Zaltrap Dosage

Recommended Dose and Schedule

Administer ZALTRAP 4 mg per kg as an intravenous (IV) infusion over 1 hour every two weeks. Administer ZALTRAP prior to any component of the FOLFIRI regimen on the day of treatment [see Clinical Studies (14)].

Continue ZALTRAP until disease progression or unacceptable toxicity.

Dose Modification/Treatment Delay Recommendations

Discontinue ZALTRAP for:

• Severe hemorrhage [see Boxed Warning, Warnings and Precautions (5.1)]
• Gastrointestinal perforation [see Boxed Warning, Warnings and Precautions (5.2)]
• Compromised wound healing [see Boxed Warning, 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 [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 recurrent or severe 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. 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)].

For toxicities related to irinotecan, 5-fluorouracil (5-FU), or leucovorin, refer to the current respective prescribing information.

Preparation for 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.

Do not re-enter the vial after the initial puncture. Discard any unused portion left in the vial.

Withdraw the prescribed dose of ZALTRAP and dilute in 0.9% sodium chloride solution, USP or 5% dextrose solution for injection, USP to achieve a final concentration of 0.6–8 mg/mL.

Use polyvinyl chloride (PVC) infusion bags containing bis (2-ethylhexyl) phthalate (DEHP) or polyolefin infusion bags.

Store diluted ZALTRAP at 2°–8°C (36°–46°F) for up to 24 hours, or at controlled room temperature 20°–25°C (68°–77°F) for up to 8 hours. Discard any unused portion left in the infusion bag.

Administration

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 (IV) 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)
• polypropylene
• polyethylene lined PVC
• polyurethane