Opdivo Dosage

Metastatic non-small cell lung cancer

240 mg every 2 weeks

or

480 mg every 4 weeks

Until disease progression or unacceptable toxicity

Advanced renal cell carcinoma

Classical Hodgkin lymphoma

Squamous cell carcinoma of the head and neck

Locally advanced or metastatic urothelial carcinoma

Esophageal squamous cell carcinoma

Unresectable or metastatic melanoma

Adult patients and pediatric patients age 12 years and older and weighing 40 kg or more:

240 mg every 2 weeks

or

480 mg every 4 weeks

Until disease progression or unacceptable toxicity

Pediatric patients age 12 years and older and weighing less than 40 kg:

3 mg/kg every 2 weeks

or

6 mg/kg every 4 weeks

Adjuvant treatment of melanoma

Adult patients and pediatric patients age 12 years and older and weighing 40 kg or more:

240 mg every 2 weeks

or

480 mg every 4 weeks

Until disease recurrence or unacceptable toxicity for up to 1 year

Pediatric patients age 12 years and older and weighing less than 40 kg:

3 mg/kg every 2 weeks

or

6 mg/kg every 4 weeks

Adjuvant treatment of urothelial carcinoma (UC)

240 mg every 2 weeks

or

480 mg every 4 weeks

Until disease recurrence or unacceptable toxicity for up to 1 year

Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer ​that has progressed following prior treatment for metastatic disease

Adult patients and pediatric patients age 12 years and older and weighing 40 kg or more:

240 mg every 2 weeks

or

480 mg every 4 weeks

Until disease progression or unacceptable toxicity

Pediatric patients age 12 years and older and weighing less than 40 kg:

3 mg/kg every 2 weeks

Unresectable or metastatic melanoma

1 mg/kg every 3 weeks
with ipilimumab 3 mg/kg

In combination with ipilimumab for a maximum of 4 doses or until unacceptable toxicity, whichever occurs earlier

Adult patients and pediatric patients age 12 years and older and weighing 40 kg or more:

240 mg every 2 weeks
or
480 mg every 4 weeks

After completing 4 doses of combination therapy, administer as single agent until disease progression or unacceptable toxicity

Pediatric patients age 12 years and older and weighing less than 40 kg:

3 mg/kg every 2 weeks
or
6 mg/kg every 4 weeks

Neoadjuvant treatment of resectable non-small cell lung cancer

360 mg every 3 weeks
with platinum-doublet chemotherapy on the same day every 3 weeks

In combination with platinum-doublet chemotherapy for 3 cycles

​Neoadjuvant: 360 mg every 3 weeks
with platinum-doublet chemotherapy on the same day every 3 weeks

​Adjuvant: 480 mg every 4 weeks

Metastatic non-small cell lung cancer expressing PD‑L1

360 mg every 3 weeks
with ipilimumab 1 mg/kg every 6 weeks

In combination with ipilimumab until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression

Metastatic or recurrent non-small cell lung cancer

360 mg every 3 weeks
with ipilimumab 1 mg/kg every 6 weeks
and histology-based platinum‑doublet chemotherapy every 3 weeks

In combination with ipilimumab until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression

2 cycles of histology-based platinum‑doublet chemotherapy

Malignant pleural mesothelioma

360 mg every 3 weeks
with ipilimumab 1 mg/kg every 6 weeks

In combination with ipilimumab until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression

3 mg/kg every 3 weeks
with ipilimumab 1 mg/kg

In combination with ipilimumab
for 4 doses

240 mg every 2 weeks
or
480 mg every 4 weeks

​After completing 4 doses of combination therapy with ipilimumab, administer as single agent until disease progression ​or unacceptable toxicity

​OPDIVO: Until disease progression, unacceptable toxicity​, or up to 2 years

​Cabozantinib: Until disease progression or unacceptable toxicity

First-line unresectable or metastatic urothelial carcinoma

360 mg every 3 weeks
Administer OPDIVO in combination with cisplatin and gemcitabine on the same day every 3 weeks

In combination with cisplatin and gemcitabine
for up to 6 cycles

240 mg every 2 weeks
or
480 mg every 4 weeks

After completing up to 6 cycles of combination therapy, administer as single agent until disease progression, unacceptable toxicity, or up to 2 years from first dose

​Pediatric patients age 12 years and older and weighing less than 40 kg:
3 mg/kg every 3 weeks
with ipilimumab 1 mg/kg

