Hepatotoxicity [see Warnings and Precautions (5.1)] | Grade 3 | - Withhold until resolution to Grade 0 to 1 or baseline.
- Resume at a reduced dose.
- For recurring Grade 3 permanently discontinue.
|
Grade 4 | |
Cardiovascular events [see Warnings and Precautions (5.2)] | Asymptomatic cardiomyopathy (left ventricular ejection fraction greater than 20% but less than 50% below baseline or below the lower limit of normal if baseline was not obtained) | - Withhold until resolution to Grade 0 to 1 or baseline.
- Resume at reduced dose.
|
Clinically manifested congestive heart failure (CHF) | |
Hypertension [see Warnings and Precautions (5.4)] | Grade 3 | - Withhold until resolution to Grade 0 to 1 or baseline.
- Resume at a reduced dose.
|
Grade 4 | |
Hemorrhagic events [see Warnings and Precautions (5.5)] | Grade 3 or 4 | - Withhold until resolution to Grade 0 to 1 or baseline.
- Either resume at a reduced dose or discontinue depending on the severity and persistence of adverse reaction.
|
Thrombotic microangiopathy [see Warnings and Precautions (5.7)] | Any Grade | |
Proteinuria or Nephrotic syndrome [see Warnings and Precautions (5.8)] | 3 or more grams proteinuria in 24 hours in the absence of nephrotic syndrome | - Withhold until resolution to Grade 0 to 1 or baseline.
- Resume at a reduced dose.
|
Nephrotic syndrome or recurrent proteinuria of 3 or more grams per 24 hours despite dose reductions | |
Dermatological toxicities Erythema multiforme (EM), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), Necrotizing fasciitis [see Warnings and Precautions (5.9)] | Any Grade | |
Reversible posterior leukoencephalopathy syndrome [see Warnings and Precautions (5.10)] | Any Grade | |
Osteonecrosis of the jaw [see Warnings and Precautions (5.13)] | Any Grade | - The safety of resumption of SUTENT after osteonecrosis has not been established.
- Either resume at a reduced dose or discontinue depending on the severity and persistence of the adverse reaction.
|
Impaired wound healing [see Warnings and Precautions (5.14)] | Any Grade | - The safety of resumption of SUTENT after resolution of wound healing has not been established.
- Either resume at a reduced dose or discontinue depending on the severity and persistence of the adverse reaction.
|