Opdivo Dosage

Generic name: nivolumab
Drug class: Anti-PD-1 monoclonal antibodies

Medically reviewed by  A Ras MD.

Recommended Adult Dosing

Dosage forms:  INJ

Melanoma

[adjuvant tx]

Dose: 240 mg IV q2wk for up to 1y; Alt: 480 mg IV q4wk for up to 1y

[metastatic or unresectable dz, monotherapy]

Dose: 240 mg IV q2wk; Alt: 480 mg IV q4wk

[metastatic or unresectable dz, combo tx]

Dose: 1 mg/kg/dose IV q3wk x4 doses w/ ipilimumab, then 240 mg IV q2wk as monotherapy; Alt: 1 mg/kg/dose IV q3wk x4 doses w/ ipilimumab, then 480 mg IV q4wk as monotherapy

Non-small cell lung CA

[resectable dz, neoadjuvant tx, combo tx]

Dose: 360 mg IV q3wk x3 doses; Info: use w/ platinum-doublet chemo

[metastatic PD-L1-expressing dz, combo tx]

Dose: 360 mg IV q3wk for up to 2y; Info: for pts w/ no EGFR or ALK genomic tumor aberrations; first-line tx; use w/ ipilimumab

[metastatic or recurrent dz, combo tx]

Dose: 360 mg IV q3wk for up to 2y; Info: for pts w/ no EGFR or ALK genomic tumor aberrations; first-line tx; use w/ ipilimumab and 2 cycles of q3wk histology-based platinum-doublet chemo

[metastatic dz, monotherapy]

Dose: 240 mg IV q2wk; Alt: 480 mg IV q4wk; Info: for pts w/ progressive dz on or after platinum-based chemo

Malignant pleural mesothelioma, unresectable

[360 mg IV q3wk for up to 2y]

Info: use w/ ipilimumab

Renal cell CA, advanced

[first-line tx, combo w/ cabozantinib]

Dose: 240 mg IV q2wk for up to 2y; Alt: 480 mg IV q4wk for up to 2y

[first-line tx, combo w/ ipilimumab]

Dose: 3 mg/kg/dose IV q3wk x4 doses w/ ipilimumab, then 240 mg IV q2wk as monotherapy; Alt: 3 mg/kg/dose IV q3wk x4 doses w/ ipilimumab, then 480 mg IV q4wk as monotherapy; Info: for pts w/ intermediate or poor risk dz

[progressive dz, monotherapy]

Dose: 240 mg IV q2wk; Alt: 480 mg IV q4wk; Info: for pts who have received prior antiangiogenic tx

Hodgkin lymphoma, relapsed or refractory

[240 mg IV q2wk]

Alt: 480 mg IV q4wk

Squamous cell head/neck CA, recurrent or metastatic

[240 mg IV q2wk]

Alt: 480 mg IV q4wk

Urothelial carcinoma

[adjuvant tx]

Dose: 240 mg IV q2wk for up to 1y; Alt: 480 mg IV q4wk for up to 1y; Info: for pts w/ high recurrence risk after radical resection

[locally advanced or metastatic]

Dose: 240 mg IV q2wk; Alt: 480 mg IV q4wk; Info: for pts w/ disease progression during or w/in 12mo of platinum-based tx

Microsatellite instability-high or mismatch repair deficient colorectal CA, metastatic

[monotherapy]

Dose: 240 mg IV q2wk; Alt: 480 mg IV q4wk; Info: for refractory or relapsed dz

[combo tx]

Dose: 3 mg/kg/dose IV q3wk x4 doses w/ ipilimumab, then 240 mg IV q2wk as monotherapy; Alt: 3 mg/kg/dose IV q3wk x4 doses w/ ipilimumab, then 480 mg IV q4wk as monotherapy; Info: for refractory or relapsed dz

Hepatocellular CA

[1 mg/kg/dose IV q3wk x4 doses w/ ipilimumab, then 240 mg IV q2wk as monotherapy]

Alt: 1 mg/kg/dose IV q3wk x4 doses w/ ipilimumab, then 480 mg IV q4wk as monotherapy; Info: for sorafenib refractory or intolerant dz

Esophageal CA

[adjuvant tx]

Dose: 240 mg IV q2wk x16wk, then 480 mg IV q4wk x36wk; Alt: 480 mg IV q4wk x1y; Info: for pts w/ completely resected esophageal or gastroesophageal junction cancer w/ residual pathologic dz after receiving neoadjuvant chemoradiation

[squamous cell carcinoma, first-line tx, combo w/ ipilimumab]

Dose: 3 mg/kg/dose IV q2wk for up to 2y; Alt: 360 mg IV q3wk for up to 2y; Info: for pts w/ unresectable advanced or metastatic esophageal squamous cell carcinoma

[squamous cell carcinoma, first-line tx, combo w/ 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 pts w/ unresectable advanced or metastatic esophageal squamous cell carcinoma

[squamous cell carcinoma, refractory, monotherapy]

Dose: 240 mg IV q2wk; Alt: 480 mg IV q2wk; Info: for pts w/ unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma after at least one fluoropyrimidine and platinum-based chemo

[advanced or metastatic dz, combo tx]

Dose: 360 mg IV q3wk for up to 2y; Alt: 240 mg IV q2wk for up to 2y; Info: for pts w/ gastroesophageal junction cancer or esophageal adenocarcinoma

Gastric CA

[360 mg IV q3wk for up to 2y]

Alt: 240 mg IV q2wk for up to 2y; Info: for pts w/ advanced or metastatic gastric or gastroesophageal junction CA; use w/ fluoropyrimidine and platinum-containing chemo

Small cell lung CA, refractory metastatic

[indication withdrawn in US]

Info: drug not shown to improve survival in pts w/ small cell lung CA

Renal dosing

eGFR >15: no adjustment; eGFR <15: not defined

HD/PD: not defined

Hepatic dosing

bilirubin 1-3x ULN or AST >ULN: no adjustment; bilirubin >3x ULN and any AST: not defined

SRC: NLM .