"Patients with advanced colorectal cancer who are no longer responding to other therapies will now have another option, a new oral medication.
The new product, a combination of trifluridine and tipiracil (Lonsurf, Taiho Pharmace"...
(oxaliplatin) injection for intravenous use
Read this Patient Information leaflet carefully before you start receiving ELOXATIN. There may be new information. It will help you learn more about ELOXATIN. This leaflet does not take the place of talking to your doctor about your medical condition or your treatment. Ask your doctor about any questions you have.
What is the most important information I should know about ELOXATIN?
ELOXATIN can cause serious allergic reactions, including allergic reactions that can lead to death. ELOXATIN is a platinum base medicine. Serious allergic reactions including death can happen 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 ELOXATIN 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:
- flushed face
- swelling of your lips or tongue
- sudden cough
- dizziness or feel faint
- chest pain
See “What are the possible side effects of ELOXATIN?” for information about other serious side effects.
What is ELOXATIN?
- stage III colon cancer after surgery to remove the tumor
- advanced colon or rectal cancer (colorectal cancer) It is not known if ELOXATIN is effective in children.
Who should not receive ELOXATIN?
Do not receive ELOXATIN if you are allergic to any of the ingredients in ELOXATIN or other medicines that contain platinum. See the end of this leaflet for a complete list of the ingredients ELOXATIN.
Ask your doctor if you are not sure if you take a medicine that contains platinum.
What should I tell my doctor before receiving ELOXATIN?
Before receiving ELOXATIN, tell your doctor about all of your medical conditions, including if you:
- have an infection
- have lung, liver, or kidney problems
- have or had heart problems such as an abnormal heart test called an electrocardiogram (ECG or EKG), a condition called long QT syndrome, an irregular or slow heartbeat, or a family history of heart problems.
- have had changes in the level of certain blood salt (electrolytes) levels, including potassium, magnesium, and calcium
- are pregnant or plan to become pregnant. ELOXATIN may harm your unborn baby. Females who are able to become pregnant should avoid becoming pregnant and should use effective birth control during treatment with ELOXATIN.
- are breastfeeding or plan to breastfeed. It is not known if ELOXATIN passes into your breast milk. You and your doctor should decide if you will receive ELOXATIN or breastfeed. You should not do both.
Tell your doctor about all the medicines you take, including prescription and over-the-counter 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.
How will I receive ELOXATIN?
- ELOXATIN is given to you into your vein through an intravenous (IV) tube.
- Your doctor will prescribe ELOXATIN in a dose that is right for you.
- Your doctor may change how often you receive ELOXATIN, your dose, or how long your infusion will take.
- You and your doctor will decide how many ELOXTIN treatments you will receive.
- It is very important that you do exactly what your doctor and nurse tell you to do.
- Some medicines may be given to you before ELOXATIN to help prevent nausea and vomiting.
- 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.
- It is important for you to keep all of your medical appointments. Call your doctor if you miss an appointment. There may be special instructions for you.
Treatment Day 1:
- ELOXATIN and leucovorin will be given through a thin plastic tube into a vein (intravenous infusion or IV) and given for 2 hours. You will be watched by a healthcare provider during this time.
- Right after the ELOXATIN and leucovorin are given, 2 doses of 5-fluorouracil will be given. The first dose is given right away into your IV tube. The second dose will be given into your IV 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.
The 5-fluorouracil will be given through your IV with a pump. If you have any problems with the pump or the tube, call your doctor, your nurse, or the person who is responsible for your pump. Do not let anyone other than a healthcare provider touch your infusion pump or tubing.
What should I avoid while receiving ELOXATIN?
- Avoid cold temperatures and cold objects. Cover your skin if you go outdoors in cold temperatures.
- Do not drink cold drinks or use ice cubes in drinks.
- Do not put ice or ice packs on your body.
- ELOXATIN can cause dizziness, vision problems, or vision loss that can affect your ability to drive or use machines. You should not drive or operate machinery if you develop these symptoms while receiving ELOXATIN.
See “How can I reduce the side effects caused by cold temperatures?” for more information.
Talk with your doctor and nurse about your level of activity during treatment with ELOXATIN. Follow their instructions.
What are the possible side effects of ELOXATIN?
ELOXATIN can cause serious side effects, including:
- See “What is the most important information I should know about ELOXATIN?”
- Nerve problems. ELOXATIN can affect how
your nerves work and make you feel. Nerve problems may happen with the first
treatment or within two days after your treatment of ELOXATIN. Nerve problems
may last a short time (acute) or may become persistent. Symptoms may improve
after stopping treatment with ELOXATIN. Exposure to cold or cold objects may
cause or worsen nerve problems. Tell your doctor right away if you get any
signs of nerve problems, including:
- very sensitive to cold temperatures and cold objects
- 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.
For information on ways to lessen or help with the nerve problems, see the end of this leaflet, “How can I reduce the side effects caused by cold temperatures?”
- 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:
- confusion or a change in the way you think
- vision problems, such as blurriness or vision loss
- Low white blood cell counts
(neutropenia). ELOXATIN can cause low white blood cells counts. Low blood
cell counts are common with ELOXATIN and can lead to serious infection and
death. Tell your doctor right away if you have a fever greater than 100.9oF
(38.3°C) or a prolonged fever greater than 100.4oF (38°C) for more than one
hour (febrile neutropenia). Call your doctor right away if you get any of the
following signs of infection:
- chills or shivering
- pain on swallowing
- sore throat
- cough that brings up mucus
- burning or pain on urination
- redness or swelling at intravenous site
- persistent diarrhea
- Lung problems (interstitial fibrosis). ELOXATIN can cause lung problems that may lead to death. 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.
- Heart problems. ELOXATIN can cause heart problems that have led to death. Your doctor may do blood and heart tests during treatment with ELOXTIN if you have certain heart problem. If you faint (lose consciousness) or have an irregular heartbeat or chest pain during treatment with ELOXATIN, tell your doctor right away as this may be a sign of a serious heart condition.
- Muscle problems. ELOXATIN can cause muscle damage (rhabdomyolysis) which can lead to death. Tell your doctor right away if you have muscle pain and swelling, along with weakness, fever, or red- brown urine.
- Harm to an unborn baby. See “What should I tell my doctor before receiving ELOXATIN?”
The most common side effects of ELOXATIN include:
- Numbness, pain, tingling, and/or burning along the nerves
- Low white blood cells (neutropenia)
- Low platelet count (important for clotting and to control bleeding)
- Low red blood cells (blood cells that carry oxygen to the tissues)
- Changes in liver function tests
- Mouth sores
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. You may report side effects to FDA at 1-800-FDA1088.
How can I 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 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 doctor know before your next treatment how well you did since your last visit.
Your doctor may have other useful tips for helping you with side effects.
General information about the safe and effective use of ELOXATIN
Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. This Patient Information leaflet summarizes the most important information about ELOXATIN. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about ELOXATIN that is written for health professionals.
What are the ingredients in ELOXATIN?
Active ingredient: oxaliplatin
Inactive ingredient: water for injection
Last reviewed on RxList: 10/19/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Eloxatin Information
Eloxatin - User Reviews
Eloxatin User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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