Oxaliplatin (Intravenous route)
- Powder for Solution
Warnings:Intravenous route(Solution;Powder for Solution)
Anaphylactic reactions to oxaliplatin have been reported, and may occur within minutes of oxaliplatin administration. Epinephrine, corticosteroids, and antihistamines have been employed to alleviate symptoms .
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Uses of This Medicine:
Oxaliplatin injection is given along with other medicines to treat advanced cancer of the colon or rectum. It is also used to treat severe colon cancer in patients who have had a surgery.
Oxaliplatin belongs to the group of medicines called antineoplastics. It 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 doctor. 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 doctor the possible side effects of this medicine as well as the benefits it can do.
This medicine is to be given only by or under the direct supervision of a doctor.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, oxaliplatin is used in certain patients with the following medical conditions:
- Colon cancer, stage II, adjuvant treatment in combination with 5-fluorouracil/leucovorin.
- Gastric carcinoma, advanced or metastatic.
- Metastatic colorectal cancer (cancer of the colon or rectum that has spread to other areas of the body), first-line therapy, in combination with bevacizumab and capecitabine.
- Metastatic pancreatic adenocarcinoma (cancer of the pancreas that has spread to other areas of the body), first-line treatment, in combination with 5-fluorouracil, leucovorin, and irinotecan.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of oxaliplatin injection in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oxaliplatin injection in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution in patients receiving oxaliplatin injection.
|All Trimesters||D||Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
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 doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Rotavirus Vaccine, Live
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Bacillus of Calmette and Guerin Vaccine, Live
- Influenza Virus Vaccine, Live
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Vaccine
- Typhoid Vaccine
- Varicella Virus Vaccine
- Yellow Fever Vaccine
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Kidney disease—Effects of oxaliplatin may be increased because of slower removal from the body.
- Liver disease or
- Lung disease or
- Peripheral neuropathy (nerve problem)—Use with caution. May make these conditions worse.
Proper Use of This Medicine:
This medicine often causes nausea and vomiting. However, it is very important that you continue to receive this medicine even if you begin to feel ill. Other medicines may be given to you to help with the nausea and vomiting. Ask your doctor for other ways to lessen these effects.
You will receive this medicine while you are in a hospital or cancer treatment center. A doctor or other trained health professional will give you this medicine. This medicine is given through a needle placed into one of your veins.
If any of this medicine gets on your skin or in your eyes, nose, or mouth, tell your doctor or nurse right away.
Oxaliplatin is usually used with other medicines to treat cancer. This combination of medicines is usually given for 2 days, but you will receive oxaliplatin on the first day only (day 1). This 2-day treatment is given again every 14 days until your body responds to the medicine.
This medicine comes with a patient information leaflet. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.
Precautions While Using This Medicine:
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Make sure your doctor knows if you are pregnant before you receive this medicine. Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.
This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, diarrhea, a fever or chills, hives, hoarseness, itching, lightheadedness or dizziness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive the medicine.
While you are being treated with oxaliplatin, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor'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 doctor 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 doctor immediately if you have persistent vomiting, diarrhea, dehydration, cough, or difficulty breathing.
- Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
- Check with your doctor immediately if you notice any redness, pain, or swelling in the area you are receiving your medicine.
- Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor 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.
Stop using this medicine and check with your doctor right away if you start having cough, shortness of breath, or any problems with breathing. These may be signs of a serious lung disease.
Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral or sensory neuropathy.
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.
This medicine may increase your chance of having blood clots or a brain condition called reversible posterior leukoencephalopathy syndrome (RPLS). Stop using this medicine and tell your doctor right away if you develop sudden and severe headaches, fainting spells, seizures, unusual drowsiness, confusion, or problems with vision, speech, or walking while you are using this medicine.
This medicine may cause blurred vision or other vision problems. If any of these occur, do not drive, use machines, or do anything else that could be dangerous if you are not able to see well. If these reactions are especially bothersome, check with your doctor.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects of This Medicine:
- More common
- Abnormal tongue sensation
- black, tarry stools
- bleeding gums
- blistering, peeling, redness, or swelling of the palms of the hands or bottoms of the feet
- blood in the urine or stools
- burning, prickling, itching, or tingling of the skin
- chest pain
- decreased feeling, or pain in the hands, feet, around the mouth, or throat
- decreased urination
- difficulty performing daily activities such as writing, buttoning, swallowing, or walking
- difficulty with articulating words
- difficulty with breathing
- difficulty with moving
- difficulty with swallowing
- dry mouth
- eye pain
- increase in heart rate
- jaw spasm
- muscle pain or stiffness
- numbness, pain, tingling, or unusual sensations in the palms of the hands or bottoms of the feet
- pain in the chest, groin, or legs, especially the calves
- pain in the joints
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- rapid breathing
- sensation of pins and needles
- severe, sudden headache
- shortness of breath
- slurred speech
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stabbing pain
- sudden loss of coordination
- sudden, severe weakness or numbness in the arm or leg
- sudden, unexplained shortness of breath
- sunken eyes
- swelling or inflammation of the mouth
- swollen glands
- troubled breathing with exertion
- unusual bleeding or bruising
- unusual tiredness or weakness
- vision changes
- wrinkled skin
- Less common
- fast heartbeat
- increased thirst
- irregular heartbeat
- loss of appetite
- mood changes
- nausea or vomiting
- numbness or tingling in the hands, feet, or lips
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- skin rash
- tightness in the chest
- Incidence not known
- Back, leg, or stomach pains
- bloated abdomen
- blue-yellow color blindness
- blurred vision
- changes in patterns and rhythms of speech
- dark urine
- decreased vision
- deep breathing
- electric shock-like sensation that moves down the back and into the legs following a bending movement of the neck
- general body swelling
- increased urination
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of deep tendon reflexes
- muscle tremors
- pain and fullness in the right upper abdomen
- severe constipation
- severe diarrhea
- severe nosebleeds
- severe stomach cramps or tenderness
- severe vomiting
- trouble with speaking
- twitches of the muscle visible under the skin
- weakness of the muscles in your face
- weight gain
- yellow eyes or skin
- Symptoms of overdose
- cough or hoarseness
- involuntary, rapid, or rhythmic movement of the eyes
- lack of coordination
- lack of sensation
- lower back or side pain
- respiratory failure
- severe weakness
- slow or irregular heartbeat
- vomiting, profuse
- More common
- Acid or sour stomach
- body aches or pain
- ear congestion
- feeling unusually cold, shivering
- loss of voice
- nasal congestion
- runny nose
- stomach discomfort, upset, or pain
- trouble sleeping
- unable to sleep
- weight loss
- Less common
- Bad, unusual, or unpleasant (after) taste
- bloated or full feeling
- bloody nose
- burning while urinating
- change in taste
- cracked lips
- dryness or soreness of the throat
- excess air or gas in stomach or intestines
- feeling of warmth
- hair loss
- passing gas
- rapid weight gain
- redness of the face, neck, arms, and occasionally upper chest
- tender, swollen glands in the neck
- thinning of the hair
- unusual tearing of the eyes
- voice changes
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.
Check with your doctor or nurse immediately if any of the following side effects occur:
Get emergency help immediately if any of the following symptoms of overdose occur:
Some 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:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 11/4/2014