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Highlights of Prescribing Information HIGHLIGHTS OF PRESCRIBING INFORMATION • Renal Failure or Impairment: Withhold or discontinue for Grade 3 or 4 These highlights do not include all the information needed to use renal failure or impairment. (2.6, 5.5) LENVIMA safely and effectively. See full prescribing information for • Proteinuria: Monitor for proteinuria prior to treatment and periodically LENVIMA. during treatment. Withhold for 2 or more grams of proteinuria per 24 hours. Discontinue for nephrotic syndrome. (2.6, 5.6) ® LENVIMA (lenvatinib) capsules, for oral use • Diarrhea: May be severe and recurrent. Promptly initiate management for Initial U.S. Approval: 2015 severe diarrhea. Withhold or discontinue based on severity. (2.6, 5.7) Fistula Formation and Gastrointestinal Perforation: Discontinue in patients ----------------------------RECENT MAJOR CHANGES-------------------------- • who develop Grade 3 or 4 fistula or any Grade gastrointestinal perforation. Indications and Usage (1.2) 08/2021 Indications and Usage (1.4) 07/2021 (2.6, 5.8) Dosage and Administration (2.3, 2.6) 08/2021 • QT Interval Prolongation: Monitor and correct electrolyte abnormalities. Dosage and Administration (2.5) 11/2020 Withhold for QT interval greater than 500 ms or for 60 ms or greater Warnings and Precautions (5.3) 08/2021 increase in baseline QT interval. (2.6, 5.9) Warnings and Precautions (5.15) 12/2020 • Hypocalcemia: Monitor blood calcium levels at least monthly and replace calcium as necessary. Withhold or discontinue based on severity. (2.6, ----------------------------INDICATIONS AND USAGE--------------------------- 5.10) LENVIMA is a kinase inhibitor that is indicated: • Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Withhold Differentiated Thyroid Cancer (DTC) for RPLS until fully resolved or discontinue. (2.6, 5.11). For the treatment of patients with locally recurrent or metastatic, • Hemorrhagic Events: Withhold or discontinue based on severity. (2.6, progressive, radioactive iodine-refractory differentiated thyroid cancer 5.12) (DTC). (1.1) • Impairment of Thyroid Stimulating Hormone Suppression/Thyroid Renal Cell Carcinoma (RCC) Dysfunction: Monitor thyroid function prior to treatment and monthly In combination with pembrolizumab, for the first line treatment of adult during treatment. (5.13) patients with advanced renal cell carcinoma (RCC). (1.2) In combination with everolimus, for the treatment of adult patients with • Impaired Wound Healing: Withhold LENVIMA for at least 1 week before advanced renal cell carcinoma (RCC) following one prior anti- elective surgery. Do not administer for at least 2 weeks following major angiogenic therapy. (1.2) surgery and until adequate wound healing. The safety of resumption of Hepatocellular Carcinoma (HCC) LENVIMA after resolution of wound healing complications has not been established. (5.14) For the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). (1.3) • Osteonecrosis of the Jaw: Consider preventive dentistry prior to treatment Endometrial Carcinoma (EC) with LENVIMA. Avoid invasive dental procedures, if possible, particularly In combination with pembrolizumab, for the treatment of patients with in patients at higher risk. (5.15) advanced endometrial carcinoma (EC) that is not microsatellite • Embryo-Fetal Toxicity: Can cause fetal harm. Advise of potential risk to a instability-high (MSI-H) or mismatch repair deficient (dMMR) who have fetus and use of effective contraception. (5.16, 8.1, 8.3) disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. (1.4) ------------------------------ADVERSE REACTIONS------------------------------- In DTC, the most common adverse reactions (incidence ≥30%) for ----------------------DOSAGE AND ADMINISTRATION------------------------- LENVIMA are hypertension, fatigue, diarrhea, arthralgia/myalgia, Single Agent Therapy: decreased appetite, decreased weight, nausea, stomatitis, headache, DTC: The recommended dosage is 24 mg orally once daily. (2.2) vomiting, proteinuria, palmar-plantar erythrodysesthesia syndrome, HCC: The recommended dosage is based on actual body weight: 12 mg abdominal pain, and dysphonia. (6.1) orally once daily for patients greater than or equal to 60 kg or 8 mg orally In RCC: once daily for patients less than 60 kg. (2.4) o The most common adverse reactions (incidence ≥20%) for Combination Therapy: LENVIMA and pembrolizumab are fatigue, diarrhea, EC: The recommended dosage is 20 mg orally once daily in combination musculoskeletal pain, hypothyroidism, hypertension, stomatitis, with pembrolizumab 200 mg administered as an intravenous infusion over decreased appetite, rash, nausea, decreased weight, dysphonia, 30 minutes every 3 weeks. (2.5) proteinuria, palmar-plantar