HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use LENVIMA safely and effectively. See full prescribing information for LENVIMA .
LENVIMA(lenvatinib ) capsules , for oral use
Initial U.S. Approval: 2015
RECENT MAJOR CHANGES
Indications and Usage, Renal Cell Carcinoma (1.2)05/2016
Dosage and Administration (2.2, 2.3, 2.4)05/2016
Warnings and Precautions (5.1 - 5.13)05/2016
INDICATIONS AND USAGE
LENVIMA is a kinase inhibitor that is indicated for:
Differentiated Thyroid Cancer (DTC): single agent for patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory DTC. (1.1)
Renal Cell Cancer (RCC): in combination with everolimus, for patients with advanced RCC following one prior anti-angiogenic therapy. (1.2)
DOSAGE AND ADMINISTRATION
Recommended dose (DTC): 24 mg orally, once daily. (2.1)
Recommended dose (RCC): 18 mg LENVIMA + 5 mg everolimus, orally, once daily. (2.2)
Administration Instructions. (2.3)
Dose Modifications for DTC and RCC. (2.4)
In patients with severe renal or hepatic impairment, the dose is 14 mg once daily in DTC and 10 mg once daily in RCC. (2.4)
DOSAGE FORMS AND STRENGTHS
Capsules: 4 mg and 10 mg. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Hypertension: Control blood pressure prior to treatment with LENVIMA.  Withhold LENVIMA for Grade 3 hypertension despite optimal anti-hypertensive therapy. Discontinue for life-threatening hypertension. (5.1)
Cardiac Failure: Monitor for clinical symptoms or signs of cardiac decompensation. Withhold LENVIMA for Grade 3 cardiac dysfunction. Discontinue for Grade 4 cardiac dysfunction. (5.2)
Arterial Thromboembolic Events: Discontinue LENVIMA following an arterial thromboembolic event. (5.3)
Hepatotoxicity: Monitor liver function tests before initiation of LENVIMA and periodically throughout treatment. Withhold LENVIMA for Grade 3 or greater liver impairment. Discontinue for hepatic failure. (5.4)
Proteinuria: Monitor for proteinuria before initiation of, and periodically throughout, treatment with LENVIMA. Withhold LENVIMA for ≥2 grams of proteinuria for 24 hours. Discontinue for nephrotic syndrome. (5.5)
Diarrhea: May be severe and recurrent. Use standard anti-diarrheal therapy. Withhold LENVIMA for Grade 3 and discontinue for Grade 4 diarrhea. (5.6)
Renal Failure and Impairment: Withhold LENVIMA for Grade 3 or 4 renal failure/impairment. (5.7)
Gastrointestinal Perforation and Fistula Formation: Discontinue LENVIMA in patients who develop gastrointestinal perforation or life-threatening fistula. (5.8)
QT Interval Prolongation: Monitor and correct electrolyte abnormalities in all patients. Withhold LENVIMA for the development of Grade 3 or greater QT interval prolongation. (5.9)
Hypocalcemia: Monitor blood calcium levels at least monthly and replace calcium as necessary. (5.10)
Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Withhold LENVIMA for RPLS until fully resolved. (5.11)
Hemorrhagic Events: Withhold LENVIMA for Grade 3 hemorrhage. Discontinue for Grade 4 hemorrhage. (5.12)
Impairment of Thyroid Stimulating Hormone Suppression/Thyroid Dysfunction: Monitor TSH levels monthly and use thyroid replacement medication as needed. (5.13)
Embryofetal Toxicity: Can cause fetal harm. Advise of potential risk to a fetus