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HIGHLIGHTS OF PRESCRIBING INFORMATION |
These highlights do not include all the information needed to use ZALTRAP safely and effectively. See full prescribing information for ZALTRAP.
ZALTRAP® (ziv-aflibercept)
Injection for Intravenous Infusion
Initial U.S. Approval: 2012
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WARNING: HEMORRHAGE, GASTROINTESTINAL PERFORATION, COMPROMISED WOUND HEALING
See full prescribing information for complete boxed warning.
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Hemorrhage: Severe and sometimes fatal hemorrhage, including gastrointestinal (GI) hemorrhage, has been reported in patients who have received ZALTRAP. Do not administer ZALTRAP to patients with severe hemorrhage. (5.1)
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Gastrointestinal Perforation: Discontinue ZALTRAP therapy in patients who experience GI perforation. (5.2)
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Compromised Wound Healing: Discontinue ZALTRAP in patients with compromised wound healing. Suspend ZALTRAP for at least 4 weeks prior to elective surgery, and do not resume for at least 4 weeks following major surgery and until the surgical wound is fully healed. (5.3)
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RECENT MAJOR CHANGES
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Warnings and Precautions (5.7) |
10/2013 |
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INDICATIONS AND USAGE
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ZALTRAP, in combination with 5-fluorouracil, leucovorin, irinotecan-(FOLFIRI), is indicated for patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen. (1)
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DOSAGE AND ADMINISTRATION
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4 mg/kg as an intravenous infusion over 1 hour every 2 weeks. (2.1, 2.4)
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Do not administer as an intravenous (IV) push or bolus. (2.4)
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DOSAGE FORMS AND STRENGTHS
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Single-use vials: 100 mg/4 mL (25 mg/mL), 200 mg/8 mL (25 mg/mL) (3)
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CONTRAINDICATIONS
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None (4)
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WARNINGS AND PRECAUTIONS
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Adverse reactions, sometimes severe and life-threatening or fatal, have been seen in clinical trials with ZALTRAP, including:
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Fistula Formation: Discontinue ZALTRAP if fistula occurs. (2.2, 5.4)
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Hypertension: Monitor blood pressure and treat hypertension. Temporarily suspend ZALTRAP if hypertension is not controlled. Discontinue ZALTRAP if hypertensive crisis develops. (2.2, 5.5)
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Arterial Thromboembolic Events (ATE) (e.g., transient ischemic attacks, cerebrovascular accident, angina pectoris): Discontinue ZALTRAP if ATE develops. (5.6)
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Proteinuria: Monitor urine protein. Suspend ZALTRAP when proteinuria ≥ 2 grams per 24 hours. Discontinue ZALTRAP if nephrotic syndrome or thrombotic microangiopathy (TMA) develops. (2.2, 5.7)
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Neutropenia and Neutropenic Complications: Delay administration of ZALTRAP/FOLFIRI until neutrophil count is ≥ 1.5 × 109/L. (5.8)
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Diarrhea and Dehydration: Incidence of severe diarrhea and dehydration is increased. Monitor elderly patients more closely. (5.9, 8.5)
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Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue ZALTRAP. (5.10)
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ADVERSE REACTIONS
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Most common adverse reactions (all grades, ≥20% incidence and at least 2% greater incidence for the ZALTRAP/FOLFIRI regimen) were leukopenia, diarrhea, neutropenia, proteinuria, AST increased, stomatitis, fatigue, thrombocytopenia, ALT increased, hypertension, weight decreased, decreased appetite, epistaxis, abdominal pain, dysphonia, serum creatinine increased, and headache. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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USE IN SPECIFIC POPULATIONS
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Pregnancy: Based on animal data, ZALTRAP may cause fetal harm. (8.1)
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Nursing Mothers: Discontinue drug or nursing taking into account the importance of the drug to the mother. (8.3)
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Females and Males of Reproductive Potential: Use highly effective contraception during and up to a minimum of 3 months after the last dose (8.8)
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See 17 for PATIENT COUNSELING INFORMATION |
Revised: 10/2013 |
