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Infliximab

اینفلیکسیمب

⚠ Unverified

🎗️ Antineoplastic And Immunomodulating AgentsTNF blocker

🤰 Pregnancy:Use with caution 🤱 Breastfeeding:Use with caution 👶 Children:Use with caution 👴 Older adults:Use with caution 🇮🇷 Registered in Iran ⛔ 1 contraindications 🇺🇸 FDA approved (BLA) BLA103772 ATC L04AB02

Market / country: 🇺🇸 USA

Remicade (US)

🧮 Dose calculator

Disease / regimen

Crohn’s disease · Regimen source: FDA Remicade · 2.1 FDA Remicade · 2.2

• Induction at weeks 0, 2 and 6, then maintenance every 8 weeks (not daily). IV infusion over at least 2 hours. FDA Remicade · 2.1
• Adults who lose response: 10 mg/kg may be considered. No response by week 14 — unlikely to respond. FDA Remicade · 2.1

Formulation

Age *

Weight (kg) *

Enter age and weight.

🛡️ Safety & information

Contraindications

⛔ Doses >5 mg/kg in moderate or severe heart failure; previous severe hypersensitivity to infliximab or murine proteins. FDA Remicade · 4

Warnings

• Boxed warning: serious infections (TB, fungal, opportunistic) and malignancy. Test for latent TB before starting and treat if positive. FDA Remicade · Boxed Warning
• Hepatosplenic T-cell lymphoma (mostly young patients on azathioprine/6-MP); infusion reactions; hepatitis B reactivation. FDA Remicade · Boxed Warning FDA Remicade · 5

Formulations

100 mg vial — powder for injection 🇺🇸 USA FDA Remicade · 3

👥 Special populations

🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Remicade · 8.1
“Risk Summary Available observational studies in pregnant women exposed to REMICADE showed no increased risk of major malformations among live births as compared to those exposed to non-biologics.”
🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Remicade · 8.2
“Risk Summary Published literature show that infliximab is present at low levels in human milk.”
👶 ChildrenUse with caution
Label: established for CD and UC at 6–17 y; boxed warning of lymphoma and malignancy in children and adolescents. FDA Remicade · 8.4
“The safety and effectiveness of REMICADE have been established in pediatric patients 6 to 17 years of age for induction and maintenance treatment of CD and UC.”
👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Remicade · 8.5
“… re close monitoring of geriatric patients for the development of serious infections is recommended [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] .”
⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.

🔗 Reference links

FDA (approval record)BLA103772
DailyMed (FDA label)FDA Remicade
MedlinePlus (NIH)Infliximab Injection
WHO ATC/DDDL04AB02
Darooyab (Iran)Infliximab

🇮🇷 Registered in Iran Darooyab · G-105/Infliximab

Dosage forms with Iranian generic codes, per Darooyab.

05831 · INFLIXIMAB 100MG VIAL · ویال اینفلیکسیمب ۱۰۰ میلی‌گرم

📚 Reference status for this drug

Shows which sources have references recorded for this drug and which do not.

FDA label (DailyMed)✅ Present
FDA Remicade · 3 FDA Remicade · 2.1 FDA Remicade · 2.2 FDA Remicade · 2.3 FDA Remicade · 2.4 FDA Remicade · 2.5 FDA Remicade · 2.6 FDA Remicade · 2.7 FDA Remicade · 2.8 FDA Remicade · 4 FDA Remicade · Boxed Warning FDA Remicade · 5 FDA Remicade · SPL approval / marketing category FDA Remicade · 8.1 FDA Remicade · 8.2 FDA Remicade · 8.4 FDA Remicade · 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)✅ Present
Darooyab · G-105/Infliximab
Clinical review⚠ Unverified