Daratumumab
داراتوموماب
🎗️ Antineoplastic And Immunomodulating AgentsCD38-directed antibody
Market / country: 🇺🇸 USA
Darzalex (US)
🧮 Dose calculator
Multiple myeloma · Regimen source: FDA Darzalex · 2.2
- • Only under an oncologist; continue until progression or unacceptable toxicity. Dose adjustments for toxicity and interactions per label. FDA Darzalex · 2.2
- • Premedicate with corticosteroid, antipyretic and antihistamine; post-infusion medicines. Type and screen before starting (cross-match interference). FDA Darzalex · 2.3FDA Darzalex · 5.2
Enter age and weight.
🛡️ Safety & information
Contraindications
- ⛔ History of severe hypersensitivity (anaphylaxis) to daratumumab or components. FDA Darzalex · 4
Warnings
- • Infusion reactions; interference with serological testing and response assessment; infections; neutropenia; thrombocytopenia; embryo-fetal toxicity. FDA Darzalex · 5
Formulations
- 20 mg/mL (100 mg/5 mL, 400 mg/20 mL) — IV — injection 🇺🇸 USA FDA Darzalex · 3
👥 Special populations
- 🤰 PregnancyDangerous / avoid
Label: combination with lenalidomide, pomalidomide or thalidomide is contraindicated in pregnancy. FDA Darzalex · 8.1
“The combination of DARZALEX and lenalidomide, pomalidomide, or thalidomide is contraindicated in pregnant women, because lenalidomide, pomalidomide, and thalidomide may cause birth defects and death of the unborn child.”
- 🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Darzalex · 8.2
“Because of the potential for serious adverse reactions in the breastfed child when DARZALEX is administered with lenalidomide, pomalidomide, or thalidomide, advise women not to breastfeed during treatment with DARZALEX.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Darzalex · 8.4
“Safety and effectiveness of DARZALEX in pediatric patients have not been established.”
- 👴 Older adultsNo specific problem stated
Label: no specific difference or dose adjustment stated for older adults. FDA Darzalex · 8.5
“No overall differences in 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 Darzalex · 8.3
“Contraception Advise females of reproductive potential to use effective contraception during treatment with DARZALEX and for 3 months after the last dose.”
🔗 Reference links
- FDA (approval record)BLA761036
- DailyMed (FDA label)FDA Darzalex
- MedlinePlus (NIH)Daratumumab Injection
- WHO ATC/DDDL01FC01
- Darooyab (Iran)Daratumumab
🇮🇷 Registered in Iran Darooyab · G-5483/Daratumumab
Dosage forms with Iranian generic codes, per Darooyab.
- 52628 · DARATUMUMAB INJECTION, SOLUTION, CONCENTRATE PARENTERAL 20 mg/1mL 20 mL · کنسانتره محلول تزریقی داراتومومب ۲۰ میلیگرم / ۱ میلیلیتر ۲۰ میلیلیتر
- 52627 · DARATUMUMAB INJECTION, SOLUTION, CONCENTRATE PARENTERAL 20 mg/1mL 5 mL · کنسانتره محلول تزریقی داراتومومب ۲۰ میلیگرم / ۱ میلیلیتر ۵ میلیلیتر
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Darzalex · 3FDA Darzalex · 2.2FDA Darzalex · 2.3FDA Darzalex · 5.2FDA Darzalex · 4FDA Darzalex · 5FDA Darzalex · SPL approval / marketing categoryFDA Darzalex · 8.1FDA Darzalex · 8.2FDA Darzalex · 8.4FDA Darzalex · 8.5FDA Darzalex · 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-5483/Daratumumab
- Clinical review⚠ Unverified