|Appearance||White to off-white powder|
|Storage and Handling||Store it at room temperature and away from excess heat and moisture.|
Lenvatinib is an anti-cancer drug for the treatment of certain kinds of thyroid cancer and for other cancers as well. It was acts as a multiple kinase inhibitor against the VEGFR1, VEGFR2 and VEGFR3 kinases.
Lenvatinib is a type of targeted therapy. This means it targets something specific to the cancer cells, therefore decreasing side effects caused by damage to the healthy cells. Lenvatinib works by blocking two processes that allow cancer cells to grow:
▪ Interfering with a protein that promotes cell division
▪ Blocking the VEGF receptor, which is responsible for angiogenesis, or the development of a blood supply to the tumor. This removes the tumor’s source of nutrients.
Lenvatinib Mechanism of Action
Lenvatinib is a receptor tyrosine kinase (RTK) inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). Lenvatinib also inhibits other RTKs that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1, 2, 3, and 4; the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET.
♦ For the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer.
♦ In combination with the drug everolimus, for the treatment of advanced renal cell carcinoma following one prior anti-angiogenic therapy.
♦ Treatment of hepatocellular (primary liver) cancer.
♦ In combination with the drug pembrolizumab for treatment of patients with advanced endometrial cancer.
Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.
Lenvatinib Side Effects & Warning
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Some people taking lenvatinib have developed a perforation (a hole or tear) or a fistula (an abnormal passageway) within the stomach or intestines. Call your doctor if you have severe stomach pain, or if you feel like you are choking and gagging when you eat or drink.
Also call your doctor at once if you have:
▪ severe diarrhea;
▪ headache, confusion, change in mental status, vision loss, seizure (convulsions);
▪ little or no urination;
▪ unusual bleeding (nosebleeds, heavy menstrual bleeding), or any other bleeding that will not stop;
▪ signs of stomach bleeding–bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
▪ heart problems–chest pain, pain in your jaw or shoulder, swelling, rapid weight gain, feeling short of breath;
▪ signs of a blood clot–sudden numbness or weakness, problems with vision or speech;
▪ liver problems–dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
▪ low calcium level–muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes);
▪ increased blood pressure–severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed.
Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.
Common side effects may include:
▪ stomach pain, nausea, vomiting, diarrhea;
▪ loss of appetite, weight loss;
▪ abnormal thyroid function tests;
▪ muscle or joint pain;
▪ swelling in your arms and legs;
▪ mouth sores;
▪ redness, itching, or peeling skin on your hands or feet;
▪ headache, tiredness;
▪ cough, trouble breathing, hoarse voice.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.