Upadacitinib
اوپاداسیتینیب
🎗️ Antineoplastic And Immunomodulating AgentsJAK inhibitor
Market / country: 🇺🇸 USA
Rinvoq (US)
🧮 Dose calculator
Rheumatoid arthritis · Regimen source: FDA Rinvoq · 2.3
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to upadacitinib. FDA Rinvoq · 4
Warnings
- • Boxed warning (JAK inhibitors): serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis. TB test before starting. FDA Rinvoq · Boxed Warning
Formulations
- 15 mg extended-release tablet — tablet 🇺🇸 USA FDA Rinvoq · 3
- 30 mg extended-release tablet — tablet 🇺🇸 USA FDA Rinvoq · 3
- 45 mg extended-release tablet — tablet 🇺🇸 USA FDA Rinvoq · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Rinvoq · 8.1
“Risk Summary Available data from the pharmacovigilance safety database and postmarketing case reports on use of RINVOQ in pregnant women are not sufficient to evaluate a drug-associated risk for major birth defects or miscarriage.”
- 🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Rinvoq · 8.2
“Because of the potential for serious adverse reactions in the breastfed infant, advise patients that breastfeeding is not recommended during treatment with RINVOQ/RINVOQ LQ, and for 6 days (approximately 10 half-lives) after the last dose.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Rinvoq · 8.4
“Polyarticular Juvenile Idiopathic Arthritis and Psoriatic Arthritis The safety and effectiveness of RINVOQ/RINVOQ LQ in pediatric patients 2 to less than 18 years of age with pJIA and psoriatic arthritis have been established.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Rinvoq · 8.5
“Rheumatoid Arthritis and Psoriatic Arthritis Of the 4381 patients treated in the five clinical trials, a total of 906 rheumatoid arthritis patients were 65 years of age or older, including 146 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 Rinvoq · 8.3
“Contraception Females Based on animal studies, upadacitinib may cause embryo-fetal harm when administered to pregnant women [see Use in Specific Populations ( 8.1 )] .”
🔗 Reference links
- FDA (approval record)NDA211675
- DailyMed (FDA label)FDA Rinvoq
- MedlinePlus (NIH)Upadacitinib
- WHO ATC/DDDL04AF03
- Darooyab (Iran)Upadacitinib
🇮🇷 Registered in Iran Darooyab · G-5556/Upadacitinib
Dosage forms with Iranian generic codes, per Darooyab.
- 53370 · UPADACITINIB 15 mg E.R Tablet · قرص آهستهرهش اوپاداسیتینیب ۱۵ میلیگرم
- 53371 · UPADACITINIB 30 mg E.R Tablet · قرص آهستهرهش اوپاداسیتینیب ۳۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Rinvoq · 3FDA Rinvoq · 2.3FDA Rinvoq · 2.5FDA Rinvoq · 2.12FDA Rinvoq · 2.6FDA Rinvoq · 2.7FDA Rinvoq · 4FDA Rinvoq · Boxed WarningFDA Rinvoq · SPL approval / marketing categoryFDA Rinvoq · 8.1FDA Rinvoq · 8.2FDA Rinvoq · 8.4FDA Rinvoq · 8.5FDA Rinvoq · 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-5556/Upadacitinib
- Clinical review⚠ Unverified