Sunitinib
سونیتینیب
🎗️ Antineoplastic And Immunomodulating AgentsMultikinase inhibitor
Market / country: 🇺🇸 USA
Sutent (US)
🧮 Dose calculator
Renal cell carcinoma · Regimen source: FDA Sutent · 2.1
- • Only under an oncologist; continue until progression or unacceptable toxicity. Dose adjustments for toxicity and interactions per label. FDA Sutent · 2.1
- • Adjuvant RCC: same schedule for up to 9 cycles. pNET: 37.5 mg continuously. FDA Sutent · 2.2FDA Sutent · 2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Warnings
- • Boxed warning: severe, sometimes fatal hepatotoxicity. FDA Sutent · Boxed Warning
- • Cardiovascular events; QT prolongation; hypertension; haemorrhage; tumour lysis; TMA; proteinuria; skin reactions; thyroid dysfunction; hypoglycaemia; osteonecrosis of the jaw. FDA Sutent · 5
Formulations
- 12.5 mg capsule — capsule 🇺🇸 USA FDA Sutent · 3
- 25 mg capsule — capsule 🇺🇸 USA FDA Sutent · 3
- 37.5 mg capsule — capsule 🇺🇸 USA FDA Sutent · 3
- 50 mg capsule — capsule 🇺🇸 USA FDA Sutent · 3
👥 Special populations
- 🤰 PregnancyDangerous / avoid
Label: can cause fetal harm. Dangerous in pregnancy. FDA Sutent · 8.1
“Risk Summary Based on animal reproduction studies and its mechanism of action, SUTENT can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] .”
- 🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Sutent · 8.2
“Because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment with SUTENT and for at least 4 weeks after the last dose.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Sutent · 8.4
“The safety and effectiveness of SUTENT in pediatric patients have not been established.”
- 👴 Older adultsNo specific problem stated
Label: no specific difference or dose adjustment stated for older adults. FDA Sutent · 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 Sutent · 8.3
“Contraception Females Advise females of reproductive potential to use effective contraception during treatment with SUTENT and for at least 4 weeks after the last dose.”
🔗 Reference links
- FDA (approval record)NDA021938
- DailyMed (FDA label)FDA Sutent
- MedlinePlus (NIH)Sunitinib
- WHO ATC/DDDL01EX01
- Darooyab (Iran)Sunitinib
🇮🇷 Registered in Iran Darooyab · G-4691/Sunitinib
Dosage forms with Iranian generic codes, per Darooyab.
- 09988 · SUNITINIB MALATE 12.5MG CAP · کپسول سونیتینیب مالات ۱۲٫۵ میلیگرم
- 09753 · SUNITINIB MALATE 25MG CAP · کپسول سونیتینیب مالات ۲۵ میلیگرم
- 07804 · SUNITINIB MALATE 50MG CAP · کپسول سونیتینیب مالات ۵۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Sutent · 3FDA Sutent · 2.1FDA Sutent · 2.2FDA Sutent · 2FDA Sutent · Boxed WarningFDA Sutent · 5FDA Sutent · SPL approval / marketing categoryFDA Sutent · 8.1FDA Sutent · 8.2FDA Sutent · 8.4FDA Sutent · 8.5FDA Sutent · 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-4691/Sunitinib
- Clinical review⚠ Unverified