Zaltrap

What is Zaltrap?

• Zaltrap (ziv-aflibercept), a vascular endothelial growth factor inhibitor used for the treatment of metastatic colorectal cancer.

What are the uses of this medicine?

• Zaltrap, in combination with fluorouracil, leucovorin, irinotecan-(FOLFIRI),used for the treatment of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen.

How does this medicine work?

• Ziv-aflibercept acts as a soluble receptor that binds to human VEGF-A, to human VEGF-B, and to human PlGF.
• By binding to these endogenous ligands, ziv-aflibercept can inhibit the binding and activation of their cognate receptors.
• This inhibition can result in decreased neovascularization and decreased vascular permeability.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No dedicated drug-drug interaction studies have been conducted for Zaltrap.

Is this medicine FDA approved?

• Initial U.S. Approval: 2012

How should this medicine be used?

Recommended dosage:

• 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.

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 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

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 100 mg/4 mL (25 mg/mL) and 200 mg/8 mL (25 mg/mL) solution in a single-dose vial

This medicine is available in fallowing brand namesː

• Zaltrap

What side effects can this medication cause?

The most common side effects of this medicine include:

• leukopenia
• diarrhea
• neutropenia
• proteinuria
• AST increased
• stomatitis
• fatigue
• thrombocytopenia
• ALT increased
• hypertension
• weight decreased
• decreased appetite
• epistaxis
• abdominal pain
• dysphonia
• serum creatinine increased
• headache

What special precautions should I follow?

• 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.
• Gastrointestinal (GI) perforation including fatal GI perforation can occur in patients receiving Zaltrap. Discontinue Zaltrap therapy in patients who experience GI perforation.
• Grade 3 impaired wound healing was reported in 2 patients (0.3%) treated with Zaltrap/FOLFIRI regimen. Withhold Zaltrap for at least 4 weeks prior to elective surgery. Do not administer for at least 4 weeks following major surgery and until wounds have adequately healed. Discontinue Zaltrap in patients with impaired wound healing. The safety of resumption of Zaltrap after resolution of wound healing complications has not been established.
• Fistula formation involving gastrointestinal and non-gastrointestinal sites occurs at a higher incidence in patients treated with Zaltrap. Discontinue Zaltrap if fistula occurs.
• Zaltrap increases the risk of Grade 3–4 hypertension. Monitor blood pressure and treat hypertension. Temporarily suspend Zaltrap if hypertension is not controlled. Discontinue Zaltrap if hypertensive crisis develops.
• ATE, including transient ischemic attack, cerebrovascular accident, and angina pectoris, occurred more frequently in patients who have received Zaltrap. Discontinue Zaltrap if ATE develops.
• Severe proteinuria, nephrotic syndrome, and thrombotic microangiopathy (TMA) occurred more frequently in patients treated with Zaltrap. Monitor urine protein. Suspend Zaltrap for proteinuria of 2 grams per 24 hours or more. Discontinue Zaltrap if nephrotic syndrome or thrombotic microangiopathy (TMA) develops.
• A higher incidence of neutropenic complications (febrile neutropenia and neutropenic infection) occurred in patients receiving Zaltrap. Delay administration of Zaltrap/FOLFIRI until neutrophil count is 1.5 × 109/L or higher.
• The incidence of severe diarrhea is increased in patients treated with Zaltrap/FOLFIRI. Incidence of severe diarrhea and dehydration is increased. Monitor elderly patients more closely.
• Based on findings from animal studies and its mechanism of action, Zaltrap can cause fetal harm when administered to pregnant women. Advise females of potential risk to fetus and need for use of effective contraception.
• Reversible Posterior Leukoencephalopathy Syndrome may occur. Discontinue Zaltrap.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Based on findings from animal reproduction studies and its mechanism of action, Zaltrap can cause fetal harm when administered to pregnant women.

Can this medicine be used in children?

• The safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• AFLIBERCEPT

Inactive ingredients:

• SUCROSE
• SODIUM CHLORIDE
• TRISODIUM CITRATE DIHYDRATE
• CITRIC ACID MONOHYDRATE
• POLYSORBATE 20
• SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
• SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
• SODIUM HYDROXIDE
• HYDROCHLORIC ACID
• WATER

Who manufactures and distributes this medicine?

• Manufactured by:

sanofi-aventis U.S. LLC Bridgewater, NJ A SANOFI COMPANY

• Zaltrap is a registered trademark of Regeneron Pharmaceuticals, Inc.

What should I know about storage and disposal of this medication?

• Store Zaltrap vials in a refrigerator at 2°C to 8°C (36°F to 46°F).
• Keep the vials in the original outer carton to protect from light.
• Discard unused portion.

• Dailymed label info on Zaltrap
• FDA Zaltrap

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