AFINITOR® Safety and Tolerability Data | VEGF–Targeted Therapy Failure
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AFINITOR is a once-daily oral inhibitor of mTOR (mammalian target of rapamycin) for patients with advanced renal cell carcinoma (RCC) whose disease has progressed on or after treatment with VEGF-targeted therapy
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Clinical Trial Design
Efficacy
Safety & Tolerability
Guidelines
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Safety and Tolerability

AFINITOR® is generally well tolerated when a VEGF**-targeted therapy fails

Only 7% of patients discontinued treatment due to adverse reactions1

AFINITOR® (everolimus) Safety and Tolerability | Most Adverse Reactions Graph
AFINITOR® (everolimus) Safety and Tolerability | Adverse Reactions Graph

  • Within each frequency grouping for each category, adverse reactions are presented in order of seriousness1
  • The most frequent Grade 3 /4 adverse reactions (those with incidence >2%) were decreased lymphocytes, increased glucose, decreased hemoglobin, decreased phosphate, increased cholesterol, infections, stomatitis, fatigue and pnuemonitis1

Laboratory tests and monitoring

Renal Function
Elevations of serum creatinine, usually mild, have been reported. Monitoring of renal function, including measurement of blood urea nitrogen (BUN) or serum creatinine, is recommended prior to the start of AFINITOR therapy and periodically thereafter.

Blood Glucose and Lipids
Hyperglycaemia, hyperlipidaemia and hypertrigylceridaemia have been reported in clinical trials. The majority of cases of hyperglycaemia occurred in patients who had an abnormal fasting glucose level before taking AFINITOR. Monitoring of fasting serum glucose is recommended prior to the start of AFINITOR therapy and periodically thereafter. When possible, optimal glycaemic control should be achieved before starting a patient on AFINITOR.

Hematologic Parameters
Decreased haemoglobin, lymphocytes, neutrophils and platelets have been reported in clinical trials. Monitoring of complete blood count is recommended prior to the start of AFINITOR therapy and periodically thereafter.

Find support resources to download for your patients with advanced renal cell carcinoma here.

Next: Guidelines

**VEGF: vascular endothelial growth factor

Reference:
1. AFINITOR [summary of product information]. Basel Switzerland: Novartis Pharma AG.