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MANAGING ADVERSE REACTIONS That May Occur with LENVIMA®

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MANAGING ADVERSE REACTIONS That May Occur With LENVIMA® For Treatment of Advanced Renal Cell Carcinoma INDICATION LENVIMA is indicated in combination with everolimus for the treatment of patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy. SELECTED SAFETY INFORMATION Warnings and Precautions Hypertension. In DTC, hypertension occurred in 73% of patients on LENVIMA (44% grade 3-4). In RCC, hypertension occurred in 42% of patients on LENVIMA + everolimus (13% grade 3). Systolic blood pressure ≥160 mmHg occurred in 29% of patients, and 21% had diastolic blood pressure ≥100 mmHg. In HCC, hypertension occurred in 45% of LENVIMA-treated patients (24% grade 3). Grade 4 hypertension was not reported in HCC. Serious complications of poorly controlled hypertension have been reported. Control blood pressure prior to initiation. Monitor blood pressure after 1 week, then every 2 weeks for the first 2 months, and then at least monthly thereafter during treatment. Withhold and resume at reduced dose when hypertension is controlled or permanently discontinue based on severity. Please see additional Selected Safety Information throughout and full Prescribing Information. Advanced Renal Cell Carcinoma (RCC) Recognize, Monitor, and Manage ARs With Recognize ARs With LENVIMA + everolimus LENVIMA® + everolimus In Study 205 RECOGNIZE ARs that may occur with LENVIMA + everolimus Most common ARs (≥30%) observed in LENVIMA + everolimus–treated patients Understand possible ARs with LENVIMA + everolimus to help you and your • Diarrhea (81%), fatigue (73%), arthralgia/myalgia (55%), decreased appetite (53%), vomiting patients prepare for the treatment journey (48%), nausea (45%), stomatitis/oral inflammation (44%), hypertension (42%), peripheral edema (42%), cough (37%), abdominal pain (37%), dyspnea (35%), rash (35%), decreased weight (34%), hemorrhagic events (32%), and proteinuria (31%)1 MONITOR ARs that may occur with LENVIMA + everolimus Most common serious ARs (≥5%) in LENVIMA + everolimus-treated patients Identify points in treatment when ARs emerged in Study 205, so you can • Renal failure (11%), dehydration (10%), anemia (6%), thrombocytopenia (5%), diarrhea (5%), provide timely management vomiting (5%), and dyspnea (5%)1 Most common grade 3-4 ARs (≥5%)1 MANAGE ARs that may occur with LENVIMA + everolimus Consider ways to approach ARs to help your patients LENVIMA 18 mg + everolimus 5 mg everolimus 10 mg on treatment Adverse reaction (n=62) (n=50) Diarrhea 19% 2% AR=adverse reaction. Fatigue 18% 2% Hypertension/increase blood pressure 13% 2% Renal failure eventb 10% 2% Proteinuria/urine protein present 8% 2% Vomiting 7% 0% SELECTED SAFETY INFORMATION Hemorrhagic eventsc 6% 2% Warnings and Precautions (cont'd) Nausea 5% 0% Cardiac Dysfunction. Serious and fatal cardiac dysfunction can occur with LENVIMA. Across Decreased appetite 5% 0% clinical trials in 799 patients with DTC, RCC, and HCC, grade 3 or higher cardiac dysfunction Arthralgia/myalgiad 5% 0% occurred in 3% of LENVIMA-treated patients. Monitor for clinical symptoms or signs of cardiac Dyspnea/exertional dyspnea 5% 8% dysfunction. Withhold and resume at reduced dose upon recovery or permanently discontinue based on severity. Study 205 was not designed to demonstrate a statistically significant difference in AR Arterial Thromboembolic Events. Among patients receiving LENVIMA or LENVIMA + rates for LENVIMA in combination with everolimus, as compared to everolimus alone.¹ everolimus, arterial thromboembolic events of any severity occurred in 2% of patients in RCC and HCC and 5% in DTC. Grade 3-5 arterial thromboembolic events ranged from 2% to 3% AR=adverse reaction. aIncludes asthenia, fatigue, lethargy and malaise across all clinical trials. Permanently discontinue following an arterial thrombotic event. The bIncludes blood creatinine increased, blood urea increased, creatinine renal clearance decreased, safety of resuming after an arterial thromboembolic event has not been established, and nephropathy toxic, renal failure, renal failure acute, and renal impairment c LENVIMA has not been studied in patients who have had an arterial thromboembolic event Includes hemorrhagic diarrhea, epistaxis, gastric hemorrhage, hemarthrosis, hematoma, hematuria, hemoptysis, lip hemorrhage, renal hematoma, and scrotal hematocele within the previous 6 months. dIncludes arthralgia, back pain, extremity pain, musculoskeletal pain, and myalgia 2 Please see additional Selected Safety Information throughout 3 and full Prescribing Information. Advanced Renal Cell Carcinoma (RCC) Recognize ARs That May Occur With LENVIMA® + everolimus In Study 205 LENVIMA + everolimus AR profile (>15%)1* LENVIMA + everolimus AR profile (>15%)1* LENVIMA 18 mg + LENVIMA 18 mg + everolimus 5 mg everolimus 10 mg everolimus 5 mg everolimus 10 mg n=62 n=50 n=62 n=50 Grade 1-4 Grade 3-4 Grade 1-4 Grade 3-4 Grade 1-4 Grade 3-4 Grade 1-4 Grade 3-4 Adverse reaction (%) (%) (%) (%) Adverse reaction (%) (%) (%) (%) Endocrine Musculoskeletal and connective tissue Hypothyroidism 24 0 2 0 Arthralgia/myalgiae 55 5 32 0 Gastrointestinal Musculoskeletal chest pain 18 2 4 0 Constipation 16 0 18 0 Nervous system Diarrhea 81 19 34 2 Headache 19 2 10 2 Dyspepsia/gastroesophageal reflux 21 0 12 0 Psychiatric Abdominal paina 37 3 8 0 Insomnia 16 2 2 0 Renal and urinary Nausea 45 5 16 0 Proteinuria/urine protein present 31 8 14 2 Oral painb 23 2 4 0 Renal failure eventf 18 10 12 2 Stomatitis/oral inflammationc 44 2 50 4 Respiratory, thoracic, and mediastinal Vomiting 48 7 12 0 Cough 37 0 30 0 General Dyspnea/exertional dyspnea 35 5 28 8 Fatigued 73 18 40 2 Dysphonia 18 0 4 0 42 2 20 0 Peripheral edema Skin and subcutaneous tissue Pyrexia/increased body temperature 21 2 10 2 Rashg 35 0 40 0 Metabolism and nutrition Vascular Decreased appetite 53 5 18 0 Hemorrhagic eventsh 32 6 26 2 Decreased weight 34 3 8 0 Hypertension/increased blood pressure 42 13 10 2 Study 205 was not designed to demonstrate a statistically significant difference in AR rates eIncludes arthralgia, back pain, extremity pain, musculoskeletal pain, and myalgia. fIncludes blood creatinine increased, blood urea increased, creatinine renal clearance decreased, for LENVIMA in combination with everolimus, as compared to everolimus alone.¹ nephropathy toxic, renal failure, renal failure acute, and renal impairment. g Includes erythema, erythematous rash, genital rash, macular rash, maculopapular rash, papular rash, AR=adverse reaction. pruritic rash, pustular rash, and septic rash. *The safety data are derived from Study 205 and an additional 11 patients in the dose escalation portion hIncludes hemorrhagic diarrhea, epistaxis, gastric hemorrhage, hemarthrosis, hematoma, hematuria, of the study who received LENVIMA 18 mg + everolimus 5 mg. hemoptysis, lip hemorrhage, renal hematoma, and scrotal hematocele. aIncludes abdominal discomfort, gastrointestinal pain, lower abdominal pain, and upper abdominal pain. bIncludes gingival pain, glossodynia, and oropharyngeal pain. cIncludes aphthous stomatitis, gingival inflammation, glossitis, and mouth ulceration. dIncludes asthenia, fatigue, lethargy, and malaise. 4 Please see additional Selected Safety Information throughout 5 and full Prescribing Information. Advanced Renal Cell Carcinoma (RCC) Grade 3-4 laboratory abnormalities in ≥3% of An established plan for AR management1 patients in the LENVIMA + everolimus arm1†‡ LENVIMA 18 mg + Managing ARs with interruptions, reductions, and/or discontinuations everolimus 5 mg everolimus 10 mg In Study 205, most patients (89%) required a dose reduction or interruption of LENVIMA® + everolimus.1 Laboratory abnormality % (n=62) % (n=50) • In the combination arm, the median of the average daily dose of LENVIMA was 13.6 mg per day Chemistry per patient2* Increased aspartate aminotransferase (AST) 3 0 • Most patients who had a dose reduction in the combination arm (74.5%) required the first dose Increased alanine aminotransferase (ALT) 3 2 reduction of LENVIMA within 3 cycles of treatment2* Increased alkaline phosphatase 3 0 *Limitations: the above 2 bullets were prespecified descriptive analyses. No conclusions can be drawn. Hyperkalemia 6 2 Hypokalemia 6 2 Adverse reaction Severitya Dose modifications for LENVIMA1 Hyponatremia 11 6 Hypertension Grade 3 • Withhold for grade 3 that persists despite optimal Hypocalcemia 6 2 antihypertensive therapy Hypophosphatemia 11 6 • Resume at reduced dose when hypertension is controlled at less than or equal to grade 2 Hyperglycemia 3 16 Grade 4 • Permanently discontinue Hypertriglyceridemia 18 18 Cardiac dysfunction Grade 3 • Withhold until improves to grade 0 to 1 or baseline Hypercholesterolemia 11 0 • Resume at a reduced dose or discontinue depending on Increased creatine kinase 3 4 the severity and persistence of AR Increased lipase 13 12 Grade 4 • Permanently discontinue Hematology Arterial thromboembolic Any grade • Permanently discontinue Anemia 8 16 event Thrombocytopenia 5 0 Hepatotoxicity Grade 3 or 4 • Withhold until improves to grade 0 to 1 or baseline • Either resume at a reduced dose or discontinue Lymphopenia 10 20 depending on severity and persistence of hepatotoxicity • Permanently discontinue for hepatic failure Study 205 was not designed to demonstrate a statistically significant difference in AR Renal failure or impairment Grade 3 or 4 • Withhold until improves to grade 0 to 1 or baseline rates for LENVIMA in combination with everolimus, as compared to everolimus alone.¹ • Resume at a reduced dose or discontinue
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