Tivozanib is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. It is available as capsules for oral use. MedsAcross supplies Tivozanib for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
Source: US FDA prescribing information
Tivozanib is a tyrosine kinase inhibitor. In vitro cellular kinase assays demonstrated that tivozanib inhibits phosphorylation of vascular endothelial growth factor receptor (VEGFR)-1, VEGFR-2 and VEGFR-3 and inhibits other kinases including c-kit and PDGFR β at clinically relevant concentrations. In tumor xenograft models in mice and rats, tivozanib inhibited angiogenesis, vascular permeability, and tumor growth of various tumor cell types including human renal cell carcinoma.
Source: US FDA prescribing information
Recommended Dose: 1.34 mg once daily with or without food for 21 days on treatment followed by 7 days off treatment (28-day cycle) until disease progression or unacceptable toxicity. Dose interruptions and/or dose reduction may be needed to manage adverse reactions. For patients with moderate hepatic impairment, reduce the dose to 0.89 mg for 21 days on treatment followed by 7 days off treatment (28-day cycle).
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Hypertension and Hypertensive Crisis: Control blood pressure prior to initiating FOTIVDA. Monitor for hypertension and treat as needed. For persistent hypertension despite use of anti-hypertensive medications, reduce the FOTIVDA dose. Cardiac Failure: Monitor for signs or symptoms of cardiac failure throughout treatment with FOTIVDA. Cardiac Ischemia and Arterial Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe arterial thromboembolic events, such as myocardial infarction and stroke. Venous Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe venous thromboembolic events. Hemorrhagic Events: Closely monitor patients who are at risk for or who have a history of bleeding.
Source: US FDA prescribing information
The following clinically significant adverse reactions are also described elsewhere in the labeling: Hypertension and Hypertensive Crisis Cardiac Failure Cardiac Ischemia and Arterial Thromboembolic Events Venous Thromboembolic Events Hemorrhagic Events Proteinuria Gastrointestinal Perforation and Fistula Formation Thyroid Dysfunction Risk of Impaired Wound Healing Reversible Posterior Leukoencephalopathy Syndrome (RPLS) The most common (≥20%) adverse reactions were fatigue, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis, and the most common Grade 3 or 4 laboratory abnormalities (≥5%) were sodium decreased, lipase increased, and phosphate decreased.
Source: US FDA prescribing information
CYP3A Inducers: Avoid concomitant use of strong CYP3A inducers. Effect of Other Drugs on FOTIVDA Strong CYP3A Inducers Concomitant use of FOTIVDA with a strong CYP3A inducer decreases tivozanib exposure, which may reduce FOTIVDA anti-tumor activity. Avoid concomitant use of strong CYP3A inducers with FOTIVDA.
Source: US FDA prescribing information
Store at 20 ° C to 25 ° C (68 ° F to 77 ° F), excursions permitted between 15°C to 30 ° C (59°F to 86 ° F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Tivozanib, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Fotivda 0.89 mg capsuleOral | AVEO Pharmaceuticals | US FDA | Available on request |
| Fotivda 1.34 mg capsuleOral | AVEO Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Tivozanib in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 2 presentations of Tivozanib and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Tivozanib, including Fotivda.
Yes. The US FDA first approved Tivozanib on 10 March 2021, according to Drugs@FDA.
Yes. Tivozanib has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Tivozanib is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Tivozanib is classified under ATC code L01EK03 (Tivozanib).
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