Tofacitinib
توفاسیتینیب
🎗️ Antineoplastic And Immunomodulating AgentsJAK inhibitor
Market / country: 🇺🇸 USA
Xeljanz (US)
🧮 Dose calculator
Rheumatoid arthritis · Regimen source: FDA Xeljanz · 2.3, Table 1
- • Moderate/severe renal or moderate hepatic impairment: 5 mg once daily. Do not start if lymphocytes <500, ANC <1000 or Hb <8. FDA Xeljanz · 2.3, Table 1
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Warnings
- • Boxed warning (JAK inhibitors): serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis. TB test before starting. FDA Xeljanz · Boxed Warning
Formulations
- 5 mg tablet — tablet 🇺🇸 USA FDA Xeljanz · 3
- 10 mg tablet — tablet 🇺🇸 USA FDA Xeljanz · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Xeljanz · 8.1
“Risk Summary The available data with XELJANZ (tablets and oral solution) and XELJANZ XR (extended-release tablets) from a pregnancy exposure registry that enrolled 11 exposed pregnant females, pharmacovigilance, and published literature are insufficient to draw conclusions about a drug‑associated risk of major birth …”
- 🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Xeljanz · 8.2
“… solution) and XELJANZ XR (extended-release tablets), such as increased risk of serious infections, advise patients that breastfeeding is not recommended during treatment and for at least 18 hours after the last dose of XELJANZ or 36 hours after the last dose of XELJANZ XR (approximately 6 elimination half-lives).”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Xeljanz · 8.4
“Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA) The safety and effectiveness of XELJANZ (tablets and oral solution) for the treatment of active pcJIA have been established in pediatric patients 2 years of age and older who have had an inadequate response or intolerance to one or more TNF blockers.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Xeljanz · 8.5
“Of the 3315 adults who were enrolled in clinical trials with RA (Studies RA-I to V), a total of 505 patients were 65 years of age and older, including 71 patients 75 years and older.”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Xeljanz · 8.3
“Contraception Females In an animal reproduction study, tofacitinib at AUC multiples of 13 times the recommended dosage of 5 mg twice daily and 6.3 times the maximum recommended dosage of 10 mg twice daily demonstrated adverse embryo-fetal findings [see Use in Specific Populations (8.1) ] .”
🔗 Reference links
- FDA (approval record)NDA203214
- DailyMed (FDA label)FDA Xeljanz
- MedlinePlus (NIH)Tofacitinib
- WHO ATC/DDDL04AF01
- Darooyab (Iran)Tofacitinib
🇮🇷 Registered in Iran Darooyab · G-4538/Tofacitinib
Dosage forms with Iranian generic codes, per Darooyab.
- 50711 · TOFACITINIB 5MG TAB · قرص توفاسیتینیب ۵ میلیگرم
- 52216 · TOFACITINIB 10MG TAB · قرص توفاسیتینیب ۱۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Xeljanz · 3FDA Xeljanz · 2.3, Table 1FDA Xeljanz · 2.5, Table 3FDA Xeljanz · Boxed WarningFDA Xeljanz · SPL approval / marketing categoryFDA Xeljanz · 8.1FDA Xeljanz · 8.2FDA Xeljanz · 8.4FDA Xeljanz · 8.5FDA Xeljanz · 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)✅ PresentDarooyab · G-4538/Tofacitinib
- Clinical review⚠ Unverified