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Tivozanib can cause severe hypertension and hypertensive crisis. Hypertension occurred in 45% of patients treated with Tivozanib, with 22% of the events > Grade 3. Median time to onset of hypertension was 2 weeks (range: 0 – 192 weeks).
Control blood pressure prior to treatment with Tivozanib. Monitor blood pressure after 2 weeks and at least monthly thereafter during treatment with Tivozanib. Treat patients with anti-hypertensive therapy when hypertension occurs during treatment with Tivozanib.
Withhold Tivozanib for severe hypertension despite optimal anti-hypertensive therapy. For persistent hypertension despite use of anti-hypertensive medications, reduce the Tivozanib dose.
Discontinue Tivozanib if hypertension is severe and persistent despite anti-hypertensive therapy and dose reduction of Tivozanib, or in patients who experience hypertensive crisis.
If Tivozanib is interrupted, monitor patients receiving anti-hypertensive medications for hypotension.
Tivozanib can cause serious, sometimes fatal, cardiac failure. Cardiac failure in Tivozanib-treated patients occurred in 1.6%, with 1% of events ≥ Grade 3, and 0.6% events were fatal.
Periodically monitor patients for symptoms of cardiac failure throughout treatment with Tivozanib.
Management of cardiac failure events may require interruption, dose reduction, or permanent discontinuation of Tivozanib therapy.
Closely monitor patients who are at risk for, or who have a history of these events (such as myocardial infarction and stroke), during treatment with Tivozanib.
Discontinue Tivozanib in patients who develop any severe or life-threatening arterial thromboembolic event.
Closely monitor patients who are at risk for, or who have a history of these events during treatment with Tivozanib.
Discontinue Tivozanib in patients who develop any severe or life-threatening venous thromboembolic event.
Monitor patients for proteinuria before initiation of, and periodically throughout, treatment with Tivozanib.
For patients who develop moderate to severe proteinuria, reduce the dose or interrupt Tivozanib treatment.
Discontinue Tivozanib in patients who develop nephrotic syndrome.
from FDA，2021.03
