Lenvatinib requires careful safety monitoring because it affects multiple signaling pathways and can cause clinically important toxicity.
Hypertension
Blood pressure should be controlled before treatment and monitored during therapy. Current U.S. labeling provides dose-modification instructions for significant hypertension.
Cardiac dysfunction
Patients should be assessed for symptoms or signs of cardiac dysfunction. Severe cardiac dysfunction may require treatment interruption or discontinuation.
Arterial thromboembolic events
Lenvatinib has been associated with arterial thromboembolic events. The U.S. label recommends discontinuation following an arterial thromboembolic event.
Liver toxicity
Hepatotoxicity is an important safety consideration. Liver-function monitoring may be required, particularly in patients receiving treatment for cancers in which liver function is already clinically relevant.
Kidney toxicity and proteinuria
Renal impairment and proteinuria are recognized risks. Urine protein and renal function may therefore require monitoring.
Gastrointestinal complications
Fistula formation and gastrointestinal perforation are serious but less common complications identified in prescribing information.
QT prolongation and electrolytes
Lenvatinib can prolong the QT interval and can cause electrolyte abnormalities such as hypocalcemia. Patients with relevant cardiac risk factors may require additional monitoring.
Hemorrhage
Hemorrhagic events have been reported and can be serious.
Thyroid dysfunction
Lenvatinib can affect thyroid function. Thyroid-function monitoring is relevant, particularly in patients treated for thyroid cancer.
Wound healing
Lenvatinib may impair wound healing. Treatment around planned surgery should therefore be coordinated with the treating clinical team.
Osteonecrosis of the jaw
Osteonecrosis of the jaw is identified as an important risk. Dental health and invasive dental procedures should be discussed with the healthcare team when appropriate.
Pregnancy
Lenvatinib may cause fetal harm. Pregnancy-related precautions should be discussed with a healthcare professional before treatment.
Breastfeeding
The U.S. label advises against breastfeeding during LENVIMA treatment.
Drug interactions
Lenvatinib’s metabolism involves CYP3A and aldehyde oxidase pathways, while its pharmacology and exposure can also be influenced by other medicines. A complete medication review is therefore important.