In the U.S.—

• Antineoplastic

Oxaliplatin ( OX-ah-lee-PLA-tin) belongs to the group of medicines called antineoplastics. It is used to treat cancer of the colon or rectum. Oxaliplatin is usually given along with other medicines to treat cancer.

Oxaliplatin interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by the medicine, other effects may also occur. Some of these may be serious and must be reported to your healthcare professional. Other effects may not be serious but may cause concern. Some effects may occur after treatment with oxaliplatin has been stopped. Be sure that you have discussed with your healthcare professional the possible side effects of this medicine as well as the good it can do.

This medicine is available only with your healthcare professional's prescription, in the following dosage forms:

Parenteral
• Injection (U.S.)

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your healthcare professional will make. For oxaliplatin the following should be considered:

Allergies—Tell your healthcare professional if you have ever had any unusual or allergic reaction to oxaliplatin or other medications or to platinum containing compounds (e.g. Platinol AQ [cisplatin], or Paraplatin [carboplatin]). Also tell your healthcare professional and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Oxaliplatin has not been studied in pregnant women. However, studies in animals have shown that oxaliplatin causes miscarriages, decreased weight or death of the fetus, and problems with bone formation. Be sure that you have discussed this with your healthcare professional before taking this medicine. Tell your healthcare professional right away if you think you have become pregnant while taking oxaliplatin.

Breast-feeding—It is not known whether oxaliplatin passes into human breast milk. Tell your healthcare professional if you are breast-feeding or if you intend to breast-feed during treatment with this medicine. Because oxaliplatin may cause serious side effects in the nursing infant, breast-feeding is not recommended while you are taking the medicine.

Children—Studies of this medicine have been done only in adult patients, and there is no specific information comparing the use of oxaliplatin in children with use in other age groups.

Older adults—This medicine has been tested in a small number of patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your healthcare professional may want to change the dose, or other precautions may be necessary. When you are taking oxaliplatin, it is especially important that your healthcare professional and pharmacist know if you are taking any other medications.

• Kidney disease—Effects of oxaliplatin may be increased because of slower removal from the body

Dosing—

This medicine often causes nausea and vomiting. However, it is very important that you continue to receive the medicine even if you begin to feel ill. Other medicines may be given to you to help with the nausea and vomiting. Ask your health care professional for other ways to lessen these effects.

The dose of oxaliplatin will be different for different patients. The dose that is used may depend on a number of things. Because this medicine can cause very serious side effects, your healthcare professional will be watching your dose very carefully and may change it as needed. If you have any questions about the proper dose of oxaliplatin, ask your healthcare professional.

It is very important that your healthcare professional check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

While you are being treated with oxaliplatin, and after you stop treatment with it, do not have any immunizations (vaccinations) without your healthcare professional's approval. Oxaliplatin may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. Do not get close to them and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Oxaliplatin can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your healthcare professional immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination and persistent diarrhea.
• Check with your healthcare professional immediately if you have persistent vomiting, diarrhea, dehydration, cough or difficulty breathing
• Check with your healthcare professional immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.
• Check with your healthcare professional immediately if you notice any redness, pain, or swelling in the area you are receiving your medicine.
• 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.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical healthcare professional, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical healthcare professional before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

• More common
  • Abnormal tongue sensation;  black, tarry stools;  bleeding gums;  blood in urine or stools;  blistering, peeling, redness, and/or swelling of palms of hands or bottoms of feet;  burning, prickling, itching, or tingling of skin;  chest pain;  chills;  confusion ;  cough;  decreased feeling, or pain in the hands, feet, around mouth, or throat;  decreased urination;  difficult breathing;  difficulty in articulating words;  difficulty in moving;  difficulty performing daily activities such as writing, buttoning, swallowing or walking;  difficulty swallowing;  dizziness;  dry mouth;  eye pain;  fainting ;  fever;  increase in heart rate;  jaw spasm;  lightheadedness ;  muscle pain or stiffness;  numbness;  numbness, pain, tingling, or unusual sensations in palms of hands or bottoms of feet;  pain in chest, groin, or legs, especially the calves;  pain in joints ;  painful or difficult urination;  pale skin;  pinpoint red spots on skin;  rapid breathing;  sensation of pins and needles;  severe, sudden headache;  shortness of breath;  slurred speech;  sore throat;  sores, ulcers, or white spots on lips or in mouth;  stabbing pain;  sudden loss of coordination;  sudden, severe weakness or numbness in arm or leg;  sudden, unexplained shortness of breath;  sunken eyes;  swelling;  swelling or inflammation of the mouth;  swollen glands;  thirst;  troubled breathing with exertion;  unusual bleeding or bruising;  unusual tiredness or weakness;  vision changes;  wrinkled skin 
  
  

• Less common
  • Convulsions;  fast heartbeat;  hives;  increased thirst;  irregular heartbeat;  itching;  loss of appetite;  mood changes;  nausea or vomiting;  numbness or tingling in hands, feet, or lips;  puffiness or swelling of the eyelids or around the eyes, face, lips or tongue;  skin rash;  tightness in chest;  wheezing 
  
  

• Symptoms of Overdose

  Get emergency help immediately if any of the following symptoms of overdose occur

  • Agitation;  black, tarry stools;  bleeding gums;  blood in urine or stools ;  burning, prickling, itching, or tingling of skin ;  chest pain or discomfort;  coma;  confusion;  cough or hoarseness;  diarrhea;  difficult urination;  disorientation;  dizziness or fainting;  fever or chills;  involuntary, rapid, rhythmic movement of the eyes;  lack of coordination;  lack of sensation ;  lethargy;  lightheadedness ;  lower back or side pain;  muscle twitching;  paralysis;  pinpoint red spots on skin;  respiratory failure ;  seizures;  severe weakness ;  shortness of breath;  slow or irregular heartbeat;  slurred speech;  tremors;  unusual tiredness;  unusual bleeding or bruising;  vomiting, profuse;  wheezing 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your healthcare professional if any of the following side effects continue or are bothersome.

• More Common
  • Abdominal pain;  acid or sour stomach ;  back pain;  belching;  body aches or pain;  diarrhea;  ear congestion;  feeling unusually cold shivering;  headache;  heartburn ;  indigestion;  loss of appetite ;  loss of voice;  nasal congestion;  nausea;  runny nose;  sleeplessness;  sneezing ;  sore throat;  stomach discomfort, upset or pain;  stuffy nose;  trouble sleeping;  unable to sleep;  weight loss 
  
  

• Less common
  • Bad, unusual or unpleasant (after) taste;  bloated, full feeling;  bloating or swelling of face, arms, hands, lower legs, or feet;  bloody nose;  burning while urinating;  change in taste ;  cracked lips;  congestion ;  dryness or soreness of throat;  excess air or gas in stomach or intestines;  feeling of warmth;  hoarseness;  passing gas;  rapid weight gain;  redness of the face, neck, arms and occasionally upper chest;  tender, swollen glands in neck;  tingling of hands or feet;  trouble in swallowing;  unusual tearing of eyes;  voice changes ;  vomiting 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Less common
  • Hair loss;  thinning of hair 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your healthcare professional.