Tivozanib (Fotivda) is a kinase inhibitor that was first approved in the United States in 2021. This medication is specifically indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) that is recurrent or refractory after two or more prior systemic therapies.

How to Use Tivozanib (Fotivda)

Indications and Recommended Dosage

Tivozanib is indicated for adult patients with advanced renal cell carcinoma that is recurrent or refractory after two or more prior systemic therapies.

The standard recommended dosage is 1.34 mg orally once daily for 21 consecutive days, followed by a 7-day drug-free period, forming a complete 28-day treatment cycle.

Treatment should be continued until disease progression or the occurrence of unacceptable toxicities.

Tivozanib can be taken with or without food. However, the capsules must be swallowed whole and should not be opened.

If a dose is missed, the regular dose should be taken at the next scheduled time. Do not take a double dose on the same day.

Dosage Forms and Strengths

Tivozanib is available as capsules in two strengths: 1.34 mg and 0.89 mg.

The 1.34 mg capsule is a bright yellow opaque capsule, with dark blue printing "TIVZ" on the cap and dark blue printing "SD" on the body.

The 0.89 mg capsule has a dark blue opaque cap and a bright yellow opaque body, with yellow printing "TIVZ" on the cap and dark blue printing "LD" on the body.

Dosage Adjustment of Tivozanib (Fotivda)

Dosage Adjustment Based on Adverse Reactions

When dosage adjustment is required due to adverse reactions, reduce the tivozanib dose to 0.89 mg and continue treatment with the 28-day cycle (21 days of administration followed by 7 days off).

Hypertension: For grade 3 hypertension that persists despite optimal antihypertensive treatment, interrupt tivozanib administration. Resume treatment at the reduced dose once hypertension is controlled to ≤ grade 2. Permanent discontinuation is required for grade 4 hypertension.

Heart Failure: For grade 3 heart failure, interrupt treatment until the condition improves to grade 0-1 or baseline. Then, decide whether to continue treatment at the reduced dose or discontinue permanently based on the severity and persistence of the adverse reaction. Permanent discontinuation is required for grade 4 heart failure events.

Arterial Thromboembolic Events: Permanent discontinuation of tivozanib is required for any grade of severe arterial thromboembolic events.

Bleeding Events: Permanent discontinuation is required for any grade of severe or life-threatening bleeding events.

Proteinuria: Interrupt treatment when urine protein ≥ 2 g/24 hours. Resume treatment at the reduced dose once urine protein ≤ 2 g/24 hours. Permanent discontinuation is required for the development of nephrotic syndrome.

Management of Other Adverse Reactions

For persistent or intolerable grade 2 or 3 adverse reactions, or grade 4 laboratory abnormalities, interrupt treatment until the condition improves to grade 0-1 or baseline. Then resume treatment at the reduced dose.

Permanent discontinuation is required for the occurrence of grade 4 adverse reactions.

For diarrhea, nausea, or vomiting, medical management is recommended before considering dose interruption or reduction.

Medication Monitoring for Tivozanib (Fotivda)

Baseline Assessment Before Initiating Treatment

Assessment of blood pressure control status.

Evaluation of cardiac function.

Screening for bleeding risk.

Detection of thyroid function.

Assessment of wound healing status.

Key Monitoring During Treatment

Monitor blood pressure at least once every 2 weeks after the start of medication and monthly during treatment.

Periodically monitor proteinuria.

Perform regular complete blood count (CBC) tests.

Monitor serum transaminase and total bilirubin levels.