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Certolizumab pegol

سرتولیزوماب پگول

⚠ Unverified

🎗️ Antineoplastic And Immunomodulating AgentsTNF blocker

🤰 Pregnancy:Use with caution 🤱 Breastfeeding:Use with caution 👶 Children:Use with caution 👴 Older adults:Use with caution 🇮🇷 Not found in Iran list ⛔ 1 contraindications 🇺🇸 FDA approved (BLA) BLA125160 ATC L04AB05

Market / country: 🇺🇸 USA

Cimzia (US)

🧮 Dose calculator

Disease / regimen

Rheumatoid arthritis · Regimen source: FDA Cimzia · 2.2 FDA Cimzia · 2.1 FDA Cimzia · 2.4 FDA Cimzia · 2.5

• Before starting: screen for active and latent TB (treat latent TB first) and complete age-appropriate vaccines. FDA Cimzia · 2.10

Formulation

Age *

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Enter age (weight is optional for this regimen).

🛡️ Safety & information

Contraindications

⛔ Serious hypersensitivity to certolizumab (angioedema, anaphylaxis, serum sickness). FDA Cimzia · 4

Warnings

• Boxed warning: serious infections (TB, invasive fungal, opportunistic) and malignancy (lymphoma, especially in children) — test for latent TB and HBV first. FDA Cimzia · Boxed Warning
• Heart failure; HBV reactivation; demyelinating disease; cytopenias; lupus-like syndrome; not with other biologics. FDA Cimzia · 5

Formulations

200 mg/mL prefilled syringe — injection 🇺🇸 USA FDA Cimzia · 3

👥 Special populations

🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Cimzia · 8.1
“Risk Summary Limited data from an ongoing pregnancy exposure registry on use of CIMZIA in pregnant women are not sufficient to inform a risk of major birth defects or other adverse pregnancy outcomes.”
🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Cimzia · 8.2
“Risk Summary In a multicenter clinical study of 17 lactating women treated with CIMZIA at 200 mg every 2 weeks or 400 mg every 4 weeks, minimal certolizumab pegol concentrations were observed in breast milk.”
👶 ChildrenUse with caution
Label: established for polyarticular JIA from 2 y; boxed warning of lymphoma and malignancy in children and adolescents. FDA Cimzia · 8.4
“The safety and effectiveness of CIMZIA for active polyarticular juvenile idiopathic arthritis has been established 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 Cimzia · 8.5
“Because there is a higher incidence of infections in the elderly population in general, use caution when treating the elderly with CIMZIA [see Warnings and Precautions (5.1) ] .”
⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.

🔗 Reference links

FDA (approval record)BLA125160
DailyMed (FDA label)FDA Cimzia
MedlinePlus (NIH)Certolizumab Injection
WHO ATC/DDDL04AB05
Darooyab (Iran)Certolizumab-Pegol

🇮🇷 Not found in Iran list Darooyab · G-2927/Certolizumab-Pegol

Darooyab lists no registered dosage form or brand for this drug. This does not prove it is unavailable.

📚 Reference status for this drug

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

FDA label (DailyMed)✅ Present
FDA Cimzia · 3 FDA Cimzia · 2.2 FDA Cimzia · 2.1 FDA Cimzia · 2.4 FDA Cimzia · 2.5 FDA Cimzia · 2.10 FDA Cimzia · 2.6 FDA Cimzia · 2.7 FDA Cimzia · 2.3 FDA Cimzia · 4 FDA Cimzia · Boxed Warning FDA Cimzia · 5 FDA Cimzia · 8.1 FDA Cimzia · 8.2 FDA Cimzia · 8.4 FDA Cimzia · 8.5 FDA Cimzia · SPL approval / marketing category
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-2927/Certolizumab-Pegol
Clinical review⚠ Unverified