Zaltrap

— THERAPEUTIC CATEGORIES —
  • Colorectal and other GI cancers

Zaltrap Generic Name & Formulations

General Description

Ziv-aflibercept 25mg/mL; soln for IV infusion after dilution; preservative-free.

Pharmacological Class

Fusion protein.

How Supplied

Single-use vials (100mg/4mL, 200mg/8mL)—1

Generic Availability

NO

Zaltrap Indications

Indications

In combination with 5-fluorouracil, leucovorin, irinotecan (FOLFIRI) for patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen.

Zaltrap Dosage and Administration

Adult

Start ziv-aflibercept prior to any component of the FOLFIRI regimen on treatment day. Give 4mg/kg as an IV infusion over 1hr every 2 weeks; continue until disease progression or unacceptable toxicity. For recurrent or severe hypertension, suspend until controlled. Upon resumption, permanently reduce to 2mg/kg. For recurrent proteinuria, suspend until proteinuria <2g per 24hrs, then permanently reduce to 2mg/kg.

Children

Not established.

Zaltrap Contraindications

Not Applicable

Zaltrap Boxed Warnings

Not Applicable

Zaltrap Warnings/Precautions

Warnings/Precautions

Increased risk of hemorrhage (may be severe/fatal); monitor for signs/symptoms. Do not start in patients with severe hemorrhage; discontinue if develops. Monitor for GI perforation, fistula formation, impaired wound healing; discontinue if occurs. Withhold for ≥4 weeks prior to elective surgery; do not give for ≥4 weeks after major surgery and until adequate wound healing. Monitor BP every 2 weeks and treat appropriately if hypertension occurs; temporarily suspend until controlled; discontinue if hypertensive crisis/encephalopathy occurs. Discontinue if arterial thromboembolic events (eg, transient ischemic attack, cerebrovascular accident, angina pectoris) occur. Monitor for proteinuria; suspend if proteinuria ≥2g per 24hrs; discontinue if nephrotic syndrome or thrombotic microangiopathy occurs. Monitor CBC with differential at baseline and prior to start of each cycle; delay until neutrophils ≥1.5x109/L. Risk of severe diarrhea and dehydration esp. in elderly (monitor). Discontinue if reversible posterior leukoencephalopathy syndrome occurs. Severe hepatic impairment (total bilirubin >3×ULN and any AST). Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 1 month after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 month after the last dose).

Zaltrap Pharmacokinetics

See Literature

Zaltrap Interactions

Not Applicable

Zaltrap Adverse Reactions

Adverse Reactions

Leukopenia, diarrhea, neutropenia, proteinuria, AST/ALT increased, stomatitis, fatigue, thrombocytopenia, hypertension, weight decreased, decreased appetite, epistaxis, abdominal pain, dysphonia, serum creatinine increased, headache.

Zaltrap Clinical Trials

See Literature

Zaltrap Note

Not Applicable

Zaltrap Patient Counseling

See Literature

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