Natalizumab
ناتالیزوماب
🎗️ Antineoplastic And Immunomodulating AgentsAnti-α4 integrin antibody
Market / country: 🇺🇸 USA
Tysabri (US)
🧮 Dose calculator
Multiple sclerosis (relapsing) · Regimen source: FDA Tysabri · 2.1
- • TOUCH program only; never IV push; use within 48 h of preparation. Observe 1 h after each of the first 12 infusions. FDA Tysabri · 2.1FDA Tysabri · 2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Current or past PML; hypersensitivity to natalizumab. FDA Tysabri · 4
Warnings
- • Boxed warning: progressive multifocal leukoencephalopathy (PML) — risk rises with anti-JCV antibodies, treatment duration and prior immunosuppressants. FDA Tysabri · Boxed Warning
- • Herpes infections (encephalitis, retinitis); hepatotoxicity; hypersensitivity. FDA Tysabri · 5
Formulations
- 300 mg/15 mL (20 mg/mL) vial for IV infusion — injection 🇺🇸 USA FDA Tysabri · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Tysabri · 8.1
“Risk Summary There are no adequate data on the risk of major birth defects, miscarriage, or other adverse maternal outcomes associated with the use of TYSABRI in pregnant women.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Tysabri · 8.2
“Risk Summary Natalizumab has been detected in human milk.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Tysabri · 8.4
“Safety and effectiveness in pediatric patients with multiple sclerosis or Crohn's disease below the age of 18 years have not been established.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Tysabri · 8.5
“Clinical studies of TYSABRI did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently than younger patients.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)BLA125104
- DailyMed (FDA label)FDA Tysabri
- MedlinePlus (NIH)Natalizumab Injection
- WHO ATC/DDDL04AG03
- Darooyab (Iran)Natalizumab
🇮🇷 Registered in Iran Darooyab · G-4040/Natalizumab
Dosage forms with Iranian generic codes, per Darooyab.
- 12534 · NATALIZUMAB 20MG/ML VIAL · ویال ناتالیزومب ۲۰ میلیگرم / میلیلیتر
- 11759 · NATALIZUMAB 300 AMP · آمپول ناتالیزومب ۳۰۰
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Tysabri · 3FDA Tysabri · 2.1FDA Tysabri · 2FDA Tysabri · 2.2FDA Tysabri · 4FDA Tysabri · Boxed WarningFDA Tysabri · 5FDA Tysabri · SPL approval / marketing categoryFDA Tysabri · 8.1FDA Tysabri · 8.2FDA Tysabri · 8.4FDA Tysabri · 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-4040/Natalizumab
- Clinical review⚠ Unverified