Pembrolizumab
پمبرولیزوماب
🎗️ Antineoplastic And Immunomodulating AgentsPD-1 blocking antibody
Market / country: 🇺🇸 USA
Keytruda (US)
🧮 Dose calculator
Lung cancer (small-cell and non-small-cell) · Regimen source: FDA Keytruda · 2.2, Table 1
- • 30-min infusion. Indication and patient selection (PD-L1, MSI) per Table 1 and 2.1. No dose reductions; withhold or discontinue for immune-mediated reactions. FDA Keytruda · 2.2FDA Keytruda · 2.1FDA Keytruda · 2.3
- • Only under an oncologist; protocol, cycle interval and adjustment rest with the treating team. FDA Keytruda · 2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Warnings
- • Severe and fatal immune-mediated reactions (pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, skin); infusion reactions; allogeneic HSCT complications; embryo-fetal toxicity. FDA Keytruda · 5
Formulations
- 25 mg/mL (100 mg/4 mL) — injection 🇺🇸 USA FDA Keytruda · 3
👥 Special populations
- 🤰 PregnancyDangerous / avoid
Label: can cause fetal harm. Dangerous in pregnancy. FDA Keytruda · 8.1
“Risk Summary Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman.”
- 🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Keytruda · 8.2
“Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with KEYTRUDA and for 4 months after the last dose.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Keytruda · 8.4
“The safety and effectiveness of KEYTRUDA as a single agent have been established in pediatric patients with melanoma, cHL, PMBCL, MCC, MSI-H or dMMR cancer, and TMB-H cancer.”
- 👴 Older adultsNo specific problem stated
Label: no specific difference or dose adjustment stated for older adults. FDA Keytruda · 8.5
“No overall differences in safety or effectiveness were observed between elderly 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 Keytruda · 8.3
“Contraception KEYTRUDA can cause fetal harm when administered to a pregnant woman [see Warnings and Precautions (5.5) , Use in Specific Populations (8.1) ].”
🔗 Reference links
- FDA (approval record)BLA125514
- DailyMed (FDA label)FDA Keytruda
- MedlinePlus (NIH)Pembrolizumab Injection
- WHO ATC/DDDL01FF02
- Darooyab (Iran)Pembrolizumab
🇮🇷 Registered in Iran Darooyab · G-2581/Pembrolizumab
Dosage forms with Iranian generic codes, per Darooyab.
- 25268 · PEMBROLIZUMAB 100MG/4ML VIAL · ویال پمبرولیزومب ۱۰۰ میلیگرم / ۴ میلیلیتر
- 51831 · PEMBROLIZUMAB 50 MG Powder For INJ · فرآورده تزریقی پمبرولیزومب ۵۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Keytruda · 3FDA Keytruda · 2.2, Table 1FDA Keytruda · 2.2FDA Keytruda · 2.1FDA Keytruda · 2.3FDA Keytruda · 2FDA Keytruda · 5FDA Keytruda · SPL approval / marketing categoryFDA Keytruda · 8.1FDA Keytruda · 8.2FDA Keytruda · 8.4FDA Keytruda · 8.5FDA Keytruda · 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-2581/Pembrolizumab
- Clinical review⚠ Unverified