Nivolumab
OPDIVO
What it isMonoclonal antibody blocking PD-1 immune-checkpoint signaling; used across several solid and hematologic cancers.
Why this onePairing it with ipilimumab adds CTLA-4 blockade for deeper responses, at the cost of much more toxicity.
What limits itImmune-related inflammation can affect any organ and may require steroids; combination therapy sharply increases risk.
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Unresectable or metastatic melanoma (single agent or with ipilimumab) | Adults & peds ≥12 yr | With ipilimumab: 1 mg/kg + ipilimumab 3 mg/kg q3wk ×4 doses, then maintenance | ≥40 kg: 240 mg q2wk or 480 mg q4wk; <40 kg: 3 mg/kg q2wk or 6 mg/kg q4wk | |
| Adjuvant treatment of completely resected Stage IIB/IIC/III/IV melanoma | Adults & peds ≥12 yr | ≥40 kg: 240 mg q2wk or 480 mg q4wk; <40 kg: 3 mg/kg q2wk or 6 mg/kg q4wk | ||
| Resectable NSCLC — neoadjuvant (with platinum-doublet chemo) | Adults | 360 mg with platinum-doublet chemo q3wk ×3 cycles | ||
| Resectable NSCLC — neoadjuvant + adjuvant | Adults | 360 mg + platinum-doublet chemo q3wk up to 4 cycles, then single-agent 480 mg q4wk up to 13 cycles (~1 yr) | ||
| Metastatic/recurrent NSCLC (1L with ipilimumab ± chemo, or later-line single agent) | Adults | 360 mg q3wk + ipilimumab 1 mg/kg q6wk (± 2 cycles platinum-doublet chemo) | Single agent: 240 mg q2wk or 480 mg q4wk | |
| Unresectable malignant pleural mesothelioma (1L, with ipilimumab) | Adults | 360 mg q3wk + ipilimumab 1 mg/kg q6wk | ||
| Advanced renal cell carcinoma (1L with ipilimumab or cabozantinib, or prior anti-angiogenic) | Adults | With ipilimumab: 3 mg/kg + ipilimumab 1 mg/kg q3wk ×4, then maintenance | 240 mg q2wk or 480 mg q4wk (± cabozantinib 40 mg PO QD) | |
| Classical Hodgkin lymphoma (1L with AVD, or relapsed/refractory) | Adults & peds ≥12 yr | 1L: ≥40 kg 240 mg + AVD q2wk ×6 cycles; <40 kg 3 mg/kg + AVD q2wk ×6 | Relapsed: 240 mg q2wk or 480 mg q4wk | |
| Recurrent/metastatic SCCHN (progression on/after platinum therapy) | Adults | 240 mg q2wk or 480 mg q4wk | ||
| Urothelial carcinoma (adjuvant; 1L with cisplatin/gemcitabine; or previously treated) | Adults | 1L: 360 mg q3wk + cisplatin/gemcitabine up to 6 cycles, then maintenance | Adjuvant/previously treated: 240 mg q2wk or 480 mg q4wk | |
| MSI-H/dMMR metastatic colorectal cancer (with ipilimumab, or after fluoropyrimidine+oxaliplatin+irinotecan) | Adults & peds ≥12 yr | With ipilimumab: ≥40 kg 240 mg + ipilimumab 1 mg/kg q3wk ×4 then maintenance; <40 kg 3 mg/kg | Single agent: 240 mg q2wk or 480 mg q4wk (<40 kg 3 mg/kg q2wk) | |
| Unresectable/metastatic hepatocellular carcinoma (with ipilimumab) | Adults | 1 mg/kg + ipilimumab 3 mg/kg q3wk ×4 doses, then maintenance | 240 mg q2wk or 480 mg q4wk | |
| Esophageal/GEJ cancer (adjuvant after CRT; ESCC 1L with chemo or ipilimumab; or previously treated ESCC) | Adults | Adjuvant: 240 mg q2wk or 480 mg q4wk for total 1 yr | ESCC 1L: 240 mg q2wk or 480 mg q4wk with fluoropyrimidine/platinum chemo or ipilimumab | |
| Gastric/GEJ cancer & esophageal adenocarcinoma, PD-L1 ≥1 (with chemo) | Adults | 360 mg q3wk or 240 mg q2wk with fluoropyrimidine- and platinum-containing chemo |
Renal No dosage adjustment (no clinically important effect on nivolumab clearance; eGFR ≥15 mL/min/1.73 m2)
Hepatic No adjustment for mild-to-moderate impairment; not studied in severe (total bilirubin >3× ULN)
IV infusion; dose and regimen vary by indication, body weight, and combination partner
Instructions
- Administer by IV infusion after dilution, at the infusion rate specified for each indication
- Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically
- Withhold or permanently discontinue based on severity/type of immune-mediated reaction
Cautions
- Severe/fatal immune-mediated reactions (pneumonitis, colitis, hepatitis/hepatotoxicity, endocrinopathies, dermatologic reactions, nephritis/renal dysfunction)
- Infusion-related reactions
- Fatal/serious complications of allogeneic HSCT
- Embryo-fetal toxicity
- Not recommended with a thalidomide analogue + dexamethasone in multiple myeloma outside controlled trials
Adverse reactions
- Single agent: fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, cough, dyspnea, decreased appetite, constipation
- With ipilimumab: fatigue, diarrhea, rash, pruritus, nausea, pyrexia, hypothyroidism, decreased appetite
Pregnancy Can cause fetal harm (animal data, mechanism; IgG4 crosses placenta); advise effective contraception
Lactation Do not breastfeed during treatment and for 5 months after the last dose
NO BOXED WARNINGS
Principal riskImmune-related adverse events, worse with combination therapy
Classes and tags
Clinical profile
Mechanism of action: Nivolumab ballicule
