Medically reviewed by Drugs.com. Last updated on Nov 25, 2020.
Recommended Dose and Schedule
The recommended dosage of ZALTRAP is 4 mg per kg of actual body weight as an intravenous infusion over 1 hour every two weeks in combination with FOLFIRI until disease progression or unacceptable toxicity. Administer ZALTRAP prior to any component of the FOLFIRI regimen on the day of treatment.
Refer to prescribing information for irinotecan, fluorouracil, and leucovorin for the recommended dosage and dosage modifications for these drugs.
Dosage Modifications for Adverse Reactions
Discontinue ZALTRAP for:
- Severe hemorrhage [see Warnings and Precautions (5.1)]
- Gastrointestinal perforation [see Warnings and Precautions (5.2)]
- Impaired wound healing [see Warnings and Precautions (5.3)]
- Fistula formation [see Warnings and Precautions (5.4)]
- Hypertensive crisis or hypertensive encephalopathy [see Warnings and Precautions (5.5)]
- Arterial thromboembolic events (ATE) [see Warnings and Precautions (5.6)]
- Nephrotic syndrome or thrombotic microangiopathy (TMA) [see Warnings and Precautions (5.7)]
- Reversible posterior leukoencephalopathy syndrome (RPLS) [see Warnings and Precautions (5.10)]
Temporarily suspend ZALTRAP:
- At least 4 weeks prior to elective surgery [see Warnings and Precautions (5.3)].
- For uncontrolled hypertension until controlled. Upon resumption, permanently reduce the ZALTRAP dose to 2 mg per kg [see Warnings and Precautions (5.5)].
- For proteinuria of 2 grams per 24 hours or more. Resume when proteinuria is less than 2 grams per 24 hours. For recurrent proteinuria, suspend ZALTRAP until proteinuria is less than 2 grams per 24 hours and then permanently reduce the ZALTRAP dose to 2 mg per kg [see Warnings and Precautions (5.7)].
Preparation and Administration
Inspect vials visually prior to use. ZALTRAP is a clear, colorless to pale yellow solution. Do not use vial if the solution is discolored or cloudy or if the solution contains particles.
Withdraw the prescribed dose of ZALTRAP and dilute in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP to achieve a final concentration of 0.6 mg/mL to 8 mg/mL.
Do not re-enter the vial after the initial puncture. Discard any unused portion left in the vial.
Use polyvinyl chloride (PVC) infusion bags containing bis (2-ethylhexyl) phthalate (DEHP) or polyolefin infusion bags.
Store diluted ZALTRAP refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours or at controlled room temperature of 20°C to 25°C (68°F to 77°F) for up to 8 hours. Discard any unused portion left in the infusion bag.
Administer the diluted ZALTRAP solution as an intravenous infusion over 1 hour through a 0.2-micron polyethersulfone filter. Do not use filters made of polyvinylidene fluoride (PVDF) or nylon.
Do not administer as an intravenous push or bolus.
Do not combine ZALTRAP with other drugs in the same infusion bag or intravenous line.
Administer ZALTRAP using an infusion set made of one of the following materials:
- PVC containing DEHP
- DEHP free PVC containing trioctyl-trimellitate (TOTM)
- polyethylene lined PVC
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