Details for: OXALIPLATIN INJECTION, USP
Company: FRESENIUS KABI CANADA LTD
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02457423 | OXALIPLATIN INJECTION, USP | OXALIPLATIN | 5 MG / ML | SOLUTION | INTRAVENOUS |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Oxaliplatin Injection, USP is a medication used in combination w ith 5-fluorouracil (5-FU) and leucovorin to treat people with:
- colon cancer after they have undergone a surgery to remove the tumor.
- metastatic colorectal cancer.
What it does
Every cell in your body contains genetic material, w hich provides “information” for organs and tissue grow th and functioning.
Oxaliplatin 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
Do not use oxaliplatin if you:
- Are allergic to oxaliplatin or other platinum containing ingredients or to any of the ingredients in the product (see the section What the non-medicinal ingredients are)
- Have numbness, w eakness, prickling or tingling in your feet or hands, w hich can spread upw ard into your legs and arms
- Have a severe kidney disease
- Are breast-feeding
- Are pregnant
What the medicinal ingredient is
oxaliplatin
What the non-medicinal ingredients are
Water for injection
What dosage form it comes in
Oxaliplatin Injection, USP 5 mg / mL is available as follow s: 50 mg / 10 mL vial – cartons of 1, 100 mg / 20 mL vial – cartons of 1, 200 mg / 40 mL vial – cartons of 1.
Warnings and precautions
Oxaliplatin Injection, USP should be given under the supervision of a doctor experienced in the use of anticancer drugs.
Oxaliplatin Injection, USP 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 Injection, USP may also cause the follow ing adverse effects, w hich may be life-threatening: irregular heartbeats; intestinal ulcers, bleeding or perforation (a hole in the intestine w all) or a decrease in blood flow to the intestines; muscular adverse effects.
BEFORE your Oxaliplatin injection, USP administration, talk to your doctor if you:
- Have ever had any unusual or allergic reaction to oxaliplatin or other medications or to platinum containing compounds
- Are taking any medicine
- Have not taken your premedication as directed
- Have a kidney disease
- Have a heart disease called “QT prolongation”
- Have recently received or plan to receive any vaccines
- Are or are planning to become pregnant. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant w hile using the medicine, tell your doctor right aw ay. Men should be advised not to father a child w hile receiving treatment w ith oxaliplatin and up to 6 months thereafter
- Are breast-feeding
Your doctor w ill need to check your blood at regular visits w hile you are using this medicine.
Nerves changes (neuropathy) can occur w ith oxaliplatin (see the section Side Effect and What to Do About Them). 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 w hen exposed to cold air. Do not take things from the freezer or refrigerator w ithout w earing gloves. Do not run the air conditioner at high levels in the house or in the car in hot w eather
Driving and operate machinery
Oxaliplatin 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 may interact w ith w arfarin (a drug that reduces clot formation in the blood).
Before using any prescription, over-the-counter medicines or herbal products, check w ith your doctor, your pharmacist or your nurse.
Proper use of this medication
Usual Dose:
Every patient is different; your doctor w ill determine w hat dose of oxaliplatin is right for you and how often you should receive it.
Oxaliplatin is an injectable medication that is given by intravenous infusion (injected slow ly in a vein) every 2 w eeks in combination w ith leucovorin and 5-fluorouracil (5-FU).
The administration of oxaliplatin 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 w ill tell you exactly w hat 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 treatment. Be sure to keep all appointments.
Overdose:
In case of overdose, you may experience increased side effects.
Missed Dose
This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor for instructions.
Side effects and what to do about them
Like many chemotherapy drugs, oxaliplatin may have side effects.
Most of the side effects that occur w ith oxaliplatin are manageable. Occasionally, it is necessary to stop the treatment
Common Side Effects
- Nausea, diarrhea, vomiting, change in taste
- Fatigue
- Stomatitis: sores in the mouth
- Pain at the injection site
- Pain in a joint
- Nose bleeding
- Respiratory problems
- Hiccups
- High blood pressure
- Neuropathy: nerve changes that can cause tingling or numbness in the extremities, muscle w eakness 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 (see the section Warnings and Precautions). A less common symptom of neuropathy is pharyngolaryngeal dysesthesia. This is the sensation of tightness or discomfort in the throat, making it seem difficult to breathe or sw allow .
Although this symptom may be frightening, it is just a sensation and does not really interfere w ith breathing. The sensation usually goes aw ay on its ow n after a few minutes.
Some people may experience more debilitating symptoms of neuropathy, w hich may interfere w ith daily activities such as the follow ing:
- Writing
- Buttoning clothes
- Sw allow ing
- Difficulty w alking
- Picking up things
Many of these neuropathy symptoms are temporary. How ever, they may continue long term.
- Neutropenia: a low er-than-normal number of neutrophils, a type of w hite blood cells. Your w hite blood cells protect your body against infection. So, if you have neutropenia, you are at higher risk of having an infection, w hich can be lifethreatening. How ever, most people receiving oxaliplatin do not develop infections, even w hen they have neutropenia.
- Thrombocytopenia: a low er-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 low er-than-normal number of red blood cells. As a result, people w ith anemia may feel tired.
Your doctor w ill be checking routinely your blood count and w ill alert you if your platelets, w hite 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 w ith your doctor if you have these symptoms.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Uncommon | |||
| Persistent vomiting or diarrhea | ✔ | ||
| Persistent cough | ✔ | ||
| Fever or signs of infection, like redness or sw elling at the injection site, a cough that brings up mucus, or a sore throat | ✔ | ||
| Allergic reactions such as trouble breathing, tightness in the throat, rash, hives, or sw elling of the lips or tongue | ✔ | ||
| Neuropathy symptoms interfering w ith daily activities | ✔ | ||
| Symptoms such as headache, altered mental functioning, seizures and abnormal vision from blurriness to vision loss | ✔ | ||
| Unknown frequency | |||
| Kidney failure (w ith symptoms such as: difficulty breathing, w eakness, tiredness, decreased urinary volume), small purple-red marks on the skin or other parts of the body. Kidney failure may be not reversible w ith discontinuation of therapy and dialysis may be required. | ✔ | ||
| Irregular heartbeat, dizziness or fainting | ✔ | ||
| Muscle pain and sw elling, w ith w eakness, fever and darkened urine | ✔ | ||
| Stomach pain, nausea, vomiting, black or red-coloured stools | ✔ | ||
| Disseminated intravascular coagulation (w hich may be lifethreatening), w ith symptoms such as: bleeding in urine or stools, small red or brow n bruises that happen easily, pain and sw elling in the low er leg, or chest pain and shortness of breath. | ✔ | ||
| Neuritis (inflammation of nerves) | ✔ | ||
| Focal nodular hyperplasia (noncancerous tumor of the liver) w ith symtoms such as recent or chronic abdominal pain or discomfort, noticeable mass, w eight loss, w eakness, and fever) | ✔ | ||
This is not a complete list of severe side effects. For any unexpected effects while taking Oxaliplatin Injection, USP, contact your doctor or pharmacist immediately.
How to store
Protect from light. Keep in original outer carton
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://w ww.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about Oxaliplatin Injection, USP:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this consumer information by visiting the Health Canada w ebsite (https://health-products.canada.ca/dpd-bdpp/indexeng.jsp); the manufacturer’s w ebsite (https://w ww.fresenius-kabi.ca), or by calling 1-877-821- 7724
This leaflet w as prepared by
Fresenius Kabi Canada Ltd.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
Last Revised: August 16, 2021