Palbociclib
پالبوسیکلیب
🎗️ Antineoplastic And Immunomodulating AgentsCDK4/6 inhibitor
Market / country: 🇺🇸 USA
Ibrance (US)
🧮 Dose calculator
Breast cancer (hormonal therapy) · Regimen source: FDA Ibrance · 2.1
- • Only under an oncologist; continue until progression or unacceptable toxicity. Dose adjustments for toxicity and interactions per label. FDA Ibrance · 2.1
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Warnings
- • Neutropenia; interstitial lung disease or pneumonitis; embryo-fetal toxicity. FDA Ibrance · 5
Formulations
- 75 mg tablet — tablet 🇺🇸 USA FDA Ibrance · 3
- 100 mg tablet — tablet 🇺🇸 USA FDA Ibrance · 3
- 125 mg tablet — tablet 🇺🇸 USA FDA Ibrance · 3
👥 Special populations
- 🤰 PregnancyDangerous / avoid
Label: can cause fetal harm. Dangerous in pregnancy. FDA Ibrance · 8.1
“Risk Summary Based on findings from animal studies and its mechanism of action, IBRANCE 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 Ibrance · 8.2
“Because of the potential for serious adverse reactions in breastfed infants from IBRANCE, advise a lactating woman not to breastfeed during treatment with IBRANCE and for 3 weeks after the last dose.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Ibrance · 8.4
“The safety and effectiveness of IBRANCE in pediatric patients have not been established.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Ibrance · 8.5
“Of 444 patients who received IBRANCE in PALOMA-2, 181 patients (41%) were ≥65 years of age and 48 patients (11%) were ≥75 years of age.”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Ibrance · 8.3
“Contraception Females IBRANCE can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] .”
🔗 Reference links
- FDA (approval record)NDA212436
- DailyMed (FDA label)FDA Ibrance
- MedlinePlus (NIH)Palbociclib
- WHO ATC/DDDL01EF01
- Darooyab (Iran)Palbociclib
🇮🇷 Registered in Iran Darooyab · G-5390/Palbociclib
Dosage forms with Iranian generic codes, per Darooyab.
- 52723 · PALBOCICLIB 75 mg CAPSULE · کپسول پالبوسیکلیب ۷۵ میلیگرم
- 50712 · PALBOCICLIB 125 mg CAPSULE · کپسول پالبوسیکلیب ۱۲۵ میلیگرم
- 52722 · PALBOCICLIB 100 mg CAPSULE · کپسول پالبوسیکلیب ۱۰۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Ibrance · 3FDA Ibrance · 2.1FDA Ibrance · 5FDA Ibrance · SPL approval / marketing categoryFDA Ibrance · 8.1FDA Ibrance · 8.2FDA Ibrance · 8.4FDA Ibrance · 8.5FDA Ibrance · 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-5390/Palbociclib
- Clinical review⚠ Unverified