This site is intended for UK healthcare professionals
Medscape UK Univadis Logo
Medscape UK Univadis Logo

Cabozantinib oral


Oral formulations of cabozantinib.

Drugs List

  • CABOMETYX 20mg tablets
  • CABOMETYX 40mg tablets
  • CABOMETYX 60mg tablets
  • cabozantinib 20mg capsules
  • cabozantinib 20mg tablets
  • cabozantinib 40mg tablets
  • cabozantinib 60mg tablets
  • cabozantinib 20mg + 80mg capsules
  • COMETRIQ 20mg capsules
  • COMETRIQ 20mg + 80mg capsules
  • Therapeutic Indications


    Hepatocellular carcinoma
    Renal cell carcinoma
    Unresectable locally advanced or metastatic medullary thyroid carcinoma

    Progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma in adults.

    Advanced renal cell carcinoma (RCC) in adults, either following prior vascular endothelial growth factor (VEGF)-targeted therapy, or in treatment-naive adults with intermediate or poor risk. Cabozantinib can also be used in combination with nivolumab as first line treatment for RCC in adults.

    Hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib.


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

    Cabozantinib tablets and capsules are not bioequivalent, and should not be used interchangeably.


    Medullary thyroid carcinoma
    140mg as capsules once daily.
    Treatment should continue until disease progression or unacceptable toxicity.

    Renal cell carcinoma
    60mg as tablets once daily.


    40mg as tablets once daily, in combination with intravenous nivolumab at either 240mg once every 2 weeks OR 480mg once every 4 weeks.

    Treatment should continue until disease progression or unacceptable toxicity.

    Hepatocellular carcinoma
    60mg as tablets once daily.
    Treatment should continue until disease progression or unacceptable toxicity.

    Patients with Hepatic Impairment

    Medullary thyroid carcinoma
    Mild to moderate hepatic impairment: 60mg once daily.

    Additional Dosage Information

    Dose adjustments
    It is expected that the majority of patients will require one or more dose adjustments due to toxicity.
    For persistent events that could become serious or intolerable a dose reduction is recommended. For grade 3 or more toxicities, or intolerable grade 2 toxicities, a dose interruption is recommended.
    If palmar-plantar erythrodysaesthesia (PPES) is severe, interrupt treatment until symptoms have returned to grade 1, resume treatment at a reduced dose.

    Medullary thyroid carcinoma
    If a dose reduction is required the dose should be reduced to 100mg once daily, and further reduced to 60mg once daily if necessary.
    Renal Cell and hepatocellular carcinoma
    If a dose reduction is required the dose should be reduced to 40mg once daily, and further reduced to 20mg once daily if necessary.
    When cabozantinib is administered in combination with nivolumab, it is recommended to reduce the dose to 20mg of cabozantinib once daily, then to 20mg of cabozantinib once every other day. See product literature for more information.

    Missed dose
    Advise patient that if a dose is missed, to take the missed dose as soon as remembered. However, if it is less than 12 hours until the next scheduled dose, wait until the next scheduled dose.


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

    Precautions and Warnings

    Family history of long QT syndrome
    Females of childbearing potential
    Patients over 75 years
    Predisposition to thromboembolic disease
    Recent radiotherapy
    Risk of haemorrhage
    Tobacco smoking
    Behcet's disease
    Cerebrovascular disorder
    Diabetes mellitus
    Electrolyte imbalance
    Giant cell arteritis
    Glucose-galactose malabsorption syndrome
    Hepatic impairment
    History of aneurysm
    History of long QT syndrome
    History of thromboembolic disorder
    History of torsade de pointes
    Inflammatory bowel disease
    Ischaemic heart disease
    Lactose intolerance
    Marfan syndrome
    Occlusive peripheral arterial disease
    Renal impairment
    Takayasu arteritis
    Thyroid tumour infiltration of trachea, bronchi or oesophagus
    Tumour infiltration of the gastrointestinal tract
    Vascular Ehlers-Danlos syndrome

