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Lenvatinib oral


Oral formulations of lenvatinib.

Drugs List

  • KISPLYX 10mg capsules
  • KISPLYX 4mg capsules
  • lenvatinib 10mg capsules
  • lenvatinib 4mg capsules
  • LENVIMA 10mg capsules
  • LENVIMA 4mg capsules
  • Therapeutic Indications


    Advanced renal cell carcinoma progressing on/after VEGF-targeted therapy
    Hepatocellular carcinoma
    Treatment of locally advanced or metastatic differentiated thyroid cancer

    Treatment of progressive, locally advanced or metastatic differentiated (papillary/follicular/Hurthle cell) thyroid carcinoma, refractory to radioactive iodine (RAI). Treatment of patients with advanced renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF)- targeted therapy when used in combination with everolimus. Treatment of advanced or unresectable hepatocellular carcinoma (HCC) in patients who have not had previous systemic therapy.


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


    Differentiated thyroid cancer
    24mg once a day, taken at the same time each day.

    Renal cell carcinoma
    18mg once a day in combination with 5mg of everolimus once a day.

    Hepatocellular carcinoma
    Bodyweight equal to or more than 60kg
    12mg once a day. Modify dose according to dose/toxicity plan.

    Bodyweight less than 60kg
    8mg once a day. Modify dose according to dose/toxicity plan.

    Patients with Renal Impairment

    Differentiated thyroid cancer
    Severe renal impairment: 14mg once a day.

    Renal cell carcinoma
    Severe renal impairment: 10mg once a day.

    Patients with Hepatic Impairment

    Differentiated thyroid cancer
    Severe hepatic impairment (Child-Pugh C): 14mg once a day.

    Renal cell carcinoma
    Severe hepatic impairment (Child-Pugh C): 10mg lenvatinib once a day. Only to be used if potential benefits of treatment outweigh the risks.

    Additional Dosage Information

    Missed Dose
    Advise patient if a dose is missed to take if within 12 hours of the normal dose. If remembered after 12 hours, the patient must skip the missed dose and resume the usual dose regime.

    Blood pressure
    Systolic BP greater than or equal to 140mmHg and less than 160mmHg or diastolic BP greater than or equal to 90mmHg and less than 100mmHg:
    Continue treatment and initiate antihypertensive treatment if patient not already receiving. If the patient is already receiving antihypertensive therapy, increase dose of current antihypertensive treatment or initiate an additional antihypertensive treatment.

    Systolic BP greater than or equal to 160mmHg or diastolic BP 100mmHg despite antihypertensive treatment:
    Suspend treatment of lenvatinib until systolic BP less than or equal to 150mmHg and diastolic BP less than or equal to 95mmHg and patient has been on a stable dose of antihypertensive for 48 hours. Resume lenvatinib at a reduced dose.

    Malignant hypertension, neurological deficit or hypertensive crisis:
    Discontinue treatment of lenvatinib and institute appropriate medical management.

    Dose Modification
    Dose modification is not generally required for mild to moderate adverse reactions (Grade 1 or 2) unless intolerable to the patient. Severe adverse reactions (Grade 3) may require interruption of therapy until improvement of the adverse reaction symptom(s) occurs to Grade 0 or 1. Treatment should then be resumed at a reduced dose.
    Treatment should be discontinued for any life threatening (grade 4) adverse reactions except for laboratory abnormalities judged to be non-life threatening, which should be managed as grade 3 adverse reactions.

    Differentiated thyroid cancer - Dose modification levels
    1st reduction: 20mg once a day.
    2nd reduction: 14mg once a day.
    3rd reduction: 10mg once a day.

    Doses lower than 10mg should be considered on an individual patient basis. At the time of writing there are limited data available on doses lower than 10mg once a day.

    Renal cell carcinoma - Dose modification levels
    1st reduction: 14mg once a day.
    2nd reduction: 10mg once a day.
    3rd reduction: 8mg once a day.