erythrodysesthesia syndrome, RCC: The recommended dosage is: abdominal pain, hemorrhagic events, vomiting, constipation, o 20 mg orally once daily with pembrolizumab 200 mg administered hepatotoxicity, headache, and acute kidney injury. (6.1) as an intravenous infusion over 30 minutes every 3 weeks. (2.3) o The most common adverse reactions (incidence ≥30%) for o 18 mg orally once daily with everolimus 5 mg orally once daily. LENVIMA and everolimus are diarrhea, fatigue, (2.3) arthralgia/myalgia, decreased appetite, vomiting, nausea, stomatitis/oral inflammation, hypertension, peripheral edema, Modify the recommended daily dose for certain patients with renal or hepatic cough, abdominal pain, dyspnea, rash, decreased weight, impairment. (2.7, 2.8) hemorrhagic events, and proteinuria. (6.1) In HCC, the most common adverse reactions (incidence ≥20%) for ---------------------DOSAGE FORMS AND STRENGTHS---------------------- LENVIMA are hypertension, fatigue, diarrhea, decreased appetite, Capsules: 4 mg and 10 mg. (3) arthralgia/myalgia, decreased weight, abdominal pain, palmar-plantar erythrodysesthesia syndrome, proteinuria, dysphonia, hemorrhagic events, -------------------------------CONTRAINDICATIONS------------------------------ hypothyroidism, and nausea. (6.1) None. (4) In EC, the most common adverse reactions (incidence ≥20%) for LENVIMA and pembrolizumab are hypothyroidism, hypertension, fatigue, diarrhea, -----------------------WARNINGS AND PRECAUTIONS------------------------ musculoskeletal disorders, nausea, decreased appetite, vomiting, stomatitis, • Hypertension: Control blood pressure prior to treatment and monitor during decreased weight, abdominal pain, urinary tract infection, proteinuria, treatment. Withhold for Grade 3 hypertension despite optimal constipation, headache, hemorrhagic events, palmar-plantar antihypertensive therapy. Discontinue for Grade 4 hypertension. (2.6, 5.1) erythrodysesthesia, dysphonia, and rash. (6.1) • Cardiac Dysfunction: Monitor for clinical symptoms or signs of cardiac dysfunction. Withhold or discontinue for Grade 3 cardiac dysfunction. To report SUSPECTED ADVERSE REACTIONS, contact Eisai Inc. at 1- Discontinue for Grade 4 cardiac dysfunction. (2.6, 5.2) 877-873-4724 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. • Arterial Thromboembolic Events: Discontinue following an arterial thromboembolic event. (2.6, 5.3) -------------------------USE IN SPECIFIC POPULATIONS---------------------- Lactation: Advise not to breastfeed. (8.2) Hepatotoxicity: Monitor liver function prior to treatment and periodically • during treatment. Withhold or discontinue for Grade 3 or 4 hepatotoxicity. See 17 for PATIENT COUNSELING INFORMATION and FDA- Discontinue for hepatic failure. (2.6, 5.4) approved patient labeling. Reference ID: 4840228 Revised: 08/2021 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 5.14 Impaired Wound Healing 1.1 Differentiated Thyroid Cancer 5.15 Osteonecrosis of the Jaw (ONJ) 1.2 Renal Cell Carcinoma 5.16 Embryo-Fetal Toxicity 1.3 Hepatocellular Carcinoma 6 ADVERSE REACTIONS 1.4 Endometrial Carcinoma 6.1 Clinical Trials Experience 2 DOSAGE AND ADMINISTRATION 6.2 Postmarketing Experience 2.1 Important Dosage Information 7 DRUG INTERACTIONS 2.2 Recommended Dosage for Differentiated Thyroid Cancer 7.1 Drugs That Prolong the QT Interval (DTC) 8 USE IN SPECIFIC POPULATIONS 2.3 Recommended Dosage for Renal Cell Carcinoma (RCC) 8.1 Pregnancy 2.4 Recommended Dosage for Hepatocellular Carcinoma (HCC) 8.2 Lactation 2.5 Recommended Dosage for Endometrial Carcinoma (EC) 8.3 Females and Males of Reproductive Potential 2.6 Dosage Modifications for Adverse Reactions 8.4 Pediatric Use 2.7 Dosage Modifications for Severe Renal Impairment 8.5 Geriatric Use 2.8 Dosage Modifications for Severe Hepatic Impairment 8.6 Renal Impairment 2.9 Preparation and Administration 8.7 Hepatic Impairment 3 DOSAGE FORMS AND STRENGTHS 10 OVERDOSAGE 4 CONTRAINDICATIONS 11 DESCRIPTION 5 WARNINGS AND PRECAUTIONS 12 CLINICAL PHARMACOLOGY 5.1 Hypertension 12.1 Mechanism of Action 5.2 Cardiac Dysfunction 12.3 Pharmacokinetics 5.3 Arterial Thromboembolic Events 13 NONCLINICAL TOXICOLOGY 5.4 Hepatotoxicity 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5.5 Renal Failure or Impairment 14 CLINICAL STUDIES 5.6 Proteinuria 14.1 Differentiated Thyroid Cancer 5.7 Diarrhea 14.2 Renal Cell Carcinoma 5.8 Fistula Formation and Gastrointestinal Perforation 14.3 Hepatocellular Carcinoma 5.9 QT Interval Prolongation 14.4 Endometrial Carcinoma (EC) 5.10 Hypocalcemia 16 HOW SUPPLIED/STORAGE AND HANDLING 5.11 Reversible Posterior Leukoencephalopathy Syndrome 17 PATIENT COUNSELING INFORMATION 5.12 Hemorrhagic Events 5.13 Impairment of Thyroid Stimulating Hormone
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