Eloxatin

Eloxatin is a prescription medication used to treat advanced colon or rectal cancer in adults. Eloxatin belongs to a group of drugs called platinum-containing antineoplastic agents, which stops cancer cells from multiplying.

This medication comes in an injectable form to be given intravenously (into a vein) at a hospital or clinic on the first day of each chemotherapy treatment course.

Some of the common side effects of Eloxatin are decreased blood count, high blood pressure, and diarrhea.

Eloxatin is a prescription anti-cancer (chemotherapy) medicine that is used with other anti-cancer medicines called 5-fluorouracil and leucovorin to treat people with:

• stage III colon cancer after surgery to remove the tumor
• advanced colon or rectal cancer (colorectal cancer).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Aventis Pharma Ltd.

• Sanofi-Aventis U.S. LLC

Eloxatin can cause serious side effects. See "Eloxatin Precautions" section.

The most common side effects of Eloxatin include:

• decreased blood counts. Eloxatin can cause a decrease in neutrophils (a type of white blood cells important in fighting in bacterial infections), red blood cells (blood cells that carry oxygen to the tissues), and platelets (important for clotting and to control bleeding).
• high blood pressure (hypertension)
• infection. Call your doctor right away if you get any of the following signs of infection:
  • fever
  • chills or shivering
  • painful swallowing
  • sore throat
  • cough that brings up mucus
  • burning or pain on urination
  • redness or swelling at intravenous site
• bleeding or bruising. Tell your doctor about any signs or symptoms of bleeding or bruising.
• diarrhea
• nausea
• vomiting
• constipation
• mouth sores
• stomach pain
• decreased appetite
• tiredness
• injection site reactions. Reactions may include redness, swelling, pain, tissue damage at the site of injection.
• hair loss (alopecia)
• dehydration (too much water loss). Call you doctor if you have signs of dehydration including:
  • tiredness
  • thirst
  • dry mouth
  • lightheadedness (dizziness)
  • decreased urination

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

Call your doctor for medical advice about side effects. 

To reduce the side effects caused by cold temperatures:

• Cover yourself with a blanket while you are getting your Eloxatin infusion.
• Do not breathe deeply when exposed to cold air.
• Wear warm clothing in cold weather at all times. Cover your mouth and nose with a scarf or a pull-down cap (ski cap) to warm the air that goes to your lungs.
• Wear gloves when taking things from the freezer or refrigerator.
• Drink fluids warm or at room temperature.
• Always drink through a straw.
• Do not use ice chips if you have nausea or mouth sores. Ask your healthcare provider or doctor about what you can use.
• Be aware that most metals are cold to touch, especially in the winter. These include your car door and mailbox. Wear gloves to touch cold objects.
• Do not run the air-conditioning at high levels in the house or in the car in hot weather.
• If your body gets cold, warm-up the affected part. If your hands get cold, wash them with warm water.
• Always let your healthcare provider or doctor know before your next treatment how well you did since your last visit.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• blood thinners such as warfarin (Coumadin)
• drugs that can decrease kidney function such as
  • acetaminophen (Tylenol)
  • aspirin
  • NSAIDs such as ibuprofen and naproxen
  • acyclovir
  • aminoglycoside medications
  • certain antibiotics
  • ACEIs such as lisinopril or quinapril
  • statins such as rosuvastatin and simvastatin
  • water pills (diuretic medications)

This is not a complete list of Eloxatin drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects can happen in people taking Eloxatin, including:

• Reversible Posterior Leukoencephalopathy (RPLS). RPLS is a rare condition that affects the brain. Tell your doctor right away if you have any of the following signs and symptoms of RPLS:
  • headache
  • confusion or a change in the way you think
  • seizures
  • vision problems, such as blurriness or vision loss. You should not drive, operate heavy machines, or engage in dangerous activities if you have vision problems while receiving Eloxatin.
• nerve problems. Eloxatin can affect how your nerves work and make you feel. Tell your doctor right away if you get any signs of nerve problems including:

• very sensitive to cold temperatures and cold objects
  • Avoid cold temperatures and cold objects. Cover your skin if you must go outside in cold temperatures.
  • Do not drink cold drinks or use ice cubes in drinks.
  • Do not put ice or ice packs on your body.
• trouble breathing, swallowing, or saying words, jaw tightness, odd feelings in your tongue, or chest pressure
• pain, tingling, burning (pins and needles, numb feeling) in your hands, feet, or around your mouth or throat, which may cause problems walking or performing activities of daily living

The first signs of nerve problems may happen with the first treatment. The nerve problems can also start up to 2 days after treatment. If you develop nerve problems, the amount of Eloxatin in your next treatment may be changed or Eloxatin treatment may be stopped.

