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Dose modifications for adverse reactions¹

Adverse Reaction	Severity*	Dose Modifications
Hypertension	Grade 3	Withhold for Grade 3 that persists despite optimal antihypertensive therapy. Resume at reduced dose when hypertension is controlled at less than or equal to Grade 2.
Hypertension	Grade 4	Permanently discontinue.
Cardiac Failure	Grade 3	Withhold until improves to Grade 0 to 1 or baseline. Resume at a reduced dose or discontinue depending on the severity and persistence of adverse reaction.
Cardiac Failure	Grade 4	Permanently discontinue.
Arterial Thromboembolic Events	Any Grade	Permanently discontinue.
Hemorrhagic Events	Grade 3 or 4	Permanently discontinue.
Proteinuria	2 grams or greater proteinuria in 24 hours	Withhold until less than or equal to 2 grams of proteinuria per 24 hours. Resume at a reduced dose. Permanently discontinue for nephrotic syndrome.
Reverse Posterior Leukoencephalopathy Syndrome	Any Grade	Permanently discontinue.
Other Adverse Reactions	Persistent or intolerable Grade 2 or 3 adverse reaction Grade 4 laboratory abnormality	Withhold until improves to Grade 0 to 1 or baseline. Resume at reduced dose.
Other Adverse Reactions	Grade 4 adverse reaction	Permanently discontinue.

*Grades are based on the National Cancer Institute Common Terminology Criteria for Adverse Events.

Reference: 1. FOTIVDA (tivozanib) [package insert]. Boston, MA: AVEO Pharmaceuticals, Inc, August 2024.

Dose modifications for adverse reactions1