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Lenvatinib 4mg Capsule
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Indications & Clinical Uses
- "Lenvatinib" is the name of an active substance, not an approved brand: no medicine is sold under the plain name Lenvatinib, so this 4 mg capsule is the Eisai product marketed as LENVIMA, and as KISPLYX for kidney cancer in the European Union.
- This catalogue entry therefore duplicates Sr 1893 (Lenvima) and Sr 1820 (Kisplyx).
- Lenvatinib mesylate is an oral tyrosine kinase inhibitor that blocks VEGF, FGFR, PDGFR, RET and KIT signalling and cuts off the blood supply tumours need.
- Approved uses in adults are radioactive iodine-refractory differentiated thyroid cancer at 24 mg daily; advanced kidney cancer with pembrolizumab at 20 mg daily or with everolimus at 18 mg daily; first-line unresectable liver cancer at 12 mg daily if you weigh 60 kg or more and 8 mg daily below 60 kg; and advanced endometrial cancer with pembrolizumab at 20 mg daily.
- Only 4 mg and 10 mg capsules exist, so every dose is built by combining capsules.
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
Lenvatinib is the active substance in LENVIMA, not a brand of its own. Lenvatinib treats radioactive iodine-refractory thyroid cancer, advanced kidney cancer with pembrolizumab or everolimus, first-line unresectable liver cancer, and advanced endometrial cancer with pembrolizumab. In Europe the kidney cancer brand is Kisplyx.
Swallow lenvatinib capsules whole once daily at the same time, with or without food. Only 4 mg and 10 mg capsules exist, so a 24 mg thyroid cancer dose is built from several capsules. If you cannot swallow them, they can be dispersed in water or apple juice and taken straight away.
Lenvatinib (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 Lenvatinib (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.
Lenvatinib doses differ by 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 for liver cancer by body weight. Never assume the capsule count from another indication.
Blood pressure is checked after one week of lenvatinib, 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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