Metastatic colorectal cancer (MCRC)

The recommended dose of aflibercept, administered as an intravenous infusion over 1 hour, is 4 mg/kg of body weight, followed by the FOLFIRI regimen. This is considered as one treatment cycle.

The FOLFIRI regimen to be used is irinotecan 180 mg/m2 intravenous infusion over 90 minutes and folinic acid (dl racemic) 400 mg/m² intravenous infusion over 2 hours at the same time on day 1 using a Y-line, followed by 5-fluorouracil (5-FU) 400 mg/m² intravenous bolus, followed by 5-FU 2400 mg/m² continuous intravenous infusion over 46 hours. The treatment cycle is repeated every 2 weeks.

Aflibercept treatment should be continued until disease progression or unacceptable toxicity occurs.

Dose modification

Aflibercept should be discontinued for:

• Severe haemorrhage
• Gastrointestinal (GI) perforation
• Fistula formation
• Hypertension that is not adequately controlled with anti-hypertensive therapy or occurrence of hypertensive crisis or hypertensive encephalopathy
• Cardiac failure and ejection fraction decreased
• Arterial thromboembolic events (ATE)
• Grade 4 venous thromboembolic events (including pulmonary embolism)
• Nephrotic syndrome or thrombotic microangiopathy (TMA)
• Severe hypersensitivity reactions (including bronchospasm, dyspnoea, angioedema, and anaphylaxis)
• Compromised wound healing requiring medical intervention
• Posterior reversible encephalopathy syndrome (PRES) (also known as reversible posterior leukoencephalopathy syndrome (RPLS))

Aflibercept should be temporarily suspended for at least 4 weeks prior to elective surgery.

Intravenous infusion over 1 hour.