Description
Oxaliplatin injection is given along with other medicines (eg, fluorouracil, leucovorin) 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 is an antineoplastic agent (cancer medicine). It interferes with the growth of cancer cells, which are eventually destroyed by the body.
This medicine is to be given only by or under the direct supervision of a doctor.
This product is available in the following dosage forms:
- Solution
- Powder for Solution
Before Using
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:
Allergies
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.
Pediatric
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.
Geriatric
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 unwanted effects (eg, diarrhea, dehydration, low potassium in the blood, unusual tiredness or weakness) to this medicine.
Breastfeeding
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.
Drug Interactions
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.
- Bacillus of Calmette and Guerin Vaccine, Live
- Bepridil
- Cisapride
- Dengue Tetravalent Vaccine, Live
- Dronedarone
- Levoketoconazole
- Measles Virus Vaccine, Live
- Mesoridazine
- Mumps Virus Vaccine, Live
- Pimozide
- Piperaquine
- Rubella Virus Vaccine, Live
- Saquinavir
- Smallpox Monkeypox Vaccine
- Sparfloxacin
- Terfenadine
- Thioridazine
- Typhoid Vaccine
- Varicella Virus Vaccine
- Yellow Fever Vaccine
- Ziprasidone
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.
- Acenocoumarol
- Adagrasib
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Alfuzosin
- Amiodarone
- Amitriptyline
- Anagrelide
- Apixaban
- Apomorphine
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Azithromycin
- Bedaquiline
- Buprenorphine
- Bupropion
- Buserelin
- Ceritinib
- Chloroquine
- Chlorpromazine
- Cholera Vaccine
- Ciprofloxacin
- Citalopram
- Clarithromycin
- Clofazimine
- Clomipramine
- Clothiapine
- Clozapine
- Crizotinib
- Cyclobenzaprine
- Dabigatran Etexilate
- Dabrafenib
- Dasatinib
- Degarelix
- Delamanid
- Desflurane
Other Interactions
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:
- Congestive heart failure or
- Electrolyte imbalance or
- Heart rhythm problems (eg, slow heartbeat)—Use with caution. May cause side effects to become worse.
- Heart rhythm problems (eg, long QT syndrome), family history of—Use is not recommended in patients with this condition.
- Kidney disease—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.
- Liver disease or
- Lung or breathing problem—Use with caution. May make these conditions worse.
Proper Use
Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
You will receive this medicine while you are in a medical facility. 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. This medicine must be given slowly, so the needle will have to stay in place for at least 2 hours.
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.
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 2 weeks until your body responds to the 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.
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.
Precautions
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.
Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment with this medicine. Female patients should use an effective form of birth control during treatment and for at least 9 months after the last dose. Male patients who have female partners should use effective birth control during treatment and for at least 6 months after the last dose. If you think a pregnancy has occurred while receiving this medicine, tell your doctor right away.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require 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.
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.
- Check with your doctor right away if you start to cough up blood or if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
- 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.
Tell your doctor right away if you have seizures, headache, confusion, vision problems, unusual drowsiness, tiredness, or weakness. These could be symptoms of a serious nervous system problem, called posterior reversible encephalopathy syndrome (PRES).
Check with your doctor right away if you start having cough, fever, 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 sensory neuropathy.
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.
Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.
Check with your doctor right away if you have dark urine, fever, muscle cramps or spasms, muscle pain or stiffness, or unusual tiredness or weakness. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.
This medicine may cause dizziness, 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.
Talk with your doctor before using this medicine if you plan to have children. Some men and women who use this medicine have become infertile (unable to have children).
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
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:
More common
- Abnormal tongue sensation
- black, tarry stools
- bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- 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
- chills
- cough
- 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
- dizziness
- dry mouth
- eye pain
- fainting
- fever
- increase in heart rate
- jaw spasm
- lightheadedness
- lower back or side pain
- muscle pain or stiffness
- numbness or painful sensations
- 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
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stabbing pain
- sunken eyes
- swelling
- swelling or inflammation of the mouth
- swollen glands
- thirst
- trouble breathing with exertion
- unsteadiness or awkwardness
- unusual bleeding or bruising
- unusual tiredness or weakness
- vision changes
- wrinkled skin
Less common
- Chest tightness
- fast heartbeat
- hives, itching, or skin rash
- increased thirst
- irregular heartbeat
- loss of appetite
- mood changes
- nausea or vomiting
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
Incidence not known
- Back, leg, or stomach pains
- blindness
- bloated stomach
- blue-yellow color blindness
- blurred vision
- changes in patterns and rhythms of speech
- dark urine
- deafness
- decreased vision
- deep breathing
- drowsiness
- 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
- irregular heartbeat, recurrent
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of deep tendon reflexes
- muscle cramps or spasms
- muscle tremors
- pain and fullness in the right upper abdomen or stomach
- restlessness
- 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
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Agitation
- coma
- cough or hoarseness
- diarrhea
- disorientation
- involuntary, rapid, or rhythmic movement of the eyes
- lack of coordination
- lack of sensation
- lethargy
- paralysis
- respiratory failure
- seizures
- slow or irregular heartbeat
- tremors
- vomiting, profuse
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:
More common
- Acid or sour stomach
- belching
- body aches or pain
- ear congestion
- feeling unusually cold, shivering
- headache
- heartburn
- indigestion
- loss of voice
- nasal congestion
- runny nose
- sneezing
- stomach discomfort, upset, or pain
- trouble sleeping
- weight loss
Less common
- Bad, unusual, or unpleasant (after) taste
- bloated or full feeling
- bloody nose
- burning while urinating
- change in taste
- congestion
- 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
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.
DRG-20068166
