Ofatumumab
اوفاتوموماب
🎗️ Antineoplastic And Immunomodulating AgentsAnti-CD20 antibody (SC)
Market / country: 🇺🇸 USA
Kesimpta (US)
🧮 Dose calculator
Multiple sclerosis (relapsing) · Regimen source: FDA Kesimpta · 2.2
- • Screen HBV, immunoglobulins and liver tests before starting. FDA Kesimpta · 2.1
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Active HBV infection; prior hypersensitivity or life-threatening injection reaction. FDA Kesimpta · 4
Warnings
- • Infections (screen HBV first); PML; reduced immunoglobulins; liver injury. FDA Kesimpta · 5
- • Injection-related reactions; fetal risk (contraception for 6 months). FDA Kesimpta · 5
Formulations
- 20 mg/0.4 mL Sensoready pen or syringe — injection 🇺🇸 USA FDA Kesimpta · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Kesimpta · 8.1
“Risk Summary There are no adequate data on the developmental risk associated with the use of KESIMPTA in pregnant women.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Kesimpta · 8.2
“Risk Summary There are no data on the presence of ofatumumab in human milk, the effects on the breastfed infant, or the effects of the drug on milk production.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Kesimpta · 8.4
“Safety and effectiveness 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 Kesimpta · 8.5
“Clinical studies of KESIMPTA did not include sufficient numbers of geriatric patients to determine whether they respond differently from younger subjects.”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Kesimpta · 8.3
“Contraception Females of childbearing potential should use effective contraception while receiving KESIMPTA and for 6 months after the last treatment of KESIMPTA.”
🔗 Reference links
- FDA (approval record)BLA125326
- DailyMed (FDA label)FDA Kesimpta
- MedlinePlus (NIH)Ofatumumab Injection (Chronic Lymphocytic Leukemia)Ofatumumab Injection (Multiple Sclerosis)
- WHO ATC/DDDL04AG12
- Darooyab (Iran)Ofatumumab
🇮🇷 Registered in Iran Darooyab · G-5290/Ofatumumab
Dosage forms with Iranian generic codes, per Darooyab.
- 51632 · OFATUMUMAB INJECTION, SOLUTION, CONCENTRATE PARENTERAL 20 mg/1mL 5 mL · کنسانتره محلول تزریقی افاتومومب 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 Kesimpta · 3FDA Kesimpta · 2.2FDA Kesimpta · 2.1FDA Kesimpta · 4FDA Kesimpta · 5FDA Kesimpta · SPL approval / marketing categoryFDA Kesimpta · 8.1FDA Kesimpta · 8.2FDA Kesimpta · 8.4FDA Kesimpta · 8.5FDA Kesimpta · 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-5290/Ofatumumab
- Clinical review⚠ Unverified