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Tivozanib oral


Oral formulations of tivozanib.

Drugs List

  • FOTIVDA 1340microgram capsules
  • FOTIVDA 890microgram capsules
  • tivozanib 1340microgram capsules
  • tivozanib 890microgram capsules
  • Therapeutic Indications


    Advanced renal cell carcinoma

    First line treatment of advanced renal cell carcinoma in adults.

    Treatment of advanced renal cell carcinoma in adults, who are VEGFR and mTOR pathway inhibitor-naive following disease progression after one treatment with cytokine therapy.


    Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.


    28 day cycle: 1340micrograms once daily for 21 days, then 7 days without treatment.

    Patients with Hepatic Impairment

    Mild hepatic impairment: No dose reduction needed.

    Moderate hepatic impairment: Reduce dose to 1340micrograms every other day.

    Severe hepatic impairment: Contraindicated.

    Additional Dosage Information

    Missed dosage
    If a dose is missed or vomited, the patient should not be given an additional dose. The usual prescribed dose should be taken at the next scheduled time.

    Dose modifications
    Grade 4 events: May require treatment to be temporarily interrupted.

    Grade 3 events: Reduce dose to 890micrograms once daily for 21 days, then 7 days without treatment.

    Grade 2 proteinuria (greater than 1.0g to 3.4g per 24 hours) or Grade 3 proteinuria (equal to or greater than 3.5g per 24 hours): Interrupt or reduce the dose.

    Persistent hypertension (despite anti-hypertensive therapy): Reduce dose. Alternatively, interrupt treatment until blood pressure is controlled, then resume at a lower dose.


    Children under 18 years
    Long QT syndrome
    Severe hepatic impairment
    Torsade de pointes
    Uncontrolled hypertension

    Precautions and Warnings

    Family history of long QT syndrome
    Females of childbearing potential
    History of significant haemorrhage
    Major surgery
    Predisposition to gastrointestinal perforation
    Predisposition to haemorrhage
    Predisposition to thromboembolic disease
    Severe trauma
    Tobacco smoking
    Behcet's disease
    Cardiac failure
    Cerebrovascular disorder
    Diabetes mellitus
    Electrolyte imbalance
    Gastrointestinal fistula
    Giant cell arteritis
    History of aneurysm
    History of thromboembolic disorder
    History of thyroid disorder
    History of torsade de pointes
    Ischaemic heart disease
    Marfan syndrome
    Mild hepatic impairment
    Occlusive peripheral arterial disease
    Severe renal impairment
    Takayasu arteritis
    Vascular Ehlers-Danlos syndrome

    Correct electrolyte disorders before treatment
    Reduce dose in patients with moderate hepatic impairment
    Advise ability to drive/operate machinery may be affected by side effects
    Ensure hypertension is controlled prior to treatment
    Treatment to be prescribed under the supervision of a specialist
    Contains tartrazine- risk of allergic reactions
    Consult local policy on the safe use of oral anti-cancer drugs
    Staff: Not to be handled by pregnant staff
    Monitor for proteinuria before and periodically during treatment
    Monitor hepatic function before treatment and regularly during treatment
    Monitor thyroid function prior to and periodically during treatment
    Screen patient for hypertension and control as appropriate
    Monitor ECG in patients at risk of QT prolongation
    Monitor for symptoms of gastrointestinal perforation or fistula
    Monitor patients for signs and symptoms of cardiac failure
    Monitor serum electrolytes
    Advise patient to report headaches, seizures, confusion, visual disturbance
    Consider discontinuing therapy if significant cardiac failure develops
    Consider dose reduction if cardiac failure occurs
    Treatment may adversely affect wound healing
    Discontinue before elective surgery: impairs wound healing
    Discontinue if Grade 4 proteinuria occurs (Nephrotic syndrome)
    Discontinue if posterior reversible encephalopathy syndrome (PRES) develops
    Interrupt therapy/reduce dose if palmar-plantar erythrodysaesthesia occurs
    Suspend treatment and/or reduce dose if grade 2 or 3 proteinuria
    Suspend treatment in severe hypertension that cannot be controlled
    Suspend treatment if bleeding requiring medical treatment occurs
    Advise patient not to take St John's wort concurrently
    Male & female: May cause infertility
    Female: Effect of hormonal contraceptive may be reduced
    Female: Use barrier contraception during and for 1 month after treatment
    Male: Use barrier contraception during and for 1 month after treatment
    Advise patient on giving up smoking

    Posterior reversible encephalopathy syndrome (PRES) has been reported in some patients treated with this agent. If patients present with symptoms indicating PRES such as headache, altered mental state, seizures and visual disturbances, an MRI should be performed. If PRES is diagnosed, treatment should be discontinued and adequate blood pressure and seizure control administration is advisable. The safety of reinstating treatment in patients previously experiencing PRES is unknown.

    Risk factors for aneurysm and artery dissection
    Use of systemic VEGF inhibitors may promote the formation of aneurysms or artery dissections, mainly in relation to aortic aneurysm rupture and aortic dissection. It is therefore important to consider the risk of aneurysm and artery dissection in patients with risk factors such as hypertension, history of aneurysm, smoking, diabetes, coronary, cerebrovascular or peripheral arterial disease, and hyperlipidaemia. Other risk factors include Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, and the use of fluoroquinolones. In patients receiving VEGF inhibitors, any modifiable risk factors such as smoking and hypertension should be reduced as far as possible.

    Pregnancy and Lactation


    Tivozanib is contraindicated during pregnancy.

    The manufacturer recommends tivozanib should not be used during pregnancy. If the patient becomes pregnant while taking tivozanib, the hazard to the foetus requires discussion. Animal studies have shown reproductive toxicity. There are no adequate data available on the use of tivozanib in human pregnancy.


    Tivozanib is contraindicated during breastfeeding.

    The manufacturer recommends women should not breastfeed during treatment with tivozanib. It is not known whether tivozanib is excreted in human milk. There is potential for serious side effects in the nursing infant.

    Side Effects

    Abdominal distension
    Abdominal pain
    Angina pectoris
    Arterial thrombosis
    Back pain
    Chest pain
    Coronary artery disorder
    Decreased appetite
    Dry mouth
    Dry skin
    Duodenal ulcer
    Ear congestion
    Elevated amylase levels
    Elevated serum lipase
    Elevated TSH
    Fungal infection
    Gamma glutamyl transferase (GGT) increased
    Gastroesophageal reflux disease
    Impaired memory
    Impaired vision
    Increase in alkaline phosphatase
    Increase in haemoglobin
    Increase in serum ALT/AST
    Increased lacrimation
    Mucosal inflammation
    Muscle weakness
    Musculoskeletal pain
    Myocardial infarction
    Myocardial ischaemia
    Nasal congestion
    Palmar-plantar erythrodysaesthesia
    Peripheral neuropathy
    Peripheral oedema
    Posterior reversible encephalopathy syndrome (PRES)
    Prolongation of QT interval
    Pulmonary oedema
    Pustular rash
    Serum creatinine increased
    Skin exfoliation
    Transient ischaemic attack
    Venous thrombosis
    Weight loss


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: November 2020

    Reference Sources

    MHRA Drug Safety Update July 2020
    Available at:
    Last accessed: 17 December 2020

    Summary of Product Characteristics: Fotivda 890mcg hard capsules. EUSA Pharma (UK) Limited. Revised September 2019.
    Summary of Product Characteristics: Fotivda 1340mcg hard capsules. EUSA Pharma (UK) Limited. Revised September 2019.

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.