• lung problems (interstitial fibrosis). Tell your doctor right away if you get a dry cough and have trouble breathing (shortness of breath) before your next treatment. These may be signs of a serious lung disease.
• liver problems (hepatotoxicity). Your doctor will do blood tests to check your liver.
• harm to an unborn baby. Eloxatin may cause harm to your unborn baby. 
• serious allergic reactions. Eloxatin can cause serious allergic reactions, including allergic reactions that may cause death. Eloxatin is a platinum base medicine. Serious allergic reactions including death can occur in people who take Eloxatin and who have had previous allergic reactions to platinum medicines. Serious allergic reactions can happen within a few minutes of your infusion or any time during your treatment with Eloxatin .

Get emergency help right away if you:

• have trouble breathing.
• feel like your throat is closing up

Call your doctor right away if you have any of the following signs or symptoms of an allergic reaction:

• rash
• flushed face
• hives
• itching
• swelling of your lips or tongue
• sudden cough
• dizziness or feel faint
• sweating
• chest pain

Do not use Eloxatin if you are allergic to any of the ingredients in Eloxatin or other medicines that contain platinum. Cisplatin and Carboplatin are other chemotherapy medicines that also contain platinum.

Eloxatin should not be given to pregnant women or women who are trying to become pregnant, because Eloxatin may cause harm to an unborn child. Women should avoid becoming pregnant while being treated with Eloxatin.

Eloxatin is not for patients with newly diagnosed colorectal cancer.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Eloxatin there are no specific foods that you must exclude from your diet when receiving Eloxatin.

Do not eat or drink anything that is colder than room temperature for five days after you receive each dose of Eloxatin.

Before receiving Eloxatin, tell your doctor if you:

• have kidney problems
• have any other medical conditions
• have had any allergic reactions to any medicines
• are pregnant or plan to become pregnant. Eloxatin may harm your unborn child. You should avoid becoming pregnant while taking Eloxatin. Talk with your doctor about how to avoid pregnancy.
• are breastfeeding or plan to breastfeed. It is not known if Eloxatin  passes into your breast milk. You and your doctor should decide whether you will stop breastfeeding or not take Eloxatin.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. It has been shown that use of Eloxatin in pregnant women caused some babies to be born with problems. However, in some serious situations, the benefit of using this medication may be greater than the risk of harm to the baby.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Eloxatin passes into your breast milk. You and your doctor should decide whether you will stop breastfeeding or not take Eloxatin.

Eloxatin is given to you through your veins (blood vessels).

• Your doctor will prescribe Eloxatin in an amount that is right for you. 
• Your doctor will treat you with several medicines for your cancer. 
• It is very important that you do exactly what your doctor and nurse have taught you to do. 
• Some medicines may be given to you before Eloxatin to help prevent nausea and vomiting. 
• Eloxatin is given with 2 other chemotherapy medicines, leucovorin and 5-fluorouracil. 
• Each treatment course is given to you over 2 days. You will receive Eloxatin on the first day only. 
• There are usually 14 days between each chemotherapy treatment course.

Treatment Day 1:

Eloxatin and leucovorin are given through a thin plastic tube put into a vein (intravenous infusion or I.V.) and given for 2 hours. You will be watched by a healthcare provider during this time.

Right after the Eloxatin and leucovorin are finished, 2 doses of 5-fluorouracil will be given. The first dose is given right away into your I.V. tube. The second dose will be given into your I.V. tube over the next 22 hours, using a pump device.

Treatment Day 2:

You will not get Eloxatin on Day 2. Leucovorin and 5-fluorouracil will be given the same way as on Day 1.

This medication is usually given by infusion into a vein over at least 2 hours by a doctor, nurse or other health care professional. It is usually given every 2 weeks along with other medications (e.g., 5-fluorouracil and leucovorin). The dosage is based on your medical condition, body size, and response to therapy.

If you accidentally take too much Eloxatin, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away. Generally, a medical professional will be present when you are given Eloxatin. He/she will help you avoid getting the wrong dose of medication. 

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• It is important for you to keep all appointments. Call your doctor if you must miss an appointment. There may be special instructions for you.
• Your doctor may change how often you get Eloxatin, how much you get, or how long the infusion will take.
• You and your doctor will discuss how many times you will get Eloxatin .

WARNING: ANAPHYLACTIC REACTIONS

Anaphylactic reactions to Eloxatin have been reported, and may occur within minutes of Eloxatin administration. Epinephrine, corticosteroids, and antihistamines have been employed to alleviate symptoms of anaphylaxis.