Eltrombopag
الترومبوپاگ
🩸 Blood And Blood Forming OrgansThrombopoietin receptor agonist
Market / country: 🇺🇸 USA
Promacta (US)
🧮 Dose calculator
Immune thrombocytopenia (ITP) · Regimen source: FDA Promacta · 2.1
- • East-/Southeast-Asian ancestry or hepatic impairment: start 25 mg. Target platelets ≥50×10⁹/L, not normalisation. FDA Promacta · 2.1
- • Fasting or with a low-calcium meal; 2 h before or 4 h after antacids, dairy and iron/calcium/zinc supplements. FDA Promacta · 2.4
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Warnings
- • Boxed warning: hepatic decompensation in hepatitis C with interferon/ribavirin; hepatotoxicity — monitor liver tests. FDA Promacta · Boxed Warning
- • Thrombotic events; cataracts; risk of MDS progression. FDA Promacta · 5
Formulations
- 12.5 mg tablet — tablet 🇺🇸 USA FDA Promacta · 3
- 25 mg tablet — tablet 🇺🇸 USA FDA Promacta · 3
- 50 mg tablet — tablet 🇺🇸 USA FDA Promacta · 3
- 75 mg tablet — tablet 🇺🇸 USA FDA Promacta · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Promacta · 8.1
“Risk Summary Available data from a small number of published case reports and postmarketing experience with PROMACTA use in pregnant women are insufficient to assess any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes.”
- 🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Promacta · 8.2
“Due to the potential for serious adverse reactions in a breastfed child from PROMACTA, breastfeeding is not recommended during treatment.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Promacta · 8.4
“The safety and efficacy of PROMACTA have been established in pediatric patients 1 year and older with persistent or chronic ITP and in pediatric patients 2 years and older with IST-naïve severe aplastic anemia (in combination with h-ATG and cyclosporine).”
- 👴 Older adultsNo specific problem stated
Label: no specific difference or dose adjustment stated for older adults. FDA Promacta · 8.5
“No overall differences in safety or effectiveness were observed between these patients and younger patients.”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Promacta · 8.3
“Contraception Based on animal reproduction studies, PROMACTA can cause fetal harm when administered to a pregnant woman.”
🔗 Reference links
- FDA (approval record)NDA022291
- DailyMed (FDA label)FDA Promacta
- MedlinePlus (NIH)Eltrombopag
- WHO ATC/DDDB02BX05
- Darooyab (Iran)Eltrombopag
🇮🇷 Registered in Iran Darooyab · G-4913/Eltrombopag
Dosage forms with Iranian generic codes, per Darooyab.
- 51000 · ELTROMBOPAG 25 mg TABLET · قرص الترومبوپاگ ۲۵ میلیگرم
- 51001 · ELTROMBOPAG 50 mg TABLET · قرص الترومبوپاگ ۵۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Promacta · 3FDA Promacta · 2.1FDA Promacta · 2.4FDA Promacta · 2FDA Promacta · 2.2FDA Promacta · 2.3, Table 3FDA Promacta · 2.3FDA Promacta · Boxed WarningFDA Promacta · 5FDA Promacta · SPL approval / marketing categoryFDA Promacta · 8.1FDA Promacta · 8.2FDA Promacta · 8.4FDA Promacta · 8.5FDA Promacta · 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-4913/Eltrombopag
- Clinical review⚠ Unverified