Drug Action
Lenvatinib is a multireceptor tyrosine kinase inhibitor.
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Drug reference
Lenvatinib is a multireceptor tyrosine kinase inhibitor.
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KISPLYX ® Advanced renal cell carcinoma following one prior vascular endothelial growth factor-targeted therapy (in combination with everolimus) (specialist use only) ▶BY MOUTH ▶Adult: 18 mg once daily, dose should be taken at the same time every day, for dose adjustment due to side- effects—consult product literature LENVIMA ® Differentiated thyroid carcinoma (specialist use only) ▶BY MOUTH ▶Adult: 24 mg once daily, dose should be taken at the same time every day, for dose adjustments due to side- effects—consult product literature Hepatocellular carcinoma (specialist use only) ▶BY MOUTH ▶Adult (body-weight up to 60 kg): 8 mg once daily, dose should be taken at the same time every day, for dose adjustments due to side-effects—consult product literature ▶Adult (body-weight 60 kg and above): 12 mg once daily, dose should be taken at the same time every day, for dose adjustments due to side-effects—consult product literature
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Fistulae
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Arterial thromboembolism within the previous 6 months. elderly (75 years and over)—reduced tolerability . hypertension—blood pressure should be well-controlled prior to treatment. impaired wound healing—consider temporary interruption of treatment for major surgical procedures
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NICE decisions ▶Lenvatinib and sorafenib for treating differentiated thyroid cancer after radioactive iodine (August 2018) NICE TA535 Lenvatinib (Lenvima ®) is recommended as an option for treating progressive, locally advanced or metastatic differentiated thyroid cancer (papillary, follicular or Hürthle cell) in adults whose disease does not respond to radioactive iodine, only if: . they have not had a tyrosine kinase inhibitor before, or . they have had to stop taking a tyrosine kinase inhibitor within 3 months of starting it because of toxicity (specifically, toxicity that cannot be managed by dose delay or dose modification), and . the manufacturer provides lenvatinib according to the commercial arrangement. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta535 ▶Lenvatinib for untreated advanced hepatocellular carcinoma (December 2018) NICE TA551 Lenvatinib (Lenvima ®) is recommended as an option for untreated, advanced, unresectable hepatocellular carcinoma in adults, only if: . they have Child–Pugh grade A liver impairment and an Eastern Cooperative Oncology Group (ECOG) Immune system and malignant disease performance status of 0 or 1, and . the manufacturer provides it according to the commercial arrangement. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta551 Scottish Medicines Consortium (SMC) decisions SMC No. SMC2138 The Scottish Medicines Consortium has advised (April 2019) that lenvatinib (Lenvima ®) is accepted for use within NHS Scotland as monotherapy for the treatment of adults with advanced or unresectable hepatocellular carcinoma who have received no prior systemic therapy. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower. SMC No. SMC2199 The Scottish Medicines Consortium has advised (November 2019) that lenvatinib (Kisplyx ®) is accepted for use within NHS Scotland in combination with everolimus for the treatment of adults with advanced renal cell carcinoma following one prior vascular endothelial growth factor-targeted therapy. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower. KISPLYX ® NICE decisions ▶Lenvatinib with everolimus for previously treated advanced renal cell carcinoma (January 2018) NICE TA498 Lenvatinib plus everolimus is recommended as an option for treating advanced renal cell carcinoma in adults who have had one previous vascular endothelial growth factor (VEGF)-targeted therapy, only if: . their Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1, and . the manufacturer provides lenvatinib with the discount agreed in the patient access scheme. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta498 LENVIMA ® Scottish Medicines Consortium (SMC) decisions The Scottish Medicines Consortium has advised (October 2016) that lenvatinib (Lenvima ®) is accepted for use within NHS Scotland for treatment of adults with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower. All Wales Medicines Strategy Group (AWMSG) decisions The All Wales Medicines Strategy Group has advised (October 2017) that lenvatinib (Lenvima ®) is recommended as an option for restricted use within NHS Wales for the treatment of adults with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine. This recommendation applies only in circumstances where the approved Wales Patient Access Scheme (WPAS) is utilised or where the list/contract price is equivalent or lower.
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RISKS OF INCORRECT DOSING OF ORAL ANTI-CANCER MEDICINES See Cytotoxic drugs p. 938.
