Select a medication above to begin.
Opdivo
nivolumab
Adult Dosing .
Dosage forms: INJ
Special Note
- [equivalency or interchangeability info]
- Info: not interchangeable with other nivolumab-containing products
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing including toxicity-related dose adjustments
melanoma
- [stage IIB, IIC, III, IV disease, adjuvant tx]
- Dose: 240 mg IV q2wk for up to 1y; Alt: 480 mg IV q4wk for up to 1y; Info: for patients with completely resected disease
- [unresectable or metastatic disease, monotherapy]
- Dose: 240 mg IV q2wk; Alt: 480 mg IV q4wk
- [unresectable or metastatic disease, combo tx]
- Dose: 1 mg/kg/dose IV q3wk for max 4 doses with ipilimumab, then 240 mg IV q2wk as monotherapy; Alt: 1 mg/kg/dose IV q3wk for max 4 doses with ipilimumab, then 480 mg IV q4wk as monotherapy
non-small cell lung CA
- [resectable disease, neoadjuvant tx, combo tx]
- Dose: 360 mg IV q3wk x3 doses; Info: for patients with tumor >4cm or node-positive disease; use with platinum-doublet chemo; may give up to 4 doses prior to adjuvant nivolumab monotherapy in patients with no EGFR or ALK genomic tumor aberrations
- [resectable disease, adjuvant tx following neoadjuvant tx, monotherapy]
- Dose: 480 mg IV q4wk for up to 13 doses; Info: for patients with tumor >4cm or node-positive disease and no EGFR or ALK genomic tumor aberrations
- [metastatic PD-L1-expressing disease, combo tx]
- Dose: 360 mg IV q3wk for up to 2y; Info: for patients with no EGFR or ALK genomic tumor aberrations; first-line tx; use with ipilimumab
- [metastatic or recurrent disease, combo tx]
- Dose: 360 mg IV q3wk for up to 2y; Info: for patients with no EGFR or ALK genomic tumor aberrations; first-line tx; use with ipilimumab and 2 cycles of q3wk histology-based platinum-doublet chemo
- [metastatic disease, monotherapy]
- Dose: 240 mg IV q2wk; Alt: 480 mg IV q4wk; Info: for patients with progressive disease on or after platinum-based chemo
malignant pleural mesothelioma, unresectable
- [360 mg IV q3wk for up to 2y]
- Info: first-line tx; use with ipilimumab
renal cell CA, advanced
- [first-line tx, combo with cabozantinib]
- Dose: 240 mg IV q2wk for up to 2y; Alt: 480 mg IV q4wk for up to 2y
- [first-line tx, combo with ipilimumab]
- Dose: 3 mg/kg/dose IV q3wk x4 doses with ipilimumab, then 240 mg IV q2wk as monotherapy; Alt: 3 mg/kg/dose IV q3wk x4 doses with ipilimumab, then 480 mg IV q4wk as monotherapy; Info: for patients with intermediate or poor risk disease
- [progressive disease]
- Dose: 240 mg IV q2wk; Alt: 480 mg IV q4wk; Info: for patients who have received prior antiangiogenic tx
Hodgkin lymphoma, classical
- [previously untreated stage III or IV disease, combo tx]
- Dose: 240 mg IV q2wk x12 doses
- [relapsed or progressive disease, monotherapy]
- Dose: 240 mg IV q2wk; Alt: 480 mg IV q4wk; Info: for patients with relapsed or progressive disease after autologous HSCT + brentuximab vedotin, or after at least 3 lines of tx, including autologous HSCT
squamous cell head/neck CA, recurrent or metastatic
- [240 mg IV q2wk]
- Alt: 480 mg IV q4wk; Info: for patients with disease progression on or after platinum-containing chemo
urothelial carcinoma
- [adjuvant tx]
- Dose: 240 mg IV q2wk for up to 1y; Alt: 480 mg IV q4wk for up to 1y; Info: for patients with high recurrence risk after radical resection
- [unresectable or metastatic disease, first-line tx]
- Dose: 360 mg IV q3wk for up to 6 cycles with combo chemo, then 240 mg IV q2wk as monotherapy for up to 2y total; Alt: 360 mg IV q3wk for up to 6 cycles with combo chemo, then 480 mg q4wk as monotherapy for up to 2y total
- [locally advanced or metastatic disease, progressive disease]
- Dose: 240 mg IV q2wk; Alt: 480 mg IV q4wk; Info: patients with disease progression on or after platinum-containing chemo
microsatellite instability-high or mismatch repair deficient colorectal CA
- [progressive metastatic disease, monotherapy]
- Dose: 240 mg IV q2wk; Alt: 480 mg IV q4wk
- [unresectable or metastatic disease, combo tx]
- Dose: 240 mg IV q3wk for max 4 doses with ipilimumab, then 240 mg IV q2wk as monotherapy for up to 2y; Alt: 240 mg IV q3wk for max 4 doses with ipilimumab, then 480 mg IV q4wk as monotherapy for up to 2y
hepatocellular CA
- [1 mg/kg/dose IV q3wk x4 doses with ipilimumab, then 240 mg IV q2wk as monotherapy]
- Alt: 1 mg/kg/dose IV q3wk x4 doses with ipilimumab, then 480 mg IV q4wk as monotherapy; Info: for patients with sorafenib refractory or intolerant disease
esophageal CA
- [adjuvant tx]
- Dose: 240 mg IV q2wk x1y; Alt: 480 mg IV q4wk x1y; Info: for patients with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease after receiving neoadjuvant chemoradiation
