OPDIVO + YERVOY
DOSING & SCHEDULE
DURATION
| DOSING & SCHEDULE | DURATION |
Induction phase*† (weight-based
3 mg/kg of OPDIVO
IV infusion† over
30 minutes
followed on the same day by
1 mg/kg of YERVOY
IV infusion† over 30 minutes
q3w for 4 doses of
combination therapy
OR
Until disease progression or unacceptable toxicity
Maintenance phase
240 mg of OPDIVO
IV infusion† over
30 minutes q2w
OR
480 mg of OPDIVO
IV infusion† over
30 minutes q4w‡
| 240 mg of OPDIVO IV infusion† over 30 minutes q2w | OR | 480 mg of OPDIVO IV infusion† over 30 minutes q4w‡ |
Until disease progression
or unacceptable toxicity
After completing 4 doses of the combination in the induction phase, administer OPDIVO as a single agent.
| ADVERSE REACTION | Severity | Dose modification |
|---|---|---|
| Pneumonitis | Grade 2 | Withhold* |
| Grade 3 or 4 | Permanently discontinue | |
| Colitis For colitis in patients treated with combination therapy with ipilimumab, please see the table below | Grade 2 or 3 | Withhold* |
| Grade 4 | Permanently discontinue | |
| Hepatitis with no tumor involvement of liver For liver enzyme elevations in patients treated with combination therapy with ipilimumab, please see the table below | AST/ALT increases to >3 times and ≤8 times the ULN OR Total bilirubin increases to >1.5 times and ≤3 times the ULN
| Withhold* |
AST/ALT increases to >8 times the ULN OR Total bilirubin increases to >3 times the ULN
| Permanently discontinue | |
| Hepatitis with tumor involvement of the liver† For liver enzyme elevations in patients treated with combination therapy with ipilimumab, please see the table below | Baseline AST/ALT is >1 and ≤3 times the ULN and increases to >5 and ≤10 times the ULN OR Baseline AST/ALT is >3 and ≤5 times the ULN and increases to >8 and ≤10 times the ULN
| Withhold* |
AST/ALT increases to >10 times the ULN OR Total bilirubin increases to >3 times the ULN
| Permanently discontinue | |
| Endocrinopathies‡ | 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 | Withhold* |
| Grade 4 increased blood creatinine | Permanently discontinue | |
| Exfoliative dermatologic conditions | Suspected SJS, TEN, or DRESS | Withhold |
| Confirmed SJS, TEN, or DRESS | Permanently discontinue | |
| Myocarditis | Grade 2, 3, or 4 | Permanently discontinue |
| Neurological toxicities | Grade 2 | Withhold* |
| Grade 3 or 4 | Permanently discontinue | |
| Infusion-related reactions | Grade 1 or 2§ | Interrupt or slow the rate of infusion |
| Grade 3 or 4§ | Permanently discontinue |