Dimethyl fumarate
دیمتیل فومارات
🎗️ Antineoplastic And Immunomodulating AgentsImmunomodulator (MS)
Market / country: 🇺🇸 USA
Tecfidera (US)
🧮 Dose calculator
Multiple sclerosis (relapsing) · Regimen source: FDA Tecfidera · 2.1
- • Swallow whole. Flushing: take with food or non-enteric-coated aspirin up to 325 mg 30 min before. CBC with lymphocytes and liver tests before starting. FDA Tecfidera · 2.1FDA Tecfidera · 2.2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to dimethyl fumarate (anaphylaxis, angioedema). FDA Tecfidera · 4
Warnings
- • PML; herpes zoster and opportunistic infections; lymphopenia (CBC every 6–12 months); liver injury. FDA Tecfidera · 5
Formulations
- 120 mg delayed-release capsule — capsule 🇺🇸 USA FDA Tecfidera · 3
- 240 mg delayed-release capsule — capsule 🇺🇸 USA FDA Tecfidera · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Tecfidera · 8.1
“Risk Summary Available data from the TECFIDERA Pregnancy Registry, observational studies, and pharmacovigilance with dimethyl fumarate use in pregnant women have not indicated an increased risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Tecfidera · 8.2
“Risk Summary There are no data on the presence of DMF or MMF in human milk.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Tecfidera · 8.4
“Safety and effectiveness in pediatric patients have not been established.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Tecfidera · 8.5
“Clinical studies of TECFIDERA did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA204063
- DailyMed (FDA label)FDA Tecfidera
- MedlinePlus (NIH)Dimethyl Fumarate
- WHO ATC/DDDL04AX07
- Darooyab (Iran)Dimethyl-Fumarate
🇮🇷 Registered in Iran Darooyab · G-4656/Dimethyl-Fumarate
Dosage forms with Iranian generic codes, per Darooyab.
- 22926 · DIMETHYL FUMARATE CAPSULE ORAL 240 mg · کپسول دیمتیل فومارات ۲۴۰ میلیگرم
- 22925 · DIMETHYL FUMARATE CAPSULE 120mg · کپسول دیمتیل فومارات ۱۲۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Tecfidera · 3FDA Tecfidera · 2.1FDA Tecfidera · 2.2FDA Tecfidera · 4FDA Tecfidera · 5FDA Tecfidera · SPL approval / marketing categoryFDA Tecfidera · 8.1FDA Tecfidera · 8.2FDA Tecfidera · 8.4FDA Tecfidera · 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-4656/Dimethyl-Fumarate
- Clinical review⚠ Unverified