Capecitabine
کپسیتابین
🎗️ Antineoplastic And Immunomodulating AgentsAntimetabolite (fluorouracil prodrug)
Market / country: 🇺🇸 USA
Xeloda (US)
🧮 Dose calculator
Colorectal cancer · Regimen source: FDA Capecitabine · 2.1
- • Only under an oncologist; dose is adjusted by response and toxicity. FDA Capecitabine · 2
- • Twice daily about 12 h apart within 30 min after a meal; days 1–14 of each 21-day cycle. Round to the nearest 150 mg. CrCl 30–50: reduce by 25%; <30 not established. FDA Capecitabine · 2.7FDA Capecitabine · 2.6
- • With oxaliplatin: 1000 mg/m² twice daily. FDA Capecitabine · 2.2
Enter age and weight.
🛡️ Safety & information
Contraindications
- ⛔ History of severe hypersensitivity to fluorouracil or capecitabine. FDA Capecitabine · 4
Warnings
- • Boxed warning: bleeding and raised INR with warfarin (monitor INR frequently). DPD deficiency: severe or fatal toxicity. Diarrhoea, hand-foot syndrome. FDA Capecitabine · Boxed WarningFDA Capecitabine · 5
Renal adjustment
- • eGFR < 51: CrCl 30–50: reduce dose by 25%; <30 dose not established. FDA Capecitabine · 2.6
Formulations
- 150 mg tablet — tablet 🇺🇸 USA FDA Capecitabine · 3
- 500 mg tablet — tablet 🇺🇸 USA FDA Capecitabine · 3
👥 Special populations
- 🤰 PregnancyDangerous / avoid
Label: can cause fetal harm. Dangerous in pregnancy. FDA Capecitabine · 8.1
“Risk Summary Based on findings in animal reproduction studies and its mechanism of action [see Clinical Pharmacology (12.1) ] , capecitabine can cause fetal harm when administered to a pregnant woman.”
- 🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Capecitabine · 8.2
“Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with capecitabine and for 1 week after the last dose.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Capecitabine · 8.4
“The safety and effectiveness of capecitabine in pediatric patients have not been established.”
- 👴 Older adultsNo specific problem stated
Label: no specific difference or dose adjustment stated for older adults. FDA Capecitabine · 8.5
“No overall differences in efficacy were observed comparing older versus younger patients with colorectal cancer, gastric, esophageal or gastrointestinal junction cancer, or pancreatic cancer using the approved recommended dosages and treatment regimens.”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Capecitabine · 8.3
“Contraception Females Advise females of reproductive potential to use effective contraception during treatment with capecitabine and for 6 months after the last dose.”
🔗 Reference links
- FDA (approval record)ANDA210203
- DailyMed (FDA label)FDA Capecitabine
- MedlinePlus (NIH)Capecitabine
- WHO ATC/DDDL01BC06
- Darooyab (Iran)Capecitabine
🇮🇷 Registered in Iran Darooyab · G-961/Capecitabine
Dosage forms with Iranian generic codes, per Darooyab.
- 02492 · CAPECITABINE 150MG TAB · قرص کاپسیتابین ۱۵۰ میلیگرم
- 02493 · CAPECITABINE 500MG TAB · قرص کاپسیتابین ۵۰۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Capecitabine · 3FDA Capecitabine · 2.1FDA Capecitabine · 2FDA Capecitabine · 2.7FDA Capecitabine · 2.6FDA Capecitabine · 2.2FDA Capecitabine · 4FDA Capecitabine · Boxed WarningFDA Capecitabine · 5FDA Capecitabine · SPL approval / marketing categoryFDA Capecitabine · 8.1FDA Capecitabine · 8.2FDA Capecitabine · 8.4FDA Capecitabine · 8.5FDA Capecitabine · 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-961/Capecitabine
- Clinical review⚠ Unverified