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ZALTRAP

ZIV-AFLIBERCEPT

Manufacturer: sanofi-aventis U.S. LLC

Score: 141.0

Quick Summary

ZALTRAP (ziv-aflibercept) is a vascular endothelial growth factor inhibitor used in combination with fluorouracil, leucovorin, and irinotecan (FOLFIRI) for the treatment of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen. The recommended dosage is 4 mg per kg of actual body weight as an intravenous infusion over 1 hour every two weeks. ZALTRAP can cause fetal harm when administered to pregnant women and has warnings for hemorrhage, gastrointestinal perforation, impaired wound healing, and other adverse reactions. Special population considerations include use during pregnancy, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • ZALTRAP is used in combination with FOLFIRI for the treatment of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen.
  • The recommended dosage is 4 mg per kg of actual body weight as an intravenous infusion over 1 hour every two weeks.

Important Safety Information

Warning

ZALTRAP can cause fetal harm when administered to pregnant women.

Contraindications

Adverse Reactions

  • Hemorrhage
  • Gastrointestinal perforation
  • Impaired wound healing
  • Fistula formation
  • Hypertension
  • Arterial thromboembolic events
  • Proteinuria
  • Neutropenia and neutropenic complications
  • Diarrhea and dehydration
  • Reversible posterior leukoencephalopathy syndrome

Dosing Recommendations

General Guidance

Discontinue ZALTRAP for severe hemorrhage, gastrointestinal perforation, impaired wound healing, fistula formation, hypertensive crisis or hypertensive encephalopathy, arterial thromboembolic events, nephrotic syndrome or thrombotic microangiopathy, and reversible posterior leukoencephalopathy syndrome.

Metastatic colorectal cancer

Adult Dose

4 mg per kg of actual body weight as an intravenous infusion over 1 hour every two weeks

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • ZALTRAP can cause fetal harm when administered to pregnant women.
  • There is insufficient data in pregnant women exposed to ZALTRAP to assess the risks.

Nursing Mothers

Pediatric Use

  • The safety and effectiveness in pediatric patients have not been established.
  • The maximum tolerated dose based on body weight in pediatric patients was lower than the dose known to be safe and effective in adults with mCRC.

Geriatric Use

  • Elderly patients (≥65 years of age) experienced higher incidences of diarrhea, dizziness, asthenia, weight decrease, and dehydration when compared to younger patients.
  • Monitor elderly patients more closely for diarrhea and dehydration.

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