- [PD-L1-expressing squamous cell carcinoma, first-line tx, combo with ipilimumab]
- Dose: 3 mg/kg/dose IV q2wk for up to 2y; Alt: 360 mg IV q3wk for up to 2y; Info: for patients with unresectable advanced or metastatic disease
- [PD-L1-expressing squamous cell carcinoma, first-line tx, combo with fluoropyrimidine and platinum-containing chemo]
- Dose: 240 mg IV q2wk for up to 2y; Alt: 480 mg IV q4wk for up to 2y; Info: for patients with unresectable advanced or metastatic disease
- [squamous cell carcinoma, progressive disease]
- Dose: 240 mg IV q2wk; Alt: 480 mg IV q2wk; Info: for patients with unresectable advanced, recurrent or metastatic disease after prior fluoropyrimidine and platinum-based chemo
- [PD-L1-expressing advanced or metastatic disease]
- Dose: 240 mg IV q2wk for up to 2y; Alt: 360 mg IV q3wk for up to 2y; Info: for patients with gastroesophageal junction CA or esophageal adenocarcinoma; part of multi-drug chemo regimen
PD-L1-expressing gastric CA, advanced or metastatic
- [240 mg IV q2wk for up to 2y]
- Alt: 360 mg IV q3wk for up to 2y; Info: for patients with gastric or gastroesophageal junction CA; part of multi-drug chemo regimen
small cell lung CA, relapsed (off-label)
- [240 mg IV q2wk]
- Info: for patients who have received prior tx other than immune checkpoint inhibitors
renal dosing
- [see below]
- eGFR >15: no adjustment; eGFR <15: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin 1-3x ULN or AST >ULN: no adjustment; bilirubin >3x ULN: not defined
Peds Dosing .
- Dosage forms: INJ
Special Note
- [equivalency or interchangeability info]
- Info: not interchangeable with other nivolumab-containing products
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing including toxicity-related dose adjustments
melanoma
- [stage IIB, IIC, III, IV disease, adjuvant tx, 12 yo and older, <40 kg]
- Dose: 3 mg/kg/dose IV q2wk for up to 1y; Alt: 6 mg/kg/dose IV q4wk for up to 1y; Info: for patients with completely resected disease
- [stage IIB, IIC, III, IV disease, adjuvant tx, 12 yo and older, >40 kg]
- Dose: 240 mg IV q2wk for up to 1y; Alt: 480 mg IV q4wk for up to 1y; Info: for patients with completely resected disease
- [unresectable or metastatic disease, monotherapy, 12 yo and older, <40 kg]
- Dose: 3 mg/kg/dose IV q2wk; Alt: 6 mg/kg/dose IV q4wk
- [unresectable or metastatic disease, monotherapy, 12 yo and older, >40 kg]
- Dose: 240 mg IV q2wk; Alt: 480 mg IV q4wk
- [unresectable or metastatic disease, combo tx, 12 yo and older, <40 kg]
- Dose: 1 mg/kg/dose IV q3wk for max 4 doses with ipilimumab, then 3 mg/kg/dose IV q2wk as monotherapy; Alt: 1 mg/kg/dose IV q3wk for max 4 doses with ipilimumab, then 6 mg/kg/dose IV q4wk as monotherapy
- [unresectable or metastatic disease, combo tx, 12 yo and older, >40 kg]
- Dose: 1 mg/kg/dose IV q3wk for max 4 doses with ipilimumab, then 240 mg IV q2wk as monotherapy; Alt: 1 mg/kg/dose IV q3wk for max 4 doses with ipilimumab, then 480 mg IV q4wk as monotherapy
Hodgkin lymphoma, classical
- [12 yo and older, <40 kg]
- Dose: 3 mg/kg/dose IV q2wk x12 doses; Max: 240 mg/dose; Info: for patients with previously untreated stage III or IV disease; part of multi-drug chemo regimen
- [12 yo and older, >40 kg]
- Dose: 240 mg IV q2wk x12 doses; Info: for patients with previously untreated stage III or IV disease; part of multi-drug chemo regimen
microsatellite instability-high or mismatch repair deficient colorectal CA
- [progressive metastatic disease, monotherapy, 12 yo and older, <40 kg]
- Dose: 3 mg/kg/dose IV q2wk
- [progressive metastatic disease, monotherapy, 12 yo and older, >40 kg]
- Dose: 240 mg IV q2wk; Alt: 480 mg IV q4wk
- [unresectable or metastatic disease, combo tx, 12 yo and older, <40 kg]
- Dose: 3 mg/kg/dose IV q3wk for max 4 doses with ipilimumab, then 3 mg/kg/dose IV q2wk as monotherapy for up to 2y; Alt: 3 mg/kg/dose IV q3wk for max 4 doses with ipilimumab, then 6 mg/kg/dose IV q4wk as monotherapy for up to 2y
- [unresectable or metastatic disease, combo tx, 12 yo and older, >40 kg]
- Dose: 240 mg IV q3wk for max 4 doses with ipilimumab, then 240 mg IV q2wk as monotherapy for up to 2y; Alt: 240 mg IV q3wk for max 4 doses with ipilimumab, then 480 mg IV q4wk as monotherapy for up to 2y
renal dosing
- [see below]
- eGFR >15: no adjustment; eGFR <15: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin 1-3x ULN or AST >ULN: no adjustment; bilirubin >3x ULN: not defined
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- multiple myeloma
- avoid: breastfeeding during tx and x5mo after D/C
- caution: patients of childbearing potential
- caution: thoracic XRT history
- caution: transplant history
- caution: transplant candidates
- caution: ipilimumab-associated immune toxicity, severe
Drug Interactions .
