Glatiramer acetate
گلاتیرامر استات
🎗️ Antineoplastic And Immunomodulating AgentsMS immunomodulator
Market / country: 🇺🇸 USA
Copaxone (US)
🧮 Dose calculator
Multiple sclerosis (relapsing) · Regimen source: FDA Copaxone · 2.1
- • 20 mg and 40 mg are not interchangeable. Never IV. Warm to room temperature first. FDA Copaxone · 2.1FDA Copaxone · 2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to glatiramer acetate or mannitol. FDA Copaxone · 4
Warnings
- • Boxed warning: life-threatening anaphylaxis, from the first dose up to years later. FDA Copaxone · Boxed Warning
- • Immediate post-injection reaction; chest pain; lipoatrophy and skin necrosis; liver injury. FDA Copaxone · 5
Formulations
- 20 mg/mL prefilled syringe (white plunger) — injection 🇺🇸 USA FDA Copaxone · 3
- 40 mg/mL prefilled syringe (blue plunger) — injection 🇺🇸 USA FDA Copaxone · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Copaxone · 8.1
“Risk Summary Available data from pharmacovigilance and published observational studies over decades of use with glatiramer acetate during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes (see Data) .”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Copaxone · 8.2
“Risk Summary There are no data on the presence of glatiramer acetate in human milk.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Copaxone · 8.4
“The safety and effectiveness of COPAXONE have not been established in patients under 18 years of age.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Copaxone · 8.5
“COPAXONE has not been studied in elderly patients.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA020622
- DailyMed (FDA label)FDA Copaxone
- MedlinePlus (NIH)Glatiramer Injection
- WHO ATC/DDDL03AX13
- Darooyab (Iran)Glatiramer-Acetate
🇮🇷 Registered in Iran Darooyab · G-3869/Glatiramer-Acetate
Dosage forms with Iranian generic codes, per Darooyab.
- 10683 · GLATIRAMER ACETATE 20MG/ML PREFILLED SYRINGE · سرنگ از پیش پرشده گلاتیرامر استات ۲۰ میلیگرم / میلیلیتر
- 23125 · GLATIRAMER ACETATE 40MG/ML PREFILLED SYRINGE · سرنگ از پیش پرشده گلاتیرامر استات ۴۰ میلیگرم / میلیلیتر
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Copaxone · 3FDA Copaxone · 2.1FDA Copaxone · 2FDA Copaxone · 4FDA Copaxone · Boxed WarningFDA Copaxone · 5FDA Copaxone · SPL approval / marketing categoryFDA Copaxone · 8.1FDA Copaxone · 8.2FDA Copaxone · 8.4FDA Copaxone · 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-3869/Glatiramer-Acetate
- Clinical review⚠ Unverified