Nivolumab
نیولوماب
🎗️ Antineoplastic And Immunomodulating AgentsPD-1 blocking antibody
Market / country: 🇺🇸 USA
Opdivo (US)
🧮 Dose calculator
Lung cancer (small-cell and non-small-cell) · Regimen source: FDA Opdivo · 2.2, Table 1
- • 30-min infusion. Combinations with ipilimumab or chemotherapy use different doses (label tables). No dose reductions. FDA Opdivo · 2.2FDA Opdivo · 2.3
- • Only under an oncologist; protocol, cycle interval and adjustment rest with the treating team. FDA Opdivo · 2
Enter age and weight.
🛡️ Safety & information
Warnings
- • Severe and fatal immune-mediated reactions (pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, skin); infusion reactions; allogeneic HSCT complications; embryo-fetal toxicity. FDA Opdivo · 5
Formulations
- 10 mg/mL (40/100/120/240 mg) — injection 🇺🇸 USA FDA Opdivo · 3
👥 Special populations
- 🤰 PregnancyDangerous / avoid
Label: can cause fetal harm. Dangerous in pregnancy. FDA Opdivo · 8.1
“Risk Summary Based on data from animal studies and its mechanism of action [see Clinical Pharmacology (12.1) ] , OPDIVO can cause fetal harm when administered to a pregnant woman.”
- 🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Opdivo · 8.2
“Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment and for 5 months after the last dose of OPDIVO.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Opdivo · 8.4
“The safety and effectiveness of OPDIVO have been established in pediatric patients aged 12 years and older for the following indications: as a single agent and in combination with ipilimumab for the treatment of unresectable or metastatic melanoma, as a single agent for the adjuvant treatment of completely resected …”
- 👴 Older adultsNo specific problem stated
Label: no specific difference or dose adjustment stated for older adults. FDA Opdivo · 8.5
“No overall differences in safety or effectiveness were observed between elderly patients and younger patients [see Clinical Studies (14.1 , 14.2 , 14.5 , 14.7 , 14.10 , 14.13 , 14.14) ].”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Opdivo · 8.3
“Contraception OPDIVO can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] .”
🔗 Reference links
- FDA (approval record)BLA125554
- DailyMed (FDA label)FDA Opdivo
- MedlinePlus (NIH)Nivolumab Injection
- WHO ATC/DDDL01FF01
- Darooyab (Iran)Nivolumab
🇮🇷 Registered in Iran Darooyab · G-5421/Nivolumab
Dosage forms with Iranian generic codes, per Darooyab.
- 50884 · NIVOLUMAB 10 MG/ML INJECTION · فرآورده تزریقی نیوولومب ۱۰ میلیگرم / میلیلیتر
- 52363 · NIVOLUMAB 40 MG/4ML INJECTION · فرآورده تزریقی نیوولومب ۴۰ میلیگرم / ۴ میلیلیتر
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Opdivo · 3FDA Opdivo · 2.2, Table 1FDA Opdivo · 2.2FDA Opdivo · 2.3FDA Opdivo · 2FDA Opdivo · 5FDA Opdivo · SPL approval / marketing categoryFDA Opdivo · 8.1FDA Opdivo · 8.2FDA Opdivo · 8.4FDA Opdivo · 8.5FDA Opdivo · 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-5421/Nivolumab
- Clinical review⚠ Unverified