Osimertinib
اوسیمرتینیب
🎗️ Antineoplastic And Immunomodulating AgentsThird-generation EGFR inhibitor
Market / country: 🇺🇸 USA
Tagrisso (US)
🧮 Dose calculator
Lung cancer (small-cell and non-small-cell) · Regimen source: FDA Tagrisso · 2.3
- • Only under an oncologist; continue until progression or unacceptable toxicity. Dose adjustments for toxicity and interactions per label. FDA Tagrisso · 2.3
- • Adjuvant after resection: up to 3 years. Select patients with an FDA-approved test. FDA Tagrisso · 2.3FDA Tagrisso · 2.2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Warnings
- • Interstitial lung disease; QT prolongation; cardiomyopathy; keratitis; SJS; cutaneous vasculitis; aplastic anaemia; myositis; embryo-fetal toxicity. FDA Tagrisso · 5
Formulations
- 40 mg tablet — tablet 🇺🇸 USA FDA Tagrisso · 3
- 80 mg tablet — tablet 🇺🇸 USA FDA Tagrisso · 3
👥 Special populations
- 🤰 PregnancyDangerous / avoid
Label: can cause fetal harm. Dangerous in pregnancy. FDA Tagrisso · 8.1
“Risk Summary Based on data from animal studies and its mechanism of action [see Clinical Pharmacology (12.1) ] , TAGRISSO can cause fetal harm when administered to a pregnant woman.”
- 🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Tagrisso · 8.2
“Because of the potential for serious adverse reactions in breastfed infants from osimertinib, advise women not to breastfeed during treatment with TAGRISSO and for 2 weeks after the last dose.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Tagrisso · 8.4
“The safety and effectiveness of TAGRISSO in pediatric patients have not been established.”
- 👴 Older adultsNo specific problem stated
Label: no specific difference or dose adjustment stated for older adults. FDA Tagrisso · 8.5
“No overall differences in safety or effectiveness were observed between patients 65 years or older and younger patients.”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Tagrisso · 8.3
“Contraception Females Advise females of reproductive potential to use effective contraception during treatment with TAGRISSO and for 6 weeks after the last dose [see Use in Specific Populations (8.1) ] .”
🔗 Reference links
- FDA (approval record)NDA208065
- DailyMed (FDA label)FDA Tagrisso
- MedlinePlus (NIH)Osimertinib
- WHO ATC/DDDL01EB04
- Darooyab (Iran)Osimertinib
🇮🇷 Registered in Iran Darooyab · G-5379/Osimertinib
Dosage forms with Iranian generic codes, per Darooyab.
- 50911 · OSIMERTINIB 80 mg TABLET · قرص اسیمرتینیب ۸۰ میلیگرم
- 50910 · OSIMERTINIB 40 mg TABLET · قرص اسیمرتینیب ۴۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Tagrisso · 3FDA Tagrisso · 2.3FDA Tagrisso · 2.2FDA Tagrisso · 5FDA Tagrisso · SPL approval / marketing categoryFDA Tagrisso · 8.1FDA Tagrisso · 8.2FDA Tagrisso · 8.4FDA Tagrisso · 8.5FDA Tagrisso · 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-5379/Osimertinib
- Clinical review⚠ Unverified