Lenvakin 10 Capsule: Each capsule contains Lenvatinib Mesylate INN equivalent to Lenvatinib 10 mg.

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.

Lenvakin is a kinase inhibitor that is indicated for:
Hepatocellular Carcinoma (HCC): As first line therapy in patients with unresectable hepatocellular carcinoma.

Differentiated Thyroid Cancer (DTC): Single agent for patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory DTC. Renal Cell Cancer (RCC): Use in combination with Everolimus, for patients with advanced RCC following one prior anti-angiogenic therapy.

Recommended dose (HCC): 12 mg orally, once daily (for adults weighing >60 Kg). 8 mg orally, once daily for adults weighing <60 Kg). Recommended dose (DTC): 24 mg orally, once daily. Recommended dose (RCC): 18 mg Lenvatinib + 5 mg Everolimus, orally, once daily

Administration Instructions: Lenvatinib capsules should be swallowed whole. Alternatively, the capsules can be dissolved in a small glass of liquid. Measure 1 tablespoon of water or apple juice and put the capsules into the liquid without breaking or crushing them. Leave the capsules in the liquid for at least 10 minutes. Stir for at least 3 minutes. Drink the mixture. After drinking, add the same amount (1 tablespoon) of water or apple juice to the glass. Swirl the contents a few times and swallow the additional liquid.

Hypertension: Control blood pressure prior to treatment with Lenvatinib. Withhold Lenvatinib for Grade 3 hypertension despite optimal antihypertensive therapy. Discontinue for life-threatening hypertension.

Hypersensitivity to the active substance or to any of the excipients.

Pregnancy: Lenvatinib can cause fetal harm when administered to pregnant woman.

Lenvakin 10 Capsule: Each HDPE container of Lenvakin 10 contains 30 capsules, a silica gel desiccant and polyester coil with a child resistant closure.

Risk Summary: It is not known whether Lenvatinib is present in human milk. However, Lenvatinib and its metabolites are excreted in rat milk at concentrations higher than in maternal. Because of the potential for serious adverse reactions in nursing infants from Lenvatinib, advise women to discontinue breastfeeding during treatment with Lenvatinib.

Effect of Other Drugs on Lenvatinib No dose adjustment of Lenvatinib is recommended when co-administered with CYP3A, P-glycoprotein (P-gp), and breast cancer resistance protein (BCRP) inhibitors and CYP3A and P-gp inducers.

Due to the high plasma protein binding, lenvatinib is not expected to be dialyzable. Death due to multiorgan dysfunction occurred in a patient who received a single dose of Lenvakin 120 mg orally.

Pediatric Use The safety and effectiveness of Lenvatinib in pediatric patients have not been established.

Do not store above 30° C. Protect from light. Keep out of the reach of children.