Overview
nivolumab
PD-1 blocking antibody
- immunomodulatory effects
Contraindicated
Avoid/Use Alternative
Monitor/Modify Tx
Adverse Reactions .
Serious Reactions
- immune-mediated reaction
- pneumonitis
- interstitial lung disease
- pleural effusion
- respiratory failure
- pulmonary embolism
- pneumonia
- sepsis
- infection, serious
- colitis
- hepatitis
- hepatotoxicity
- ascites
- esophageal varices
- hemorrhage
- pancreatitis
- diabetes mellitus, type 1
- endocrinopathy
- adrenal insufficiency
- hypophysitis
- thyroiditis
- hypopituitarism
- hypothyroidism
- hyperthyroidism
- hypoparathyroidism
- heart failure
- renal failure
- nephritis
- encephalitis
- meningitis
- uveitis
- Vogt-Koyanagi-Harada-like syndrome
- blindness
- autoimmune neuropathy
- demyelination
- nerve paresis
- Guillain-Barre syndrome
- myasthenia gravis
- myocarditis
- pericarditis
- vasculitis
- myositis
- rhabdomyolysis
- polymyalgia rheumatica
- histiocytic necrotizing lymphadenitis
- hemolytic anemia, autoimmune
- aplastic anemia
- anemia
- neutropenia
- thrombocytopenia
- immune thrombocytopenic purpura
- lymphopenia
- hemophagocytic lymphohistiocytosis
- infusion reaction, severe
- Stevens-Johnson syndrome
- toxic epidermal necrolysis
- erythema multiforme
- exfoliative dermatitis
- drug reaction with eosinophilia and systemic symptoms
- tumor lysis syndrome
Common Reactions
- fatigue
- musculoskeletal pain
- rash
- diarrhea
- cough
- nausea
- pruritus
- URI
- appetite decr.
- arthralgia
- dyspnea
- constipation
- abdominal pain
- fever
- vomiting
- hypothyroidism
- headache
- dizziness
- UTI
- weight loss
- edema
- back pain
- vitiligo
- peripheral neuropathy
- hyperthyroidism
- hyperglycemia
- infusion reaction
- lymphopenia
- ALT or AST incr.
- anemia
- hyponatremia
- alk phos incr.
- Cr incr.
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; Cr, LFTs, TFTs at baseline, then periodically; glucose; signs/symptoms of infusion reaction
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; risk of embryo-fetal toxicity, including spontaneous abortion and stillbirth, based on animal data at 9-42x systemic exposure and drug's mechanism of action
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective contraception during tx and for at least 5mo after D/C in patients of childbearing potential
Lactation
Clinical Summary
avoid breastfeeding during tx and x5mo after D/C; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for nivolumab: other; CYP450: unknown
Excretion: for nivolumab: other; Half-life: 25 days
Subclass: Immunotherapy, Immune Checkpoint Inhibitors ; Immunotherapy, PD-1/PD-L1 Inhibitors
Mechanism of Action
for nivolumab: binds to PD-1 receptor on T-cells, blocking PD-1 pathway-mediated inhibition of anti-tumor immune response, resulting in decreased tumor growth (monoclonal antibody)
Formulary .
No Formulary Selected
Manufacturer/Pricing .
Manufacturer: Bristol-Myers Squibb Co.
DEA/FDA: Rx
Retail Price
Estimated prices only. For current pricing, visit GoodRx.
intravenous solution:
- 240 mg/24 mL (1 vial, 24 mL): $6,925.00
intravenous solution:
- 100 mg/10 mL (1 vial, 10 mL): $2,891.00
intravenous solution:
- 40 mg/4 mL (2 vial, 4 mL): $2,315.00
Join Now to View Patient Handouts!
Create a FREE epocrates Online account to access patient medication instructions. Your patients and caregivers will appreciate you printing these friendly handouts, available in English and Spanish. Each handout addresses common concerns such as how to take the medication, and possible side effects.
Current Members: Sign In.
Pill Pictures
Join Now to View Pill Pictures!
Create a FREE epocrates Online account to access full-color images of medications within the drug monograph.
Current Members: Sign In.