Abiraterone acetate
آبیراترون
🎗️ Antineoplastic And Immunomodulating AgentsCYP17 inhibitor
Market / country: 🇺🇸 USA
Zytiga (US)
🧮 Dose calculator
Prostate cancer · Regimen source: FDA Zytiga · 2.1
- • High-risk castration-sensitive: prednisone 5 mg once daily. No food 2 h before and 1 h after. With strong CYP3A4 inducers twice daily. FDA Zytiga · 2.2FDA Zytiga · 2FDA Zytiga · 2.5
- • With a GnRH analogue or after bilateral orchiectomy. FDA Zytiga · 2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Warnings
- • Hypokalaemia, fluid retention and cardiovascular events (mineralocorticoid excess); adrenal insufficiency; hepatotoxicity (tests before and during); more fractures and deaths with radium-223; hypoglycaemia. FDA Zytiga · 5
Formulations
- 500 mg film-coated tablet — tablet 🇺🇸 USA FDA Zytiga · 3
- 250 mg tablet — tablet 🇺🇸 USA FDA Zytiga · 3
👥 Special populations
- 🤰 PregnancyDangerous / avoid
Label: can cause fetal harm. Dangerous in pregnancy. FDA Zytiga · 8.1
“Based on findings from animal studies and the mechanism of action, ZYTIGA can cause fetal harm and potential loss of pregnancy.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Zytiga · 8.2
“Risk Summary The safety and efficacy of ZYTIGA have not been established in females.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Zytiga · 8.4
“Safety and effectiveness of ZYTIGA in pediatric patients have not been established.”
- 👴 Older adultsNo specific problem stated
Label: no specific difference or dose adjustment stated for older adults. FDA Zytiga · 8.5
“No overall differences in safety or effectiveness were observed between these elderly 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 Zytiga · 8.3
“Contraception Males Based on findings in animal reproduction studies and its mechanism of action, advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 weeks after the final dose of ZYTIGA [see Use in Specific Populations (8.1) ] .”
🔗 Reference links
- FDA (approval record)NDA202379
- DailyMed (FDA label)FDA Zytiga
- MedlinePlus (NIH)AbirateroneNiraparib and Abiraterone
- WHO ATC/DDDL02BX03
- Darooyab (Iran)Abiraterone
🇮🇷 Registered in Iran Darooyab · G-4866/Abiraterone
Dosage forms with Iranian generic codes, per Darooyab.
- 19011 · ABIRATERON 250MG TAB · قرص آبیراترون ۲۵۰ میلیگرم
- 52063 · ABIRATERON 500MG TAB · قرص آبیراترون ۵۰۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Zytiga · 3FDA Zytiga · 2.1FDA Zytiga · 2.2FDA Zytiga · 2FDA Zytiga · 2.5FDA Zytiga · 5FDA Zytiga · 8.1FDA Zytiga · 8.2FDA Zytiga · 8.4FDA Zytiga · 8.5FDA Zytiga · 8.3FDA Zytiga · SPL approval / marketing category
- 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-4866/Abiraterone
- Clinical review⚠ Unverified