Oxaliplatin belongs to the group of cancer-fighting medications known as antineoplastics, and specifically to the group of antineoplastics known as platinum-containing compounds. Oxaliplatin prevents the growth of cancer cells by interfering with the genetic material DNA, which is necessary for reproduction of cells.

Oxaliplatin is used in combination with other cancer medications to treat metastatic colorectal cancer (i.e., colorectal cancer that has spread). It is also used to treat colon cancer in people who have had surgery to remove the tumour. It is used in combination with 5-fluorouracil (5-FU) and leucovorin (LV).

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.

The recommended dose varies according to body size and may be adjusted if side effects occur. Oxaliplatin will be injected by the doctor or by a health care professional under direct supervision of the doctor.

Oxaliplatin is given as an intravenous infusion (injected slowly into the vein over a period of several hours). It is usually injected through a specially prepared site on the skin. The medication is usually given once every 2 weeks as part of a treatment schedule that also includes other cancer medications.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. It is important to follow the treatment schedule prescribed by your doctor. Your doctor may decide on a dosage schedule different from that described here. Very careful handling of this medication is required. It is always administered in a hospital or similar setting with access to sterile equipment for preparation.

You may need to take medication before you are given oxaliplatin to help lessen the nausea this medication may cause. Your doctor will tell you which medication to take and for how long.

This medication should be stored at room temperature, protected from light, and kept out of the reach of children.

Solution for injection

Each clear, glass, single-use vial with a gray stopper and crimping seal with flip-off cap containing 50 mg, 100 mg, or 200 mg of oxaliplatin as a sterile, preservative-free, aqueous solution at a concentration of 5 mg/mL. Nonmedicinal ingredient: Water for Injection, USP.

Lyophilized powder for injection

50 mg vial
Each clear, single-use, glass vial with a gray stopper and crimping seal with flip-off cap containing 50 mg of oxaliplatin as a sterile, preservative-free lyophilized powder for reconstitution. Nonmedicinal ingredient: lactose monohydrate.

100 mg vial
Each clear, single-use, glass vial with a gray stopper and crimping seal with flip-off cap containing 100 mg of oxaliplatin as a sterile, preservative-free lyophilized powder for reconstitution. Nonmedicinal ingredient: lactose monohydrate.

Do not use oxaliplatin if you:

• are sensitive or allergic to oxaliplatin or any ingredients of this medication
• are sensitive or allergic to any platinum-containing compounds (such as cisplatin)
• are pregnant or breast-feeding
• have severely reduced kidney function

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• changes to sense of taste
• constipation
• diarrhea
• fatigue
• hair loss
• hiccups
• pain at injection site
• loss of appetite
• mouth sores
• nausea and vomiting
• symptoms of nerve changes (such as tingling or numbness in the hands and feet, muscle weakness, or unusual sensations)

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• increased blood pressure
• irregular heartbeat, dizziness. or fainting
• joint pain
• persistent cough (cough that doesn't seem to go away)
• persistent diarrhea (diarrhea that doesn't seem to go away)
• persistent vomiting (vomiting that doesn’t seem to go away)
• signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
• signs of bleeding (e.g., bloody nose, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
• signs of a blood clot in the arm or leg (tenderness, pain, swelling, warmth, or redness in the arm or leg) or lungs (difficulty breathing, sharp chest pain that is worse when breathing in, coughing, coughing up blood, sweating, or passing out)
• signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
• signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine)
• signs of muscle damage (e.g., muscle pain, tenderness or weakness, or brown or discoloured urine)
• symptoms of liver problems (such as yellow eyes or skin, abdominal pain, loss of appetite, pale stools, itchy skin, or dark urine)
• tingling or numbness in the hands and feet or muscle weakness that interferes with daily activities (buttoning clothes, swallowing, difficulty walking).
• vision changes

Seek immediate medical attention if any of the following occur:

• symptoms of a serious allergic reaction (such as difficulty breathing, hives, or swelling of the face or throat)
• symptoms of gastrointestinal (stomach or intestine) bleeding (such as blood in the stools; black, tarry stools; coughing or vomiting up of blood or material that looks like coffee grounds; abdominal pain; shortness of breath; and weakness or fatigue)
• symptoms of lung problems (such as coughing, shortness of breath, or wheezing)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Anemia: Oxaliplatin may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired or pale skin, contact your doctor as soon as possible.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.