Adult patients and pediatric patients age 12 years and older and weighing 40 kg or more:

240 mg every 2 weeks
or
480 mg every 4 weeks

Pediatric patients age 12 years and older and weighing less than 40 kg:

3 mg/kg every 2 weeks
or
​6 mg/kg every 4 weeks

Hepatocellular carcinoma

1 mg/kg every 3 weeks
with ipilimumab 3 mg/kg

In combination with ipilimumab
for ​a maximum of 4 doses

240 mg every 2 weeks
or
480 mg every 4 weeks

After completing ​a maximum of 4 doses of combination therapy, administer as single agent until disease progression, unacceptable toxicity​, or up to 2 years

Esophageal squamous cell carcinoma

240 mg every 2 weeks
or
480 mg every 4 weeks

Administer OPDIVO in combination with fluoropyrimidine- and platinum‑containing chemotherapy

OPDIVO: Until disease progression, unacceptable toxicity, or up to 2 years

Chemotherapy: Until disease progression or unacceptable toxicity

3 mg/kg every 2 weeks
or
360 mg every 3 weeks
with ipilimumab 1 mg/kg every 6 weeks

In combination with ipilimumab until disease progression, unacceptable toxicity, or up to 2 years

Immune-Mediated Adverse Reactions

Pneumonitis

Grade 2

Withholda

Grades 3 or 4

Permanently discontinue

Colitis

For colitis in patients treated with combination therapy with ipilimumab, see Table 4.

Grade 2 or 3

Withholda

Grade 4

Permanently discontinue

Hepatitis with no tumor involvement of the liver

For liver enzyme elevations in patients treated with combination therapy with ipilimumab, see Table 4.

AST/ALT increases to >3 and ≤8 times ULN

or

Total bilirubin increases to >1.5 and ≤3 times ULN.

Withholda

AST or ALT increases to >8 times ULN

or

Total bilirubin increases to >3 times ULN.

Permanently discontinue

Hepatitis with tumor involvement of the liverb

For liver enzyme elevations in patients treated with combination therapy with ipilimumab, see Table 4.

Baseline AST/ALT is >1 and ≤3 times ULN and increases to >5 and ≤10 times ULN

or

Baseline AST/ALT is >3 and ≤5 times ULN and increases to >8 and ≤10 times ULN.

Withholda

AST/ALT increases to >10 times ULN

or

Total bilirubin increases to >3 times ULN.

Permanently discontinue

Endocrinopathiesc

Grade 3 or 4

Withhold until clinically stable or permanently discontinue depending on severity

Nephritis with Renal Dysfunction

Grade 2 or 3 increased blood creatinine

Withholda

Grade 4 increased blood creatinine

Permanently discontinue

Exfoliative Dermatologic Conditions

Suspected SJS, TEN, or DRESS

Withhold

Confirmed SJS, TEN, or DRESS

Permanently discontinue

Myocarditis

Grades 2, 3, or 4

Permanently discontinue

Neurological Toxicities

Grade 2

Withholda

Grade 3 or 4

Permanently discontinue

Other Adverse Reactions

Infusion-Related Reactions

Grade 1 or 2

Interrupt or slow the rate of infusion

OPDIVO in combination with ipilimumab

Colitis

Grade 2

Withholda

Grade 3 or 4

Permanently discontinue

Hepatitis with no tumor involvement of the liver

or

Hepatitis with tumor involvement of the liver/non-HCC

AST/ALT increases to >3 times ULN and ≤5 times ULN

or

Total bilirubin increases to ≥1.5 and ≤3 times ULN.

Withholda

AST or ALT >5 times ULN

or

Total bilirubin >3 times ULN.

Permanently discontinue

Hepatitis with tumor involvement of the liverb/HCC

Baseline AST/ALT is >1 and ≤3 times ULN and increases to >5 and ≤10 times ULN

or

Baseline AST/ALT is >3 and ≤5 times ULN and increases to >8 and ≤10 times ULN.

Withholda

AST/ALT increases to >10 times ULN

or

Total bilirubin increases to >3 times ULN.

Permanently discontinue

OPDIVO in combination with cabozantinib

Liver enzyme elevations

ALT or AST >3 times ULN but ≤10 times ULN with concurrent total bilirubin <2 times ULN

Withholdc both OPDIVO and cabozantinib until adverse reactions recoverd to Grades 0‑1