LORBRENA™ has a generally manageable safety profile with a low discontinuation rate^2*

• In the pooled safety population, the most frequent adverse reactions in ≥ 20% of 476 patients who received LORBRENA™ were edema (56%), peripheral neuropathy (44%), weight gain (31%), cognitive effects (28%), fatigue (27%), dyspnea (27%), arthralgia (24%), diarrhea (23%), mood effects (21%), and cough (21%)¹
• The most frequent Grade 3-4 laboratory abnormalities in ≥ 20% of 476 patients who received LORBRENA™ were hypercholesterolemia (21%) and hypertriglyceridemia (21%)¹
• In previously untreated ALK-Positive Metastatic NSCLC (CROWN Study), serious adverse reactions occurred in 34% of patients treated with LORBRENA™; the most frequently reported serious adverse reactions were pneumonia (4.7%), dyspnea (2.7%), respiratory failure (2.7%), cognitive effects (2.0%), and pyrexia (2.0%)¹
• Fatal adverse reactions occurred in 3.4% of patients treated with LORBRENA™ and included pneumonia (0.7%), respiratory failure (0.7%), cardiac failure acute (0.7%), pulmonary embolism (0.7%), and sudden death (0.7%)¹
• Permanent discontinuation of LORBRENA™ due to adverse reactions occurred in 6.7% of patients¹
• Adverse reactions leading to dose interruptions occurred in 49% of patients treated with LORBRENA™¹
• Adverse reactions leading to dose reductions occurred in 21% of patients treated with LORBRENA™¹
• In previously treated ALK-Positive Metastatic NSCLC, serious adverse reactions occurred in 32% of the 295 patients; the most frequently reported serious adverse reactions were pneumonia (3.4%), dyspnea (2.7%), pyrexia (2%), mental status changes (1.4%), and respiratory failure (1.4%)¹
• Permanent discontinuation of LORBRENA™ for adverse reactions occurred in 8% of patients¹
• Approximately 24% of patients required at least 1 dose reduction for adverse reactions¹

Abbreviations: AST, Aspartate aminotransferase; ALK, Anaplastic lymphoma kinase; NSCLC: non-small cell lung cancer.