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→Appendix 1: lenvatinib
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▶Common or very common Alopecia. appetite decreased. arthralgia. asthenia. cerebrovascular insufficiency. cholecystitis. constipation. dehydration. diarrhoea. dizziness. dry mouth. dysphonia. electrolyte imbalance. embolism and thrombosis. gastrointestinal discomfort. gastrointestinal disorders. headache. heart failure. hepatic disorders. hypercholesterolaemia. hypertension. hypoalbuminaemia. hypotension. hypothyroidism. increased risk of infection. insomnia. lymphopenia. malaise. metrorrhagia. mucositis. myalgia. myocardial infarction. nausea. oral disorders. oropharyngeal pain. pain. peripheral oedema. proteinuria. QT interval prolongation. renal impairment. renal tubular necrosis. skin reactions. taste altered. thrombocytopenia. vomiting . weight decreased ▶Uncommon Pancreatitis. paresis. posterior reversible encephalopathy syndrome (PRES). splenic infarction ▶Frequency not known Fistula SIDE-EFFECTS, FURTHER INFORMATION Manufacturer advises gastrointestinal toxicity should be actively managed — dehydration and/or hypovolaemia caused by gastrointestinal toxicity are identified as primary risk factors for renal impairment or failure.
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Manufacturer advises women of child-bearing potential should use highly effective contraception during treatment and for 1 month after the last dose, an additional barrier method of contraception should be used in women using oral hormonal contraceptives. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Manufacturer advises avoid unless potential benefit outweighs risk—teratogenic in animal studies. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Manufacturer advises avoid—present in milk in animal studies.
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KISPLYX ® Manufacturer advises caution in severe impairment (risk of increased exposure). Dose adjustments Manufacturer advises dose reduction to 10 mg once daily in severe impairment. LENVIMA ® Manufacturer advises caution. ▶When used for Hepatocellular carcinoma Manufacturer advises avoid in severe impairment (no information available). Dose adjustments ▶When used for Differentiated thyroid carcinoma Manufacturer advises dose reduction to 14 mg once daily in severe impairment; further dose adjustments may be necessary based on tolerability—consult product literature.
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KISPLYX ® Manufacturer advises avoid in end-stage renal disease. Dose adjustments Manufacturer advises reduce dose to 10 mg once daily in severe impairment; further dose adjustments may be necessary based on individual tolerability—consult product literature. Immune system and malignant disease LENVIMA ® ▶When used for Differentiated thyroid carcinoma Manufacturer advises caution in severe impairment; avoid in end-stage renal disease. ▶When used for Hepatocellular carcinoma The available data do not allow for a dosing recommendation in severe impairment—consult product literature. Dose adjustments ▶When used for Differentiated thyroid carcinoma Manufacturer advises dose reduction to 14 mg once daily in severe impairment; further dose adjustments may be necessary based on tolerability—consult product literature.
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▶Manufacturer advises monitor blood pressure after 1 week of treatment, then every 2 weeks for the first 2 months, and then monthly thereafter; monitor for signs and symptoms of cardiac decompensation (adjust dose as necessary— consult product literature). ▶Manufacturer advises monitor liver function before treatment, then every 2 weeks for the first 2 months, and then monthly thereafter; monitor urine protein regularly. ▶Manufacturer advises monitor ECG and electrolytes before and periodically during treatment (calcium levels should be monitored at least monthly), correct electrolyte abnormalities prior to treatment; monitor thyroid function before and regularly during treatment.
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Manufacturer advises capsules should be swallowed whole. Alternatively, capsules may be added to a tablespoon of water or apple juice in a small glass (without breaking or crushing), allowed to sit for at least 10 minutes, then stirred for at least 3 minutes to dissolve the capsule shells before swallowing; the same amount of liquid should then be added to the glass, swirled a few times, then swallowed.
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There can be variation in the licensing of different medicines containing the same drug. Capsule CAUTIONARY AND ADVISORY LABELS 25 ▶Kisplyx (Eisai Ltd) A Lenvatinib (as Lenvatinib mesilate) 4 mg Kisplyx 4mg capsules | 30 capsule P £1,437.00 (Hospital only) Lenvatinib (as Lenvatinib mesilate) 10 mg Kisplyx 10mg capsules | 30 capsule P £1,437.00 (Hospital only) ▶Lenvima (Eisai Ltd) A Lenvatinib (as Lenvatinib mesilate) 4 mg Lenvima 4mg capsules | 30 capsule P £1,437.00 Lenvatinib (as Lenvatinib mesilate) 10 mg Lenvima 10mg capsules | 30 capsule P £1,437.00
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Missed doses Manufacturer advises if a dose is more than 12 hours late, the missed dose should not be taken and the next dose should be taken at the normal time. Driving and skilled tasks Manufacturer advises patients and carers should be counselled on the effects on driving and performance of skilled tasks—increased risk of fatigue and dizziness.
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18 mg once daily, dose should be taken at the
First-line fragment. Read the complete Indications and Dose section above.
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24 mg once daily, dose should be taken at the
First-line fragment. Read the complete Indications and Dose section above.
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8 mg once daily, dose
First-line fragment. Read the complete Indications and Dose section above.
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12 mg once daily,
First-line fragment. Read the complete Indications and Dose section above.
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