Enzalutamide
انزالوتامید
🎗️ Antineoplastic And Immunomodulating AgentsAndrogen receptor inhibitor
Market / country: 🇺🇸 USA
Xtandi (US)
🧮 Dose calculator
Prostate cancer · Regimen source: FDA Xtandi · 2.1
- • Swallow whole. Grade ≥3 reaction: hold one week, then same or 120/80 mg. Strong CYP2C8 inhibitors: 80 mg. FDA Xtandi · 2.1FDA Xtandi · 2.2FDA Xtandi · 2.3
- • With a GnRH analogue or after bilateral orchiectomy. FDA Xtandi · 2.1
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Warnings
- • Seizure; PRES; hypersensitivity; ischaemic heart disease; falls and fractures; embryo-fetal toxicity; dysphagia/choking. FDA Xtandi · 5
Formulations
- 40 mg capsule — capsule 🇺🇸 USA FDA Xtandi · 3
- 80 mg tablet — tablet 🇺🇸 USA FDA Xtandi · 3
👥 Special populations
- 🤰 PregnancyDangerous / avoid
Label: can cause fetal harm. Dangerous in pregnancy. FDA Xtandi · 8.1
“Based on animal reproductive studies and mechanism of action, XTANDI can cause fetal harm and loss of pregnancy.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Xtandi · 8.2
“Risk Summary The safety and efficacy of XTANDI have not been established in females.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Xtandi · 8.4
“Safety and effectiveness of XTANDI in pediatric patients have not been established.”
- 👴 Older adultsNo specific problem stated
Label: no specific difference or dose adjustment stated for older adults. FDA Xtandi · 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 Xtandi · 8.3
“Contraception Males Based on findings in animal reproduction studies, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of XTANDI [see Use in Specific Populations ( 8.1 )] .”
🔗 Reference links
- FDA (approval record)NDA203415
- DailyMed (FDA label)FDA Xtandi
- MedlinePlus (NIH)Enzalutamide
- WHO ATC/DDDL02BB04
- Darooyab (Iran)Enzalutamide
🇮🇷 Registered in Iran Darooyab · G-5392/Enzalutamide
Dosage forms with Iranian generic codes, per Darooyab.
- 53117 · ENZALUTAMIDE 40MG TABLET · قرص انزالوتامید ۴۰ میلیگرم
- 53118 · ENZALUTAMIDE 80MG TABLET · قرص انزالوتامید ۸۰ میلیگرم
- 22558 · ENZALUTAMIDE 40MG SOFTGEL · ژل انزالوتامید ۴۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Xtandi · 3FDA Xtandi · 2.1FDA Xtandi · 2.2FDA Xtandi · 2.3FDA Xtandi · 5FDA Xtandi · SPL approval / marketing categoryFDA Xtandi · 8.1FDA Xtandi · 8.2FDA Xtandi · 8.4FDA Xtandi · 8.5FDA Xtandi · 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-5392/Enzalutamide
- Clinical review⚠ Unverified