INDICATION |
RECOMMENDED OPDIVO DOSAGE*†‡ |
DURATION OF THERAPY |
---|
Unresectable or metastatic melanoma
|
1 mg/kg of OPDIVO q3w with ipilimumab 3 mg/kg intravenously |
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 of OPDIVO q2w
OR
480 mg of OPDIVO q4w§ |
After completing 4 doses of combination therapy, administer as single agent until disease progression or unacceptable toxicitiy |
Pediatric patients age 12 years and older and weighing less than 40 kg:
3 mg/kg of OPDIVO q2w
OR
6 mg/kg of OPDIVO q4w |
Neoadjuvant treatment of resectable non-small cell lung cancer
|
360 mg of OPDIVO q3w with platinum-doublet chemotherapy on the same day every 3 weeksII
|
In combination with platinum-doublet chemotherapy for 3 cycles
|
Neoadjuvant and adjuvant treatment of resectable non-small cell lung cancer |
Neoadjuvant: 360 mg of OPDIVO q3w with platinum-doublet chemotherapy on the same day every 3 weeksII |
Neoadjuvant treatment in combination with chemotherapy for up to 4 cycles or until disease progression or unacceptable toxicity, followed by adjuvant treatment with OPDIVO as a single agent after surgery for up to 13 cycles (approximately 1 year) or until disease recurrence or unacceptable toxicity |
Adjuvant: 480 mg every 4 weeks |
Metastatic non-small cell lung cancer expressing PD-L1¶ |
360 mg of OPDIVO q3w 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 of OPDIVO q3w with ipilimumab 1 mg/kg every 6 weeks and histology-based platinum-doublet chemotherapy every 3 weeksII |
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 of OPDIVO q3w 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 |
Advanced renal cell carcinoma |
3 mg/kg of OPDIVO q3w with ipilimumab 1 mg/kg intravenously |
In combination with ipilimumab for 4 doses
|
240 mg of OPDIVO q2w
OR
480 mg of OPDIVO q4w§
Administer OPDIVO in combination with cabozantinib 40 mg orally once daily without food |
OPDIVO: Until disease progression, unacceptable toxicity, or up to 2 years
|
Cabozantinib: Until disease progression or unacceptable toxicity
|
240 mg of OPDIVO q2w
OR
480 mg of OPDIVO q4w§ |
After completing 4 doses of combination therapy with ipilimumab, administer as single agent until disease progression or unacceptable toxicity
|
First-line unresectable or metastatic urothelial carcinoma |
360 mg of OPDIVO q3w
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 of OPDIVO q2w
OR
480 mg of OPDIVO q4w§ |
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 |
Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer |
Adult patients and pediatric patients age 12 years and older and weighing 40 kg or more:
240 mg of OPDIVO q3w with ipilimumab 1 mg/kg intravenously |
In combination with ipilimumab for a maximum of 4 doses
|
Pediatric patients age 12 years and older and weighing less than 40 kg: 3 mg/kg of OPDIVO q3w with ipilimumab 1 mg/kg intravenously |
Adult patients and pediatric patients age 12 years and older and weighing 40 kg or more:
240 mg of OPDIVO q2w
OR
480 mg of OPDIVO q4w |
After completing a maximum of 4 doses of combination therapy, administer as single agent until disease progression or unacceptable toxicity, or up to 2 years |
Pediatric patients age 12 years and older and weighing less than 40 kg:
3 mg/kg of OPDIVO q2w or 6 mg/kg of OPDIVO q4w |
Hepatocellular carcinoma |
1 mg/kg of OPDIVO q3w with ipilimumab 3 mg/kg intravenously |
In combination with ipilimumab for a maximum of 4 doses
|
240 mg of OPDIVO q2w
OR
480 mg of OPDIVO q4w§ |
After completing a maximum of 4 doses of combination therapy, administer as a single agent until disease progression, unacceptable toxicity, or up to 2 years |
Esophageal squamous cell carcinoma |
240 mg of OPDIVO q2w
OR
480 mg of OPDIVO q4w§
Administer OPDIVO in combination with fluoropyrimidine- and platinum-containing chemotherapyII |
OPDIVO: Until disease progression, unacceptable toxicity, or up to 2 years |
Chemotherapy: Until disease progression or unacceptable toxicity |
3 mg/kg of OPDIVO q2w
OR
360 mg of OPDIVO q3w with ipilimumab 1 mg/kg every 6 weeks |
In combination with ipilimumab until disease progression, unacceptable toxicity, or up to 2 years |
Gastric cancer, Gastroesophageal junction cancer, and Esophageal adenocarcinoma |
240 mg of OPDIVO q2w with fluoropyrimidine- and platinum-containing chemotherapyII every 2 weeks
OR
360 mg of OPDIVO q3w with fluoropyrimidine- and platinum-containing chemotherapyII every 3 weeks |
Until disease progression, unacceptable toxicity, or up to 2 years |