Adverse Reaction

Severity1

Sorafenib Tablets Dosage

Modification

Cardiovascular Events [see Warnings and Precautions (5.1)]

Cardiac Ischemia and/or

Infarction

Grade 2 and above

Permanently discontinue.

Congestive Heart Failure

Grade 3

Interrupt2 until Grade 1 or

less, resume at reduced dose by 1 dose level.3

Grade 4

Permanently discontinue.

Hemorrhage [see Warnings

and Precautions (5.2)]

Grade 2 and above requiring medical

intervention

Permanently discontinue.

Hypertension [see Warnings

and Precautions (5.3)]

Grade 2 (symptomatic/persistent)

OR

Grade 2 symptomatic increase by greater than 20 mm Hg (diastolic) or greater than 140/90 mm Hg if previously within normal limits

OR

Grade 3

Interrupt until symptoms

resolve and diastolic blood pressure less than 90 mm Hg, then resume at reduced dose by 1 dose level.3

If needed, reduce another dose level.3

Grade 4

Permanently discontinue.

Gastrointestinal Perforation

[see Warnings and

Precautions (5.5)]

Any grade

Permanently discontinue.

QT Interval Prolongation

[see Warnings and

Precautions (5.9)]

Greater than 500 milliseconds

OR

Increase from baseline of 60 milliseconds or greater

Interrupt and correct

electrolyte abnormalities (magnesium, potassium, calcium).

Use medical judgement before restarting.

Drug-Induced Liver Injury

[see Warnings and

Precautions (5.10)]

Grade 3 ALT or higher in the absence of another cause4

OR

AST/ALT greater than 3 × upper limit normal (ULN) with bilirubin

greater than 2 × ULN in the absence of another cause4

Permanently discontinue.

Non-hematological toxicities [see Adverse

Reactions (6.1)]

Grade 2

Continue treatment at

reduced dose by 1 dose level.

Grade 3

1st occurrence

Interrupt until Grade 2 or

less, then resume at reduced dose by 1 dose level.

No improvement within 7 days

OR

2nd or 3rd occurrence

Interrupt until Grade 2 or

less, then resume at reduced dose by 2 dose levels.

4th occurrence

Interrupt until Grade 2 or

less, then resume at reduced dose by 2 dose levels for HCC or 3 dose levels for DTC.

Grade 4

Permanently discontinue.

sorafenib

Product monograph

Family members