    Correct electrolyte disorders before treatment
    Reduce dose in patients with hepatic impairment
    Suspend treatment if planned surgery within next 28 days
    Advise ability to drive/operate machinery may be affected by side effects
    Anti-diarrhoeals may be required during treatment
    Consider a dental exam & appropriate preventive dentistry before treatment
    Ensure hypertension is controlled prior to treatment
    Give pre-treatment counselling and consideration of oocyte cryopreservation
    Give pre-treatment counselling and consideration of sperm cryopreservation
    Monitor closely patient for toxicity during first 8 weeks
    Not all formulations are licensed for all uses
    Treatment to be initiated by specialist
    Some formulations contain lactose
    Different oral formulations are not interchangeable (not bioequivalent)
    Advise patient to have no food for 2 hours before and 1 hour after dose
    Consult local policy on the safe use of oral anti-cancer drugs
    Staff: Not to be handled by pregnant staff
    Perform liver function tests before commencing therapy
    Consider monitoring ECG in patients at risk of QT prolongation
    Monitor blood pressure
    Monitor for protein in urine
    Monitor for signs and symptoms of hepatic encephalopathy
    Monitor for signs of osteonecrosis
    Monitor for symptoms of gastrointestinal perforation or fistula
    Monitor hepatic enzymes
    Monitor patients with hepatic impairment for adverse effects
    Monitor platelets
    Monitor serum electrolytes
    Advise patient to report headaches, seizures, confusion, visual disturbance
    Consider non-GI fistula if patient presents with mucositis
    Consider the use of anti-emetics before and during therapy
    Discontinue if osteonecrosis of jaw occurs
    Reduce dose for persistent serious or intolerable toxicities
    Treatment may adversely affect wound healing
    May affect results of some laboratory tests
    Discontinue if arterial thromboembolism develops
    Discontinue if fistulae develop during treatment
    Discontinue if myocardial infarction occurs
    Discontinue if nephrotic syndrome occurs
    Discontinue if posterior reversible encephalopathy syndrome (PRES) develops
    Discontinue permanently if hypertensive crisis occurs
    Discontinue treatment if gastrointestinal perforation occurs
    Interrupt therapy/reduce dose if palmar-plantar erythrodysaesthesia occurs
    Suspend treatment if grade 3 or intolerable grade 2 toxicities
    Suspend treatment in severe hypertension that cannot be controlled
    Discontinue if wound healing requires medical intervention
    Advise patient not to take St John's wort concurrently
    Grapefruit juice should not be taken simultaneously
    May cause impaired fertility
    Male & female: Two methods of contraception required (including barrier)
    Male & female:Contraception required during & for 4 months after treatment
    Breastfeeding: Do not breastfeed during & for 4 months after treatment
    Advise patient how to prevent dehydration
    Advise patient of need for high oral hygiene standards
    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.

    Clinical judgement should be used to decide when to resume treatment after surgery based on adequate wound healing.

    RET mutation status should be established prior to treatment. For patients whose RET status could be negative, a possible lower benefit should be taken into account before individual treatment decisions.

    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


    Cabozantinib is contraindicated during pregnancy.

    Use of cabozantinib during pregnancy is contraindicated by the manufacturer. Animal studies have shown teratogenic effects. Human data is limited and as such a potential risk cannot be ruled out.


    Cabozantinib is contraindicated during breastfeeding.

    The manufacturer does not recommend breastfeeding whilst taking cabozantinib and for at least 4 months after treatment. The presence of cabozantinib in human breast milk and the effect on exposed infants are unknown.

    Side Effects

    Acute renal failure
    Alterations in hepatic enzymes
    Alterations in pancreatic enzymes
    Anal fissure
    Angina pectoris
    Arterial thrombosis
    Atrial fibrillation
    Attention disturbances
    Blood glucose disturbances
    Changes of blood pressure
    Cholestatic hepatitis
    Creatine phosphokinase increased
    Decreased appetite
    Dream abnormalities
    Ear pain
    Electrolyte disturbances
    Elevated triglyceride levels
    Elevated TSH
    Eye disorder
    Fungal infection
    Gastro-intestinal haemorrhage
    Gastro-intestinal perforation
    Gastro-intestinal symptoms
    Hepatic encephalopathy
    Impaired consciousness
    Impaired healing
    Increase in lactate dehydrogenase
    Increase in plasma cholesterol
    Increased platelet count
    Increases in eosinophils
    Mucosal inflammation
    Muscle spasm
    Musculoskeletal pain
    Myocardial infarction
    Osteonecrosis (primarily of the jaw)
    Painful extremities
    Palmar-Plantar Erythrodysaesthesia syndrome
    Peripheral coldness
    Peripheral neuropathy
    Posterior reversible encephalopathy syndrome (PRES)
    Pulmonary embolism
    Reduced partial thromboplastin time
    Skin disorder
    Speech disturbances
    Supraventricular tachycardia
    Venous thrombosis
    Weight loss
    White blood cell count raised

    Further Information

    Last Full Review Date: December 2019

    Reference Sources

    Summary of Product Characteristics: Cabometyx 20mg Film-coated tablets. Ipsen Ltd. Revised October 2022.
    Summary of Product Characteristics: Cabometyx 40mg Film-coated tablets. Ipsen Ltd. Revised October 2022.
    Summary of Product Characteristics: Cabometyx 60mg Film-coated tablets. Ipsen Ltd. Revised October 2022.
    Summary of Product Characteristics: Cometriq hard capsules. Ipsen Ltd. Revised April 2020.

    MHRA Drug Safety Update July 2020
    Available at:
    Last accessed: 10 November 2020

    NICE Evidence Services Available at: Last accessed: 12 December 2019

    Access the full UK drug database with a FREE Medscape UK Account
    It takes just a few minutes, and you’ll get unlimited access to information on over 11,000 UK drugs.
    Register for Free

    Already a member? Log in

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

    FDB Logo

    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.