VEGFR tyrosine-kinase inhibitor Pregnancy: Tivozanib should not be used during pregnancy. There are no data from use in pregnant women and animal studies have shown reproductive toxicity. Women of childbearing potential should avoid becoming pregnant, and female partners of male patients should also avoid pregnancy; effective contraception should be used by male and female patients and their partners during therapy and for at least one month after completing therapy (women using hormonal contraceptives should add a barrier method). Women should not breast-feed while taking tivozanib (§4.6).

Tivozanib (Specialist drug)

Brand names: Fotivda

Tivozanib is an oral vascular endothelial growth factor receptor tyrosine kinase inhibitor used in the first-line treatment of advanced renal cell carcinoma. It is a specialist drug initiated under oncology supervision.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 1340 microgram once daily for 21 days, followed by a 7-day rest period, comprising one complete treatment cycle of 4 weeks.

Route: Oral. Capsules must be swallowed whole with a glass of water and must not be opened; may be taken with or without food.

Frequency: Once daily for 21 days of each 28-day cycle, then 7 days off. Continue this schedule until disease progression or unacceptable toxicity.

Max: No more than one dose must be taken per day (§4.2).

Dose modification: when dose reduction is necessary the dose can be reduced to 890 microgram once daily on the normal 21-days-on / 7-days-off schedule. In the pivotal study the dose was reduced for Grade 3 events and interrupted for Grade 4 events. Missed dose: do not take a replacement dose — take the next dose at the next scheduled time; the same applies in the case of vomiting. Hepatic impairment: all patients should have liver function tests (ALT, AST, bilirubin, alkaline phosphatase) before starting and during treatment; no dose adjustment in mild impairment; patients with moderate hepatic impairment should be treated with only one 1340 microgram capsule every other day because of increased exposure; not recommended in severe hepatic impairment; use with caution and close monitoring of tolerability in mild and moderate impairment. Elderly: no dose adjustment required in patients 65 years of age or older. Paediatric: safety and efficacy in children and adolescents below 18 years have not been established, no data are available, and there is no relevant use in the paediatric population in advanced renal cell carcinoma (§4.2). Treatment should be supervised by a physician experienced in the use of anticancer therapies. Blood pressure should be well controlled before initiating.

Dose adjustments

Renal

No dose adjustment is required in patients with mild or moderate renal impairment. Caution is advised in patients with severe renal impairment due to limited experience, and in patients undergoing dialysis as there is no experience in this population (§4.2).

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance or to any of the excipients (§4.3)
Co-administration with herbal preparations containing St John's wort (Hypericum perforatum) (§4.3)

Side effects

Hypertension (47.6%) — the most important serious adverse reaction; also persistent severe hypertension
Dysphonia (26.9%)
Fatigue (25.8%)
Diarrhoea (25.5%)
Hypothyroidism (very common)
Anaemia and decreased appetite (very common)

Interactions

Herbal preparations containing St John's wort (Hypericum perforatum) — co-administration is contraindicated (eMC §4.3, cross-referencing §4.5)
US label §7.1 (eMC §4.5 was not in the fetched bundle): avoid concomitant use of strong CYP3A inducers, which decrease tivozanib exposure and may reduce anti-tumour activity

Clinical monograph

How it works

It inhibits VEGF receptors, blocking tumour angiogenesis and thereby restricting tumour blood supply and growth.

Prescribing in practice

Hypertension is very common and can be severe, so blood pressure must be controlled before starting and monitored throughout treatment.
It carries risks of bleeding, arterial and venous thromboembolic events, and impaired wound healing, so it should be withheld around surgery.
It can cause hypothyroidism and proteinuria, and interacts with strong CYP3A4 modulators.

Monitoring

Monitor blood pressure, thyroid function and urinary protein, and review for bleeding or thromboembolic symptoms during treatment.

Counselling the patient

Have your blood pressure checked regularly and report severe headaches or visual disturbance.
Tell your team before any planned surgery or dental procedures.
Report unusual bleeding, swelling or signs of a clot such as a painful swollen leg or breathlessness.

Evidence & guidelines

Tivozanib was evaluated against sorafenib in advanced renal cell carcinoma in the TIVO-1 and TIVO-3 trials supporting its licensed use.

Reference: NICE TA512; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Drugs

Fruquintinib (Specialist drug) · VEGFR tyrosine-kinase inhibitor

Pathways