Bleeding: This medication can reduce the number of platelet cells in the blood. Platelets help the blood to clot, and a shortage could make you bleed more easily. Tell your doctor of any signs that your blood is not clotting as quickly. Such symptoms may include black and tarry stools, blood in the urine, easy bruising, or cuts that won't stop bleeding.

Blood clots: This medication may increase the chance of blood clot formation in the small blood vessels of the body, causing reduction of blood flow to organs or the extremities.

If you have a history of clotting you may be at increased risk of experiencing blood clot-related problems such as heart attack, stroke, or clots in the deep veins of your leg. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision or difficulty speaking, contact your doctor immediately.

Cold temperatures: Exposure to cold temperatures can cause prickling, tingling, or abnormal sensations in the hands, feet, mouth, or throat. It may also cause throat or chest tightness.

To reduce your risk of these problems, avoid cold temperatures and cold objects. For example, avoid cold drinks and do not use ice cubes in your drinks. Do not put ice packs on your body or use an air conditioner at high levels. If exposed to cold air, do not breathe deeply. If you are getting things out of the freezer or fridge, wear gloves.

Drowsiness/reduced alertness: Oxaliplatin may cause dizziness, vision problems, and loss of sense of balance. Do not drive or operate machinery until you know how this medication affects you.

Gastrointestinal (stomach and bowel) problems: Rarely, oxaliplatin can cause perforation (holes) in the stomach or intestines. If you experience severe abdominal pain, fever, vomiting, or black and tarry stools, contact your doctor immediately.

Heart rhythm: Oxaliplatin can cause changes to the normal rhythm of the heart, including the irregular heart rhythm QT prolongation. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death. If you are at risk for heart rhythm problems (e.g., people with heart failure, angina, low potassium or magnesium levels), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Infection: As well as killing cancer cells, this medication can reduce the number of cells that fight infection in the body (white blood cells). Avoid contact with people with contagious infections and tell your doctor if you begin to notice signs of an infection, such as fever or chills.

Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Kidney function: Oxaliplatin can have harmful effects on the kidneys. If you experience signs of decreased kidney function, such as reduced urine production; fluid build-up; or swelling in the ankles, feet and hands; fatigue; or abdominal pain, contact your doctor as soon as possible.

If you have reduced kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Oxaliplatin may reduce liver function. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Lung problems: This medication may cause lung problems that make breathing difficult, including interstitial lung disease. If you experience a cough that doesn't seem to go away, shortness of breath, or difficulty breathing, contact your doctor as soon as possible.

Medical tests: While you are receiving treatment with oxaliplatin, your doctor will recommend regular blood tests to monitor the health of your liver, kidneys, and blood cells. You will also have regular neurological exams to check the health of your nervous system.

Neuropathy: Neuropathy, or nerve changes, may occur while you are receiving oxaliplatin. If you experience symptoms of nerve changes (such as tingling or numbness in the hands, feet, or throat; muscle weakness; or unusual sensations that affect your daily activities), contact your doctor. These symptoms are usually temporary but may continue long term. Although uncommon, some people experience a type of neuropathy which causes a sensation of tightness or discomfort in the throat. This symptom usually goes away after a few minutes. Contact your doctor if you have any concerns.

Posterior Reversible Encephalopathy Syndrome: Very rarely, this medication can cause a reversible brain problem called PRES (posterior reversible encephalopathy syndrome). If you develop a seizure, headache, weakness, confusion, loss of vision, or other vision changes while using this medication, get immediate medical attention.

Pregnancy: There is a possibility of birth defects if either the father or mother is using oxaliplatin at the time of conception, or if it is taken by the mother during pregnancy. Effective birth control should be practiced by both men and women while using this medication. If you become pregnant while taking this medication, contact your doctor immediately. This medication should not be used during pregnancy. Men should not father a child during treatment and for 6 months after receiving oxaliplatin.

Breast-feeding: It is not known if oxaliplatin passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. This medication should not be used by breast-feeding women.

Children: The safety and effectiveness of using this medication have not been established for children.

There may be an interaction between oxaliplatin and any of the following:

• amphotericin B
• BCG
• bupropion
• clozapine
• denosumab
• echinacea
• leflunomide
• other medications used to treat cancer (e.g., cabazitaxel, docetaxel, topotecan)
• phenytoin
• tacrolimus
• vaccines
• warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.