ELOXATIN^® is an anti-cancer (chemotherapy) medicine that is used with other anti-cancer medicines called 5-fluorouracil and leucovorin to treat adults with:

		stage III colon cancer after surgery to remove the tumor
		advanced colon or rectal cancer (colo-rectal cancer)

Important Safety Information Including Boxed Warning

Anaphylactic-like reactions to ELOXATIN have been reported and may occur within minutes of ELOXATIN administration. Epinephrine, corticosteroids, and antihistamines have been employed to alleviate symptoms. Continue below

What is ELOXATIN (oxaliplatin injection)?

ELOXATIN (oxaliplatin injection) is a medicine approved by the Food and Drug Administration (FDA) that is used with 2 other chemotherapy drugs, 5-fluorouracil and leucovorin (5-FU/LV), to treat adults with stage III colon cancer after surgery to remove the tumor and advanced colon or rectal (colo-rectal cancer). It is not known if ELOXATIN (oxaliplatin injection) works in children.

ELOXATIN (oxaliplatin injection) For Stage III Colon Cancer:

ELOXATIN (oxaliplatin injection) with infusional 5-fluorouracil and leucovorin was shown to lower the chance of colon cancer returning in some patients when given to patients with stage III colon cancer after surgery to remove the tumor. ELOXATIN also increases survival in some patients with stage III colon cancer. The most common adverse reactions seen in the study were nerve problems (peripheral neuropathy), a decrease in white blood cells, red blood cells, and platelets, nausea, vomiting, diarrhea, tiredness, mouth sores and an increase in liver enzymes.

For Advanced Colorectal Cancer (Also Known as Stage IV or Metastatic Cancer):

ELOXATIN with infusional 5-fluorouracil and leucovorin was also shown to increase survival, shrink tumors and delay growth of tumors in some patients with advanced colorectal cancer. The most common adverse reactions seen in the study were nerve problems (peripheral neuropathy), a decrease in white blood cells, nausea, vomiting, diarrhea, and tiredness.

In patients over 65 years old:

The effectiveness of ELOXATIN (oxaliplatin injection) combination therapy was not conclusive in patients ≥65 years of age receiving adjuvant treatment of stage III colon cancer who had their primary tumors surgically removed. Patients ≥65 receiving ELOXATIN (oxaliplatin injection) combination therapy for adjuvant treatment of colorectal cancer experienced more severe (Grade 3-4) low white blood cell counts than patients <65 years of age.

For patients with advanced colorectal cancer, ELOXATIN (oxaliplatin injection) combination therapy has been proven as effective in patients ≥65 as it is in younger patients. The rate of overall adverse reactions, including the more severe adverse reactions (Grade 3-4) were similar in older (≥65 years old) and younger (<65 years old) patients. The incidence of diarrhea, dehydration, low potassium, low white blood cells, fatigue, and a loss of consciousness were higher in patients ≥65 receiving treatment of advanced colorectal cancer.

Important Safety Information

Do not take ELOXATIN if you are allergic to any of the ingredients in ELOXATIN or other medicines that contain platinum. Tell your doctor right away if you feel like your throat is closing up, have shortness of breath, a flushed face, a rash, itching/hives, swelling of lips or tongue, sudden cough, dizziness, sweating or chest pain.
ELOXATIN can cause nerve problems. Tell your doctor right away if you become sensitive to cold temperatures and cold objects; have trouble breathing, swallowing or saying words; experience jaw tightness, odd feelings in your tongue, or chest pressure; pain; tingling or burning in your hands, feet or around your mouth or throat.
Tell your doctor if you develop a dry cough or have trouble breathing; these may be signs of serious lung disease.
ELOXATIN can cause liver problems (hepatotoxicity); your doctor will do blood tests to watch for this.
Because of the potential risk of fetal harm, pregnant women should not receive ELOXATIN. Women of childbearing potential should avoid becoming pregnant while receiving ELOXATIN.
ELOXATIN can cause a decrease in white blood cells, which can lead to infections. Tell your doctor right away if develop any of the following signs of infection: fever, chills, or shivering; cough that brings up mucus, burning or pain on urination, pain on swallowing; sore throat; or redness or swelling at injection site.
Other common side effects of ELOXATIN include a decrease in white blood cells, red blood cells, and platelets, nausea, vomiting, diarrhea, and tiredness.
Tell your doctor about all the medications you take, including prescription and non-prescription medications, vitamins and herbal supplements.

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of ELOXATIN. For more information, ask your doctor or pharmacist.