Fotivda

Advanced renal cell carcinoma (RCC) — relapsed or refractory, after two or more prior systemic therapies

1.34 mg orally once daily for 21 days followed by 7 days off treatment (28-day cycle)
Take with or without food
Dose reductions: 0.89 mg daily, then discontinue
Hepatic impairment (moderate): Reduce to 0.89 mg daily

Capsules: 0.89 mg, 1.34 mg

None listed.

• Hypertension: 45% (22% Grade ≥3). Control BP before initiation. Monitor every 2 weeks for first 2 months then monthly.
• Cardiac Failure: 1.6% (Grade ≥3). Monitor for signs and symptoms.
• Cardiac Ischemia Events: 4% including MI.
• Arterial and Venous Thromboembolic Events: 4% arterial, 3% venous.
• Hemorrhage: 11% (Grade ≥3: 3.3%).
• Proteinuria: 8%. Monitor urinalysis periodically.
• Thyroid Dysfunction: Hypothyroidism in 11%. Monitor TSH at baseline and periodically.
• Wound Healing Complications: Withhold at least 24 days before elective surgery.
• RPLS and GI Perforation
• Embryo-Fetal Toxicity

Fatigue (44%), hypertension (45%), diarrhea (31%), decreased appetite (28%), nausea (24%), dysphonia (22%), hypothyroidism (11%), cough (11%), stomatitis (11%), vomiting (10%)

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

Consult the complete prescribing information for drug interactions, including effects on CYP enzymes, transporters, and concomitant medications that may require dose adjustments or monitoring.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Tivozanib is a potent and selective inhibitor of VEGFR-1, VEGFR-2, and VEGFR-3 at picomolar concentrations, with minimal off-target kinase activity. This selectivity for VEGFRs reduces off-target side effects seen with less selective multi-kinase inhibitors. By blocking VEGFR signaling, tivozanib inhibits tumor angiogenesis, vascular permeability, and tumor growth.

Tmax: 2-24 hours. Half-life: approximately 4.5 days. Protein binding: >99%. Metabolized by CYP3A4 and CYP1A1. Fecal excretion (79%), urinary excretion (12%).

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• TIVO-3 — Tivozanib vs. sorafenib in relapsed/refractory advanced RCC. Phase III, n=350.
  🔬 NCT02627963 ↗ 📄 Primary Publication ↗

Fotivda has FDA-approved indications across the following cancer types covered on PipelineEvidence: