Blinatumomab
بلیناتوموماب
🎗️ Antineoplastic And Immunomodulating AgentsBispecific CD19/CD3 T-cell engager
Market / country: 🇺🇸 USA
Blincyto (US)
🧮 Dose calculator
Acute lymphoblastic leukaemia (ALL) · Regimen source: FDA Blincyto · 2.1FDA Blincyto · 2.2FDA Blincyto · 2.3
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to blinatumomab or components. FDA Blincyto · 4
Warnings
- • Boxed warning: life-threatening cytokine release syndrome; neurological toxicities including ICANS. FDA Blincyto · Boxed Warning
- • Infections; tumour lysis; neutropenia; elevated liver enzymes; pancreatitis; leukoencephalopathy; preparation errors; benzyl alcohol toxicity in neonates. FDA Blincyto · 5
Formulations
- 35 mcg vial — powder for injection 🇺🇸 USA FDA Blincyto · 3
👥 Special populations
- 🤰 PregnancyDangerous / avoid
Label: can cause fetal harm. Dangerous in pregnancy. FDA Blincyto · 8.1
“Risk Summary Based on its mechanism of action, BLINCYTO may 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 Blincyto · 8.2
“Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in breastfed infants from BLINCYTO, including B-cell lymphocytopenia, advise patients not to breastfeed during treatment with BLINCYTO and for 48 hours after the last dose.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Blincyto · 8.4
“Relapsed or Refractory B-cell Precursor ALL The safety and efficacy of BLINCYTO have been established in pediatric patients one month and older with relapsed or refractory B-cell precursor ALL.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Blincyto · 8.5
“However, elderly patients experienced a higher rate of serious infections and neurological toxicities, including cognitive disorder, encephalopathy, and confusion [see Warnings and Precautions (5.2 , 5.3) ] .”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Blincyto · 8.3
“Contraception Females Advise females of reproductive potential to use effective contraception during treatment with BLINCYTO and for 48 hours after the last dose.”
🔗 Reference links
- FDA (approval record)BLA125557
- DailyMed (FDA label)FDA Blincyto
- MedlinePlus (NIH)Blinatumomab Injection
- WHO ATC/DDDL01FX07
- Darooyab (Iran)Blinatumomab
🇮🇷 Registered in Iran Darooyab · G-5470/Blinatumomab
Dosage forms with Iranian generic codes, per Darooyab.
- 52711 · BLINATUMOMAB INJECTION, POWDER, FOR SOLUTION PARENTERAL 38.5 ug · پودر برای تهیه محلول تزریقی بلیناتومومب ۳۸٫۵ میکروگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Blincyto · 3FDA Blincyto · 2.1FDA Blincyto · 2.2FDA Blincyto · 2.3FDA Blincyto · 4FDA Blincyto · Boxed WarningFDA Blincyto · 5FDA Blincyto · SPL approval / marketing categoryFDA Blincyto · 8.1FDA Blincyto · 8.2FDA Blincyto · 8.4FDA Blincyto · 8.5FDA Blincyto · 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-5470/Blinatumomab
- Clinical review⚠ Unverified