Opdivo

Adult Dosing .

Dosage forms:  INJ

Special Note

[formulation clarification]

Info: not interchangeable w/ other nivolumab-containing products

[uses, dosing may vary]

Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing incl. toxicity-related dose adjustments

melanoma

[stage IIB, IIC, III, IV dz, adjuvant tx]

Dose: 240 mg IV q2wk for up to 1y; Alt: 480 mg IV q4wk for up to 1y; Info: for pts w/ completely resected dz

[unresectable or metastatic dz, monotherapy]

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

[unresectable or metastatic dz, combo tx]

Dose: 1 mg/kg/dose IV q3wk for max 4 doses w/ ipilimumab, then 240 mg IV q2wk as monotherapy; Alt: 1 mg/kg/dose IV q3wk for max 4 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: for pts w/ tumor >4cm or node-positive dz; use w/ platinum-doublet chemo; may give up to 4 doses prior to adjuvant nivolumab monotherapy in pts w/ no EGFR or ALK genomic tumor aberrations

[resectable dz, adjuvant tx following neoadjuvant tx, monotherapy]

Dose: 480 mg IV q4wk for up to 13 doses; Info: for pts w/ tumor >4cm or node-positive dz and no EGFR or ALK genomic tumor aberrations

[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: first-line tx; 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]

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

Hodgkin lymphoma, classical

[240 mg IV q2wk]

Alt: 480 mg IV q4wk; Info: for relapsed or refractory dz after autologous HSCT + brentuximab vedotin, or after at least 3 lines of tx, incl. autologous HSCT

squamous cell head/neck CA, recurrent or metastatic

[240 mg IV q2wk]

Alt: 480 mg IV q4wk; Info: for pts w/ dz 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 pts w/ high recurrence risk after radical resection

[unresectable or metastatic dz, first-line tx]

Dose: 360 mg IV q3wk for up to 6 cycles w/ combo chemo, then 240 mg IV q2wk as monotherapy for up to 2y total; Alt: 360 mg IV q3wk for up to 6 cycles w/ combo chemo, then 480 mg q4wk as monotherapy for up to 2y total

[locally advanced or metastatic dz, progressive dz]

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

microsatellite instability-high or mismatch repair deficient colorectal CA

[progressive metastatic dz, monotherapy]

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

[unresectable or metastatic dz, combo tx]

Dose: 240 mg IV q3wk for max 4 doses w/ ipilimumab, then 240 mg IV q2wk as monotherapy for up to 2y; Alt: 240 mg IV q3wk for max 4 doses w/ ipilimumab, then 480 mg IV q4wk as monotherapy for up to 2y

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 x1y; 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 dz

[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 dz

[squamous cell carcinoma, progressive dz]

Dose: 240 mg IV q2wk; Alt: 480 mg IV q2wk; Info: for pts w/ unresectable advanced, recurrent or metastatic dz after prior fluoropyrimidine and platinum-based chemo

[advanced or metastatic dz]

Dose: 240 mg IV q2wk for up to 2y; Alt: 360 mg IV q3wk for up to 2y; Info: for pts w/ gastroesophageal junction CA or esophageal adenocarcinoma; part of multi-drug chemo regimen

gastric CA

[240 mg IV q2wk for up to 2y]

Alt: 360 mg IV q3wk for up to 2y; Info: for pts w/ advanced or metastatic gastric or gastroesophageal junction CA; part of multi-drug chemo regimen

small cell lung CA, relapsed (off-label)

[240 mg IV q2wk]

Info: for pts who have received prior tx other than immune checkpoint inhibitors w/ chemo-free interval <6mo

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

[formulation clarification]

Info: not interchangeable w/ other nivolumab-containing products

[uses, dosing may vary]

Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing incl. toxicity-related dose adjustments

melanoma

[stage IIB, IIC, III, IV dz, 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 pts w/ completely resected dz

[stage IIB, IIC, III, IV dz, 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 pts w/ completely resected dz

[unresectable or metastatic dz, monotherapy, 12 yo and older, <40 kg]

Dose: 3 mg/kg/dose IV q2wk; Alt: 6 mg/kg/dose IV q4wk

[unresectable or metastatic dz, monotherapy, 12 yo and older, >40 kg]

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

[unresectable or metastatic dz, combo tx, 12 yo and older, <40 kg]

Dose: 1 mg/kg/dose IV q3wk for max 4 doses w/ ipilimumab, then 3 mg/kg/dose IV q2wk as monotherapy; Alt: 1 mg/kg/dose IV q3wk for max 4 doses w/ ipilimumab, then 6 mg/kg/dose IV q4wk as monotherapy

[unresectable or metastatic dz, combo tx, 12 yo and older, >40 kg]

Dose: 1 mg/kg/dose IV q3wk for max 4 doses w/ ipilimumab, then 240 mg IV q2wk as monotherapy; Alt: 1 mg/kg/dose IV q3wk for max 4 doses w/ ipilimumab, then 480 mg IV q4wk as monotherapy

microsatellite instability-high or mismatch repair deficient colorectal CA

[progressive metastatic dz, monotherapy, 12 yo and older, <40 kg]

Dose: 3 mg/kg/dose IV q2wk

[progressive metastatic dz, monotherapy, 12 yo and older, >40 kg]

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

[unresectable or metastatic dz, combo tx, 12 yo and older, <40 kg]

Dose: 3 mg/kg/dose IV q3wk for max 4 doses w/ 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 w/ ipilimumab, then 6 mg/kg/dose IV q4wk as monotherapy for up to 2y

[unresectable or metastatic dz, combo tx, 12 yo and older, >40 kg]

Dose: 240 mg IV q3wk for max 4 doses w/ ipilimumab, then 240 mg IV q2wk as monotherapy for up to 2y; Alt: 240 mg IV q3wk for max 4 doses w/ 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