Zaltrap 100 mg/4 ml IV Infusion

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Detail Description

Generic: Aflibercept | Dosage Form: IV Infusion | Manufacturer: Synovia Pharma PLC.

Indications

Aflibercept, 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.

Dosage & Administration

4 mg/kg as an intravenous infusion over 1 hour every 2 weeks. Do not administer as an intravenous (IV) push or bolus.

Interaction

No dedicated drug-drug interaction studies have been conducted for Aflibercept. No clinically important pharmacokinetic drug-drug interactions were found between ziv-aflibercept and irinotecan/SN-38 or 5-FU, based on cross-study comparisons and population pharmacokinetic analyses.

Side Effects

Most common adverse reactions (all grades, ≥20% incidence and at least 2% greater incidence for the Aflibercept/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

Precautions & Warnings

Adverse reactions, sometimes severe and life-threatening or fatal, have been seen in clinical trials with Aflibercept, including:

Fistula Formation: Discontinue Aflibercept if fistula occurs.
Hypertension: Monitor blood pressure and treat hypertension. Temporarily suspend Aflibercept if hypertension is not controlled. Discontinue Aflibercept if hypertensive crisis develops.
Arterial Thromboembolic Events (ATE) (e.g., transient ischemic attacks, cerebrovascular accident, angina pectoris): Discontinue Aflibercept if ATE develops.
Proteinuria: Monitor urine protein. Suspend Aflibercept when proteinuria ≥ 2 grams per 24 hours. Discontinue Aflibercept if nephrotic syndrome or thrombotic microangiopathy (TMA) develops.
Neutropenia and Neutropenic Complications: Delay administration of Aflibercept/FOLFIRI until neutrophil count is ≥ 1.5 × 109/L.
Diarrhea and Dehydration: Incidence of severe diarrhea and dehydration is increased. Monitor elderly patients more closely.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue Aflibercept.

Overdose Effects

There have been no cases of overdose reported with Aflibercept. There is no information on the safety of Aflibercept given at doses exceeding 7 mg per kg every 2 weeks or 9 mg per kg every 3 weeks.

Therapeutic Class

Cytotoxic Chemotherapy

Storage Conditions

Store Aflibercept vials in a refrigerator at 2 to 8° C . Keep the vials in the original outer carton to protect from light.

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