    Hepatocellular carcinoma
    Bodyweight equal to or more than 60kg
    1st occurrence: 8mg once a day
    2nd occurrence: 4mg once a day
    3rd occurrence: 4mg every other day

    Bodyweight less than 60kg
    1st occurrence: 4mg once a day
    2nd occurrence: 4mg every other day
    3rd occurrence: Discontinue

    The following lenvatinib dose modifications for toxicity related to lenvatinib are recommended. For toxicities relating to everolimus, refer to everolimus product literature. For toxicities related to both lenvatinib and everolimus, reduce lenvatinib before reducing everolimus.

    Hypertension Grade 3 despite antihypertensive therapy: Interrupt until Grade 0, 1 or 2. Grade 4: Discontinue and do not resume. Proteinuria Greater than or equal to 2gm per 24 hours: Interrupt until resolves to less than 2gm per 24 hours. QT prolongation Greater than 500msec: Interrupt until resolves to less than 480msec or baseline. The dose should be adjusted or interrupted depending on the severity and persistence of hypocalcaemia, and the presence of ECG changes.


    Children under 18 years
    End stage renal disease
    Long QT syndrome
    Torsade de pointes
    Uncontrolled hypertension

    Precautions and Warnings

    Asian ancestry
    Family history of long QT syndrome
    Females of childbearing potential
    History of radiotherapy
    Patients over 75 years
    Recent surgery
    Risk of haemorrhage
    Tobacco smoking
    Weight below 60kg
    Behcet's disease
    Cerebrovascular disorder
    Decompensated cardiac failure
    Diabetes mellitus
    Electrolyte imbalance
    Giant cell arteritis
    History of aneurysm
    History of torsade de pointes
    Ischaemic heart disease
    Marfan syndrome
    Occlusive peripheral arterial disease
    Recent arterial thromboembolic disorder
    Severe hepatic impairment
    Severe renal impairment
    Takayasu arteritis
    Vascular Ehlers-Danlos syndrome

    Correct electrolyte disorders before treatment
    Reduce dose in patients with severe hepatic impairment
    Reduce dose in patients with severe renal impairment
    Advise ability to drive/operate machinery may be affected by side effects
    Consider a dental exam & appropriate preventive dentistry before treatment
    Ensure hypertension is controlled prior to treatment
    May increase risk of fistula occurring
    Not all available brands are licensed for all indications
    Treatment to be initiated and supervised by a specialist
    Consult local policy on the safe use of oral anti-cancer drugs
    Staff: Not to be handled by pregnant staff
    Monitor thyroid stimulating hormone (TSH) before & during treatment
    Monitor blood pressure after 1week, every 2 weeks for 2 months then monthly
    Monitor calcium levels at least monthly
    Monitor ECG in patients at risk of QT prolongation
    Monitor for gastrointestinal toxicity
    Monitor for protein in urine
    Monitor for symptoms of gastrointestinal perforation or fistula
    Monitor liver function before, every 2 weeks for 2 months & then monthly
    Monitor patients for signs and symptoms of cardiac failure
    Monitor serum electrolytes
    Advise patient to report diarrhoea
    Advise patient to report headaches, seizures, confusion, visual disturbance
    May increase the risk of tumour associated haemorrhage
    Treatment may adversely affect wound healing
    Consider dose modification if proteinuria greater than or equal to 2+
    Consider interrupting treatment if symptoms of cardiac dysfunction occur
    Discontinue if arterial thromboembolism develops
    Discontinue if grade 4 toxicity occurs
    Discontinue if nephrotic syndrome occurs
    Discontinue if posterior reversible encephalopathy syndrome (PRES) develops
    Discontinue if renal failure develops
    Discontinue if severe haemorrhage occurs
    Discontinue permanently if any grade 4 fistula occurs
    Discontinue permanently if grade 4 diarrhoea occurs
    Interrupt treatment and/or reduce dose for any grade 3 toxicity
    Interrupt treatment if QTc exceeds 500msec and consider dose modification
    Female:Non-hormonal contraception advised until 1 month after treatment
    Advise patient on giving up smoking

