Tivozanib (1 brand name, 1 dosage form, 0 routes)
Available dosage forms: CAPSULE.
Brand Names
- TIVOZANIB
Indications and Usage
FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
Contraindications
None.
Adverse Reactions
The following clinically significant adverse reactions are also described elsewhere in the labeling: Hypertension and Hypertensive Crisis [see WARNINGS AND PRECAUTIONS (5.1)] Cardiac Failure [see WARNINGS AND PRECAUTIONS (5.2)] Cardiac Ischemia and Arterial Thromboembolic Events [see WARNINGS AND PRECAUTIONS (5.3)] Venous Thromboembolic Events [see WARNINGS AND PRECAUTIONS (5.4)] Hemorrhagic Events [see WARNINGS AND PRECAUTIONS (5.5)] Proteinuria [see WARNINGS AND PRECAUTIONS (5.6)] Gastrointestinal Perforation and Fistula Formation [see WARNINGS AND PRECAUTIONS (5.7)] Thyroid Dysfunction [see WARNINGS AND PRECAUTIONS (5.8)] Risk of Impaired Wound Healing [see WARNINGS AND PRECAUTIONS (5.9)] Reversible Posterior Leukoencephalopathy Syndrome (RPLS) [see WARNINGS AND PRECAUTIONS (5.10)]
Mechanism of Action
Tivozanib is a tyrosine kinase inhibitor. In vitro cellular kinase assays demonstrated that tivozanib inhibits phosphorylation of vascular endothelial growth factor receptor (VEGFR)-1, VEGFR-2 and VEGFR-3 and inhibits other kinases including c-kit and PDGFR β at clinically relevant concentrations. In tumor xenograft models in mice and rats, tivozanib inhibited angiogenesis, vascular permeability, and tumor growth of various tumor cell types including human renal cell carcinoma.
Overdosage
Overdosage with FOTIVDA can cause severe hypertension and hypertensive crisis that may result in death [see WARNINGS AND PRECAUTIONS (5.1)] . During clinical studies, three patients inadvertently received doses ≥ 2.68 mg (≥ 2 times the recommended dose) of FOTIVDA. One patient who received two daily doses of 8.9 mg of FOTIVDA experienced hypertensive crisis with severe hypertensive retinopathy; a second patient who received three doses of 1.34 mg in one day experienced fatal uncontrolled hypertension; and a third patient who received two doses of 1.34 mg FOTIVDA in one day experienced persistent hypertension lasting over 5 days. There is no specific treatment or antidote for FOTIVDA overdose. In cases of suspected overdose, withhold FOTIVDA, closely monitor patients for hypertension and hypertensive crisis and other potential adverse reactions. Immediately manage signs or symptoms of hypertension and provide other supportive care as clinically indicated.