Belimumab
بلیموماب
🎗️ Antineoplastic And Immunomodulating AgentsAnti-BLyS antibody
Market / country: 🇺🇸 USA
Benlysta (US)
🧮 Dose calculator
Lupus erythematosus · Regimen source: FDA Benlysta · 2.2
- • 1-hour infusion; consider premedication for infusion reactions. FDA Benlysta · 2.2
Enter age and weight.
🛡️ Safety & information
Contraindications
- ⛔ Prior anaphylaxis, SJS or TEN with belimumab. FDA Benlysta · 4
Warnings
- • Serious infections; hypersensitivity and anaphylaxis (sometimes delayed); SJS/TEN; depression and suicidality; malignancy; no live vaccines. FDA Benlysta · 5
Formulations
- 400 mg vial — powder for injection 🇺🇸 USA FDA Benlysta · 3
- 120 mg vial — powder for injection 🇺🇸 USA FDA Benlysta · 3
- 200 mg/mL autoinjector or prefilled syringe — injection 🇺🇸 USA FDA Benlysta · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Benlysta · 8.1
“Risk Summary Available data on use of BENLYSTA in pregnant women, from observational studies, published case reports, and postmarketing surveillance, are insufficient to determine whether there is a drug-associated risk for major birth defects or miscarriage.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Benlysta · 8.2
“Risk Summary No information is available on the presence of belimumab in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Benlysta · 8.4
“The safety and effectiveness of BENLYSTA have been established for the treatment of active SLE and active lupus nephritis in pediatric patients 5 years of age and older who are receiving standard therapy.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Benlysta · 8.5
“Use with caution in geriatric patients.”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Benlysta · 8.3
“Contraception Following an assessment of benefit versus risk, if prevention of pregnancy is warranted, females of reproductive potential should use effective contraception during treatment and for at least 4 months after the final treatment.”
🔗 Reference links
- FDA (approval record)BLA125370
- DailyMed (FDA label)FDA Benlysta
- MedlinePlus (NIH)Belimumab Injection
- WHO ATC/DDDL04AG04
- Darooyab (Iran)belimumab
🇮🇷 Registered in Iran Darooyab · G-4850/belimumab
Dosage forms with Iranian generic codes, per Darooyab.
- 17619 · BELIMUMAB 120MG 5ML VIAL · ویال بلیمومب ۱۲۰ میلیگرم ۵ میلیلیتر
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Benlysta · 3FDA Benlysta · 2.2FDA Benlysta · 2.3FDA Benlysta · 4FDA Benlysta · 5FDA Benlysta · SPL approval / marketing categoryFDA Benlysta · 8.1FDA Benlysta · 8.2FDA Benlysta · 8.4FDA Benlysta · 8.5FDA Benlysta · 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-4850/belimumab
- Clinical review⚠ Unverified