Metastatic colorectal cancer (MCRC)

Active Ingredient: Aflibercept

Indication for Aflibercept

Population group: only adults (18 years old or older)

Aflibercept in combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) chemotherapy is indicated in adults with metastatic colorectal cancer (MCRC) that is resistant to or has progressed after an oxaliplatin-containing regimen.

For this indication, competent medicine agencies globally authorize below treatments:

4 mg/kg once every 2 weeks

Route of admnistration

Intravenous

Defined daily dose

4 - 4 mg per kg of body weight

Dosage regimen

From 4 To 4 mg per kg of body weight once every 14 day(s)

Loading dose

4 mg per kg of body weight

Maintenance dose

4 mg per kg of body weight

Detailed description

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.

Dosage considerations

Intravenous infusion over 1 hour.

Active ingredient

Aflibercept

Aflibercept, also known as VEGF TRAP in the scientific literature, is a recombinant fusion protein consisting of VEGF-binding portions from the extracellular domains of human VEGF receptors 1 and 2 fused to the Fc portion of the human IgG1. Aflibercept blocks the activation of VEGF receptors and the proliferation of endothelial cells, thereby inhibiting the growth of new vessels that supply tumours with oxygen and nutrients.

Read more about Aflibercept

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