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Etanercept

اتانرسپت

⚠ 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) BLA103795 ATC L04AB01

Market / country: 🇺🇸 USA

Enbrel (US)

🧮 Dose calculator

Disease / regimen

Rheumatoid arthritis · Regimen source: FDA Enbrel · 2

⛔ 50 mg SC once WEEKLY (not daily), with or without methotrexate. FDA Enbrel · 2

🛡️ Safety & information

Contraindications

⛔ Sepsis. FDA Enbrel · 4

Warnings

• Boxed warning: serious infections (TB, fungal, opportunistic) and malignancy. Test for latent TB before starting and treat if positive. FDA Enbrel · Boxed Warning

Formulations

50 mg/mL prefilled syringe or autoinjector — injection 🇺🇸 USA FDA Enbrel · 3
25 mg/0.5 mL single-dose vial — injection 🇺🇸 USA FDA Enbrel · 3

👥 Special populations

🤰 PregnancyUse with caution
Label: available studies do not reliably support an association with major birth defects. FDA Enbrel · 8.1
“Available studies with use of etanercept during pregnancy do not reliably support an association between etanercept and major birth defects.”
🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Enbrel · 8.2
“Risk Summary Data from published literature show that etanercept is present in low levels in human milk but is not detected in the plasma of breastfed infants (see Data ) .”
👶 ChildrenUse with caution
Label: established for pJIA from 2 y; boxed warning of lymphoma and malignancy in children and adolescents. FDA Enbrel · 8.4
“The safety and effectiveness of Enbrel have been established in pediatric patients 2 years of age and older with pJIA.”
👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Enbrel · 8.5
“Because there is a higher incidence of infections in the elderly population in general, caution should be used in 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)BLA103795
DailyMed (FDA label)FDA Enbrel
MedlinePlus (NIH)Etanercept Injection
WHO ATC/DDDL04AB01
Darooyab (Iran)Etanercept

🇮🇷 Registered in Iran Darooyab · G-68/Etanercept

Dosage forms with Iranian generic codes, per Darooyab.

04008 · ETANERCEPT 25MG VIAL · ویال اتانرسپت ۲۵ میلی‌گرم
21559 · ETANERCEPT 50MG PREFILLED SYRINGE · سرنگ از پیش پرشده اتانرسپت ۵۰ میلی‌گرم
08170 · ETANERCEPT 50MG VIAL · ویال اتانرسپت ۵۰ میلی‌گرم
52294 · ETANERCEPT INJECTION, SOLUTION SUBCUTANEOUS 25 mg/0.5mL · فرآورده تزریقی اتانرسپت ۲۵ میلی‌گرم / ۰٫۵ میلی‌لیتر

📚 Reference status for this drug

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

FDA label (DailyMed)✅ Present
FDA Enbrel · 3 FDA Enbrel · 2 FDA Enbrel · 2.4 FDA Enbrel · 4 FDA Enbrel · Boxed Warning FDA Enbrel · SPL approval / marketing category FDA Enbrel · 8.1 FDA Enbrel · 8.2 FDA Enbrel · 8.4 FDA Enbrel · 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-68/Etanercept
Clinical review⚠ Unverified