INDICATIONS AND USAGE（适应症）

Differentiated Thyroid Cancer

LENVIMA is indicated for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC).

Renal Cell Carcinoma

LENVIMA, in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

LENVIMA, in combination with everolimus, is indicated for the treatment of adult patients with advanced RCC following one prior anti-angiogenic therapy.

Hepatocellular Carcinoma

LENVIMA is indicated for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).

Endometrial Carcinoma

LENVIMA, in combination with pembrolizumab, is indicated for the treatment of patients with advanced endometrial carcinoma (EC) that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

DOSAGE（服用剂量）

Important Dosage Information

Reduce the dose for certain patients with renal or hepatic impairment.

Take LENVIMA 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.

Recommended Dosage for Differentiated Thyroid Cancer (DTC)

The recommended dosage of LENVIMA is 24 mg orally once daily until disease progression or until unacceptable toxicity.

Recommended Dosage for Renal Cell Carcinoma (RCC)

First-Line Treatment of Patients with Advanced RCC

The recommended dosage of LENVIMA is 20 mg orally once daily in combination with pembrolizumab 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or until unacceptable toxicity or up to 2 years. After completing 2 years of combination therapy, LENVIMA may be administered as a single agent until disease progression or until unacceptable toxicity.

Refer to the pembrolizumab prescribing information for other pembrolizumab dosing information.

Previously Treated RCC

The recommended dosage of LENVIMA is 18 mg in combination with 5 mg everolimus orally once daily until disease progression or until unacceptable toxicity.

Refer to the everolimus prescribing information for recommended everolimus dosing information.

Recommended Dosage for Hepatocellular Carcinoma (HCC)

The recommended dosage of LENVIMA 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 LENVIMA orally once daily until disease progression or until unacceptable toxicity.

Recommended Dosage for Endometrial Carcinoma (EC)

The recommended dosage of LENVIMA is 20 mg orally once daily, in combination with pembrolizumab 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks, until unacceptable toxicity or disease progression.

Refer to the pembrolizumab prescribing information for other pembrolizumab dosing information.

ADVERSE REACTIONS（不良反应）

The following adverse reactions are discussed elsewhere in the labeling:

Hypertension

Cardiac Dysfunction

Arterial Thromboembolic Events

Hepatotoxicity

Renal Failure and Impairment

Proteinuria

Diarrhea

Fistula Formation and Gastrointestinal Perforation

QT Interval Prolongation

Hypocalcemia

Reversible Posterior Leukoencephalopathy Syndrome

Hemorrhagic Events

Impairment of Thyroid Stimulating Hormone Suppression/Thyroid Dysfunction

Impaired Wound Healing

Osteonecrosis of the Jaw (ONJ)

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/f4bedd21-efde-44c6-9d9c-b48b78d7ed1e/spl-doc?hl=Lenvatinib

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