Consumer Information for: ELOXATIN

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

ELOXATIN is a medication used in combination with 5- fluorouracil (5-FU) and leucovorin to treat people with:

  • colon cancer after they have undergone a surgery to remove the tumor.
  • metastatic colorectal cancer.
What it does

Every cell in your body contains genetic material, which provides “information” for organs and tissue growth and functioning.

ELOXATIN links to the genetic material contained in the cell and inhibits the replication process, causing the eventual death of the cancer cell.

When it should not be used

Do not use ELOXATIN if you:

  • Are allergic to oxaliplatin or other platinum containing ingredients or to any of the ingredients in the product (see the section “What the non-medicinal ingredients are”)
  • Have a severe kidney disease
  • Are breast-feeding
  • Are pregnant
What the medicinal ingredient is
  • oxaliplatin
What the non-medicinal ingredients are
  • In the lyophilized powder: lactose.
  • In the aqueous solution: Water for injection
What dosage form it comes in

ELOXATIN is available in two dosage forms:

Powder for injection: 50 mg and 100 mg per vial
Solution for injection: 5 mg/mL in a vial of 10 mL, 20 mL, and 40 mL.

Warnings and precautions

Serious Warnings and Precautions

ELOXATIN should be given under the supervision of a doctor experienced in the use of anti-cancer drugs.

ELOXATIN may cause severe allergic reactions, liver problems, decrease in the production of blood cells, life-threatening complications due to infections, neuropathy (nerve changes) and respiratory problems (interstitial lung disease that may result in death).

ELOXATIN may also cause the following adverse effects, which may be life-threatening: irregular heartbeats; intestinal ulcers, bleeding or perforation (a hole in the intestine wall) or a decrease in blood flow to the intestines; muscular adverse effects.

BEFORE your ELOXATIN injection, talk to your doctor if you:

  • Have ever had any unusual or allergic reaction to ELOXATIN or other medications or to platinum containing compounds
  • Are taking any medicine
  • Have not taken your premedication as directed
  • Have a kidney disease
  • Have a heart disease called “QT prolongation”
  • Are or are planning to become pregnant. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away. Men should be advised not to father a child while receiving treatment with ELOXATIN and up to 6 months thereafter.
  • Are breast-feeding

Your doctor will need to check your blood at regular visits while you are using this medicine.

Nerves changes (neuropathy) can occur with ELOXATIN (see the section “Side Effect and What to Do About Them”). Exposure to cold can trigger this side effect. Avoid cold drinks and the use of ice cubes in drinks. Avoid cold temperatures and cold objects. Cover your skin if you must go outside in cold temperatures. Do not put ice or ice packs on your body. Do not breathe deeply when exposed to cold air. Do not take things from the freezer or refrigerator without wearing gloves. Do not run the air conditioner at high levels in the house or in the car in hot weather.

Driving and operate machinery
ELOXATIN may cause dizziness, other neurological disorders that affect balance, and vision problems including reversible short-term loss of vision. Do not drive or operate machinery until you know how the drug affects you.

Interactions with this medication

ELOXATIN may interact with warfarin (a drug that reduces clot formation in the blood).

Before using any prescription, over-the-counter medicines or herbal products, check with your doctor, your pharmacist or your nurse.

Proper use of this medication

Usual Dose

Every patient is different; your doctor will determine what dose of ELOXATIN is right for you and how often you should receive it.

ELOXATIN is an injectable medication that is given by intravenous infusion (injected slowly in a vein) every 2 weeks in combination with leucovorin and 5-fluorouracil (5-FU).

The administration of ELOXATIN may require you to take medication before each treatment begins (premedication). The purpose of this premedication is to help lessen the nausea. Your doctor, nurse or pharmacist will tell you exactly what premedication you need to take and for how long.

If you forget to take your premedication as directed, make sure to tell your doctor before you get your ELOXATIN treatment. Be sure to keep all appointments.

Overdose

In case of overdose, you may experience increased side effects.

If you suspect an overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

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

Side effects and what to do about them

Like many chemotherapy drugs, ELOXATIN may have side effects.

Most of the side effects that occur with ELOXATIN are manageable. Occasionally, it is necessary to stop the treatment.

