Opdivo Qvantig (nivolumab/ hyaluronidase-nvhy)

Adult Dosing .

Dosage forms:  INJ: 120 mg/2000 units per mL

Special Note

[equivalency or interchangeability info]

Info: not interchangeable with other nivolumab-containing products

[drug name clarification]

Info: nonproprietary name = nivolumab/hyaluronidase-nvhy

[uses, dosing may vary]

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

renal cell CA, advanced

[first-line tx, combo with cabozantinib]

Dose: 600 mg/10,000 units SC q2wk for up to 2y; Alt: 1200 mg/20,000 units SC q4wk for up to 2y

[first-line tx, monotherapy following ipilimumab and IV nivolumab]

Dose: 600 mg/10,000 units SC q2wk; Alt: 1200 mg/20,000 units SC q4wk; Info: for patients with intermediate or poor risk disease

[progressive disease]

Dose: 600 mg/10,000 units SC q2wk; Alt: 1200 mg/20,000 units SC q4wk; Info: for patients who have received prior antiangiogenic tx

melanoma

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

Dose: 600 mg/10,000 units SC q2wk for up to 1y; Alt: 1200 mg/20,000 units SC q4wk for up to 1y; Info: for patients with completely resected disease

[unresectable or metastatic disease]

Dose: 600 mg/10,000 units SC q2wk; Alt: 1200 mg/20,000 units SC q4wk; Info: use as monotherapy or as monotherapy following ipilimumab and IV nivolumab

non-small cell lung CA

[resectable disease, neoadjuvant tx, combo tx]

Dose: 900 mg/15,000 units SC 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/hyaluronidase monotherapy in patients with no EGFR or ALK genomic tumor aberrations

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

Dose: 1200 mg/20,000 units SC 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 disease]

Dose: 600 mg/10,000 units SC q2wk; Alt: 1200 mg/20,000 units SC q4wk; Info: for patients with progressive disease on or after platinum-based chemo

squamous cell head/neck CA, recurrent or metastatic

[600 mg/10,000 units SC q2wk]

Alt: 1200 mg/20,000 units SC q4wk; Info: for patients with disease progression on or after platinum-containing chemo

urothelial carcinoma

[adjuvant tx]

Dose: 600 mg/10,000 units SC q2wk for up to 1y; Alt: 1200 mg/20,000 units SC q4wk for up to 1y; Info: for patients with high recurrence risk after radical resection

[unresectable or metastatic disease, first-line tx]

Dose: 900 mg/15,000 units SC q3wk for up to 6 cycles with combo chemo, then 600 mg/10,000 units SC q2wk as monotherapy for up to 2y total; Alt: 900 mg/15,000 units SC q3wk for up to 6 cycles with combo chemo, then 1200 mg/20,000 units SC q4wk as monotherapy for up to 2y total

[locally advanced or metastatic disease, progressive disease]

Dose: 600 mg/10,000 units SC q2wk; Alt: 1200 mg/20,000 units SC q4wk; Info: patients with disease progression on or after platinum-containing chem

microsatellite instability-high or mismatch repair deficient colorectal CA

[unresectable or metastatic disease]

Dose: 600 mg/10,000 units SC q2wk for up to 2y; Alt: 1200 mg/20,000 units SC q4wk for up to 2y; Info: use as monotherapy following ipilimumab and IV nivolumab

[progressive metastatic disease]

Dose: 600 mg/10,000 units SC q2wk; Alt: 1200 mg/20,000 units SC q4wk

hepatocellular CA, unresectable or metastatic

[first-line tx]

Dose: 600 mg/10,000 units SC q2wk for up to 2y; Alt: 1200 mg/20,000 units SC q4wk for up to 2y; Info: use as monotherapy following ipilimumab and IV nivolumab

[sorafenib refractory or intolerant disease]

Dose: 600 mg/10,000 units SC q2wk; Alt: 1200 mg/20,000 units SC q4wk; Info: use as monotherapy following ipilimumab and IV nivolumab

esophageal CA

[adjuvant tx]

Dose: 600 mg/10,000 units SC q2wk for up to 1y; Alt: 1200 mg/20,000 units SC q4wk for up to 1y; 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]

Dose: 600 mg/10,000 units SC q2wk for up to 2y; Alt: 1200 mg/20,000 units SC q4wk for up to 2y; Info: for patients with unresectable advanced or metastatic disease; part of multi-drug chemo regimen

[squamous cell carcinoma, progressive disease]

Dose: 600 mg/10,000 units SC q2wk; Alt: 1200 mg/20,000 units SC q4wk; 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: 600 mg/10,000 units SC q2wk for up to 2y; Alt: 900 mg/15,000 units SC 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

[600 mg/10,000 units SC q2wk for up to 2y]

Alt: 900 mg/15,000 units SC q3wk for up to 2y; Info: for patients with advanced or metastatic gastric or gastroesophageal junction CA; part of multi-drug chemo regimen

small cell lung CA, relapsed (off-label)

[600 mg/10,000 units SC q2wk]

nfo: for patients who have received prior tx other than immune checkpoint inhibitors

renal dosing

[see below]

eGFR >24: no adjustment; eGFR <24: not defined

HD/PD: not defined

hepatic dosing

[not defined]

Peds Dosing .

Dosage forms:  INJ: 120 mg/2000 units per mL

Special Note

[equivalency or interchangeability info]

Info: not interchangeable with other nivolumab-containing products

[drug name clarification]

Info: nonproprietary name = nivolumab/hyaluronidase-nvhy

[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, 30-39 kg]

Dose: 300 mg/5000 units SC q2wk for up to 1y; Alt: 600 mg/10,000 units SC 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: 600 mg/10,000 units SC q2wk for up to 1y; Alt: 1200 mg/20,000 units SC q4wk for up to 1y; Info: for patients with completely resected disease

[unresectable or metastatic disease, 12 yo and older, 30-39 kg]

Dose: 300 mg/5000 units SC q2wk; Alt: 600 mg/10,000 units SC q4wk; Info: use as monotherapy or as monotherapy following ipilimumab and IV nivolumab

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

Dose: 600 mg/10,000 units SC q2wk; Alt: 1200 mg/20,000 units SC q4wk; Info: use as monotherapy or as monotherapy following ipilimumab and IV nivolumab

microsatellite instability-high or mismatch repair deficient colorectal CA

[unresectable or metastatic disease, 12 yo and older, 30-39 kg]

Dose: 300 mg/5000 units SC q2wk for up to 2y; Alt: 600 mg/10,000 units SC q4wk for up to 2y; Info: use as monotherapy following ipilimumab and IV nivolumab

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

Dose: 600 mg/10,000 units SC q2wk for up to 2y; Alt: 1200 mg/20,000 units SC q4wk for up to 2y; Info: use as monotherapy following ipilimumab and IV nivolumab

[progressive metastatic disease, 12 yo and older, 30-39 kg]

Dose: 300 mg/5000 units SC q2wk; Alt: 600 mg/10,000 units SC q4wk

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

Dose: 600 mg/10,000 units SC q2wk; Alt: 1200 mg/20,000 units SC q4wk

renal dosing

[see below]

eGFR >24: no adjustment; eGFR <24: not defined

HD/PD: not defined

hepatic dosing

[not defined]