and use of effective contraception. (5.14, 8.1, 8.3)
ADVERSE REACTIONS
In DTC, the most common adverse reactions (incidence greater than or equal to 30%) for LENVIMA are hypertension, fatigue, diarrhea, arthralgia/myalgia, decreased appetite, weight decreased, nausea, stomatitis, headache, vomiting, proteinuria, palmar-plantar erythrodysesthesia syndrome, abdominal pain, and dysphonia. (6.1)
In RCC, the most common adverse reactions (greater than 30%) for LENVIMA + everolimus are diarrhea, fatigue, arthralgia/myalgia, decreased appetite, vomiting, nausea, stomatitis/oral inflammation, hypertension, peripheral edema, cough, abdominal pain, dyspnea, rash, weight decreased, hemorrhagic events, and proteinuria. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Eisai Inc. at 1-877-873-4724 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Lactation: Discontinue breastfeeding. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 2/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Differentiated Thyroid Cancer
1.2 Renal Cell Carcinoma
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dose for DTC
2.2 Recommended Dose for RCC
2.3 Administration Instructions
2.4 Dose Modifications for DTC and RCC
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypertension
5.2 Cardiac Dysfunction
5.3 Arterial Thromboembolic Events
5.4 Hepatotoxicity
5.5 Proteinuria
5.6 Diarrhea
5.7 Renal Failure and Impairment
5.8 Gastrointestinal Perforation and Fistula Formation
5.9 QT Interval Prolongation
5.10 Hypocalcemia
5.11 Reversible Posterior Leukoencephalopathy Syndrome
5.12 Hemorrhagic Events
5.13 Impairment of Thyroid Stimulatin |
