Patient Medication Information: uses, side effects, how to take - Oxaliplatin for Injection
ABOUT THIS MEDICATION
What the medication is used for:
Oxaliplatin for Injection/Oxaliplatin Injection is a medication used in combination with 5-fluorouracil (5-FU) and Leucovorin to treat people with large bowel (colorectal) cancer that has spread to other parts of the body.
What it does:
Oxaliplatin is a chemotherapy drug used to prevent the further growth of cancer cells, and eventually cause their death. Chemotherapy works by having the medicine flow through your blood to nearly every part of the body.
Every cell in your body contains genetic material, which provides “information” for organs and tissue growth and functioning. Oxaliplatin for Injection/Oxaliplatin Injection links to the genetic material contained in the cell and inhibits the replication process, causing the eventual death of the cancer cell.
When it should not be used:
You should not use Oxaliplatin for Injection/Oxaliplatin Injection if you are allergic to platinum or other medicines containing platinum (example: carboplatin, cisplatin), if you have severe kidney disease, or if you are pregnant or breast-feeding.
What the medicinal ingredient is:
Oxaliplatin.
What the important nonmedicinal ingredients are:
Powder dosage form: Lactose monohydrate.
Solution dosage form: Tartaric acid.
What dosage forms it comes in:
Oxaliplatin for Injection is available in 2 strengths of a lyophilized powder dosage form:
- Lyophilized powder for injection, 50 mg per vial
- Lyophilized powder for injection, 100 mg per vial
Which provide a final concentration of 5 mg/mL when reconstituted with water for injection or 5% dextrose injection.
Oxaliplatin for Injection, 5 mg/mL is also available as a sterile solution for injection available in vials of 10 mL, 20 mL and 40 mL.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
OXALIPLATIN FOR INJECTION/OXALIPLATIN INJECTION should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapy agents. OXALIPLATIN FOR INJECTION/OXALIPLATIN INJECTION may cause severe allergic reactions, liver problems, decrease in the production of blood cells, life-threatening complications due to infections, neuropathy (nerve changes) and respiratory problems (interstitial lung disease that may result in death). OXALIPLATIN FOR INJECTION/OXALIPLATIN INJECTION may also cause the following adverse effects, which may be life-threatening: irregular heartbeat; intestinal ulcers, bleeding or perforation (a hole in the intestine wall) or a decrease in blood flow to the intestines; muscular adverse effects. |
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BEFORE you use Oxaliplatin for Injection/Oxaliplatin Injection, talk to your doctor or pharmacist if you:
- have ever suffered an unusual or allergic reaction to Oxaliplatin for Injection/Oxaliplatin Injection or other oxaliplatin- or platinum-containing medicines such as carboplatin, cisplatin, or Eloxatin.
- are pregnant or planning to become pregnant. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away. Men should be advised not to father a child while receiving treatment with Oxaliplatin for Injection/Oxaliplatin Injection and up to 6 months thereafter.
- are breast-feeding. We do not know whether Oxaliplatin for Injection/Oxaliplatin Injection can pass through your milk and if it can harm your baby. You will need to decide whether to stop breast-feeding or to choose not to take Oxaliplatin for Injection/Oxaliplatin Injection.
- have a reduced number of red or white blood cells.
- have tingling and numbness in the fingers and/or toes.
- are taking any medicine.
- have not taken your premedication as directed.
- have kidney problems.
- have a heart disease called ‘‘QT prolongation’’.
Your doctor will need to check your blood at regular visits while you are using this medicine.
Nerves changes (neuropathy) can occur with Oxaliplatin for Injection/Oxaliplatin Injection (see Side Effects and What to Do About Them below). Exposure to cold can trigger this side effect. 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.
Driving and Operating Machinery
Oxaliplatin for Injection/Oxaliplatin Injection may cause dizziness, other neurological disorders that affect balance, and vision problems including reversible short-term loss of vision. Do not drive or operate machinery until you know how the drug affects you.
INTERACTIONS WITH THIS MEDICATION
Oxaliplatin for Injection/Oxaliplatin Injection may interact with drugs, such as warfarin, that reduce clot formation in the blood. Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, as well as herbal supplements. Before using any prescription, over-the-counter medicines or herbal products, check with your doctor, your pharmacist or your nurse.
PROPER USE OF THIS MEDICATION
Usual Dose
The dose of Oxaliplatin for Injection/Oxaliplatin Injection is calculated from your height and weight and is based on your body surface area. The usual dose is 85 mg/m2 of body surface area once every 2 weeks before the infusion of the other anticancer medicines (leucovorin and 5-fluorouracil).
The dose you receive will depend on results of the blood tests the doctor has taken before your first treatment and before each treatment cycle, and whether you have previously experienced side effects with Oxaliplatin for Injection/Oxaliplatin Injection.
Oxaliplatin for Injection/Oxaliplatin Injection is an injectable medication that is given by intravenous infusion (injected slowly in a vein).
The administration of Oxaliplatin for Injection/Oxaliplatin Injection may require you to take medication before each treatment begins (premedication). The purpose of this premedication is to help lessen the nausea. Your doctor, nurse or pharmacist will tell you exactly what premedication you need to take and for how long.
If you forget to take your premedication as directed, make sure to tell your doctor before you get your Oxaliplatin for Injection/Oxaliplatin Injection treatment.
Overdose
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
An overdose of this medicine may be dangerous. Your doctor will ensure that the correct dose for your condition is given.
