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Lenvima 10mg Capsule
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Indications & Clinical Uses
- Lenvima 10 mg hard capsules contain lenvatinib (as lenvatinib mesylate), an oral tyrosine kinase inhibitor from Eisai that blocks VEGF, FGFR, PDGFR, RET and KIT signalling and so cuts off the blood supply tumours need to grow.
- Approved uses in adults are locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer at 24 mg once daily; advanced renal cell carcinoma with pembrolizumab as first-line treatment at 20 mg once daily, or with everolimus after earlier anti-angiogenic therapy at 18 mg once daily; first-line unresectable hepatocellular carcinoma at 12 mg once daily if you weigh 60 kg or more and 8 mg once daily below 60 kg; and advanced endometrial carcinoma that is mismatch-repair proficient or not MSI-high, with pembrolizumab, at 20 mg once daily after previous systemic therapy.
- In the European Union the same molecule is sold as KISPLYX for kidney cancer, so the two brands must never be swapped without checking the dose.
- Capsules come in 4 mg and 10 mg only.
Side Effects
- Very common effects across the approved uses are high blood pressure, tiredness, diarrhoea, loss of appetite, weight loss, joint and muscle pain, nausea, vomiting, mouth inflammation, hoarse voice, protein in the urine, headache, underactive thyroid, rash, constipation, abdominal pain and hand-foot skin reaction with red, sore, peeling palms and soles.
- There is NO boxed warning on the US lenvatinib label - stated here so its absence is not mistaken for an omission - but the label carries serious warnings you must recognise.
- Bleeding can be severe or fatal: report a sudden severe headache, coughing or vomiting blood, black stools or heavy nosebleeds.
- Seek urgent help for chest pain, one-sided weakness, fainting or a racing heartbeat (heart failure, arterial clots, QT prolongation), severe abdominal pain (bowel perforation or fistula), yellow skin or dark urine (liver injury), a large fall in urine output, or new confusion, seizures or visual loss.
Precautions & Warnings
- Blood pressure must be controlled before treatment starts, then checked after one week, every two weeks for the first two months and monthly afterwards.
- Liver function is tested before treatment, every two weeks for two months and then monthly; urine protein, kidney function, thyroid function, blood calcium and electrolytes are also monitored, with ECGs for anyone with heart disease, electrolyte disturbance or other medicines that prolong the QT interval.
- Treatment is permanently stopped after any arterial clot such as a heart attack or stroke, and after any bowel perforation or grade 3-4 fistula.
- Because wound healing is impaired, treatment is held for at least one week before planned surgery and not restarted for at least two weeks afterwards until the wound has healed; have a dental check before starting, because jaw bone damage can occur.
- It can harm an unborn baby, so effective contraception is needed during treatment and for 30 days after the last dose.
Avoid Interactions
- Tell the prescriber about every medicine, herbal product and supplement before starting.
- Effects that increase risk or toxicity: other medicines that prolong the QT interval, including class Ia and class III antiarrhythmics, some antibiotics, antifungals, antipsychotics and antimalarials, raise the risk of dangerous heart rhythms, so ECGs and electrolytes are monitored and low potassium, magnesium and calcium are corrected first; anticoagulants, antiplatelet drugs and non-steroidal anti-inflammatories add to bleeding risk; other medicines that raise blood pressure, damage the liver or the kidneys, or cause diarrhoea compound the same toxicities; bisphosphonates and denosumab add to the risk of jaw bone damage.
- Effects that reduce benefit: nothing on the label is described as lowering lenvatinib's effect, but enzyme-inducing herbal products such as St John's wort should be avoided unless the prescriber agrees.
- Capsules may be swallowed whole or dispersed in water or apple juice, and any dispersed dose must be taken straight away.
References
Frequently Asked Questions
Lenvima (lenvatinib) treats radioactive iodine-refractory differentiated thyroid cancer, advanced kidney cancer with pembrolizumab or everolimus, first-line unresectable liver cancer, and advanced endometrial cancer with pembrolizumab. It is a tyrosine kinase inhibitor that cuts off the blood supply tumours need to grow.
Swallow Lenvima capsules whole once daily at the same time each day, with or without food. Only 4 mg and 10 mg capsules exist, so your dose is built from a combination. If you cannot swallow them, they may be dispersed in water or apple juice and taken straight away.
Lenvima (lenvatinib) commonly causes high blood pressure, tiredness, diarrhoea, weight loss, nausea, mouth soreness, hoarse voice, protein in the urine and sore peeling palms and soles. Get urgent help for severe headache, coughing blood, black stools, chest pain, one-sided weakness or severe abdominal pain.
Avoid pregnancy while taking Lenvima (lenvatinib) and for 30 days after the last dose, and avoid St John's wort. Tell your prescriber before adding drugs that prolong the QT interval, blood thinners, anti-inflammatory painkillers or bisphosphonates. Hold treatment for a week before planned surgery or dental work.
The Lenvima dose depends on the cancer: 24 mg daily for thyroid cancer, 20 mg with pembrolizumab for kidney or endometrial cancer, 18 mg with everolimus for kidney cancer, and 12 mg or 8 mg daily for liver cancer by body weight. In Europe kidney cancer uses the brand Kisplyx.
Blood pressure is checked one week after starting Lenvima, every two weeks for two months, then monthly. Liver function follows the same schedule, and urine protein, kidney function, thyroid function, calcium and electrolytes are monitored, with ECGs if you have heart disease or take QT-prolonging medicines.
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