Tivozanib (Fotivda) is an oral kinase inhibitor. It was approved by the U.S. FDA in 2021 for the treatment of advanced renal cell carcinoma that is relapsed or refractory after two or more lines of systemic therapy. As a novel anti-tumor drug targeting vascular endothelial growth factor receptors (VEGFR), its rational use involves standard administration regimens, dose adjustments based on adverse reactions, and individualized strategies for patients with special physiological conditions.

How to Use Tivozanib (Fotivda)

Standard Usage and Administration Regimen

The recommended dose of tivozanib is 1.34 mg once daily, which can be taken with or without food.

It is necessary to strictly follow the 28-day cycle of "21 days of medication + 7 days of drug holiday" until disease progression or intolerable toxic reactions occur.

Key Notes on Administration Details

Capsules should be swallowed whole; do not chew or damage the capsule structure.

If a dose is missed, take the medication as usual at the next scheduled time. Do not take a double dose on the same day to make up for the missed dose.

Baseline blood pressure must be controlled (systolic blood pressure ≤ 150 mmHg, diastolic blood pressure ≤ 100 mmHg) before starting treatment.

The drug must be discontinued for at least 24 days before elective surgery, and administration can only resume after confirming wound healing following major surgery.

Dose Adjustment of Tivozanib (Fotivda)

Hypertension Management

Grade 3 hypertension (persistent despite optimal antihypertensive treatment) → Discontinue medication temporarily.

After blood pressure is controlled to ≤ Grade 2 → Resume medication at a reduced dose.

Grade 4 hypertension or hypertensive crisis → Discontinue medication permanently.

Management of Cardiac and Thrombotic Events

Heart failure or Grade 3 arterial/venous thromboembolism → Discontinue medication temporarily; resume at a reduced dose after improvement to Grade 0-1.

Severe or life-threatening thrombotic events → Discontinue medication immediately and permanently.

Management of Other Key Adverse Reactions

Proteinuria (24-hour urinary protein ≥ 2 g) → Discontinue medication temporarily; resume at a reduced dose after it decreases to ≤ 2 g/24 hours.

Nephrotic syndrome → Discontinue medication permanently.

Bleeding events (severe bleeding of any grade) → Discontinue medication permanently.

Persistent Grade 2-3 adverse reactions or Grade 4 laboratory abnormalities → Discontinue temporarily; resume at a reduced dose after improvement to Grade 0-1.

Tivozanib (Fotivda) Usage in Special Populations

Patients with Hepatic Impairment

Mild impairment (total bilirubin ≤ upper limit of normal [ULN] with AST > ULN, or total bilirubin 1-1.5 × ULN) → No dose adjustment required.

Moderate impairment (total bilirubin 1.5-3 × ULN) → Dose must be reduced to 0.89 mg.

Severe impairment (total bilirubin 3-10 × ULN) → Avoid use.

Pregnant and Lactating Women

Pregnancy: Contraindicated. Animal studies have shown that doses lower than the clinical dose can cause embryonic death and malformations.

Contraception requirements: Effective contraceptive measures must be used during treatment and for 1 month after the last dose.

Lactation: Breastfeeding is prohibited during treatment and for 1 month after discontinuing the drug.

Elderly Patients and Patients with Renal Impairment

Patients aged ≥ 65 years: No dose adjustment required, but close monitoring is necessary.

Mild to severe renal impairment (creatinine clearance 15-89 mL/min) → Standard dose applies.

End-stage renal disease: No recommended dose has been established yet.