Missed Dose
This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor for instructions. Be sure to keep all appointments.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, Oxaliplatin for Injection/Oxaliplatin Injection can cause side effects. Everyone reacts differently to chemotherapy and not all people will experience every side effect. If you experience any side effect it is important that you inform your doctor before your next treatment. Most of the side effects that occur with Oxaliplatin for Injection/Oxaliplatin Injection are manageable. Occasionally, it is necessary to stop the treatment.
Common Side Effects
- Trouble breathing (shortness of breath), speaking or swallowing.
- Nausea and vomiting, diarrhea and change in taste.
- Fatigue or tiredness.
- Stomatitis (sores in the mouth).
- Hiccups.
- High blood pressure.
- Pain at the injection site.
- Pain in a joint.
- Nose bleeds.
- Changes to the number of blood cells.
Neuropathy: nerve changes that can cause tingling or numbness in your fingers, toes, in and around your mouth or in the throat, a reduced sense of touch, or other altered sensations.
Exposure to cold is one of the most common triggers of neuropathy. Touching cold objects or frozen items, consuming cold foods or beverages, and breathing cold air may cause these unpleasant nerve sensations.
A less common symptom of neuropathy is laryngopharyngeal dysesthesia. This is the sensation of tightness or discomfort in the throat, making it seem difficult to breathe or swallow. Although this symptom may be frightening, it is just a sensation and does not really interfere with breathing. The sensation usually goes away on its own after a few minutes.
Some people may experience more debilitating symptoms of neuropathy, which may interfere with daily activities such as the following:
- Writing
- Buttoning clothes
- Swallowing
- Difficulty walking
- Picking up things
Many of these neuropathy symptoms are temporary. However, they may continue long-term.
- Neutropenia: a lower-than-normal number of neutrophils, a type of white blood cells. Your white blood cells protect your body against infection. So if you have neutropenia, you are at higher risk of having an infection, which can be life-threatening. However, most people receiving Oxaliplatin for Injection/Oxaliplatin Injection do not develop infections, even when they have neutropenia.
- Thrombocytopenia: a lower-than-normal number of platelets. Platelets have an important role in the control of bleeding. Therefore, a reduction in their number may increase the tendency to bleed.
- Anemia: a lower-than-normal number of red blood cells. As a result, people with anemia may feel tired.
Your doctor will be checking routinely your blood count and will alert you if your platelets, white or red blood cells are low.
Other Possible Side Effects are:
- Constipation
- Stomach pain
- Loss of appetite
- Hair loss
- Reversible short-term loss of vision
- Deep vein thrombosis (blood clot in the deep vein)
- Interstitial lung disease (respiratory symptoms such as rapid breathing and shortness of breath)
Discuss with your doctor if you have these symptoms.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM |
| Symptom / Effect | Talk with your doctor or pharmacist | Stop taking the drug and call your doctor or pharmacist | |||
|---|---|---|---|---|---|
| Only if severe | In all cases | ||||
| Uncommon | |||||
| Fever, shivering, signs of infection, like redness or swelling at the injection site, a cough that brings up mucous, or sore throat | √ | ||||
| Abnormal bruising | √ | ||||
| Pain on swallowing | √ | ||||
| Signs of dehydration (too much water loss), thirst or dry mouth | √ | ||||
| Persistent vomiting or diarrhea | √ | ||||
| Persistent cough | √ | ||||
| Fatigue | √ | ||||
| Allergic reactions such as trouble breathing, tightness in the throat, rash, hives, or swelling of the lips or tongue | √ | ||||
| Neuropathy symptoms interfering with daily activities | √ | ||||
| Symptoms such as headache, altered mental functioning, seizures and abnormal vision from blurriness to vision loss | √ | ||||
| Unknown frequency | |||||
| Kidney failure (with symptoms such as: difficulty breathing, weakness, tiredness, decreased urinary volume), small purple-red marks on the skin or other parts of the body. Kidney failure may be not reversible with discontinuation of therapy and dialysis may be required. | √ | ||||
| Irregular heartbeat, dizziness or fainting | √ | ||||
| Muscle pain and swelling, with weakness, fever and darkened urine | √ | ||||
| Stomach pain, nausea, vomiting, black or red-coloured stools | √ | ||||
| Symptom / Effect | Talk with your doctor or pharmacist | Stop taking the drug and call your doctor or pharmacist |
|---|
| Only if severe | In all cases |
|---|---|
| Disseminated intravascular coagulation (which may be life-threatening), with symptoms such as: bleeding in urine or stools, small red or brown bruises that happen easily, pain and swelling in the lower leg, or chest pain and shortness of breath. | |
| √ |
This is not a complete list of side effects. For any unexpected effects while taking Oxaliplatin for Injection/Oxaliplatin Injection, contact your doctor or pharmacist.
HOW TO STORE IT
Unopened vials of Oxaliplatin for Injection should be stored between 15 and 25°C, protected from light.
Unopened vials of Oxaliplatin Injection should be stored between 15 and 25°C. Protect from freezing. Protection from light is not required.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
Postage-paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect. NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice. |
MORE INFORMATION
Your doctor, pharmacist and nurse are always your best source of information about your condition and treatment. If you have additional questions or concerns, be sure to ask them.
This document plus the full product monograph, prepared for health professionals, can be found by contacting the sponsor, Hospira Healthcare Corporation, at: 1-866-488-6088.
Last prepared: December 09, 2015