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Adalimumab

آدالیمومب

⚠ 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 🇺🇸 FDA approved (BLA) BLA125057 ATC L04AB04

Market / country: 🇺🇸 USA

Humira (US)

🧮 Dose calculator

Disease / regimen

Rheumatoid arthritis · Regimen source: FDA Humira · 2.2

⛔ 40 mg SC every OTHER WEEK (not daily). In RA without methotrexate some benefit from 40 mg weekly or 80 mg every other week. FDA Humira · 2.2

🛡️ Safety & information

Warnings

• Boxed warning: serious infections (TB, fungal, opportunistic) and malignancy. Test for latent TB before starting and treat if positive. FDA Humira · Boxed Warning
• Lymphoma and malignancy in children and adolescents; hepatitis B reactivation; heart failure; demyelinating disease; no live vaccines. FDA Humira · 5

Formulations

40 mg/0.4 mL or 40 mg/0.8 mL pen/syringe (also 80 mg, 20 mg, 10 mg) — injection 🇺🇸 USA FDA Humira · 3

👥 Special populations

🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Humira · 8.1
“Risk Summary Available studies with use of adalimumab during pregnancy do not reliably establish an association between adalimumab and major birth defects.”
🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Humira · 8.2
“Risk Summary Limited data from case reports in the published literature describe the presence of adalimumab in human milk at infant doses of 0.1% to 1% of the maternal serum concentration.”
👶 ChildrenUse with caution
Label: established for JIA from 2 y and some other indications; boxed warning of lymphoma and malignancy in children and adolescents. FDA Humira · 8.4
“The safety and effectiveness of HUMIRA have been established for: reducing signs and symptoms of moderately to severely active polyarticular JIA in pediatric patients 2 years of age and older.”
👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Humira · 8.5
“In patients treated with HUMIRA, closely monitor for the development of infection or malignancy [see Warnings and Precautions ( 5.1 , 5.2 )] .”
⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.

🔗 Reference links

FDA (approval record)BLA125057
DailyMed (FDA label)FDA Humira
MedlinePlus (NIH)Adalimumab Injection
WHO ATC/DDDL04AB04
Darooyab (Iran)Adalimumab

🇮🇷 Registered in Iran Darooyab · G-5/Adalimumab

Dosage forms with Iranian generic codes, per Darooyab.

16164 · ADALIMUMAB 40MG/0.8ML INJ · فرآورده تزریقی آدالیمومب ۴۰ میلی‌گرم / ۰٫۸ میلی‌لیتر
52035 · ADALIMUMAB 50 mg/1mL 0.4ML INJ · فرآورده تزریقی آدالیمومب ۵۰ میلی‌گرم / ۱ میلی‌لیتر ۰٫۴ میلی‌لیتر

📚 Reference status for this drug

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

FDA label (DailyMed)✅ Present
FDA Humira · 3 FDA Humira · 2.2 FDA Humira · 2 FDA Humira · 2.7 FDA Humira · Boxed Warning FDA Humira · 5 FDA Humira · SPL approval / marketing category FDA Humira · 8.1 FDA Humira · 8.2 FDA Humira · 8.4 FDA Humira · 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-5/Adalimumab
Clinical review⚠ Unverified