    Patients with pre-existing hypertension should be on a stable dose of antihypertensive treatment 1 week prior to treatment. Antihypertensive treatment should be initiated as soon as an elevated blood pressure is confirmed. The degree of tumour invasion/infiltration of major blood vessels should be considered because of the potential risk of severe haemorrhage associated with tumour shrinkage or necrosis following lenvatinib therapy. Arterial thromboembolism has been reported in patients receiving lenvatinib, caution should be used in patients who have had an arterial thromboembolism within the previous 6 months. Patients aged 75 years or over, of Asian race and with comorbidities (hypertension, hepatic or renal impairment) and/or have a body weight of less than 60kg appear to have a reduced tolerability to lenvatinib. These patients excluding those with renal and hepatic impairment should initiate treatment at the normal recommended dose, which should then be modified based on patient tolerability. Posterior Reversible Encephalopathy Syndrome (PRES) also known as Reversible Posterior Leucoencephalopathy Syndrome (RPLS) Posterior reversible encephalopathy syndrome (PRES) has been reported in some patients. 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 control 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


    Lenvatinib is contraindicated during pregnancy.

    The manufacturer does not recommend using lenvatinib during pregnancy unless clearly necessary and after careful consideration of the needs of the mother and risk to the foetus. Animal studies have shown teratogenic effects. Human data is limited and as such a potential risk cannot be ruled out.


    Lenvatinib is contraindicated during breastfeeding.

    Use of lenvatinib when breastfeeding is contraindicated by the manufacturer. Animal data reports levels of lenvatinib in the breast milk, however presence in human breast milk is unknown. Effects on exposed infants are unknown.


    Advise patient to swallow whole with water at the same time each day. OR Alternatively, whole capsules may be added to a tablespoon of water or apple juice in a small glass to produce a suspension. Leave the whole capsules in the liquid for at least 10 minutes and then stir for at least 3 minutes to dissolve the capsule shells. Swallow the suspension. After drinking, add the same amount of water or apple juice to the same glass to swirl and swallow.

    Advise patient to report headaches, seizures, confusion and visual disturbances.

    Advise patient to report diarrhoea.

    Advise female patients to use a non-hormonal contraceptive during and for 1 month after treatment.

    Advise patient ability to drive/operate machinery may be affected by side effects.

    Side Effects

    Arterial thrombosis
    Artery dissection
    Back pain
    Cardiac failure
    Cerebrovascular accident
    Decreased appetite
    Decreased ejection fraction
    Dry mouth
    Elevated amylase levels
    Elevated serum lipase
    Elevated TSH
    Fatal intracranial haemorrhage
    Gamma glutamyl transferase (GGT) increased
    Gastro-intestinal pain
    Gastro-intestinal perforation
    Hepatic impairment
    Impaired healing
    Increase in alkaline phosphatase
    Increase in blood urea or creatinine
    Increase in serum ALT/AST
    Intracranial bleeding
    Musculoskeletal pain
    Myocardial infarction
    Nephrotic syndrome
    Non-gastrointestinal fistula
    Oral mucositis
    Oral pain
    Osteonecrosis (primarily of the jaw)
    Painful extremities
    Palmar-Plantar Erythrodysaesthesia syndrome
    Perineal abscess
    Peripheral oedema
    Posterior reversible encephalopathy syndrome (PRES)
    Prolongation of QT interval
    Pulmonary embolism
    Renal failure
    Renal impairment
    Serum bilirubin increased
    Splenic infarction
    Transient ischaemic attack
    Urinary tract infections
    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: April 2021

    Reference Sources

    MHRA Drug Safety Update July 2020
    Available at:
    Last accessed: 07 April 2021

    Summary of Product Characteristics: Kisplyx 4mg and 10mg hard capsules. Eisai Ltd. Revised February 2021.
    Summary of Product Characteristics: Lenvima 4mg and 10mg capsules. Eisai Ltd. Revised March 2021.

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

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