Zaltrap: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

ZALTRAP (pronounced zal-trap) is a prescription anti-cancer medicine used in combination with chemotherapy to treat cancers of the colon and/or rectum in adults.

It is not known if ZALTRAP is safe or effective in children under 18 years of age.

What it does:

ZALTRAP works by stopping the growth of new blood vessels. If blood vessels cannot provide cancer cells with nutrients and oxygen, the cancer cells cannot grow. In clinical studies, ZALTRAP in combination with chemotherapy has been shown to shrink or slow cancer growth, and help patients live longer.

When it should not be used:

Do not use ZALTRAP if you are allergic to aflibercept or to any ingredients in the product (see section What the nonmedicinal ingredients are: below).

ZALTRAP should not be used for injection in the eye (see section WARNINGS AND PRECAUTIONS below)

What the medicinal ingredient is: aflibercept

What the nonmedicinal ingredients are: citric acid monohydrate, polysorbate 20, sodium chloride, sodium citrate dihydrate, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sucrose, water; sodium hydroxide and/or hydrochloric acid.

What dosage forms it comes in:

ZALTRAP is a concentrated solution for injection (25 mg/mL) and is available in vials of 4mL and 8mL.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

• Hemorrhage: Zaltrap can cause severe and sometimes fatal hemorrhage (bleeding), including gastrointestinal hemorrhage (bleeding of the stomach or bowel). Zaltrap should be stopped if these happen.
• Gastrointestinal Perforations/Wound Healing Complications: Zaltrap can cause gastrointestinal perforation (hole in the stomach or bowel) and wound dehiscence (wounds opening and not healing), which can be fatal. Zaltrap should be stopped if these happen, and within one month of having surgery. Gastrointestinal perforation can happen at any time during treatment: symptoms include abdominal pain, constipation and vomiting

Before receiving ZALTRAP, tell your doctor if you:

• have had bleeding problems
• are or have recently been coughing up blood
• have blood clotting problems
• have high blood pressure
• have kidney or liver problems
• have heart or circulation problems, or history of stroke
• have history of seizures
• have gastrointestinal problems such as gastric ulcers or diverticulitis, or history of prior perforation of the intestine
• are allergic or sensitive to or have had a reaction to any medicine
• have recent treatments for cancer that your doctor is not aware of
• are taking blood thinners (such as warfarin (Coumadin^®) or heparin) for the treatment of blood clots
• have had tooth extraction or any other surgery within the last 4 weeks or if you have a surgical wound that has not healed
• you are going to have an operation or a dental or medical procedure. ZALPTRAP should not be given or should be stopped 4 weeks before surgery.

• are pregnant or plan to become pregnant. ZALTRAP may harm your unborn baby. You should not become pregnant while receiving ZALTRAP therapy and for 6 months after your last dose of ZALTRAP. Tell your doctor right away if you become pregnant or are concern that you have become pregnant while receiving ZALTRAP therapy.

• are breastfeeding or plan to breastfeed. It is not known if ZALTRAP passes into your breast milk. You should not breastfeed while receiving ZALTRAP therapy.

Use a condom every time you have sexual intercourse with a woman who is pregnant or can get pregnant while you are taking ZALTRAP and for 6 months after your last dose of ZALTRAP.

ZALTRAP may affect your vision or concentration, or the ability to react. If you experience these symptoms, do not drive or use any tools or machines.

ZALTRAP was not developed to be injected in the eye. ZALTRAP must not be injected into the eye, since it may severely damage it.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor and pharmacist about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine. Talk with your doctor and pharmacist before starting any new medicines.

PROPER USE OF THIS MEDICATION

Usual dose:

• ZALTRAP will be given to you by an infusion into your vein (intravenous) over approximately 1 hour, followed by a chemotherapy regimen.
• ZALTRAP is usually given every 2 weeks. Your doctor will decide how often you will receive ZALTRAP and if you need adjustment in the dose.

Overdose:

Missed Dose:

This medicine needs to be given on a fixed schedule. If you miss an appointment, call your doctor or nurse for instructions.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Side effects that may occur in some patients receiving ZALTRAP in combination with chemotherapy include:

Very common (may affect more than 1 in 10 patients):

• increased blood pressure
• too much protein in the urine
• diarrhea
• nausea
• vomiting
• abdominal pain
• infections

• low white blood cell counts (neutropenia).

  • low red blood cell count (anemia)
  • low blood platelet count (bruising and bleeding)
  • decreased appetite
  • weight loss
  • headache
  • painful sores in the mouth
  • change in voice (hoarseness)
  • nose bleed
  • bleeding from the rectum
  • feeling tired and weak
  • changes in skin, or skin rash
  • hair loss
  • changes in kidney function
  • back pain
  • fever

Common side effects (less than 1 in 10 patients but more than 1 in 100 patients):

• dehydration

Uncommon (less than 1 in 1000 patients but more than 1in 10,000 patients):

• gastrointestinal perforations
• wound healing complications

This is not a complete list of side effects. For any unexpected effects while taking ZALTRAP, contact your doctor or pharmacist.

HOW TO STORE IT

ZALTRAP is usually kept at the pharmacy and stored in a refrigerator (2-8^oC), protected from light.

REPORTING SUSPECTED SIDE EFFECTS

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found at:

http://www.sanofi.ca, or by contacting the sponsor, sanofi-aventis Canada Inc., at: 1-800-265-7927.

Last revised: August 3, 2016

Zaltrap^™ is a trademark of Sanofi, France.