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Teriflunomide

تری‌فلونوماید

⚠ Unverified

🎗️ Antineoplastic And Immunomodulating AgentsImmunomodulator (MS)

🤰 Pregnancy:Contraindicated 🤱 Breastfeeding:Dangerous / avoid 👶 Children:Safety not established 👴 Older adults:Use with caution ⚥ Females & males of reproductive potential:Use with caution 🇮🇷 Registered in Iran ⛔ 1 contraindications 🇺🇸 FDA approved (NDA) NDA202992 ATC L04AK02

Market / country: 🇺🇸 USA

Aubagio (US)

🧮 Dose calculator

Disease / regimen

Multiple sclerosis (relapsing) · Regimen source: FDA Aubagio · 2

Formulation

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🛡️ Safety & information

Contraindications

⛔ Severe hepatic impairment; pregnancy, or females of reproductive potential not using effective contraception; hypersensitivity; current leflunomide. FDA Aubagio · 4 FDA Aubagio · Boxed Warning

Warnings

• Boxed warning: hepatotoxicity (monthly ALT for 6 months) and embryofetal toxicity (exclude pregnancy before starting; accelerated elimination with cholestyramine or charcoal). FDA Aubagio · Boxed Warning FDA Aubagio · 5

Formulations

7 mg tablet — tablet 🇺🇸 USA FDA Aubagio · 3
14 mg tablet — tablet 🇺🇸 USA FDA Aubagio · 3

👥 Special populations

🤰 PregnancyContraindicated
Label: contraindicated in pregnancy. FDA Aubagio · 4
“Severe hepatic impairment ( 4 , 5.1 ) Pregnancy ( 4 , 5.2 , 8.1 ) Hypersensitivity ( 4 , 5.5 ) Current leflunomide treatment ( 4 ) AUBAGIO is contraindicated in/with: Patients with severe hepatic impairment [see Warnings and Precautions (5.1) ] .”
🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Aubagio · 8.2
“Because of the potential for adverse reactions in a breastfed infant from AUBAGIO, women should not breastfeed during treatment with AUBAGIO.”
👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Aubagio · 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 Aubagio · 8.5
“Clinical studies of AUBAGIO did not include patients over 65 years old.”
⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Aubagio · 8.3
“Contraception Females Females of reproductive potential should use effective contraception while taking AUBAGIO.”

🔗 Reference links

FDA (approval record)NDA202992
DailyMed (FDA label)FDA Aubagio
MedlinePlus (NIH)Teriflunomide
WHO ATC/DDDL04AK02
Darooyab (Iran)Teriflunomide

🇮🇷 Registered in Iran Darooyab · G-3853/Teriflunomide

Dosage forms with Iranian generic codes, per Darooyab.

52932 · TERIFLUNOMIDE 7MG TAB · قرص تریفلونوماید ۷ میلی‌گرم
22698 · TERIFLUNOMIDE 14MG TAB · قرص تریفلونوماید ۱۴ میلی‌گرم

📚 Reference status for this drug

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

FDA label (DailyMed)✅ Present
FDA Aubagio · 3 FDA Aubagio · 2 FDA Aubagio · 4 FDA Aubagio · Boxed Warning FDA Aubagio · 5 FDA Aubagio · SPL approval / marketing category FDA Aubagio · 8.2 FDA Aubagio · 8.4 FDA Aubagio · 8.5 FDA Aubagio · 8.3
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-3853/Teriflunomide
Clinical review⚠ Unverified