INDICATIONS AND USAGe: Lenvatinib is indicated as monotherapy for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcino- ma (DTC), refractory to radioactive iodine (RAI). Lenvatinib is indicated as monotherapy for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy.

 DOSAGE AND ADMINISTRATION Recommended Dosage for Differentiated Thyroid Cancer (DTC) The recommended dosage of lenvatinib is 24 mg orally once daily until disease progression or until unacceptable toxicity. Recommended Dosage for Renal Cell Carcinoma (RCC) The recommended dosage of lenvatinib is 18 mg in combina- tion with 5 mg everolimus orally once daily until disease progression or until unacceptable toxicity. Refer to everolimus prescribing information for recommended everolimus dosing information. Recommended Dosage for Hepatocellular Carcinoma (HCC) The recommended dosage of lenvatinib is based on actual body weight, 12 mg for patients greater than or equal to 60 kg or 8 mg for patients less than 60 kg. Take lenvatinib orally once daily until disease progression or until unacceptable toxicity. Reduce the dose for certain patients with renal or hepatic impairment, Take lenvatinib once daily, with or without food, at the same time each day. If a dose is missed and cannot be taken within 12 hours, skip that dose and take the next dose at the usual time of administration.

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