Tivozanib (Fotivda) is a kinase inhibitor, primarily indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) who have previously received two or more lines of systemic therapy.
Precautions for Tivozanib (Fotivda) Administration
Confirmation of Indication
This product is intended for patients with advanced renal cell carcinoma who are relapsed or refractory after two or more lines of systemic therapy.
Risk Assessment Factors
Before medication administration, it is essential to focus on assessing the following conditions in patients: blood pressure control status, cardiac function, bleeding risk, baseline thyroid function, and liver function status.
No relevant studies have been conducted on patients with systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg.
Cardiovascular System Risks
Hypertension is one of the most common adverse reactions of this product, with an incidence rate of up to 45%, among which hypertension of Grade 3 or higher accounts for 22%.
Blood pressure must be controlled before treatment, and regular blood pressure monitoring should be performed at 2 weeks after treatment initiation and then monthly thereafter.
For persistent hypertension, dose adjustment or temporary drug discontinuation is required.
Bleeding Risk Management
The incidence of bleeding events is 11%, with 0.2% of cases resulting in death.
Patients with bleeding risk or a history of bleeding require close monitoring; permanent drug discontinuation is necessary if severe bleeding occurs.
Medication in Special Populations
Patients with moderate hepatic impairment need to have their dose adjusted to 0.89 mg.
The dosage for patients with severe hepatic impairment has not been determined, and the use of this product should be avoided.
The recommended dosage for patients with end-stage renal disease has also not been established.
Identification of Severe Adverse Events
Heart failure (incidence rate: 1.6%).
Arterial thromboembolic events (incidence rate: 2%).
Venous thromboembolic events (incidence rate: 2.4%).
Gastrointestinal perforation and fistula formation.
Reversible posterior leukoencephalopathy syndrome.
Monitoring for Tivozanib (Fotivda) Administration
Laboratory Monitoring
Liver function (incidence rates of elevated ALT and AST are 30% and 28%, respectively).
Renal function (incidence rate of elevated creatinine is 50%).
Electrolyte levels (incidence rate of decreased blood sodium is 36%).
Specialist Assessment Items
Blood pressure monitoring (once every 2 weeks initially, then once a month thereafter).
Thyroid function testing.
Quantitative urinary protein measurement.
Neurological symptom assessment.
