Vedolizumab
ودولیزوماب
🎗️ Antineoplastic And Immunomodulating AgentsAnti-α4β7 integrin antibody
Market / country: 🇺🇸 USA
Entyvio (US)
🧮 Dose calculator
Ulcerative colitis · Regimen source: FDA Entyvio · 2
- • Infuse over about 30 min. After two IV doses, may switch to 108 mg SC every 2 weeks. Stop if no benefit by week 14. FDA Entyvio · 2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Prior serious hypersensitivity to vedolizumab. FDA Entyvio · 4
Warnings
- • Infusion and hypersensitivity reactions; infections; progressive multifocal leukoencephalopathy (PML); liver injury; complete immunisations before starting. FDA Entyvio · 5
Formulations
- 300 mg vial — powder for injection 🇺🇸 USA FDA Entyvio · 3
- 108 mg/0.68 mL prefilled syringe or pen — injection 🇺🇸 USA FDA Entyvio · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Entyvio · 8.1
“Risk Summary Available data from the Organization of Teratology Information Specialists (OTIS)/MotherToBaby ENTYVIO Pregnancy Registry, published literature and pharmacovigilance in pregnant women have not reliably identified an ENTYVIO-associated risk of major birth defects, miscarriage or adverse maternal or fetal …”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Entyvio · 8.2
“Risk Summary Data from a clinical lactation study show the presence of vedolizumab in human milk.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Entyvio · 8.4
“Safety and effectiveness of ENTYVIO in pediatric patients have not been established.”
- 👴 Older adultsNo specific problem stated
Label: no specific difference or dose adjustment stated for older adults. FDA Entyvio · 8.5
“However, no overall differences in safety or effectiveness were observed between these patients and younger adult patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)BLA125476
- DailyMed (FDA label)FDA Entyvio
- MedlinePlus (NIH)Vedolizumab Injection
- WHO ATC/DDDL04AG05
- Darooyab (Iran)Vedolizumab
🇮🇷 Registered in Iran Darooyab · G-4574/Vedolizumab
Dosage forms with Iranian generic codes, per Darooyab.
- 52954 · VEDOLIZUMAB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PARENTERAL 300 mg · محلول تزریقی ودولیزومب ۳۰۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Entyvio · 3FDA Entyvio · 2FDA Entyvio · 4FDA Entyvio · 5FDA Entyvio · SPL approval / marketing categoryFDA Entyvio · 8.1FDA Entyvio · 8.2FDA Entyvio · 8.4FDA Entyvio · 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-4574/Vedolizumab
- Clinical review⚠ Unverified