Common Side Effects

  • Nausea, diarrhea, vomiting, change in taste
  • Fatigue
  • Stomatitis: sores in the mouth
  • Pain at the injection site
  • Pain in a joint
  • Nose bleeding
  • Respiratory problems
  • Hiccups
  • High blood pressure
  • Neuropathy: nerve changes that can cause tingling or numbness in the extremities, muscle weakness or other altered sensations.

Exposure to cold is one of the most common triggers of neuropathy. Touching cold objects or frozen items, consuming cold foods or beverages, and breathing cold air may cause these unpleasant nerve sensations (see the section “Warnings and Precautions”).

A less common symptom of neuropathy is pharyngolaryngeal dysesthesia. This is the sensation of tightness or discomfort in the throat, making it seem difficult to breathe or swallow.

Although this symptom may be frightening, it is just a sensation and does not really interfere with breathing. The sensation usually goes away on its own after a few minutes.

Some people may experience more debilitating symptoms of neuropathy, which may interfere with daily activities such as the following:

  • Writing
  • Buttoning clothes
  • Swallowing
  • Difficulty walking
  • Picking up things

Many of these neuropathy symptoms are temporary. However, they may continue long term.

  • Neutropenia: a lower-than-normal number of neutrophils, a type of white blood cells. Your white blood cells protect your body against infection. So, if you have neutropenia, you are at higher risk of having an infection, which can be life-threatening. However, most people receiving ELOXATIN® do not develop infections, even when they have neutropenia.>
  • Thrombocytopenia: a lower-than-normal number of platelets. Platelets have an important role in the control of bleeding. Therefore, a reduction in their number may increase the tendency to bleed
  • Anemia: a lower-than-normal number of red blood cells. As a result, people with anemia may feel tired.

Your doctor will be checking routinely your blood count and will alert you if your platelets, white or red blood cells are low.

Other Possible Side Effects are:

  • Constipation
  • Stomach pain
  • Loss of appetite
  • Hair loss
  • Reversible short-term loss of vision
  • Deep vein thrombosis (blood clot in the deep vein)
  • Interstitial lung disease (respiratory symptoms such as rapid breathing and shortness of breath)

Discuss with your doctor if you have these symptoms.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases Stop taking drug and talk with your doctor or pharmacist
Uncommon
Persistent vomiting or diarrhea   ✔  
Persistent cough   ✔  
Fever or signs of infection, like redness or swelling at the injection site, a cough that brings up mucus, or a sore throat   ✔  
Allergic reactions such as trouble breathing, tightness in the throat, rash, hives, or swelling of the lips or tongue   ✔  
Neuropathy symptoms interfering with daily activities   ✔  
Symptoms such as headache, altered mental functioning, seizures and abnormal vision from blurriness to vision loss   ✔  
Unknown frequency
Kidney failure (with symptoms such as: difficulty breathing, weakness, tiredness, decreased urinary volume), small purple-red marks on the skin or other parts of the body. Kidney failure may be not reversible with discontinuation of therapy and dialysis may be required.   ✔  
Irregular heartbeat, dizziness or fainting   ✔  
Muscle pain and swelling, with weakness, fever and darkened urine   ✔  
Stomach pain, nausea, vomiting, black or redcoloured stools   ✔  
Disseminated intravascular coagulation (which may be life-threatening), with symptoms such as: bleeding in urine or stools, small red or brown bruises that happen easily, pain and swelling in the lower leg, or chest pain and shortness of breath.   ✔  

This is not a complete list of severe side effects. If you have any unexpected effects while taking this drug, contact your doctor or pharmacist.

How to store

The unopened vials with solution for injection should be stored at 25o C (excursions permitted between 15-30°C) in their original packaging. Do not freeze. Protect from light.

The unopened vials with powder for injection should be stored between 15-30°C in their original packaging. Do not freeze. Protect from light.

Reporting side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa, Ontario
      K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

Your doctor, pharmacist and nurse are always your best source of information about your condition and treatment. If you have additional questions or concerns, be sure to ask them.

This document plus the full Product Monograph, prepared for health professionals can be found at: www.sanofi.ca or by contacting the sponsor, sanofiaventis Canada Inc., at: 1-800-265-7927

This leaflet was prepared by sanofi-aventis Canada Inc

Last revised: March 13, 2015

Date modified: