Fotivda Disease Interactions

Hypertension has been observed in patients treated with naxitamab. Most hypertensive events occurred on the day of the infusion and may occur up to 9 days after the infusion. Do not administer this drug to patients with uncontrolled hypertension. Interrupt therapy and resume at a reduced rate or permanently discontinue based on severity. It is recommended to monitor blood pressure during the infusion, an at least daily on Days 1 to 8 of each cycle.

Tivozanib can cause cardiac ischemia and arterial thromboembolic events. It has not been studied in patients who had an arterial thrombotic event, myocardial infarction, or unstable angina within the preceding 6 months before drug initiation. Monitor patients at risk for, or who have a history of these events (e.g., myocardial infarction, stroke), during therapy. Discontinue tivozanib in patients who develop any severe or life-threatening arterial thromboembolic events.

Tivozanib can cause serious, sometimes fatal, cardiac failure. Tivozanib has not been studied in patients with symptomatic cardiac failure within the preceding 6 months before drug initiation. Periodically monitor for cardiac failure throughout therapy with tivozanib. Management of cardiac failure may require interruption, dose reduction, or permanent discontinuation.

Tivozanib can cause serious, sometimes fatal, hemorrhagic events. Hemorrhagic events occurred in 11% of patients treated with tivozanib, including death (0.2%). Tivozanib has not been studied in patients with significant bleeding within the preceding 6 months before therapy initiation. Closely monitor patients who are at risk for or who have a history of bleeding during therapy.

Reduce the dose of tivozanib in patients with moderate (total bilirubin greater than 1.5 to 3 times ULN with any AST) hepatic impairment. The dose in patients with severe (total bilirubin greater than 3 to 10 times ULN with any AST) hepatic impairment has not been established.

Tivozanib has not been studied in patients with systolic blood pressure greater than 150 mmHg or diastolic blood pressure greater than 100 mmHg. Control blood pressure prior to initiating therapy. Monitor blood pressure after 2 weeks and at least monthly thereafter. Treat patients with antihypertensives when hypertension occurs. Withhold therapy for severe hypertension despite optimal antihypertensive therapy. For persistent hypertension (despite use of antihypertensive medications), reduce the dose. Discontinue if hypertension is severe and persistent despite antihypertensive therapy and dose reduction or in patients who experience hypertensive crisis.

No dose modification is recommended for patients with mild to severe renal impairment (CrCl 15 to 89 mL/min). The recommended dose for patients with end-stage renal disease has not been established. Additionally, this drug caused proteinuria in 8% of patients with 2% of events Grade 3. Acute kidney injury has been reported. Monitor patients for proteinuria before initiation of, and periodically throughout, therapy. For patients who develop moderate to severe proteinuria, reduce the dose or interrupt therapy. Discontinue therapy in patients who develop nephrotic syndrome.

Tivozanib causes thyroid dysfunction. Caution is advised in patients that already have any thyroid disorder, they should have their disorder treated before initiation and monitored during therapy.

Tivozanib can cause serious, sometimes fatal, venous thromboembolic events. Venous thromboembolic events occurred in 2.4% of patients treated with tivozanib, including death (0.3%). Closely monitor patients who are at risk for, or who have a history of these events during therapy. Discontinue therapy in patients who develop any severe or life-threatening venous thromboembolic event.