Ibrutinib
ایبروتینیب
🎗️ Antineoplastic And Immunomodulating AgentsBTK inhibitor
Market / country: 🇺🇸 USA
Imbruvica (US)
🧮 Dose calculator
Chronic lymphocytic leukaemia (CLL) · Regimen source: FDA Imbruvica · 2.1
- • Only under an oncologist; continue until progression or unacceptable toxicity. Dose adjustments for toxicity and interactions per label. FDA Imbruvica · 2.1
- • Chronic GVHD: ≥12 years 420 mg; 1–<12 years 240 mg/m² (max 420). Swallow tablets or capsules whole with water. FDA Imbruvica · 2.1
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Warnings
- • Haemorrhage; infections; arrhythmias, cardiac failure and sudden death; hypertension; cytopenias; second primary malignancies; hepatotoxicity; embryo-fetal toxicity. FDA Imbruvica · 5
Formulations
- 70 mg capsule — capsule 🇺🇸 USA FDA Imbruvica · 3
- 140 mg capsule — capsule 🇺🇸 USA FDA Imbruvica · 3
- 140 mg tablet — tablet 🇺🇸 USA FDA Imbruvica · 3
- 280 mg tablet — tablet 🇺🇸 USA FDA Imbruvica · 3
- 420 mg tablet — tablet 🇺🇸 USA FDA Imbruvica · 3
👥 Special populations
- 🤰 PregnancyDangerous / avoid
Label: can cause fetal harm. Dangerous in pregnancy. FDA Imbruvica · 8.1
“Risk Summary IMBRUVICA can cause fetal harm based on findings from animal studies.”
- 🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Imbruvica · 8.2
“Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with IMBRUVICA and for 1 week after the last dose.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Imbruvica · 8.4
“Chronic GVHD The safety and effectiveness of IMBRUVICA have been established for treatment of cGVHD after failure of one or more lines of systemic therapy in pediatric patients 1 year of age and older.”
- 👴 Older adultsNo specific problem stated
Label: no specific difference or dose adjustment stated for older adults. FDA Imbruvica · 8.5
“No overall differences in effectiveness were observed between younger and older patients.”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Imbruvica · 8.3
“Contraception Females Advise females of reproductive potential to use effective contraception during treatment with IMBRUVICA and for 1 month after the last dose.”
🔗 Reference links
- FDA (approval record)NDA205552
- DailyMed (FDA label)FDA Imbruvica
- MedlinePlus (NIH)Ibrutinib
- WHO ATC/DDDL01EL01
- Darooyab (Iran)Ibrutinib
🇮🇷 Registered in Iran Darooyab · G-3748/Ibrutinib
Dosage forms with Iranian generic codes, per Darooyab.
- 50769 · IBRUTINIB CAPSULE ORAL 140 mg · کپسول ایبروتینیب ۱۴۰ میلیگرم
- 52760 · IBRUTINIB CAPSULE ORAL 70 mg · کپسول ایبروتینیب ۷۰ میلیگرم
- 52992 · IBRUTINIB CAPSULE ORAL 420 mg · کپسول ایبروتینیب ۴۲۰ میلیگرم
- 52700 · IBRUTINIB TABLET ORAL 140 mg · قرص ایبروتینیب ۱۴۰ میلیگرم
- 52993 · IBRUTINIB TABLET ORAL 560 mg · قرص ایبروتینیب ۵۶۰ میلیگرم
- 52991 · IBRUTINIB TABLET ORAL 280 mg · قرص ایبروتینیب ۲۸۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Imbruvica · 3FDA Imbruvica · 2.1FDA Imbruvica · 5FDA Imbruvica · SPL approval / marketing categoryFDA Imbruvica · 8.1FDA Imbruvica · 8.2FDA Imbruvica · 8.4FDA Imbruvica · 8.5FDA Imbruvica · 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-3748/Ibrutinib
- Clinical review⚠ Unverified