Important INLYTA ® (axitinib) Safety Information 13

Serious adverse reactions reported in patients receiving INLYTA were arterial embolic and thrombotic events, venous embolic and thrombotic events, haemorrhage (including gastrointestinal haemorrhage, cerebral haemorrhage and haemoptysis), gastrointestinal perforation and fistula formation, hypertensive crisis, and posterior reversible encephalopathy syndrome.

The most common (≥ 20%) adverse reactions observed following treatment with INLYTA were diarrhoea, hypertension, fatigue, dysphonia, nausea, decreased appetite, and palmar-plantar erythrodysaesthesia (hand-foot) syndrome.

About SUTENT ® (sunitinib malate)

SUTENT ® is approved for gastrointestinal stromal tumors (GIST) after disease progression on or intolerance to imatinibmesylate, for advanced RCC, and for progressive, well-differentiated pancreatic neuroendocrine tumors (NET) in patients with unresectable locally advanced or metastatic disease.

SUTENT is an oral multi-kinase inhibitor that works by blocking multiple molecular targets implicated in the growth, proliferation and spread of cancer. 8b Two important SUTENT targets, vascular endothelial growth factor receptor (VEGFR) and platelet-derived growth factor receptor (PDGFR) are expressed by many types of solid tumors and are thought to play a crucial role in angiogenesis, the process by which tumors acquire blood vessels, oxygen and nutrients needed for growth. SUTENT also inhibits other targets important to tumor growth, including KIT, FLT3 and RET.

Important SUTENT ® (sunitinib malate) Safety Information 14

Serious adverse reactions associated with sunitinib are renal failure, heart failure, pulmonary embolism, intestinal perforation, and haemorrhages (e.g. respiratory, gastrointestinal, tumour haemorrhages).

The most common (≥20%) adverse events (AEs) in patients receiving SUTENT were decreased appetite, taste disturbance, hypertension, fatigue, gastrointestinal disorders, skin discoloration, and hand-foot syndrome. Fatal events, other than those listed, included multi-system organ failure, disseminated intravascular coagulation, peritoneal hemorrhage, rhabdomyolysis, cerebrovascular accident, dehydration, adrenal insufficiency, renal failure, respiratory failure, pleural effusion, pneumothorax, shock, and sudden death.

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