Ruxolitinib cream 1.5%
کرم روکسولیتینیب ۱٫۵٪
🧴 DermatologicalsTopical JAK inhibitor
Market / country: 🇺🇸 USA
Opzelura (US)
🧮 Dose calculator
Vitiligo · Regimen source: FDA Opzelura · 2.2
🛡️ Safety & information
Warnings
- • Boxed warning (JAK inhibitors): serious infections, mortality, malignancy, MACE and thrombosis. FDA Opzelura · Boxed Warning
Formulations
- Ruxolitinib 1.5% cream (60 g, 100 g) — cream 🇺🇸 USA FDA Opzelura · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Opzelura · 8.1
“Risk Summary Available data from pregnancies reported in clinical trials with OPZELURA are not sufficient to evaluate a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes.”
- 🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Opzelura · 8.2
“Because of the serious adverse findings in adults, including risks of serious infections, thrombocytopenia, anemia, and neutropenia, advise women not to breastfeed during treatment with OPZELURA and for approximately four weeks after the last dose (approximately 5‑6 elimination half-lives).”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Opzelura · 8.4
“Atopic Dermatitis The safety and effectiveness of OPZELURA for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis have been established in non-immunocompromised pediatric patients ages 2 years and older whose disease is not adequately controlled with topical prescription …”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Opzelura · 8.5
“Of the 1249 total subjects with atopic dermatitis in clinical trials with OPZELURA, 115 (9%) were 65 years of age and older [see Clinical Studies ( 14.1 ) ] .”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA215309
- DailyMed (FDA label)FDA Opzelura
- MedlinePlus (NIH)❌ None
- WHO ATC/DDDD11AH09
- Darooyab (Iran)❌ None
🇮🇷 Not found in Iran list Darooyab · search
Darooyab lists no registered dosage form or brand for this drug. This does not prove it is unavailable.
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Opzelura · 3FDA Opzelura · 2.2FDA Opzelura · 2.1FDA Opzelura · Boxed WarningFDA Opzelura · SPL approval / marketing categoryFDA Opzelura · 8.1FDA Opzelura · 8.2FDA Opzelura · 8.4FDA Opzelura · 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 · search
- Clinical review⚠ Unverified