Eloxatin is a platinum based cancer medicine that interferes with the growth and spread of cancer cells in the body.

Eloxatin infusion is used together with fluorouracil and leucovorin, to treat colon and rectal cancer.

It is not known if Eloxatin infusion is effective in children.

Eloxatin can cause a severe or life-threatening allergic reaction. Get emergency medical help if you have: rash, hives, itching, sweating; chest pain, warmth or redness in your face, feeling light-headed; sudden cough, difficult breathing; swelling of your face, lips, tongue, or throat.

Before taking this medicine

You should not be treated with Eloxatin if you have ever had an allergic reaction to oxaliplatin or similar medications such as carboplatin (Paraplatin) or cisplatin (Platinol).

To make sure Eloxatin is safe for you, tell your doctor if you have ever had:

• an active or recent infection;

• kidney disease;

• liver disease;

• heart disease, heart rhythm disorder;

• long QT syndrome (in you or a family member);

• an electrolyte imbalance (such as low levels of calcium, potassium, or magnesium in your blood);

• breathing disorder; or

• a nerve problem.

Oxaliplatin can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, do not use Eloxatin if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 9 months after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 6 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Eloxatin.

Oxaliplatin may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because oxaliplatin can harm an unborn baby.

Do not breastfeed while using Eloxatin, and for at least 3 months after your last dose.

Eloxatin is given as an infusion into a vein. A healthcare provider will give you this injection.

Eloxatin must be given slowly, and the infusion can take at least 2 hours to complete.

Eloxatin is usually given once every 2 weeks. Your doctor will determine how long to treat you with this medicine.

You may be given medication to prevent nausea or vomiting.

Receiving Eloxatin can make you more sensitive to cold, which can cause numbness, tingling, and muscle spasms. This includes exposure to cold temperature and coming into contact with cold objects. To prevent discomfort, follow these steps:

• do not inhale deeply when you are exposed to cold air;

• cover your skin, head, and face when you are outside in cold temperatures;

• wear gloves when handling cold objects or refrigerated foods;

• do not run an air conditioner at very cool temperature in your home or car (even during hot weather);

• do not drink cold drinks or use ice cubes in drinks;

• do not put ice packs on your body.

Chemotherapy often causes nausea or mouth sores. Do not eat ice chips to ease these discomforts because you will be more sensitive to cold. Talk to your doctor about other ways to treat nausea or mouth sores. You may be given other medications to prevent nausea or vomiting while you are receiving Eloxatin.

Eloxatin can lower your blood cell counts. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results.

Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

Usual Adult Dose for Colorectal Cancer:

85 mg/m2 via IV infusion over 120 minutes every 2 weeks; administer in combination with infusional 5-fluorouracil and leucovorin.

Duration of Therapy:
-Adjuvant Treatment of Stage III Colon Cancer: Total of 6 months (12 cycles)
-Treatment of Advanced Colorectal Cancer: Until disease progression or unacceptable toxicity

Comments:
-Premedication with antiemetics, including 5-HT3 blockers with or without dexamethasone, is recommended.
-Consult the manufacturer product information for 5-fluorouracil and leucovorin dosing recommendations.

Uses: In combination with infusional 5-fluorouracil and leucovorin:
-Adjuvant treatment of Stage III colon cancer in patients who have undergone complete resection of the primary tumor.
-Treatment of advanced colorectal cancer.

You should not be treated with Eloxatin if you have ever had an allergic reaction to oxaliplatin or similar medications such as carboplatin (Paraplatin) or cisplatin (Platinol).

To make sure Eloxatin is safe for you, tell your doctor if you have ever had:

• an active or recent infection;

• kidney disease;

• liver disease;

• heart disease, heart rhythm disorder;

• long QT syndrome (in you or a family member);

• an electrolyte imbalance (such as low levels of calcium, potassium, or magnesium in your blood);

• breathing disorder; or

• a nerve problem.

Oxaliplatin can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, do not use Eloxatin if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 9 months after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 6 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Eloxatin.

Oxaliplatin may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because oxaliplatin can harm an unborn baby.

Do not breastfeed while using Eloxatin, and for at least 3 months after your last dose.

Contact your doctor if you miss an appointment for your Eloxatin injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid cold temperatures and cold objects, including ice, cold drinks, and skin exposure to cold temperatures.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Eloxatin may cause blurred vision and may impair your reactions. Avoid driving or hazardous activity until you know how oxaliplatin will affect you.

Oxaliplatin can cause a severe or life-threatening allergic reaction. Some people receiving a Eloxatin injection have had a reaction to the infusion within minutes after the medicine is injected into the vein. Tell your caregiver right away if you feel dizzy, short of breath, confused, sweaty, itchy, or have diarrhea, chest pain, warmth or redness in your face, or feel like you might pass out.

Get emergency medical help if you have signs of an allergic reaction to Eloxatin: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• increased sensitivity to cold temperatures and cold objects;

• numbness, tingling, or burning pain that interferes with daily activities;

• severe or ongoing diarrhea or vomiting;

• confusion, change in mental status, vision problems, seizure (convulsions);

• pain or burning when you urinate;

• sudden chest pain or discomfort, wheezing, dry cough, feeling short of breath;

• pain, redness, swelling, or skin changes where the injection was given;

• dehydration symptoms - feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;

• heart problems - headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

• liver problems - nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• muscle problems - unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine;

• nerve problems - jaw or chest tightness, eye pain, strange feeling in your tongue, problems with speech or swallowing; or

• low blood cell counts - fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common Eloxatin side effects may include:

• nausea, vomiting, diarrhea;

• numbness, tingling, burning pain;

• low blood cell counts;

• abnormal liver function tests;

• mouth sores; or

• feeling tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with oxaliplatin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.