAB 400MG/20ML VIAL · ویال توسیلیزومب ۴۰۰ میلیگرم / ۲۰ میلیلیتر
- 16254 · TOCILIZUMAB 80MG/4ML VIAL · ویال توسیلیزومب ۸۰ میلیگرم / ۴ میلیلیتر
- 50908 · TOCILIZUMAB 200MG/10ML VIAL · ویال توسیلیزومب ۲۰۰ میلیگرم / ۱۰ میلیلیتر
- 52706 · TOCILIZUMAB 162MG/0.9ML VIAL · ویال توسیلیزومب ۱۶۲ میلیگرم / ۰٫۹ میلیلیتر
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Actemra · 3FDA Actemra · 2.2FDA Actemra · 2.1FDA Actemra · 2.3FDA Actemra · 2.5FDA Actemra · 2.6FDA Actemra · 2.7FDA Actemra · 2.8FDA Actemra · 4FDA Actemra · Boxed WarningFDA Actemra · 5FDA Actemra · SPL approval / marketing categoryFDA Actemra · 8.1FDA Actemra · 8.2FDA Actemra · 8.4FDA Actemra · 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-4308/Tocilizumab
- Clinical review⚠ Unverified