Gefitinib
جفیتینیب
🎗️ Antineoplastic And Immunomodulating AgentsEGFR inhibitor
Market / country: 🇺🇸 USA
Iressa (US)
🧮 Dose calculator
Lung cancer (small-cell and non-small-cell) · Regimen source: FDA Iressa · 2.2
- • Only under an oncologist; continue until progression or unacceptable toxicity. Dose adjustments for toxicity and interactions per label. FDA Iressa · 2.2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Warnings
- • Interstitial lung disease; hepatotoxicity; GI perforation; severe diarrhoea; keratitis; bullous skin disorders; embryo-fetal toxicity. FDA Iressa · 5
Formulations
- 250 mg tablet — tablet 🇺🇸 USA FDA Iressa · 3
👥 Special populations
- 🤰 PregnancyDangerous / avoid
Label: can cause fetal harm. Dangerous in pregnancy. FDA Iressa · 8.1
“Risk Summary Based on its mechanism of action and animal data, IRESSA can cause fetal harm when administered to a pregnant woman.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Iressa · 8.2
“Animal studies indicate the gefitinib and its metabolites are present in rat milk at a concentration higher than those in maternal plasma.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Iressa · 8.4
“The safety and effectiveness of IRESSA in pediatric patients have not been established.”
- 👴 Older adultsNo specific problem stated
Label: no specific difference or dose adjustment stated for older adults. FDA Iressa · 8.5
“No overall differences in safety were observed between patients 65 years and older and those younger than 65 years.”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Iressa · 8.3
“Contraception Based on its mechanism of action and animal data, IRESSA can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] .”
🔗 Reference links
- FDA (approval record)NDA206995
- DailyMed (FDA label)FDA Iressa
- MedlinePlus (NIH)Gefitinib
- WHO ATC/DDDL01EB01
- Darooyab (Iran)Gefitinib
🇮🇷 Registered in Iran Darooyab · G-1008/Gefitinib
Dosage forms with Iranian generic codes, per Darooyab.
- 08108 · GEFITINIB 250MG TAB · قرص جفیتینیب ۲۵۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Iressa · 3FDA Iressa · 2.2FDA Iressa · 5FDA Iressa · SPL approval / marketing categoryFDA Iressa · 8.1FDA Iressa · 8.2FDA Iressa · 8.4FDA Iressa · 8.5FDA Iressa · 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-1008/Gefitinib
- Clinical review⚠ Unverified